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

Section 4 Protocol Review
Section 5 Institutional Review Board
Section 6 Principal Investigator
Section 7 Recruitment and Participant Rights
Section 8 Research Involving Vulnerable Participants
Section 9 Informed Consent
Section 10 HIPAA
Section 11 Research Involving Drugs and Devices
Section 12 Research Procedures
Section 13 Reporting Responsibility
Section 14 Conflict of Interest
Section 15 Non-Compliance
Section 16 References


Section 1 Wayne State University Human Research Policy

1-2 Wayne State University Human Research Protection Program (August 2024 updated, admin update 12.2024)

1-3 Wayne State University Human Protection Program: Roles and Responsibilities (August 2024 updated, admin update 12.2024)

1-4 What is Human Participant Research? (July 2024 updated)

1-5 Flexible Review and Oversight of Research Not Covered by Federalwide Assurance (November 2024 updated)


Section 2 Ethical Principles

2-1 Belmont Report

2-2 Nuremberg Code

2-3 Declaration of Helsinki


Section 3 WSU Affiliate Contracts and Agreements

3-3 John D. Dingell Veterans Administration Medical Center Memo of Understanding (February 2016)

VA Reference Documents: 


Section 4 Protocol Review

4-1 Types of IRB Reviews (August 2024 update)

4-2 Initial Protocol Submission Requirements (September 2023 update, admin update 12.2024)

4-3 Unexpected Problems (see 13-1 under Section 13)

4-4 Exempt Review Procedures (update May 2024)

4-5 Expedited Review Procedures (November 2024 update)

4-6 Amendments to the Research Protocols and Informed Consent (October 2024 update)

4-7 Continuation/Renewal of Protocol (October 2024 update)

4-8 Closure of a Research Protocol (October 2024 update)

4-9 Determining Projects that Require Additional Verification (October 2024 update)

4-10 Criteria for Determining Frequency of Review (October 2024 update)

4-11 Outcomes of Proposal Reviews by the Institutional Review Board (October 2024 update)

4-12 Notification of IRB Decisions to Principal Investigator and PI Response (August 2024 update)

4-13 Conditional Approvals and Subsequent Decisions by IRB Chairs (October 2024 update)

4-14 General Counsel: Roles and Responsibilities (October 2024 update)

4-15 Document Retention for Research Protocols (November 2024 update)

4-16 Quality Improvement Program (October 2024 update)

4-17 External IRB & Reliance Agreements for Multi Site Research (October 2024 update)

4-18 Transitioning to the Revised Common Rule (October 2024 update)

4-19 HRPP Emergency Preparedness Response formerly Public Health Crisis Emergency Plan Policy (November 2024 update)


Section 5 Institutional Review Board

5-1 Expectations of IRB Membership (October 2024 update)

5-2 Selection and Review of Institutional Review Board Members and Staff (October 2024 update)

5-3 Policy and Procedure Development and Approval (October 2024 update)

5-4 Selection of Alternative IRB Member for Duly Constituted Meeting (October 2024)

5-5 Minutes Requirements (October 2024 update)


Section 6 Principal Investigator

6-1 Principal Investigator: Roles and Responsibilities (November 2024 update, admin update 12.2024)

6-2 Investigator Initiated Research (October 2024)

6-3 Collaborating Research (October 2024 updated)

6-4 International Research (October 2024 update)

6-5 State and Local Statutes (admin update January 2024)

6-6 Department of Defense Requirements for Human Subject Research Protection (October 2024 update) There is new policy revision coming soon (March 2025) for Department of Defense.  See Department of Defense Requirements Policy Guidance with a summary of forthcoming revisions. 

6-7 Additional Requirements for Research Involving Other Federal Agencies (November 2024 update) There is a new policy revision coming soon (March 2025) for Additional Requirments for Research Involving Other Federal Agencies.  See the Additional Requirements for Research Involving Other Federal Agencies Policy Guidance with a summary of forthcoming revisions. 


Section 7 Recruitment and Participant Rights

7-1 Recruitment of Research Participants (November 2024 update)

7-2 The Inclusion of Pregnant Women in Research (October 2024 update)

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