7-3 Diversity, Equity, and Inclusion of Research Participants (Revised October 2024) Previously titled: Inclusion of Women and Minorities in Research

7-4 Advertising for Research Participants (October 2024 update)

7-5 Finders Fee (October 2024 update)

7-6 Costs Associated with Research Participation (October 2024 update)

7-7 Compensation for Research Participation (October 2024 update)

Section 8 Research Involving Vulnerable Participants

8-1 Research Involving Fetuses and Neonates (October 2024 update)

8-2 Vulnerable Participants: Children (October 2024 update)

8-3 Vulnerable Participants: with Impaired Decision Making Ability (November 2024 update)

8-4 Vulnerable Participants: Prisoners (October 2024 update)

8-5 Vulnerable Participants: Terminally Ill (October 2024 update)

8-6 Vulnerable Participants: Normal Volunteers (October 2024 update)

8-7 Vulnerable Participants: Students, Trainees and Employees (October 2024 update)

Section 9 Informed Consent

9-1 Requirements of Informed Consent (November 2024 update)

9-2 Informed Consent Involving Non-English Speaking Participants (October 2024 update)

9-3 Informed Consent Process (November 2024 update)

9-4 Obtaining Permission from Legally Authorized Representatives or Family Members (October 2024 update)

Section 10 HIPAA

10-1 HIPAA Requirements in Research (October 2024 update)

Section 11 Research Involving Drugs and Devices

11-1 Research and Expanded Access Involving Investigational Drugs (August 2024 updated) formerly Investigational Drug Research

11-2 Approved and Unapproved Devices in Research (October 2024 updated)

11-3 Emergency Single Time Use of a Test Article (Drug, Biologic, Device) (October 2024 update)

11-4 Humanitarian Use Device:This content is now contained within revised policies 11-1 and 11-2

11-5 Off Label Use of Drugs and Devices:This content is now contained within revised policies 11-1 and 11-2

11-6 Planned Emergency Research (October 2024 update)

11-7 Compassionate and Expanded Use of Drugs and Devices: This content is now contained within revised policies 11-1 and 11-2

Section 12 Research Procedures

12-1 The Use of Biological Specimens in Research (October 2024 update)

12-2 Data Safety and Monitoring in Research (October 2024 update)

12-3 Research Studies Involving the Collection of Blood Samples (October 2024)

Section 13 Reporting Responsibility

13-1 Unanticipated Problems and Other Reportable Events (October 2024 update)

13-2 IRB Reporting Unanticipated Problems, Suspensions and Terminations, Serious & Continuing Non-Compliance (January 2024 update)

13-3 (see policy 13-1 and the Unanticipated Event Reporting Form)

13-4 (see policy 13-1 and the Unanticipated Event Reporting Form)

13-5 Veteran Affairs Reporting Responsibilities and Procedures (November 2024 update)

Section 14 Conflict of Interest

14-1 Conflict of Interest: Principal Investigator/Key Personnel (October 2024)

14-2 Conflict of Interest: Institutional Review Board Members and IRB Administration Staff (October 2024 update)

Section 15 Non-Compliance

15-1 Identifying, Defining and Managing Non-Compliance in Human Research (October 2024 update)

15-2 For Cause Audits (October 2024)

15-3 Suspension and Termination of Research Protocols (October 2024 update)

Section 16 References

16-1 Glossary

16-2 FDA

16-3 OHRP

16-4 Dingell Veterans Administration Policy

16-5 Good Clinical Practice

16-6 FDA Guidance

16-7 FDA Devices

16-8 Department of Defense (DoD)

16-9 Department of Energy (DoE)

16-10 Department of Education

16-11 Environmental Protection Agency (EPA)

16-12 NIH Human Subjects Research

16-13 NIH Certificates of Confidentiality

16-14 HIPAA Flowcharts

16-15 HIPAA Tip Sheet

Revised Common Rule (RCR)

Contact Information
IRB Administration Office
87 E. Canfield, Second Floor
Detroit , MI 48201
313-577-1628

Division of Research, Office of Research Compliance 313-577-9064

Division of Research & Innovation

IRB Institutional Review Board

Human Research Protection Program

Institutional Review Board Policies and Procedures

Contents

Section 1 Wayne State University Human Research Policy

Section 2 Ethical Principles

Section 3 WSU Affiliate Contracts and Agreements

VA Reference Documents:

Section 4 Protocol Review

Section 5 Institutional Review Board

Section 6 Principal Investigator

Section 7 Recruitment and Participant Rights