Date: Monday, May 27, 2019 5:05:02 PM
   
01. General Study Information

 

All questions marked with a red asterisk (*) require a response. Questions without a red asterisk may or may not require a response, depending on those questions' applicability to this study.

 

 
1.1*  Study Title:
 
Understanding Program Structure Representation via fNIRS
 
 
 
1.1.1  Full Study Title:
 
Toward Understanding Program Structure Representation via Functional Near-Infrared Spectroscopy
 
 
 

1.1.2  If there are other U-M studies related to this project, enter the eResearch ID number (HUM#) or IRBMED Legacy study number. Examples of related projects include, but are not limited to:

  • Projects funded under the same grant
  • IRBMED Legacy study being migrated into eResearch
  • Previously approved Umbrella applications (such as Center Grants or approvals for release of funding)
  • Previously approved projects for which this is a follow up study
 
 
 
1.2*  Principal Investigator:
 
Westley Weimer  
Note: If the user is not in the system, you may Create A New User Account... 
 
 
 
1.3  Study Team Members:
 
Study Team MemberStudy Team RoleAppointment DeptAppointment Selection Complete?StudentFriend AccountCOI Review RequiredEdit RightsAccepted Role?PEERRS Human Subjects?
Westley WeimerPIEECS - CSE DivisionYesnoNonoyesN/Ayes
Xiaosu HuCo-InvestigatorUMOR Center Human Growth & DevYesnoNonoyesYesyes
Yu HuangCo-InvestigatorEECS - CSE DivisionYesyesNonoyesYesyes
Jessica KimCo-InvestigatorUMOR Center Human Growth & DevYesnoNonoyesYesyes
Ioulia KovelmanCo-InvestigatorLSA PsychologyYesnoNonoyesYesyes
Kevin LeachCo-InvestigatorEECS - CSE DivisionYesnoNonoyesYesyes
Xinyu LiuCo-InvestigatorLSA MathematicsYesyesNonoyesYesyes
Tyler SantanderOther N/AnoYesnoyesYesyes

 
 
 
1.8*  Project Summary:
 
Computer programs are developed using highly structured programming
languages that tell the computer what to do. Program representation
refers to the way the language is used to create order and structure
within the program. For example, banking software may represent an
individual account with a sequence of numbers referring to credits and
debits over time. This program representation is often a design
decision made by one or more software developers. Skilled software
developers internalize a number of common structures used to realize
large computer programs. While many studies have addressed best
practices for code review, style, and software architecture, very few
have approached understanding cognitive processes involved in software
development. This study proposes using functional near-infrared
spectroscopy (fNIRS) to measure those cognitive processes.

We believe that understanding the correlation between manipulation
program representation and related tasks will inform the software
engineering community about how to better assess or train individuals
who write software. This study will ask participants to read code and
look at program representations and perform mental rotation tasks while
wearing an fNIRS cap to measure these correlations.

Secondly, this study will compare manipulating program representation to
mental rotation. Participants will be shown several
three-dimensional objects and asked if one can be rotated to match
another. Many previous studies in the psychology literature demonstrate
a clear relationship between the amount of rotation required to match
rotated objects and the time taken to respond to the query.

In this study, participants will answer a pre-questionnarie and complete
a training session. Then, they will spend approximately 70 minutes
wearing an fNIRS cap rotating between the program representation
manipulation and mental rotation tasks. In the end, they will have a conversation-based post questionnaire with the study investigator about how they get the decision for some sample questions they encountered.

The data generated will be used to find correlations between tasks. We
hypothesize that cognitive processes involved in program representation
will be similar to mental rotation tasks. The similarities between
these tasks will help the software engineering community to improve
training for individuals involved in software development.
 
 
Additional Help
1.9*  Select the appropriate IRB:
 
Health Sciences and Behavioral Sciences
 
 
 
 
1.10*  Estimated Study Start Date (Not required for IRBMED): (mm/dd/yyyy)
 
2/1/2018 
 
 
 
 
1.11*  Estimated Duration of Study:
 
90 minutes per participant, multiple participants over the course of 12 weeks.
 
 
 
 

01-1. Application Type

 
1-1.1* Select the appropriate application type.
 


  Application Type Description
Human Subjects research involving interaction or intervention (formerly Standard, non-exempt research project - or - Exempt) Studies that involve either or both of the following:
  • Interaction, including communication or interpersonal contact between investigator and subject
  • Intervention, including both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or subject’s environment that are performed for research purposes
Interaction/Intervention studies may also have a "secondary research" component.
 
Does the research involve any of the following:
  1. more than minimal risk to participants?
  2. use of drugs or medical devices?
  3. target prisoners as research subjects?
  4. collection of biospecimens from subjects (including blood, saliva, cheek swabs)?
  Yes No
 
Secondary research uses of private information or biospecimens "Secondary research" are studies that involve ONLY re-using private information and/or biospecimens that are collected for some other "primary" or "initial" activity, such as other earlier research studies, a biorepository holding specimens obtained with "broad consent," clinical care, or educational records. Includes Exemption 4 and “not regulated” projects.

Do NOT use this application type for:
  • Studies that also have an interaction/intervention component, such as primary collection of information or biospecimens for the purposes of the study. (Choose instead "Human subjects research involving interaction or intervention.")
  • Projects involving secondary use of information/biospecimens for only non- research purposes, such as QA/QI, case studies on one or two individuals, or use in a class to teach research methods. (Choose instead "Activities not regulated as human subjects research.")
Activities Not Regulated as human subjects research Not all activities that involve people, their data, or specimens are covered by the regulations governing human subjects research (45 CFR 46 or 21 CFR 50/56).

IRB review is required for the following activities ONLY to assess compliance with HIPAA or other regulations or institutional policies:
  • Research on existing data or specimens that have been coded before the researcher receives them, but identifiers still exist.
  • Research Involving Deceased Individuals Only
  • Pre-review of Clinical Data Sets Preparatory to Research
  • Standard Public Health Surveillance or Prevention Activities
IRB review is not required for the following activities, but researchers may wish complete this brief application to generate a determination letter for funding or publication purposes, or to request IRB review to confirm the “Not Regulated” determination:
  • Case Studies
  • Class Activities
  • Journalism/Documentary Activities
  • Oral History
  • Quality Assurance and Quality Improvement Activities
  • Research on Organizations
  • Research using Publicly Available Data Sets
Projects lacking immediate plans for involvement of human subjects, their data, and/or their specimens Activities such as training grants, program projects, center grants, or multi-phase studies not involving human subjects until later years. Before release of funding, some agencies may require IRB acknowledgement of the future use of human subjects.

These projects are sometimes referred to as "umbrella projects" or "dry applications."
Single-patient Expanded Access Drug or Biologic (Emergency Use or Non-Emergency/Compassionate Use) Use of an investigational drug or biologic, outside of a clinical trial, under a single-patient IND issued by the FDA for a patient faced with a serious or life-threatening disease or condition.
  • Contact the IRB Chair-on-Call as soon as possible once the decision to use the investigational drug or biologic is made.
  • Submission for IRB review and approval is required, prior to use if feasible. If this was an emergency use, submit no later than five days after use of the investigational agent.
  • This includes both one-time use and continuing therapy.
Single-patient Expanded Access Device Use (Emergency Use or Non-Emergency/Compassionate Use) Use of an investigational device, outside of a clinical trial, when this is the only option available for a patient faced with a serious or life-threatening disease or condition.
  • Contact the IRB Chair-on-Call as soon as possible once the decision to use the investigational device is made.
  • Submission for IRB review and approval is required, prior to device use if feasible. If this was an emergency use, submit no later than five days after use of the investigational device.
  • This includes both one-time use and continuing therapy.
Humanitarian Use Device (HUD) under a HDE Non-research, on-label use of an HUD under a Humanitarian Device Exemption (HDE)
Requesting Review by a Non-UM IRB Use ONLY to request deferral of IRB oversight for UM activities to a non-UM IRB.
Multi-site Research where U-M is a Coordinating Center and/or IRB of Record Do not use Multi-site Research application type when U-M is only a performance site - select Standard application type.

Select when U-M is any of the following:

  • Data Coordinating Center;
  • Clinical Coordinating Center; or
  • IRB of Record for non-U-M sites (for U-M to be IRB of Record you must contact your IRB for prior acknowledgement).
When U-M is also a performance site, a separate application is required for local site considerations.
Refer to special requirements at the IRB website.
 
 
 
 
 
01-2. Standard Study Information

 

 
1-2.1*  Who initiated this study?
 
Investigator


 
 
 
1-2.2*  Are you or any students working on this project being paid from a federally funded training grant?
 
  Yes No
 
 
 
1-2.3  This study is currently associated with the following department.  To associate this research with a different department, click Select. If the department has defaulted to "student", click select to specify the department through which this application is being submitted. 
 
CoE Electrical & Computer Sci
 
 
 
 
1-2.5*  Is the study related to cancer, cancer risk, or cancer care delivery?
 
  Yes No
 
 
 
 
1-2.7*  Has the scientific merit of this study already been peer reviewed (i.e., reviewed by one or more recognized authorities on the subject)?
 
  Yes No
 
 
 
 
1-2.8*  Is this a clinical trial?
 
  Yes No
 
 
 
Study Team Detail

 

 
1.4  Team Member:
 
Westley Weimer
   
Preferred email: weimerw@umich.edu
Business phone 734-615-9916
Business address: EECS/CSE 4636 Beyster 48109-2121

 
 
 
 
1.5  Function with respect to project:
 
PI
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  Westley Weimer Full CV0.01
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
 
C1  Do you, your spouse, domestic partner, or dependents have any outside interests or relationships to companies or entities related to this research that the IRB should consider?
Examples of outside interests include, but are not limited to the following:
  • receiving compensation whose value could be affected by the study outcome
  • IN THE AGGREGATE, expecting to receive compensation from the sponsor of the research of $10,000 or greater in the next year
  • having a proprietary interest in the sponsor of the research or a product tested by this research including but not limited to, a patent, trademark, copyright, or licensing agreement, or the right to receive royalties from product commercialization
  • individually or collectively, having an ownership interest (equity or stock options) in the sponsor of the research or product being tested whose value cannot be readily determined through reference to public prices
  • individually or collectively, having an ownership interest (equity or stock options) in a company or product whose value could be affected by the study outcome
  • IN THE AGGREGATE, having an ownership interest (equity or stock options) in the sponsor of the research that exceeds $10,000 or 1% when the sponsor is a publicly traded entity
  • receiving significant payments of other sorts with an aggregate value of $10,000 or more (or payment of ANY amount to medical school or hospital employees) made directly by the sponsor of this research for unrestricted research or education, equipment, consultancy, or honorarium
  • holding a position of management or leadership in company or entity related to this research including, but not limited to, officer, director, or member of an advisory board.
  • providing consulting services or serve on a Speaker’s Bureau, either paid or unpaid, to the financial or non-financial sponsor of this study
  • when the sponsor is a publicly traded entity, having any ownership interest (equity or stock options) in the sponsor
  • expecting to receive any loans, educational support, contributions of in-kind for equipment, or any other non-compensatory payment from the sponsor of the research in the next year
 
 
 
C2  Please provide a detailed description of the outside interest in the box below.
 
 
 
 
C2.1  Where have you submitted a disclosure of this outside interest?
 
 
 
 
C2.2  Has a management plan been formalized?
 
 
 
 
C2.2.1  Click the View Management Plan in M-Inform button below to see your management plan for this study.
 
 
 
 
 
C2.2.2  If no, describe the financial interest in sufficient detail to permit the COI Ancillary Committee and the IRB to determine if such involvement represents a potential conflict-of-interest and/or should be disclosed to potential research subjects in the informed consent form.
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Xiaosu Hu
   
Preferred email: xiaosuhu@umich.edu
Business phone 734-615-9390
Business address: DENT Biologic & Material Sciences MBNI 201 Zina Pitcher Pl 48109-5720

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
   Hu_CV.pdf0.07
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Yu Huang
   
Preferred email: yhhy@umich.edu
Business phone 734-647-4255
Business address: EECS - CSE Division 3709 Beyster 48109-2121

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  resume.pdf0.01
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Jessica Kim
   
Preferred email: jessjkim@umich.edu
Business phone 734-647-3712
Business address: LSA Psychology B242 East Hall 48109-1043

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  Resume0.01
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Ioulia Kovelman
   
Preferred email: kovelman@umich.edu
Business phone 734-647-3712
Business address: RCGD-Rsrch Cntr for Grp Dyn 5006 ISR-Thompson 48104-1248

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
   Kovelman CV0.08
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Kevin Leach
   
Preferred email: kjleach@umich.edu
Business phone 734-926-2495
Business address: CSE 2909 Beyster 48109-2121

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  kleach-resume.pdf0.01
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Xinyu Liu
   
Preferred email: xinyuliu@umich.edu
Business phone
Business address: 48109

 
 
 
 
1.5  Function with respect to project:
 
Co-Investigator
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
Yes
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  xinyu liu resume.pdf0.01
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
Study Team Detail

 

 
1.4  Team Member:
 
Tyler Santander
   
Preferred email: t.santander@psych.ucsb.edu
Business phone
Business address: Dept. of Psychological & Brain Sciences 93106

 
 
 
 
1.5  Function with respect to project:
 
Other
 
 
 
1.6  Allow this person to EDIT the application, including any supporting documents/stipulations requested during the review process:
 
Yes
 
 
 
1.7  Include this person on all correspondences regarding this application: (Note: This will include all committee correspondence, decision outcomes, renewal notices, and adverse event submissions.)
 
No
 
 
 
Credentials: Required for PI, Co-Is and Faculty Advisors
 
 
 
 
 
Upload or update your CV, resume, or biographical sketch.
 
NameVersion
  SantanderTyler_2019CV.pdf0.02
 
 
 
 

Financial Interest Screening Questions for Study Team Members Not Affiliated with the University of Michigan:  Required for all roles except Administrative Staff  

Below, you be asked several questions intended to identify Financial Interests and relationships that may be relevant to THIS RESEARCH.  These may include Intellectual Property Interests (IP interests), as well as relationships with entities whose interests may affect/be affected by this research.  If relevant to this research, you should also consider companies that compete commercially with the research sponsor or the manufacturer of the study drug, device or other investigational item if you know that the competitor's Financial Interests would reasonably appear to be affected by this research.

In relation to THIS RESEARCH, for the past 12 months, do you or your Family member (your spouse, domestic partner, or dependent) have or anticipate having any of the following Financial Interests:
 
 
 
 
 

F1.  Are any activities or relationships with an entity, whether paid or unpaid, where that entity's financial interests could be affected by this research?  Examples include service on a board of directors, service on a scientific advisory board, consultant, officer, manager, or partner.

 
No
 
 
 
 
F2.  An Equity Interest in any publicly traded or privately owned entity whose financial interests could be affected by this research, including but not limited to shares of stock or stock options?  DO NOT include equity held in a mutual, pension, or investment fund over which you have no control with regard to investment decisions.

 
No
 
 
 
 
F3.  An investorship or ownership interest in any Intellectual Property (IP) that is being tested, evaluated, developed in, or its commercial value will be affected by this research?  This includes IP that is the subject of a copyright, issued patent or a patent application (regardless of whether it has been licensed or optioned). 
 
No
 
 
 
F4.  Any payments over $5,000 (USD) received for the past 12 months (apart from any payments from the University of Michigan), including salary, honoraria, fees, or other forms of compensation or anything of value, from any entity that has a financial interest in this research?
 
No
 
 
 

F5.  If any of the above is answered "yes", you must complete this form and upload the completed form below.
 
 
 
 
 
 
 
  Conflict of Interest Detail:  Required for all roles except Administrative Staff  
 
 
 
 
 
   
 
02. Sponsor/Support Information

 

The following sections request details about the current or pending sponsorship/support of this study. Consider all of the choices below and complete the appropriate sections.
* Note: At least one of the following sections must be answered. Multiple forms of funding or support must be added one at a time.

 

 
2.1  Please select all Proposal Approval Forms (PAFs), Awards (AWDs), and/or Unfunded Agreements (UFAs) associated with this study. 
 
Click here to indicate that a PAF(s) has not been initiated.


IDTitlePIDirect SponsorPrime SponsorStateHas SUBKs?Related Awards
There are no items to display


Award IDTitlePIDirect SponsorPrime SponsorStateHas SUBKs?Project PeriodAwarded PAFs
There are no items to display


UFA IDTitlePIStateCategoryStart DateEnd Date
There are no items to display
 
 
 
 
2.1.1* Indicate the specific name of the financial sponsor for the clinical research study.
Note: For institutionally sponsored trials or studies, list the name of the applicable funding agencies.
 
 
 
 
 
 
 
2.2  Internal UM Sponsor(s)/Support: [Including department or PI discretionary funding]
 
 TypeDepartment SponsorSupport Type
ViewPI Discretionary FundsEECS - CSEFinancial
 
 
 
 
2.3  Check here if the proposed study does not require external or internal sponsorship or support:
 
 
 
 
 
2.4* Is there any other financial or non-financial sponsorship or support not covered in the sections above?
 
  Yes No 
 
 
 
Internal Sponsor Detail

 

 
2.2.1*  Department Sponsor/Support:
 
EECS - CSE
 
 
 
 
2.2.2*  Sponsor Type:
 
PI Discretionary Funds


If other, please specify:
 
 
 
 
2.2.3*  Support Type:
 
Financial
 
 
 
 
2.2.4*  Is the support confirmed?
 
  Yes No
 
 
 
 
2.2.5* Please describe the award/support:
 
Startup funding for PI Weimer's research group.
 
 
Additional Help
 
2.2.6  Upload Supporting Documentation
 
NameVersion
  funding-support.pdf0.01
 
 
 
03. UM Study Functions

 
3.1*  Indicate all functions that will be performed at University of Michigan locations.

Select all that apply:
Recruitment (including screening)
Interaction (e.g., information gathering, survey, interview, focus groups, etc.)
Intervention (e.g., use of drug or device, medical procedures, educational intervention, group intervention, social/psychological intervention etc.)
Observation of behavior (direct or indirect)
Qualitative research (e.g., 'member checking', open-ended questions, etc.)
Primary or secondary analysis (data/specimen)
Storage (data and/or specimen): Responsible for the management, security and transfer of study data and/or specimens.

If other, please specify.

  

If University of Michigan will be performing coordinating center activities, contact your IRB prior to
continuing to ensure you have chosen the appropriate application type for your project.
 
3.1.1*  As the Operations, Coordinating or Lead Center describe the mechanisms in place to ensure that management, data analysis, and Data Safety and Monitoring systems are adequate for each site.

 
3.1.2*  Describe the plan for communicating interim results (e.g. adverse events, unanticipated events or interim data):

 
3.1.3*  Describe the plan for communicating any protocol modification by the site(s):

 
 
 
3.2*  Will U-M be the IRB of Record?
An IRB is considered the IRB of Record when it assumes IRB responsibilities for another institution.
  Yes No
  
 
03-1. Performance Sites

 
3-1.1*  Performance Sites:
LocationCountry"Engaged" in the research?Performance Site TypeSite Function
University of MichiganUSAyes Qualitative research,Intervention,Storage,Interaction,Analysis,Observation,Recruitment
 
 
  
Additional Help
Performance Site Detail

 
3-1.2*  Location or Institution:
University of Michigan
  
3-1.3  Address:
City
State
Country* USA
 
3-1.4*  Function of this location with respect to this study:
Select all that apply:
Recruitment (including screening)
Interaction (e.g., information gathering, survey, interview, focus groups, etc.)
Intervention (e.g., use of drug or device, medical procedures, educational intervention, group intervention, social/psychological intervention etc.)
Observation of behavior (direct or indirect)
Qualitative research (e.g., 'member checking', open-ended questions, etc.)
Primary or secondary analysis (data/specimen)
Storage (data and/or specimen): Responsible for the management, security and transfer of study data and/or specimens.


If other, please specify:

  
3-1.5*  Will this site be "engaged" in the conduct of the research?
  Yes No
  
Additional Help
3-1.6  If known, provide the Federalwide Assurance (FWA) number for this location.
FWA00004969
  
3-1.7  If applicable, indicate what organization, agency or government office has reviewed this research and provided its approval (e.g., IRB, ethics committee, school district office, prison official, nursing home administrator).
 
3-1.8  Upload any location site approval documentation here:
NameVersion
There are no items to display
 
05. Research Design

 

 
5.1*  Is there a stand-alone scientific protocol document and/or research plan associated with this application?
 
  Yes No
 
 
 
 
5.1.1*  Click ADD to attach the document(s) electronically.
 
 
NameVersion
There are no items to display
 
 
 
5.1.2*  Indicate the section where each of the following are covered in the attached protocol:
 
Objective   We seek to study the cognitive processes and neural representation
associated with completing data structure manipulation tasks typical in
the software engineering discipline. We also seek to investigate
differences in neural representation between manipulating data
structures and performing mental rotation tasks.
Specific Aim/Hypothesis   We hypothesize that neural representation is similar whether a human is
performing data structure manipulation or mental rotation tasks.
Background Information   The process of designing software, called software engineering, involves
several stages. While many models exist for this process, most of them
contain the same ore phases: requirements specification, software
design, implementation, verification, and maintenance. Briefly,
requirements specifications describes the process of deciding how to
software is supposed to behave. Then, based upon these requirements, a
number of design decisions are made for the software system in the
software design stage. Implementation describes the time actually coding
the software system. In the verification stage, software is tested to
ensure that it adheres to its specifications. After the software is
sufficiently tested, it is deployed for use. Finally, the maintenance
stage describes the ongoing process of repairing the software when a
defect is found and supporting the users of the software.

These stages all take time, though software maintenance is by far the
most time-consuming aspect of software development This stems from a
number of reasons, but primarily from the fact that it is much more
difficult to repair a defect after the development stage. This could be
true because the software engineers are less familiar with the code as
time goes by, or because making a change to repair a defect can affect
other parts of the software the were built on top of the defect.
Regardless of cause, it has been empirically demonstrated that the
majority of software costs come from this maintenance process. As a
result, software companies are eager to deploy any solution that will
decrease the time spent in maintenance.

One common approach to reducing time spent maintaining software is to
make fewer mistakes in the initial implementation process. Implementing
software frequently involves the design and manipulation of data
structures, which are used to represent data within the program. For
example, banking software may represent individual accounts as a
sequence of numbers corresponding to debits and credits over time. Such
a sequence could be stored in a list within the banking software.
Unfortunately, structures can become quite complicated in production
software. As a result, structures that are too complex for developers to
manipulate mentally may cause implementation errors leading to buggy
software and expensive maintenance. Thus, understanding how humans
think about data structures is critical to reducing errors introduced by
structures that are overly complex or by developers who fail to
completely understand structures in large codebases.

To our knowledge, only two previous studies have considered looking at the
cognitive processes involved in coding, and both used fMRI rather than fNIRS.
Understanding understanding source code with functional magnetic imaging was
published in the International Conference on Software Engineering in 2014. In
this study, the cognitive processes involved in the act of code comprehension -
reading and understanding code - are measured in an fMRI. The results of this
experiment support the aforementioned claim: reading code is very similar to
reading any other natural language. While this study intrigued many researchers
in the software engineering community, it did not carry any opportunity for
impacting the practices of the field. The other study, Decoding the
representation of code in the brain: An fMRI study of code review and
expertise, was published in ICSE in 2017 and received a distinguished paper
award. This study investigated the neural activity involved in code
comprehension and prose review, ultimately finding a distinction between the
two tasks. Our study aims to apply many of the same techniques, but learn about
a process that is used very commonly in the software engineering field. It is
our hope that the results will be both intriguing and impactful to real
software companies and institutions.
Methodology   1. Recruitment
Graduate students, undergraduate students, professors, and any adult who
has the fundamental knowledge of data structure(equivalent to EECS280
and EECS281 in the university of Michigan) would all be considered
eligible.

We use three ways to advertise this study:
(i) In-class advertisement
Participants will be identified by their presence in various Computer
science venues (classes,etc.). We target the EECS 300 and 400 level
classes and labs. We will give a short presentation about our study.

To prevent concerns of coercion, we will take the following steps (PI
Weimer's class also follows the same steps):

1) The instructor will not advertise or be involved in the selection or
recruitment of participants. Instead, Research Fellow Kevin Leach, Graduate
Student Yu Huang and/or undergrad Xinyu Liu will adversie the study and recruit
participants. In any of the classes, if the investigator is the instructor or teaching assistant of the class, they will be excluded from the advertisement and selection of participants correspondingly in the class. In any class, we do not do real-time recruitment. The recruitment will only be done through emails offline.


2) We will make it very clear in the presentation that students will not
be given extra credit. The participation is not relavant to their course
grade at all.

3) The recruitment is completely out of the calss through emails. The
instructor has no access to the participation information.


(ii) Email advertisement
We will send an advertisement email to the computer science mailing
list. In the email, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and
recruitment contact information(Graduate Yu Huang's email).

(iii) Flyers
We will put flyer in the EECS hallway, Beyster Hallway, and pirepont
commons hallway to advertise the study. On the flyer, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and the
recruitment contact information(Graduate Yu Huang's email).

Participants will be recruited through emails: contact the
study team by emailing Graduate Yu huang
their intention. Then, we will arrange an experiment time and email the
participant the time and location of the experiment. The email will be
sent to the participant within 3 days after they inform us their
intention of participation.



2. Consent Process
Through recruitment (as introduced in the recruitment), every participant is scheduled with an appointment.
They will complete the experiment in the fNIRS lab of the University of
Michigan assisted with the study investigators. Before the experiment,
the participant needs to read through the consent form and sign it to
confirm their wills of participation.

3. Description of the experiment
1)The participant will finish a short questionnaire (about 2
minutes) to record information like gender, sex, year in school,
programming language experience. In the questionnaire, a uniq ID is assigned to each participant. that unique ID (not identifiable) will also be used to name the fNIRS data file. So the fNIRS data is connected with the participant.

2)The study investigators will fit the fNIRS cap on the
participant's head. At the same time, the participant will be shown a
training video(20 minutes) which introduces the organization of the
experiment and overviews the terminology and relevant data structure
knowledge used in the experiment.

3)After the training video, the experiment will be conducted on the
computer in the lab. The experiment includes questions on data structure
program tasks and 3D mental rotation tasks. All the mental rotation
tasks are from a publicly published library. Each task lasts for no
longer than 30 seconds. Between the data structure tasks and mental
rotation tasks, there will be a 5 minute break. Water and snacks are
served. The experiment will last for about 80 minutes including the training video.

All the experiment tasks are in the attached tasks.pptx file. Every
task is an two-option question. The participant needs to press the
corresponding key of the keyboard to provide the answer.

4)Then the experiment is done. After the experiment, we will ask the
participant with a short questionnaire. The study investigators will
bring up a few of the sample questions in the experiment and ask the
participant to explain their decision. This post questionnaire is
audio-based that will last about 10 minutes In the end, we will give the participant $50 check or cash based on their own option. In total, the entire study for one participant will take about 80 minutes.

If the participant withdraws the study before the experiment is finished, we will still pay the participant $20 cash or check based on their own preference immediately after they stop the experiment.



5) With all the fnirs data we collect, we will employ techniques from graph theory and statistical machine learning to model spatial dependencies across brain regions and use
those to predict (i.e. decode) individual difference factors.



4. security
The email address will be safely stored and there is no identifiable
info of the fNIRS signal data at all. For incentives, we will not
collect anything more that what HSIP requires. For each participant who
completed the study, we will pay a $50 check or cash right after the they complete the experiment. For those who stopped and
did not finish the experiment, we will pay them
$20 check or cash instead. This is done through HSIP.

All the experiment data is stored in a secured university server.
Statistical Design   1) We intend to collect basic information from participants including gender, the year in school, programming language, so that we can determine if differences in gender, sex, programming
language, and levels of experience affect the neural activations
associated with these tasks; and

2) We will employ techniques from graph theory and statistical machine
learning to model spatial dependencies across brain regions and use
those to predict (i.e. decode) individual difference factors.
 
 
 
5.1.3*  Study team Experience: Briefly outline the experience and competence of the study team to pursue the proposed study.
 
PI Weimer has previously conducted IRB-approved fMRI research involving
software engineering tasks while at the University of Virginia.
Research Fellow Kevin Leach and graduate student Yu Huang have both
conducted IRB-approved human studies. All three have published
peer-reviewed publications based upon such human studies.

PI Weimer has extensive experience researching program analysis and
software engineering.

In this study, PI Weimer will supervise the design of the experiment and data analysis, but will not involve in the recruitment of the participants. Research Fellow Kevin Leach, graduate student Yu Huang and undergrad Xinyu Liu will design the experiment with PI Weimer. Yu Huang, Xinyu Liu and Kevin Leach will recruit participants and do the fNIRS experiments with the participants. Xiaosu Hu, Jessica Kim and Ioulia Kovelman are collaborators from Department of Psychology who are running the fNIRS labs. They will help to get the experiment equipment set up and data processing. The data analysis work will be conducted by Kevin Leach, Tyler Santander, Yu Huang, Xinyu Liu under the supervision of PI Weimer, also with the help of Xiaosu Hu, Jessica Kim and Ioulia Kovelman.
 
 
 
 
 
5.2*  Will the involvement of ANY subjects in this study be limited to analysis of their existing data or specimens?
 
  Yes No
 
 
 
 
5.2.1*  How many subjects are represented in the data or specimens to be analyzed?
 
(do not enter commas, dots, or special characters)
 
 
 
 
 
5.3*  Will the study involve recruitment and/or participation of subjects in order to produce new data (e.g., surveys, interaction, intervention)?  [Require sections 8-1 and 11-3]
 
  Yes No
 
 
 
5.4*  List the inclusion and exclusion criteria for this study population and/or data set. (If covered in attached protocol, indicate section)
 
Participants will be excluded if they don't have fundamental computer science data structure knowledge, which is equivalent to EECS 280 and EECS281 in the University of Michigan or if they do not sign the consent form. More details is in the consent form in 10.1
 
 
 
5.5  Identify any racial, ethnic, or gender group(s) that will be specifically excluded from participation in this research study and provide a compelling justification for such exclusion:
 
None.
 
 
 
5.6*  Indicate the age range (in years) of the subject population in this study.
 
Minimum Age:   18
Maximum Age:   65If no upper limit, enter "999"
 
 
 
 
5.7*  Will the study be conducted according to ICH-GCP E6 guidelines? Check the study protocol (especially Signature Page and Ethical Guidelines section) prior to answering this question. If the answer is “yes” – see helptext for details.
 
  Yes No
 
 
 
 
 
 
5.8*  The primary risk of conducting research with secondary data or specimens is a breach of confidentiality or privacy, which may cause psychological, social/reputation, legal, or financial harm. Indicate any risks to subjects other than these risks from a breach of confidentiality or privacy. If there are none, answer “none.”
 
 
 
 
Additional Help
 
 
 
05-1. Research Design
 
In its review of research applications, the IRB considers whether research procedures are consistent with sound research design in order to yield the expected results.  Scientific merit is examined in relationship to the risks and benefits of the research.  This section covers the overall research design of the project.  Later sections will ask more specific questions about benefits, risks, special review considerations, targeted populations, recruitment strategies, and experimental methodologies/procedures.
5-1.1*  Objective: What is the overall purpose of this research study? 
We seek to study the cognitive processes and neural representation
associated with completing data structure manipulation tasks typical in
the software engineering discipline. We also seek to investigate
differences in neural representation between manipulating data
structures and performing mental rotation tasks.
  
5-1.2*  Specific Aim(s): What is (are) the specific aim(s) of this study and/or what hypothesis (hypotheses) is (are) to be tested?
We hypothesize that neural representation is similar whether a human is
performing data structure manipulation or mental rotation tasks.
 
5-1.3*  Background: What prior information or knowledge exists to support the conduct of this study?
The process of designing software, called software engineering, involves
several stages. While many models exist for this process, most of them
contain the same ore phases: requirements specification, software
design, implementation, verification, and maintenance. Briefly,
requirements specifications describes the process of deciding how to
software is supposed to behave. Then, based upon these requirements, a
number of design decisions are made for the software system in the
software design stage. Implementation describes the time actually coding
the software system. In the verification stage, software is tested to
ensure that it adheres to its specifications. After the software is
sufficiently tested, it is deployed for use. Finally, the maintenance
stage describes the ongoing process of repairing the software when a
defect is found and supporting the users of the software.

These stages all take time, though software maintenance is by far the
most time-consuming aspect of software development This stems from a
number of reasons, but primarily from the fact that it is much more
difficult to repair a defect after the development stage. This could be
true because the software engineers are less familiar with the code as
time goes by, or because making a change to repair a defect can affect
other parts of the software the were built on top of the defect.
Regardless of cause, it has been empirically demonstrated that the
majority of software costs come from this maintenance process. As a
result, software companies are eager to deploy any solution that will
decrease the time spent in maintenance.

One common approach to reducing time spent maintaining software is to
make fewer mistakes in the initial implementation process. Implementing
software frequently involves the design and manipulation of data
structures, which are used to represent data within the program. For
example, banking software may represent individual accounts as a
sequence of numbers corresponding to debits and credits over time. Such
a sequence could be stored in a list within the banking software.
Unfortunately, structures can become quite complicated in production
software. As a result, structures that are too complex for developers to
manipulate mentally may cause implementation errors leading to buggy
software and expensive maintenance. Thus, understanding how humans
think about data structures is critical to reducing errors introduced by
structures that are overly complex or by developers who fail to
completely understand structures in large codebases.

To our knowledge, only two previous studies have considered looking at the
cognitive processes involved in coding, and both used fMRI rather than fNIRS.
Understanding understanding source code with functional magnetic imaging was
published in the International Conference on Software Engineering in 2014. In
this study, the cognitive processes involved in the act of code comprehension -
reading and understanding code - are measured in an fMRI. The results of this
experiment support the aforementioned claim: reading code is very similar to
reading any other natural language. While this study intrigued many researchers
in the software engineering community, it did not carry any opportunity for
impacting the practices of the field. The other study, Decoding the
representation of code in the brain: An fMRI study of code review and
expertise, was published in ICSE in 2017 and received a distinguished paper
award. This study investigated the neural activity involved in code
comprehension and prose review, ultimately finding a distinction between the
two tasks. Our study aims to apply many of the same techniques, but learn about
a process that is used very commonly in the software engineering field. It is
our hope that the results will be both intriguing and impactful to real
software companies and institutions.
  
5-1.4*  Briefly outline the special expertise and qualifications of the PI, Co-Investigators, and/or Faculty Advisors to conduct and/or oversee the particular procedures or activities involved in this particular study.  This will supplement information provided in the study team CVs.
PI Weimer has previously conducted IRB-approved fMRI research involving
software engineering tasks while at the University of Virginia.
Research Fellow Kevin Leach and graduate student Yu Huang have both
conducted IRB-approved human studies. All three have published
peer-reviewed publications based upon such human studies.

PI Weimer has extensive experience researching program analysis and
software engineering.

In this study, PI Weimer will supervise the design of the experiment and data analysis, but will not involve in the recruitment of the participants. Research Fellow Kevin Leach, graduate student Yu Huang and undergrad Xinyu Liu will design the experiment with PI Weimer. Yu Huang, Xinyu Liu and Kevin Leach will recruit participants and do the fNIRS experiments with the participants. Xiaosu Hu, Jessica Kim and Ioulia Kovelman are collaborators from Department of Psychology who are running the fNIRS labs. They will help to get the experiment equipment set up and data processing. The data analysis work will be conducted by Kevin Leach, Tyler Santander, Yu Huang, Xinyu Liu under the supervision of PI Weimer, also with the help of Xiaosu Hu, Jessica Kim and Ioulia Kovelman.

  
5-1.5*  Methodology: Describe the design and procedures to be used to accomplish the specific aims of the study. Describe the advantages of any innovative methodologies. 
1. Recruitment
Graduate students, undergraduate students, professors, and any adult who
has the fundamental knowledge of data structure(equivalent to EECS280
and EECS281 in the university of Michigan) would all be considered
eligible.

We use three ways to advertise this study:
(i) In-class advertisement
Participants will be identified by their presence in various Computer
science venues (classes,etc.). We target the EECS 300 and 400 level
classes and labs. We will give a short presentation about our study.

To prevent concerns of coercion, we will take the following steps (PI
Weimer's class also follows the same steps):

1) The instructor will not advertise or be involved in the selection or
recruitment of participants. Instead, Research Fellow Kevin Leach, Graduate
Student Yu Huang and/or undergrad Xinyu Liu will adversie the study and recruit
participants. In any of the classes, if the investigator is the instructor or teaching assistant of the class, they will be excluded from the advertisement and selection of participants correspondingly in the class. In any class, we do not do real-time recruitment. The recruitment will only be done through emails offline.


2) We will make it very clear in the presentation that students will not
be given extra credit. The participation is not relavant to their course
grade at all.

3) The recruitment is completely out of the calss through emails. The
instructor has no access to the participation information.


(ii) Email advertisement
We will send an advertisement email to the computer science mailing
list. In the email, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and
recruitment contact information(Graduate Yu Huang's email).

(iii) Flyers
We will put flyer in the EECS hallway, Beyster Hallway, and pirepont
commons hallway to advertise the study. On the flyer, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and the
recruitment contact information(Graduate Yu Huang's email).

Participants will be recruited through emails: contact the
study team by emailing Graduate Yu huang
their intention. Then, we will arrange an experiment time and email the
participant the time and location of the experiment. The email will be
sent to the participant within 3 days after they inform us their
intention of participation.



2. Consent Process
Through recruitment (as introduced in the recruitment), every participant is scheduled with an appointment.
They will complete the experiment in the fNIRS lab of the University of
Michigan assisted with the study investigators. Before the experiment,
the participant needs to read through the consent form and sign it to
confirm their wills of participation.

3. Description of the experiment
1)The participant will finish a short questionnaire (about 2
minutes) to record information like gender, sex, year in school,
programming language experience. In the questionnaire, a uniq ID is assigned to each participant. that unique ID (not identifiable) will also be used to name the fNIRS data file. So the fNIRS data is connected with the participant.

2)The study investigators will fit the fNIRS cap on the
participant's head. At the same time, the participant will be shown a
training video(20 minutes) which introduces the organization of the
experiment and overviews the terminology and relevant data structure
knowledge used in the experiment.

3)After the training video, the experiment will be conducted on the
computer in the lab. The experiment includes questions on data structure
program tasks and 3D mental rotation tasks. All the mental rotation
tasks are from a publicly published library. Each task lasts for no
longer than 30 seconds. Between the data structure tasks and mental
rotation tasks, there will be a 5 minute break. Water and snacks are
served. The experiment will last for about 80 minutes including the training video.

All the experiment tasks are in the attached tasks.pptx file. Every
task is an two-option question. The participant needs to press the
corresponding key of the keyboard to provide the answer.

4)Then the experiment is done. After the experiment, we will ask the
participant with a short questionnaire. The study investigators will
bring up a few of the sample questions in the experiment and ask the
participant to explain their decision. This post questionnaire is
audio-based that will last about 10 minutes In the end, we will give the participant $50 check or cash based on their own option. In total, the entire study for one participant will take about 80 minutes.

If the participant withdraws the study before the experiment is finished, we will still pay the participant $20 cash or check based on their own preference immediately after they stop the experiment.



5) With all the fnirs data we collect, we will employ techniques from graph theory and statistical machine learning to model spatial dependencies across brain regions and use
those to predict (i.e. decode) individual difference factors.



4. security
The email address will be safely stored and there is no identifiable
info of the fNIRS signal data at all. For incentives, we will not
collect anything more that what HSIP requires. For each participant who
completed the study, we will pay a $50 check or cash right after the they complete the experiment. For those who stopped and
did not finish the experiment, we will pay them
$20 check or cash instead. This is done through HSIP.

All the experiment data is stored in a secured university server.



  
5-1.6*  Statistical Design: Describe the statistical design of the research study, including methods used to analyze data.
1) We intend to collect basic information from participants including gender, the year in school, programming language, so that we can determine if differences in gender, sex, programming
language, and levels of experience affect the neural activations
associated with these tasks; and

2) We will employ techniques from graph theory and statistical machine
learning to model spatial dependencies across brain regions and use
those to predict (i.e. decode) individual difference factors.
  
06. Benefits and Risks
 
6.1 *  Describe the potential benefits of this research to society.
There are no direct health benefits to the participants. The primary
benefits of the study are best realized at the societal and scientific
levels. The data gained from this study, along with the conclusions
drawn from it, will help shape and improve the software engineering
skills through improvements in training and the education in computer science.
 
6.2 *  Will results of the research be communicated back to the subjects?
  Yes No
 
 
6.2.1 *  Explain the plan and process.
 
 
 
6.3 *  Describe any direct risks to the public or community, which could result from this research?
The two expected risks are boredom and stiffness from wearing the fNRIS
cap. There are no known physical risks associated with the use of
fNIRS.
  
 
6.4 *  Does this project involve study arms that have differing levels of benefit or risks to subjects?
  Yes No
  
 

6.5 *  Benefits and Risks: 


Click "Add" to begin entering the benefit and risk level detail information associated with this study.

 NameRisk LevelDirect Benefit
ViewHUM00139618No more than minimal riskno
 
Benefits and Risk Level Detail

If a study involves multiple arms or phases that pose different levels of risk or direct benefits to subjects, then create an entry for each arm or phase using the "OK and Add Another" option at the bottom of this page.  Only one entry is necessary if the risk level and the direct benefit to subjects is the same for the entire project, even if the study involves multiple arms or phases.

 
 
6.5.1 * Name of Arm (experimental group, study wave, etc.)
 
HUM00139618
 
 
 
 
6.5.2 *  Description of Arm (experimental group, study wave, etc.)
 
 
 
 
 
 
6.6 * Are there potential direct benefits of this research to the subjects?
 
  Yes No
 
 
 
 
6.6.1 *  Describe the potential direct benefits.
 
 
 
 
 
 
6.7 *  Provide a description of the foreseeable risks to subjects.  For studies involving multiple arms or phases, enter the risks for this arm or phase only. 
Provide a description of the foreseeable risks to the subjects.
For EACH identified risk, include:
  • Likelihood of the risk,
  • Seriousness to the subject; and
  • What measures will be taken to minimize the risk (for example, study design includes the substitution of procedures already being performed on the subject for diagnostic or treatment purposes, or in a study of Post-Traumatic Stress Disorder, the investigator takes steps to identify, manage, or refer as appropriate, subjects for whom the study may evoke very difficult emotions)
          If possible, please use the following categories to assess the likelihood:
 
  • "Common" (i.e., approximate incidence > 25%)
  • "Likely" (i.e., approximate incidence of 10-25%)
  • "Infrequent" (i.e., approximate incidence of 1-10%)
  • "Rare" (i.e., approximate incidence < 1%):
Minor risks that could result from the use of the fNIRS device is breach of confidentiality, boredom, and slight discomfort while wearing the device. To avoid these risks, we will ask participants if they are uncomfortable with the device on. If they are uncomfortable, we will adjust the device to minimize discomfort. Participants will be instructed that they can leave the study at any time (including if they are bored). The light emitted from the device is less intense than a light bulb and is safe for use with adults.
 
 
 
 
6.8 *  What is the level of risk of harm to the subjects, resulting from this arm of the research?  For studies involving multiple arms or phases, enter the level of risk for this arm or phase only.
  Risk LevelDescription
 
 
 
 
6.9 *  Discuss why the risks to the subjects are reasonable in relation to the anticipated benefits.
fNIRS is an experimental brain imaging method that is helping to provide new neuroimaging data in populations that are unsuited for fMRI studies, can be performed at a much lower cost than fMRI, and admits more ecologically valid experimentation than in an fMRI. As the potential risks are minimal and temporary, they are reasonable in relation to the novel information that will be learned as a result.
 
 
 
 
07. Special Considerations

 

 
7.1*  Does this study involve human tissue or biological specimens (use, collection, or secondary analysis)  (e.g. blood, urine, bone marrow, skin, etc.)?  [Require Section 18]
 
  Yes No 
 
 
 
 
7.1.1*  Will genetic analysis be performed on any specimens acquired in conjunction with this study?  [Require Section 20]
 
  Yes No 
 
 
 
 
 
7.2*  Does this study involve the secondary analysis of a pre-existing data set, including data associated with any specimens identified in response to question 7.1?  [Require Section 24]
 
  Yes No
 
 
 
7.3*   Will the research involve the access, collection, use, maintenance, or disclosure of protected health information (PHI)? PHI is:
  • information about a subject's past, present, or future physical or mental health, the provision of healthcare to a subject, or payment for the provision of healthcare to a subject; AND
  • maintained by a HIPAA-covered entity (e.g. healthcare provider, healthcare plan, or healthcare clearinghouse).
[Require Section 25]
 
[Require Section 25-1]
 
 
  Yes No
 
 
 
07-1. Special Considerations - Continued

 

 
7-1.1*  Will subjects receive payment or other incentives for their participation in the study? [Require Section 13]
 
  Yes No
 
 
 
7-1.2*  Will subjects undergo healthcare-related treatments or procedures (standard of care and/or research) as part of the study? [Require Section 14]
 
  Yes No
 
 
 
7-1.3*  Does this study involve the deception or concealment of subjects? [Require Section 27]
 
  Yes No
 
 
 
7-1.4*  Excluding routine email correspondence, does this study involve the use of the Internet or email as an integral part of the research design or will sensitive information be transmitted by e-mail? [Require Section 28]
 
  Yes No
 
 
 
7-1.5*  Will the study collect data using surveys, interviews, or focus groups? [Require Section 29]
 
  Yes No
 
 
 
7-1.6*  Does this study require subjects to listen to an audio recording or view images? [Require Section 31]
 
  Yes No
 
 
 
7-1.7*  Will any drugs, biologics, radiopharmaceuticals, nutritional (e.g., herbal or alternative medication) supplements or other material be administered, implanted, or applied to the subjects as the object of the study? [Require Section 15]
 
  Yes No
PLEASE NOTE: Since drugs are being used in this study, a MiChart order may need to be created; please allow sufficient time for the MiChart orderset to be created before starting your study.
 		  
 
 
7-1.8*  Will the study involve a placebo (drug, device, procedure, intervention, surgery, etc.) control group? [Require Section 17]
 
  Yes No
 
 
 
 
7-1.8.1*  Is the placebo for a drug? [Require Section 15]
 
  Yes No
 
 
 
 
 
7-1.9*  Will the study involve human embryonic stem cells (hESCs) or induced pluripotent stem cells? [Require Section 19]
  Yes No
 
 
 
 
7-1.10*  Will the study have a Data and Safety Monitoring Plan (DSMP)? [Require Section 32]
 
  Yes No
 
 
 
 
7-2. Special Consideration - Continued

 

 
7-2.1*  Will any devices be used, administered, implanted, or applied to the subjects, or will human specimens be used to test in vitro diagnostic devices?
[IRBMED Applications Require Section 16]
 
  Yes No
 
 
 
 
7-2.1.1*  Describe all devices that are the OBJECT of the study, or ARE RELEVANT to the study. If this study is designed to test the safety or efficacy of any of these devices, then this project is FDA-regulated and must be reviewed by IRBMED.
 
fNIRS device in the UMich Psychology lab.
 
 
 
 
 
 
7-2.2*  Is the research testing or utilizing a health-related mobile software application that is:
  • Designed for a handheld (e.g., smartphone) or wearable mobile device (e.g., exercise tracking), or
  • Tailored to a mobile platform (i.e., a handheld commercial or off-the-shelf computing platform, with or without wireless connectivity) but executed (run) from a server
and the mobile software application/platform performs any of the following:
  • Uses a built-in feature of a device such as light, vibration, or camera to perform a medical device function.
  • Connects or links to an existing device to control its operation, function, or energy source.
  • Uses patient-specific data from a connected device including a sensor or electrode to monitor, manipulate, calculate, or analyze information.
  • Conveys diagnostic information, or provides education materials or encouragement.
  • Performs calculations, conversions, measurements or interpretations.
 
  Yes No

Note: If there is intent to introduce the mobile medical app into commercial distribution or to publish via an app store (e.g., Google or Apple), you must contact the Office of Technology Transfer at 734-763-0614 or um-software@umich.edu to discuss licensure and U-M branding.

 
 
 
 
 
7-2.2.1*  Is the mobile technology intended for use in performing a medical device function (i.e. for diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease)? If so, it is a medical device, regardless of the platform on which it is run. [IRBMED Applications Require Section 16]
 
  Yes No
 
 
 
 
 
7-2.2.2*  Describe the health-related mobile software application and its intended use.
 
 
 
 
 
7-2.3*  Will the subjects be exposed to any ionizing radiation during the course of this study? [Require Section 21]
 
  Yes No
 
 
 
 
7-2.3.1*  Will radiopharmaceuticals be administered to subjects as part of this study? [Require Section 15]
 
  Yes No
 
 
 
 
 
7-2.4*  Will any organs, tissues, or cells from humans (including fetal tissue) or animals be administered to the subjects for the purposes of this study? [Require Section 22]
 
  Yes No
 
 
 
7-2.5*  Does this study involve a gene transfer intervention or an intervention based on recombinant DNA technology? [Require Section 23]
 
  Yes No
 
 
 
   
08. Subject Participation

 
8.1*  Please indicate the number of subjects to be enrolled from ALL study locations to achieve the goal of the study:
30
  
8.2* Enter the estimated number of subjects to be enrolled at each University of Michigan site:
 
8.2* Enter the estimated number of subjects to be enrolled at each site:
 

 
Location or Institution

Total
University of Michigan
   Adults 30
   Children 0

Total from all University of Michigan sites:   30
 
Additional Help

 

08-1. Subject Recruitment

 
8-1.1*  At what point in the study are you planning on beginning the recruitment of subjects?
0-2 years after approval
 
8-1.2*  Indicate which of the following established subject pools, if any, will be used for recruitment.  
Select all that apply:
N/A

Provide Related UM IRB Project Number or Subject Pool Description:



  
8-1.3*  Describe the manner in which potential study subjects will be recruited. List how, when, who will recruit and where they will be recruited. Include any provisions to protect or maintain subject privacy. 
Our recruitment is planned as:

1. Recruitment
Graduate students, undergraduate students, professors, and any adult who
has the fundamental knowledge of data structure(equivalent to EECS280
and EECS281 in the university of Michigan) would all be considered
eligible.

We use three ways to advertise this study:
(i) In-class advertisement
Participants will be identified by their presence in various Computer
science venues (classes,etc.). We target the EECS 300 and 400 level
classes and labs. We will give a short presentation about our study.

To prevent concerns of coercion, we will take the following steps (PI
Weimer's class also follows the same steps):

1) The instructor will not advertise or be involved in the selection or
recruitment of participants. Instead, Research Fellow Kevin Leach, Graduate
Student Yu Huang and/or undergrad Xinyu Liu will adversie the study and recruit
participants. In any of the classes, if the investigator is the instructor or teaching assistant of the class, they will be excluded from the advertisement and selection of participants correspondingly in the class. In any class, we do not do real-time recruitment. The recruitment will only be done through emails offline.

2) We will make it very clear in the presentation that students will not
be given extra credit. The participation is not relevant to their course
grade at all.

3) The recruitment is completely out of the class through emails. The
instructor has no access to the participation information.


(ii) Email advertisement
We will send an advertisement email to the computer science mailing
list. In the email, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and
recruitment contact information(Graduate Yu Huang's email).

(iii) Flyers
We will put flyer in the EECS hallway, Beyster Hallway, and pirepont
commons hallway to advertise the study. On the flyer, we will demonstrate the information of the study
including basic requirement, incentives, the design of the study and the
recruitment contact information(Graduate Yu Huang's email).

Participants will be recruited through emails: contact the
study team by emailing Graduate Yu huang
their intention. Then, we will arrange an experiment time and email the
participant the time and location of the experiment. The email will be
sent to the participant within 3 days after they inform us their
intention of participation.


Through recruitment (as introduced in the recruitment), every participant is scheduled with an appointment.
They will complete the experiment in the fNIRS lab of the University of
Michigan assisted with the study investigators. Before the experiment,
the participant needs to read through the consent form and sign it to
confirm their wills of participation.

How to protect the subject privacy other than the protection in the recruitment:
The email address will be safely stored and there is no identifiable
info of the fNIRS signal data at all (we use de-identified unique Id to connect the fnirs data and questionnaire). For incentives, we will not
collect anything more that what HSIP requires. For each participant who
completed the study, we will pay a $50 check or cash right after the they complete the experiment. For those who stopped and
did not finish the experiment, we will pay them
$20 check or cash instead. This is done through HSIP.

All the experiment data is stored in a secured university server. Also, all the fnirs data is deidentified. Only the study team member have access to it.





  
Additional Help
8-1.3.1  If applicable, how will prospective subjects' healthcare providers (e.g., physician, dentist, etc.) be involved in the recruitment and/or be notified of their individual patients' participation in the study?

 
8-1.4*  Explain how the recruitment strategy is equitable and represents the population required for the study.  If the information is covered in the attached protocol, please indicate section.
Any adult eligible for fNRIS can participate in this study provided they demonstrate the required basic programming expertise for completing the software engineering tasks. The requirement of the basic knowledge of programming is included in all types of the advertisement of this study. Every candidate participant will be assessed for minimal expertise using the same set of questions after receiving informed consent (the pre-questionnaire in section29.1).
 
8-1.5*  Does the recruitment strategy involve contacting individuals multiple times in an effort to secure their initial enrollment into the study?
  Yes No
 
 
8-1.5.1*  Describe how frequently and in what manner individuals will be contacted.  If the information is covered in the attached protocol, please indicate section.
 
 
 
8-1.6*  Indicate which methods will be used for recruitment?
Check all that apply:
Face-to-face contact (e.g. during a health care visit or an interview at a home address, etc.)
Email
Public advertisement (e.g., bulletin boards, newspapers, radio, TV, websites, or on-hold telephone scripts, etc.)

If other please specify:



  
8-1.7  How will any email, address, and/or telephone lists be obtained?

 
8-1.8*  What materials will be used for recruitment? The IRB must approve all recruitment materials.

See Help for important information regarding the requirements for recruitment materials

Check all that apply:
Pre-screening questions
Flyers
Oral scripts
Email messages

If other please specify:


If Web pages will be used, provide the Web address (URL) for the location where the pages will be posted (also upload the content of the pages below):


Upload recruitment materials here:

See Help for more information about working with documents (e.g. uploading, downloading, and editing).


NameVersion
   fnirs_cfp_flyer.docx0.02
   recruitment_speech.docx0.03
   recuitment_email.docx0.03

Check here if any of the materials are not available electronically.

Note: Study Teams are encouraged to scan and upload documents. See Help for a list of sites with scanning facilities

 
Additional Help
09. Survey Populations

 
9.1*  Is the study limited to a survey of either:
  • The general adult population (aged 18 or older); or
  • A subgroup of the general population which does not specifically target:
  • Pregnant women and/or fetuses
  • Lactating women
  • Women of child-bearing potential
  • Prisoners
  • Cognitively impaired adults
  • College students
  • Economically or educationally disadvantaged persons
  • Patients of the study team
  • Employees, students or trainees of the study team
  • Family members of the study team
where the survey is the sole interaction with the subject and does not pose more than minimal risk?
  Yes No
 
09-1. Subject Populations

 

 
9-1.1*  Is the research designed to include or allow the following populations?
 

Select all that apply

Normal, healthy subjects
Adults age 18 and older
Minors able to consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (e.g. emancipated minors or minors seeking treatment for certain conditions.)
Children and/or Viable Neonates (i.e. persons who have not yet reached the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted) [Require Sections 33 and 41]
Neonates of uncertain viability and/or nonviable neonates (do not check this box if the research is solely retrospective. For retrospective research regarding neonates of uncertain viability, check the box for 'Children'. See Help for additional information.) [Require Section 34]
Individuals and/or products involving human in vitro fertilization
Pregnant women and/or fetuses [Require Sections 35 and 41]
Lactating women [Require Section 36]
Women of child-bearing potential [Require Section 37]
Prisoners (If the research includes a study population that is likely to become incarcerated during the conduct of the research, also select this category) [Require Section 38 and 41]
Cognitively impaired adults [Require Sections 39 and 41]
College students [Require Sections 40 and 41]
Economically or educationally disadvantaged persons [Require Section 41]
Patients of the study team [Require Section 41]
Employees, students or trainees of the study team [Require Section 41]
Family members of the study team [Require Section 41]
Unknown, unspecified population
 
 
 
10. Informed Consent - Adults

 


 
10.1*  What type of informed consent will be obtained from adults or minors legally able to consent to treatments or procedures involved in the research?
 
 
With signature:
Comprehensive written
Written assent for cognitively or decisionally impaired adults
Without signature (waiver of documentation):
Comprehensive written
Comprehensive oral consent script
Assent for cognitively or decisionally impaired adults
Waivers of informed consent:
Request for waiver of informed consent/parental permission/legally authorized representative consent (Note: no longer required for screening/recruitment)
Request for waiver of assent for cognitively or decisionally impaired adults
Other:
Short form, comprehensive oral script, and witness
Request for alteration of informed consent requirements
Pre-existing consent(s) covers this activity
Re-consent/assent subjects for use of existing data/records/specimens for a new research purpose
 
 
Additional Help

 
10.1.2*  Describe the process to seek and obtain informed consent and/or assent from adults. If requesting a waiver of documentation of assent, provide justification here.
 
Research Fellow Kevin Leach and/or graduate student Yu Huang and/or Undergrad Xinyu Liu will sit with the subject and explain
the experiment, the process of the study, their rights, risks, and benefits. Subjects will be given as much time as they require to read, understand, and sign off on the informed
consent form.
 
 
Additional Help
10.1.3*  Is the cognitive capacity of the subjects expected to change significantly during the study?
 
  Yes No
 
 
 

10-1. Informed Consent

 
10-1.1*  All documents related to consent, assent, permission, and or debriefing documents, including oral scripts must be uploaded here. If you are requesting a waiver of documentation of informed consent, upload a copy of any written materials to be provided to participants, and provide a written description of any information to be provided orally.
 
10-1.1*  All template documents related to consent, assent, permission, and or debriefing documents, including oral scripts must be uploaded here. If you are requesting a waiver of documentation of informed consent, upload a copy of any written materials to be provided to participants, and provide a written description of any information to be provided orally.
 
NameVersion
   informed-consent.docx0.05

 
Additional Help
 
10-1.1.1*  Does the Informed Consent use the sentences required for Applicable Clinical Trials: "A description of this clinical trial will be available on www.ClinicalTrials.gov, as required by US law. This website will not include information that can identify you. At most, the website will include a summary of the results. You can search this website at any time."?
  Yes No
  
 
 
10-1.2* Will the subjects be audiotaped, videotaped, or photographed (identifiable images of subject) during the research?
  Yes No
  
Additional Help
10-1.3*  Is there a substantial likelihood that the research will be conducted among a non-English-speaking population?
  Yes No
  
Additional Help
 
10-1.3.1*  Identify the language(s) expected to be encountered:
LanguageTranslation Detail
There are no items to display

 
 
 
10-1.4*  Indicate which anticipated costs could be the full or partial responsibility of the subject.

Check all that apply:
Parking
Travel

If other, please specify:

 
10-1.5*  Is the study designed to collect identifiable information from primary research subjects about other individuals, including family members?
  Yes No
  
Additional Help
10-1.6*  At the conclusion of this study, will specimens and/or data be retained for future research use?
  Yes No
  
 
10-1.7*  Does the informed consent document explicitly notify subjects that their data and/or specimens will be stored for future research?
  Yes No
  
10-1.8*  Are subjects required to agree to retention of their data and/or specimens as a condition of participating in the research?
  Yes No
  
 
10-1.8.1*  Provide a justification for this requirement. If the information is included in the attached protocol, please indicate section.
 
 
 
11. Confidentiality/Security/Privacy

 


 
11.1*  Will the study team access any data that is linked to a subject's identity by name or other identifier or code? [Require Section 11-1]
 
  Yes No
 
 
Additional Help
11.2*  Explain how the subjects' privacy will be protected.
 
The email address will be safely stored and there is no identifiable
info of the fNIRS signal data at all. For incentives, we will not
collect anything more that what HSIP requires.

All the experiment data is stored in a secured university server.
 
 
Additional Help
11.3* How will the study team protect research records, data, and/or specimens against inappropriate use or disclosure, or malicious or accidental loss or destruction in order to protect the confidentiality of subject data?
 
Select all that apply:
Locked office
Locked cabinet or storage unit
Restricted access
Secure laptop
Individual ID plus password protection
Encryption of digital data
Network restrictions
Security software (firewall, anti-virus, anti-intrusion) is installed and regularly updated on all servers, workstations, laptops, and other devices used in the project
Safe disposition/destruction of data or devices, as appropriate (e.g., shredding paper documents, destroying disks or thumb drives, secure erasure of electronic media)


If other please specify:
 
 
 
11.4* Does either statement apply to this research:
Research has NIH, CDC, or FDA funding, or other federal funding from an agency that automatically issues a Certificate of Confidentiality as part of the terms of the award:

The study will include identifiable sensitive information, identifiable biospecimens, individual human-level genomic data/biospecimens, or any information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request for the information, and other available data sources could be used to deduce the identity of an individual.

or

Research does NOT have NIH, CDC, or FDA funding, or other federal funding from an agency that automatically issues a Certificate of Confidentiality as part of the terms of the award:

The study will include identifiable, sensitive information or identifiable biospecimens that, if revealed, might place the subjects at risk for personal safety, criminal or civil liability, or damage to their financial standing, employability, insurability, or reputation.

[Require Section 11-2]
  Yes No
 
 
 
11.5*  Will data be provided to a repository as part of a data sharing agreement?
 
  Yes No
 
 
 
 
11.5.1*  Please indicate the repository:
 
Select all that apply:
There are no items to display


If Other, please specify:
 
 
 
 
 
11.6*  What will happen to the data and/or any specimens at the conclusion of this study?
 
Select all that apply:
Retain for future research use - requires Section 11-4
 
 
 
 
11.6.1*  If the data and/or specimens will be destroyed, describe the specific plan that will be employed following the required retention period.
 
 
 
 
 
 
11.6.2*  If the data and/or specimens will be retained for study recordkeeping purposes, provide the following information (if covered in the attached protocol, please indicate section):
 
  • expected duration of the retention period,
  • any changes in the conditions or arrangements for storage of research data/specimens during the retention period, if different from those listed above in question 11.3.
 
 
 
 
 
11-1. Identifiable Data

Completion of this section is required based on the response provided to question 11.1.

 
11-1.1*  Indicate how subjects are identified in the research records.
Select all that apply:
Coded or Indirect Identifiers - data record includes a link to direct identifiers (e.g., name, initials, phone number, SSN, or medical record number linked to data record but stored separately)
No Identifiers (De-identified, Anonymous, or Anonymized) - stored data record is stripped of all identifiers

 
11-1.2*  Explain the necessity for collecting or maintaining data linked to subjects' identities. If the information is covered in the attached protocol, please indicate section.
HSIP will require name and address for distributing the incentives.
Emails will be used for recruitment. But the email address will not be linked with the experiment data.
 
11-1.3*  How long will the identifiers be retained?
Until the participants have been remunerated.
 
11-1.4*  Will individually identifiable sensitive data be accessed, collected, used, maintained, or disclosed in the study?
  Yes No
 
 
11-1.4.1*  Will a continuous, periodic, or automatic feed of sensitive data be set up to provide data directly from any University information system (e.g., M-Pathways, U-M Data Warehouse, CareWeb)?
  Yes No
 
11-1.4.2*  Will sensitive data be accessed by individuals who are not University employees?
  Yes No
 
11-1.4.3*  Will sensitive data be stored on or accessed from computer equipment that is not maintained and supported by a University IT services provider (e.g., ITS, MCIT, MSIS) - such as home computers, grant-funded computers, etc.?
  Yes No
 
11-1.4.4*  Will sensitive data be stored on portable devices (e.g., laptops, PDAs, flash drives) in unencrypted form?
  Yes No
 
 
11-3. End of Subject Participation

 
11-3.1*  What specific criteria will be used to prematurely end a particular subject's participation in the study  (If covered in attached protocol or informed consent, indicate specific location).
If the participant does not confirm the consent or they do not have the required fundamental knowledge, they will be removed from the study. In the consent form, we indicate:
The researchers may remove you from the study even if you want to continue your participation
if the researchers believe it is not in your best interest to continue, if your condition changes and
requires treatment, or if you do not follow the instructions from the researchers.
 
11-3.2*  If a participant withdraws from the research, what is the plan to use, disclose, store, or destroy the participant's data and/or specimen?
Destroy any electronic data related to the participant securely, and destroy copies of the survey used
to filter participants.
 
11-4. Retention of Data and/or Specimens Detail

Retention may be for future research by the investigator and/or the creation of a bank or repository.

Completion of this section is required based on the response provided to question 11.6.

 
11-4.1*  What is the intent or purpose of retaining the data and/or specimens?
For follow up work and dissemination to the academic community. This domain of research is largely
unexplored and related data is difficult to obtain. The academic community would benefit greatly from
having (anonymized) data available for comparison in subsequent studies.
  
11-4.2*  Where will you store the data and/or specimens?
Only at the University of Michigan

If Other Institutions, please specify:
  
11-4.3*  Describe the arrangements for the storage conditions, management, and security of the data and/or specimens.  Include the following as applicable:   
  • Personnel access to data and/or specimens
  • Whether identifiers will be removed and the key to any code destroyed
  • For coded data and/or specimens, indicate who holds key to the code and where it is stored in relation to the data and/or specimens
  • Storage plan
  • Plan to protect privacy in transfer to other collaborators.
PI Weimer has secure office space allocated in the Beyster building for storing sensitive information. Only PI Weimer and Research Fellow Leach will have key access to the office.

Participant identifiers(emails for recruitment only) will not be stored after the recruitment. Research data will be stored on encrypted volumes secured by a passphrase that will be shared between PI Weimer, Research Fellow Leach, and UMich collaborator Xiaosu Hu.

 
13. Subject Payments Or Other Incentives

Completion of this section is required based on the response provided to question 7-1.1 or 7-3.3.

 
13.1*  Indicate all payments or other incentives provided to subjects for their participation in this study:
Select all that apply:
Cash
Check


If other, please specify:
 
13.2*  If the subject is a child (under the age of majority), are any of the payments or incentives intended for the parent/guardian of the child?
N/A
 
13.3*  Estimate the maximum total payment (including cash, checks, gift cards, and other cash-equivalent incentives) that an individual subject could receive for participating in this research in a single calendar year.
$26-$100
 
 
13.3.1*  Please indicate what information you will be collecting from subjects in order to distribute their incentive or compensation.
Select all that apply:
Name
Address
Email
 
 
 
13.4*  Describe the frequency of the payments or incentives. If applicable, list any healthcare procedure(s) that will be provided to subjects at no charge.
One payment will be issued immediately after the participant completes the fNIRS study.
 
13.5*  What is the justification for offering these payments or incentives?
The study will take approximately 90 minutes of the participants' time. Additionally, participants are required to have a minimal expertise with computer science. We want to compensate participants for their time at a reasonable rate.
 
13.6*  What is the plan to compensate subjects withdrawing from the research prior to completing the entire study.
Participants that withdraw will receive $20 check or cash.
  
29. Survey Research

Completion of this section is required based on the response provided to question 7-1.5.

 
29.1*  Provide a list of all surveys and interviews used in the study:
Name# of QuestionsDurationSensitive?Disturbing?
background questionnaire (pre-questionnaire)62 minutesnono
post questionnaire65 minutesnono

 
Additional Help
29.13*  Will the research involve the use of focus groups?
  Yes No
 
 
29.13.1*  How will the identity of individuals participating in the groups be protected?
 
 
 
29.14*  Is any of the material disturbing?
  Yes No
 
 
29.15*  Describe the arrangements made to provide professional counseling or support resources to any subjects desiring such assistance as a result of their participation in the study.

 
29.16*  Indicate how the list of counseling or support resources will be provided:

If other, please specify:


  
 
Survey Detail

 
29.2*  Survey or interview name:
background questionnaire (pre-questionnaire)
 
29.3*  Is the design or development of this survey instrument dependent on receipt of funding or hiring of personnel?
  Yes No
 
 
29.4*  In what manner will the survey or interview be conducted (e.g., in-person, Internet, mail, telephone, etc.)? Special Note: For electronic surveys, the eResearch ID number must be included in the informed consent document (uploaded in section 10-1) or other material that serves as the informed consent.
in-person
 
29.5*  What is the predicted response rate?
100 %
  
29.6*  What is the total number of questions?
6
 
29.7*  What is the anticipated cumulative amount of time required for each subject?
2 minutes
  
29.8*  What is the total number of interviews/data collection interactions with an individual subject?
1
 
29.9*  Does the survey or interview contain questions of a sensitive nature (e.g., mental illness, sexual abuse, illicit drug use, etc.)?
  Yes No
 
29.10*  Is the survey or interview likely to produce psychological discomfort or negative feelings in the subjects?
  Yes No
 
29.11*  Has the survey instrument been validated or used in standard practice?
  Yes No
 
 
29.11.1*  If yes, describe the origin of the instrument.
The background questionnaire is a paper-based survey. It is very short and to collect very basic information of the participant. The information does not contain any identifiable information.
 
 
 
29.12*  Upload the survey instrument here.
NameVersion
  background_questionnaire0.01
 
Additional Help
Survey Detail

 
29.2*  Survey or interview name:
post questionnaire
 
29.3*  Is the design or development of this survey instrument dependent on receipt of funding or hiring of personnel?
  Yes No
 
 
29.4*  In what manner will the survey or interview be conducted (e.g., in-person, Internet, mail, telephone, etc.)? Special Note: For electronic surveys, the eResearch ID number must be included in the informed consent document (uploaded in section 10-1) or other material that serves as the informed consent.
in-person audio-based questionnaire
 
29.5*  What is the predicted response rate?
100 %
  
29.6*  What is the total number of questions?
6
 
29.7*  What is the anticipated cumulative amount of time required for each subject?
5 minutes
  
29.8*  What is the total number of interviews/data collection interactions with an individual subject?
1
 
29.9*  Does the survey or interview contain questions of a sensitive nature (e.g., mental illness, sexual abuse, illicit drug use, etc.)?
  Yes No
 
29.10*  Is the survey or interview likely to produce psychological discomfort or negative feelings in the subjects?
  Yes No
 
29.11*  Has the survey instrument been validated or used in standard practice?
  Yes No
 
 
29.11.1*  If yes, describe the origin of the instrument.
the post questionnaire is an audio-based questionnaire. It asks how the participant reason about the questions. Audio-based questionnaire saves the participant's time. Also, the conversation is to debrief the participant from the 70-minute computer-based experiment.
 
 
 
29.12*  Upload the survey instrument here.
NameVersion
  post_questionnaire0.01
 
Additional Help
31. Watching/Listening to Audiovisual Materials

Completion of this section is required based on the response provided to question 7-1.6.

 
31.1*  Please upload copies of all audio-visual materials used in the research.
NameVersion
  tasks.pptx0.01
  training_video_20min0.02

Check here to indicate that the material is not available electronically.
 
31.2*  Are any of the materials likely to produce psychological discomfort or negative feelings in the subjects?
  Yes No
 
 
31.2.1*  Describe the arrangements made to provide professional counseling or support resources to any subjects desiring such assistance following their participation in the study.

 
31.2.2*  Indicate how the list of counseling or support resources will be provided:

If other, please specify:


  
 
32. Data Safety And Monitoring Plan
 
Completion of this section is required based on the response provided to question 7-1.10.

The principal investigator (PI) has the ultimate responsibility for the conduct of this research study. The study-specific scientific protocol should include detailed information about tests and procedures employed to safeguard the health and safety of the subjects. Additionally, the PI must prepare a specific data and safety monitoring plan taking into account national guidelines and the study's complexity, risk, and size. The plan should include the administrative processes for recording and evaluating the data quality and integrity. The plan should also specify the responsibilities of research team members and the schedules for reviewing and reporting study progress and adverse events.

Components of this plan relating to the protection of subject privacy and data confidentiality should already have been included in the Confidentiality/Security section of this application.

Additionally, certain members of the research team must complete the PEERRS mandatory training on human subject protection. This includes personnel joining the study team after the initiation of the study.
  The Risk Level has been indicated as:
 
NameRisk LevelDirect Benefit
HUM00139618No more than minimal riskno
 
32.1*  Indicate who will provide study information and instructions to the subjects beyond what is included in the informed consent document.
Select all that apply:
There are no items to display

If other, please specify:

  
32.2*  Indicate who will obtain informed consent from the subjects.
Select all that apply:
Co-I

If other, please specify:

  
32.3*  Indicate what mechanism(s) will be used for monitoring subjects and identifying adverse events.

Mechanism (Select at least one:)

Conducted by:

 


  

 

Direct interviews/ physical exams conducted by:

Select all that apply:
Co-I


 

 


  

 

Review of lab work, tests, procedures, etc. by:
Select all that apply:
PI
Co-I


 

 


  

 

Telephone follow-up conducted by:
Select all that apply:
There are no items to display


 

Self-reporting by subject  

Instructions must be included in the Informed Consent Document. 


  

Other
Reminder: Adverse Events that come to the attention of any member of the study team must be reported to the PI in a timely manner.
  
32-1. Data and Safety Monitoring Plan - AE Reporting

Adverse Event (AE) Reporting

 
32-1.1*  Adverse events will be reported to:
 OrganizationReporting Mechanism
IRBeResearch AE/ORIO submission
DSMB/DSC/independent monitor 
UMHS Cancer Center DSMB 
Federal oversight agencies (FDA, RAC, etc) 
Sponsor (federal, industry, private, etc) 
Other 

If other, please specify:



  
32-1.2*  Indicate the AE reporting timetable that will be used to report adverse events to the IRB:
Standard IRBMED AE reporting timetable
 
 
32-1.2.1*  Indicate the reason for selecting the study-specific AE reporting rather than the Standard IRBMED AE Reporting Timetable.
Select all that apply:
There are no items to display

If other, please specify:


  
32-1.2.2*  Provide the study-specific AE reporting plan.   If the study-specific AE reporting plan is included in the previously uploaded scientific protocol, indicate section.
NameVersion
There are no items to display

Indicate specific protocol section here:


  
Additional Help
 
 
 
32-1.3*  Affirm that the adverse events will be reported to the IRB according to the following generalized AE GRADING SCALE:
  • 0 - No adverse event
  • 1 - Mild AE – No treatment needed
  • 2 - Moderate AE – Resolved with treatment
  • 3 - Severe AE – Inability to carry on normal activities, required professional medical attention
  • 4 - Life-threatening or disabling AE
  • 5 - Fatal AE
  
32-1.4*  Will Serious Adverse Events (SAEs) be categorized according to the following FDA definition?
N/A - not FDA-regulated
  • Death
  • A life-threatening adverse drug experience
  • Inpatient hospitalization or prolongation of existing hospitalization
  • A persistent or significant disability/incapacity
  • A congenital anomaly/birth defect
  • Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.
 
32-1.5*  Affirm that either the principal investigator or a co-investigator will determine the ATTRIBUTION/RELATEDNESS for each adverse event.
  • Definitely related
  • Probably related
  • Possibly related
  • Unlikely to be related
  • Definitely not related
  
32-1.6*  Affirm that the EXPECTEDNESS will be assigned for each adverse event according to the following definitions:
  • Unexpected adverse events (i.e., has NOT been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation)
  • Expected adverse events (i.e., has been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB/DSC Reports, published literature, other documentation, or characteristics of the study population)
  
32-2. Data Safety and Monitoring Plan - Monitoring the Study

Monitoring the Study

 
32-2.1*  Indicate the frequency with which the study team will conduct scheduled assessments of study recruitment, data integrity and quality, adverse events, withdrawals, and compliance with protocol plan.
Monthly

If other, please specify:

  
 
32-2.1.1*  If quarterly or other, provide a justification for the assessment schedule.
 
 
 
32-2.2*  Study oversight and safety monitoring may be required based on the nature, size, and complexity of the study.  Indicate the responsible entities.
 Select all that apply:
No additional monitoring is required – the nature, size, and complexity of this study does not require additional safety monitoring to that provided by the IRB.
Independent monitor
Internal committee
Sponsor
Data and Safety Monitoring Board (DSMB) or Data Safety Committee (DSC)
UMHS Cancer Center DSMB
Other

If other, please specify:

If no additional monitoring is required, jump to 32-2.3.
  
32-2.2.1  Provide the names and areas of expertise of those providing this additional monitoring 
 
32-2.2.2  Indicate the frequency with which the additional monitoring activities will be conducted.

If other, please specify:

  
32-2.2.3  Indicate the data that will be reviewed.
Select all that apply:
There are no items to display
 
32-2.2.4  If a DSMB or DSC charter exists, upload it here.
NameVersion
There are no items to display
 
Additional Help
32-2.3*  Monitoring reports will be provided to:
 OrganizationReporting Mechanism
IRB (required)eResearch
Federal oversight agencies (FDA, RAC, etc.) 
Sponsor (federal, industry, private, etc.) 
Other 

If other, please specify:

  

41. Subjects Vulnerable to Coercion

Completion of this section is required based on the response provided to question 9-1.1 or 9-2.1.

The following subject populations, vulnerable to coercion or undue influence, have been identified for inclusion in the study.
College Students
 
 
41.1*  What is the justification for the inclusion of these subject populations?
 
It requires the participants to have some basic software knowledge as what is covered in a 200-level courses in the CS department in University of Michigan. The participants will spend around 90 minutes using a computer and wearing a fNIRs cap. Thus the recruitment is open to college students, or research fellows/professors who is able to take such an experiment.
 
 
 
41.2*  Describe the additional safeguards that have been included in this study to protect the rights and welfare of these subjects.
 
All participants will read through and sign a consent form based on their own wills. The participants can quit the experiment anytime during the experiment. In this case, they will still receive a $20 check or cash based on their own preference.
 
 
 
44. Additional Supporting Documents

 
44.1  Please upload any additional supporting documents related to your study that have not already been uploaded. Examples include, but are not limited to, data collection sheets, newsletters, subject brochures, and instructional brochures.
NameVersion
There are no items to display
 
 
44.2 Enter any information that should show in a “Supporting Documents” list on the current submission’s approval notice, such as document names and version numbers or version dates. Text entered here will AUTOMATICALLY appear word-for-word on the approval letter.
 
 

45. End of Application

 

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