Wayne State University

Policies and the Human Research Protection Program Manual

Contents

The Human Research Protection Program Manual
Section 1 Wayne State University Human Research Policy
Section 2 Ethical Principles
Section 3 WSU Affiliate Contracts and Agreements

Institutional Review Board Policies and Procedures
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


The Human Research Protection Program Manual

Section 1 Wayne State University Human Research Policy

1-2 Wayne State University Human Research Protection Program (3/2015)

1-3 Wayne State University Human Protection Program: Roles and Responsibilities (3/2015)

1-4 What is Human Participant Research? (3/2015)

1-5 Flexible Review and Oversight of Research Not Covered by Federalwide Assurance (3/2016)

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


Institutional Review Board Policies and Procedures

Section 4 Protocol Review

4-1 Types of IRB Reviews

4-2 Initial Protocol Submission Requirements (3/2015)

4-3 Unexpected Problems (3/2015) (Also refer to Section 13)

4-4 Exempt Review Procedures

4-5 Expedited Review Procedures (3/2015)

4-6 Amendments to the Research Protocols and Informed Consent (3/2015)

4-7 Continuation/Renewal of Protocol (3/2015)

4-8 Closure of a Research Protocol (3/2015)

4-9 Determining Projects that Require Additional Verification

4-10 Criteria for Determining Frequency of Review (2/2012)

4-11 Outcomes of Proposal Reviews by the Institutional Review Board

4-12 Notification of IRB Decisions to Principal Investigator and PI Response

4-13 Conditional Approvals and Subsequent Decisions by IRB Chairs

4-14 General Counsel: Roles and Responsibilities

4-15 Document Retention for Research Protocols (3/2015)

4-16 Quality Improvement Program (3/2015)

4-17 External IRB Policy (3/2015)

Section 5 Institutional Review Board

5-1 Expectations of IRB Membership (3/2015)

5-2 Selection and Review of Institutional Review Board Members and Staff (3/2015)

5-3 Policy and Procedure Development and Approval

5-4 Selection of Alternative IRB Member for Duly Constituted Meeting (3/2015)

5-5 Minutes Requirements (3/2015)

Section 6 Principal Investigator

6-1 Principal Investigator: Roles and Responsibilities (3/2015)

6-2 Investigator Initiated Research

6-3 Collaborating Research

6-4 International Research (3/2015)

6-5 State and Local Statutes

6-6 Department of Defense Requirements for Human Subject Research Protection (3/2015)

Section 7 Recruitment and Participant Rights

7-1 Recruitment of Research Participants

7-2 The Inclusion of Pregnant Women in Research (3/2015)

7-3 The Inclusion of Women and Minorities in Research

7-4 Advertising (10/2012)

7-5 Finders Fee (3/2015)

7-6 Costs Associated with Research Participation

7-7 Compensation for Research Participation (3/2015)

Section 8 Research Involving Vulnerable Participants

8-1 Research Involving Fetuses and Neonates (3/2015)

8-2 Vulnerable Participants: Children (3/2015)

8-3 Vulnerable Participants: Cognitively Impaired and Mentally Disabled (3/2015)

8-4 Vulnerable Participants: Prisoners (10/2013)

8-5 Vulnerable Participants: Terminally Ill

8-6 Vulnerable Participants: Normal Volunteers

8-7 Vulnerable Participants: Students, Trainees and Employees

Section 9 Informed Consent

9-1 Informed Consent Options (3/2015)

9-2 Informed Consent Involving Non-English Speaking Participants (10/2012)

9-3 Informed Consent Process

9-4 Obtaining Permission from Legally Authorized Representatives or Family Members (3/2015)

Section 10 HIPAA

10-1 HIPAA Requirements in Research

10-2 HIPAA Flowcharts

10-3 HIPAA Tip Sheet

Section 11 Research Involving Drugs and Devices

11-1 Investigational Drug Research (3/2017)

11-2 Approved and Unapproved Devices in Research

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

11-4 Humanitarian Use Device

11-5 Off Label Use of Drugs and Devices

11-6 Planned Emergency Research

11-7 Compassionate and Expanded Use of Drugs and Devices

Section 12 Research Procedures

12-1 The Use of Biological Specimens in Research (3/2015)

12-2 Data Safety and Monitoring in Research

12-3 Research Studies Involving the Collection of Blood Samples (9/2016)

Section 13 Reporting Responsibility

13-1 Unexpected Problems (3/2015)

13-2 Reporting Unexpected Problems (3/2015)

13-3 Adverse Event Algorithm

13-4 Determining which Adverse Events are Unexpected

Section 14 Conflict of Interest

14-1 Conflict of Interest: Principal Investigator/Key Personnel

14-2 Conflict of Interest: Institutional Review Board Members and IRB Administration Staff

Section 15 Non-Compliance

15-1 Identifying, Defining and Managing Non-Compliance in Human Research (3/2015)

15-2 For Cause Audits

15-3 Suspension and Termination of Research Protocols (3/2015)

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)


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