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 (7/2022 updated)
1-3 Wayne State University Human Protection Program: Roles and Responsibilities (3/2020 updated)
1-4 What is Human Participant Research? (3/2015)
1-5 Flexible Review and Oversight of Research Not Covered by Federalwide Assurance (12/2018)
Section 2 Ethical Principles
Section 3 WSU Affiliate Contracts and Agreements
3-3 John D. Dingell Veterans Administration Medical Center Memo of Understanding (2/2016)
VA Reference Documents:
- VHA Directive 1200.05
- VHA Handbook 1058.01 Research Compliance Reporting Requirements
- VHA Handbook 1058.03 Assurance of Protections of Human Subjects in Research
- VHA Handbook 1108.14 Investigational Drugs and Supplies
- Office of Research and Development Veterans Health Administration Guidance on Approval of International Research
Section 4 Protocol Review
4-2 Initial Protocol Submission Requirements (09/2023 update)
4-3 Unexpected Problems (see 13-1 under Section 13)
4-4 Exempt Review Procedures (2/2020 update & RCR update)
4-5 Expedited Review Procedures (update 9/2023)
4-6 Amendments to the Research Protocols and Informed Consent (2/2020 update)
4-7 Continuation/Renewal of Protocol (update 12.2022)
4-8 Closure of a Research Protocol (2/2022 update)
4-9 Determining Projects that Require Additional Verification (11/2019 update)
4-10 Criteria for Determining Frequency of Review (11/2019 update)
4-11 Outcomes of Proposal Reviews by the Institutional Review Board (11/2019 update)
4-12 Notification of IRB Decisions to Principal Investigator and PI Response
4-13 Conditional Approvals and Subsequent Decisions by IRB Chairs (11/2019 update)
4-14 General Counsel: Roles and Responsibilities
4-15 Document Retention for Research Protocols (11/2019 update)
4-16 Quality Improvement Program (11/2019 update)
4-17 External IRB & Reliance Agreements for Multi Site Research (10.2022 updated)
4-18 Transitioning to the Revised Common Rule
4-19 Public Health Crisis Emergency Policy (New policy)
Section 5 Institutional Review Board
5-1 Expectations of IRB Membership (5/2023 update)
5-2 Selection and Review of Institutional Review Board Members and Staff (2/2021 update)
5-3 Policy and Procedure Development and Approval (12/2019 update)
5-4 Selection of Alternative IRB Member for Duly Constituted Meeting (11/2019)
5-5 Minutes Requirements (3/2020 update)
Section 6 Principal Investigator
6-1 Principal Investigator: Roles and Responsibilities (11/2019 update)
6-2 Investigator Initiated Research
6-3 Collaborating Research (12/2019 updated)
6-4 International Research (3/2020 update)
6-5 State and Local Statutes (admin upate 01/2024)
6-6 Department of Defense Requirements for Human Subject Research Protection (2/2020 update)
6-7 Additional Requirements for Research Involving Other Federal Agencies (NEW)
Section 7 Recruitment and Participant Rights
7-1 Recruitment of Research Participants (11/2019 update)
7-2 The Inclusion of Pregnant Women in Research (11/2019 update)
7-3 The Inclusion of Women and Minorities in Research
7-4 Advertising for Research Participants (12/2019 updated)
7-5 Finders Fee (3/2015)
7-6 Costs Associated with Research Participation
7-7 Compensation for Research Participation (11/2019 update)
Section 8 Research Involving Vulnerable Participants
8-1 Research Involving Fetuses and Neonates (11/2019 update)
8-2 Vulnerable Participants: Children (12/2021 update)
8-3 Vulnerable Participants: with Impaired Decision Making Ability (updated 12/2018)
8-4 Vulnerable Participants: Prisoners (11/2019 update)
8-5 Vulnerable Participants: Terminally Ill (11/2019 update)
8-6 Vulnerable Participants: Normal Volunteers
8-7 Vulnerable Participants: Students, Trainees and Employees (11/2019 update)
Section 9 Informed Consent
9-1 Requirements of Informed Consent (2/2020 update formerly titled Informed Consent Options)
9-2 Informed Consent Involving Non-English Speaking Participants (updated 3/2018)
9-3 Informed Consent Process (updated 9/2018)
9-4 Obtaining Permission from Legally Authorized Representatives or Family Members (12/2018 update)
Section 10 HIPAA
10-1 HIPAA Requirements in Research (update 7/2023)
Section 11 Research Involving Drugs and Devices
11-1 Research and Expanded Access Involving Investigational Drugs (10/2019 revised) formerly Investigational Drug Research
11-2 Approved and Unapproved Devices in Research (10/2019 updated)
11-3 Emergency Single Time Use of a Test Article (Drug, Biologic, Device) (11/2019 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 (2/2020 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 (12/2018-RCR update)
12-2 Data Safety and Monitoring in Research (11/2019 update)
12-3 Research Studies Involving the Collection of Blood Samples (9/2016)
Section 13 Reporting Responsibility
13-1 Unanticipated Problems and Other Reportable Events (admin updated 11.2022)
13-2 IRB Reporting Unanticipated Problems, Suspensions and Terminations, Serious & Continuing Non-Compliance (admin update 01/2024)
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 (7/2021 update)
Section 14 Conflict of Interest
14-1 Conflict of Interest: Principal Investigator/Key Personnel (11/2019 update)
14-2 Conflict of Interest: Institutional Review Board Members and IRB Administration Staff (11/2019 update)
Section 15 Non-Compliance
15-1 Identifying, Defining and Managing Non-Compliance in Human Research (revised 8.1.2019)
15-2 For Cause Audits (11/2019 update)
15-3 Suspension and Termination of Research Protocols (revision 8.1.2019)
Section 16 References
16-4 Dingell Veterans Administration Policy
16-8 Department of Defense (DoD)
16-9 Department of Energy (DoE)
16-11 Environmental Protection Agency (EPA)
16-12 NIH Human Subjects Research
16-13 NIH Certificates of Confidentiality
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