TABLE OF CONTENTS
Section 1 Wayne State University Human Research Policy
1-1 Letter from the President
1-2 Wayne State University Human Research Protection Program
1-3 Wayne State University Human Protection Program: Roles and Responsibilities
1-4 What is Human Participant Research?
Section 2 Ethical Principles
2-1 Belmont Report
2-2 Nuremberg Code
2-3 Declaration of Helsinki
Section 3 WSU Affiliate Contracts and Agreements
3-1 Wayne State University Federal Wide Assurance
3-2 Detroit Medical Center IRB Agreement
3-3 John D. Dingell Veterans Administration Medical Center Memo of Understanding
Human Investigation Committee Policies and Procedures
Section 4 Protocol Review
4-1 Types of IRB Reviews
4-2 Initial Protocol Submission Requirements
4-3 Unexpected Events (Policy under revision. Please check back soon)
4-4 Exempt Review Procedures
4-5 Expedited Review Procedures
4-6 Amendments to the Research Protocols and Informed Consent
4-7 Continuation/Renewal of Protocol
4-8 Closure of a Research Protocol
4-9 Determining Projects that Require Additional Verification
4-10 Criteria for Determining Frequency of Review
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
Section 5 Institutional Review Board
5-1 Expectations of IRB Membership
5-2 Selection and Review of Institutional Review Board Members and Staff
5-3 Policy and Procedure Development and Approval
5-4 Selection of Alternative IRB Member for Duly Constituted Meeting
Section 6 Principal Investigator
6-1 Principal Investigator: Roles and Responsibilities
6-2 Investigator Initiated Research
6-3 Collaborating Research
6-4 International Research
6-5 State and Local Statutes
Section 7 Recruitment and Participant Rights
7-1 Recruitment of Research Participants
7-2 The Inclusion of Pregnant Women in Research
7-3 The Inclusion of Women and Minorities in Research
7-4 Advertising
7-5 Finders Fee
7-6 Costs Associated with Research Participation
7-7 Compensation for Research Participation
Section 8 Research Involving Vulnerable Participants
8-1 Research Involving Fetuses and Neonates
8-2 Vulnerable Participants: Children
8-3 Vulnerable Participants: Cognitively Impaired and Mentally Disabled
8-4 Vulnerable Participants: Prisoners
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
9-2 Informed Consent Involving Non-English Speaking Participants
9-3 Informed Consent Process
9-4 Obtaining Permission from Legally Authorized Representatives or Family Members
Section 10 HIPAA
10-1 HIPAA Requirements in Research
10-2 HIPAA Flowcharts
10-3 HIPAA Tip Sheet
10-4 HIPAA Summary Form
10-5 Data Use Agreement
Section 11 Research Involving Drugs and Devices
11-1 Investigational Drug Research
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
12-2 Data Safety and Monitoring in Research
12-3 Research Studies Involving the Collection of Blood Samples
Section 13 Reporting Responsibility
13-1 Adverse Reactions and Unexpected Events (Policy under revision. Please check back soon)
13-2 Deviations and Violations (Policy under revision. Please check back soon)
13-3 Reporting of Unanticipated Problems, Terminations, Suspensions and Serious and Continuing Non-Compliance (Policy under revision. Please check back soon)
13-4 Institutional Officials and Reporting Responsibilities (Policy under revision. Please check back soon)
Section 14 Conflict of Interest
14-1 Conflict of Interest: Principal Investigator/Key Personnel
14-2 Conflict of Interest: Institutional Review Board Members and HIC Staff
Section 15 Non-Compliance
15-1 Identifying, Defining and Managing Non-Compliance in Human Research
15-2 For Cause Audits
15-3 Suspension and Termination of Research Protocols
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
Section 17 Human Investigation Committee Forms
17-1 Administrative Application
17-2 Adverse Reaction and Unexpected Event Form (Policy under revision. Please check back soon)
17-3 Amendment Submission Form
17-4 Authorization to Use Another IRB for Protocol Approval Agreement
17-5 Authorization to be the IRB of Record for Collaborating Entity
17-6 Closure Form
17-7 Continuation Submission Form
17-8 Coordinating Center Application
17-9 Initial Submission Reviewer Form
17-10 Exempt Medical Reviewer Form
17-11 Expedited Medical Reviewer Form
17-12 Expedited Continuation Reviewer Form
17-13 Full Board Continuation Reviewer Form
17-14 Amendment Reviewer Form
17-15 Behavioral Exempt/Expedited Reviewer Form
17-16 Humanitarian Use Device (HUD) Form
17-17 Medical Exemption Protocol Summary Form
17-18 Medical/Behavioral Protocol Summary Form
17-19 Emergency Single Time Use of a Test Article
17-20 VA Reviewer Checklist
Section 18 Human Investigation Committee Processes and Procedures
18-1 Adverse Reaction/Unexpected Events: Office Process
18-2 New Protocol Submission: Office Process
18-3 Amendment Submissions: Office Process
18-4 Continuation Submissions: Office Process
Contact Information
Human Investigation Committee Office (HIC)
101 Alexandrine
Detroit , Mi 48202 (map)
(313) 577-1628
Research Compliance Process Improvement Coordinator (313) 577-2901
Education Coordinator (313) 577-9534
HIC Chair (313) 577-1628
Research Compliance Office (313) 577-9064
