University of Michigan
Medical School
Institutional Review Board (IRBMED)
Standard Operating Procedures
(Link to Full Version)
Part 1 – Introduction, Purpose, and Ethical Principles - This section describes the mission of the University of Michigan Medical School Institutional Review Board (IRBMED), the purpose of the IRBMED, the authority under which it operates, and the scope of research conducted at the University. (PDF Version)
I. Mission Statement and Organizational Summary
II. Scope of Human Research at the University
III. Institutional Authority
IV. Limitation on Institutional Authority
V. Protection from Undue Influence
VI. Ethical Principles
Part 2 – Organization of the IRBMED - This section describes the organization of the University of Michigan Medical School Institutional Review Board (IRBMED) and the roles and responsibilities of the various units that guide and support the program. (PDF Version)
I. Key Organizational Representatives
II. Organizational Entities That Support the IRBMED
A. Office of the Vice President for Research (OVPR)
B. The Academic Units
C. Other University of Michigan Institutional Review Boards (IRBs)
D. Other Research Review Units
E. Roles and Responsibilities of Other Units Supporting IRBMED
F. Independence of Research Review Units and Response to Undue Influence
G. Relationship with the Research Community
III. Resources
Part 3 – HRPP Policy - This section describes the process by which the University’s Human Research Protection Program (HRPP) policies, including the IRBMED policies, are developed, approved, and implemented, and articulates minimum requirements for IRBMED SOPs and Policies. (PDF Version)
I. Introduction
II. The Operations Manual (OM)
III. IRBMED Standard Operating Policies (SOPs) and Procedures
A. General Provisions
B.Organization and Personnel
C. IRBMED Functions and Operations
D. IRBs Reviewing and Monitoring FDA-Regulated Research
E. IRBMED Members, Consultants, Staff, Guests, Convened Board and Institutional Conflicts of Interest
F. Records and Reports
G. Educational Activities
H. IRBMED Internal Review of Operations
I. Other Review Units
J. International Research
Part 4 – Activities Subject to the HRPP - This section reviews how the conduct of human research triggers a broad array of regulatory and institutional requirements, including advance approval from IRBs and other review units. To determine whether a particular activity is subject to the University’s HRPP or when the requirements of the HRPP are triggered, four questions must be answered. First, is it human research under the Common Rule? Second, is it human research under FDA regulations? Third, is the University of Michigan engaged in the research? And finally, when does the research begin and end? Analysis of these questions is described below, in the decision aids attached to the Appendix, and posted at http://www.hrpp.umich.edu. (PDF Version)
I. Determining What Is Research and What Is Not
II. Determining Whether Research Involves Human Subjects
III. Determining Whether the University Is Engaged in Human Research
IV. Determining When Research Begins and Ends
V. Authority to Make Human Research/Not Human (Not OHRP/FDA-Regulated) Research Determinations and Notification of Decisions
A. Authority to Make Human Research/Not Human (Not OHRP/FDA-Regulated) Research Determinations
B. Illustrations
C. Student Practicum and Internships
D. Quality Improvement Activities vs. Human Research
E. Public Health Not Human Research
F. Notification of Decisions
G. Review of Emergency Use of Investigational Agents
H Review of Humanitarian Use Devices (HUD) under a Humanitarian Device Exemption (HDE)
I. Non-Research Use of Investigational Products Regulated by the FDA
VI. Policy on Exempt Research
A. Introduction
B. Categories of Eligibility for Exempt Determination
C. Authority to Grant Exempt Status
D. Notification and Documentation of Exempt Status
Part 5 – IRB Jurisdiction and Cooperative Research - This section describes the scope of jurisdiction of the various University IRBs and policies on cooperative research and deferred review. (PDF Version)
I. Which University of Michigan IRB
A. IRB–Flint
B. IRB–Dearborn
C. IRB–Health Sciences and Behavioral Science (IRB-HSBS)
D. IRBMED
E. Ensuring Adequate IRB Capacity
II. Cooperative Research
A. Engagement in Human Research
B. Default Position on Outside Entities Engaged in University Research
C. Researcher and IRB Responsibilities with Regard to Performance Sites Not Engaged in Research
D. Special University IRB Responsibilities for Multi-Site Research in Which the University Is Involved
III. Coordinated or Joint Review
A. Facilitated Review
B. IRB-of-Record
C. Responsibilities of the HRPP and Local IRB in Multi-Site Research
IV. Unaffiliated Investigators
Part 6 – Roles and Responsibilities of Investigators and Research Staff - This section describes the scope of jurisdiction of the various University IRBs and policies on cooperative research and deferred review. (PDF Version)
I. Eligibility to Perform Research at the University of Michigan
A. Who May Apply to Serve as Principal Investigator on IRB Applications
B. Other Key Personnel
II. Roles and Responsibilities of Investigators and Research Staff
A. Generally
B. Studies Regulated by the Food and Drug Administration
III. Education
Part 7 – Participant Protection - All non-exempt human research subject to the HRPP is reviewed and must be approved by the applicable Institutional Review Board or other duly constituted committee approved by the Office of the Vice President for Research, using criteria similar to those applied to federally-funded research and consistent with the principles outlined in the Belmont Report. This section describes some of the ways research participants are protected under the HRPP. (PDF Version)
I. HRPP Protection Extends to All Subjects
II. Data and Safety Monitoring Plans
III. Payment to Research Subjects
IV. Vulnerable Subjects
Special Review Considerations for Projects Involving Vulnerable Populations
A. Research Involving Pregnant Women, Human Fetuses, and Neonates
B. Research Involving Prisoners
C. Research Involving Children
D. Research Involving Adults with Cognitive Impairment or Otherwise Impaired Decision-Making Capacity
V. Compensation for Injuries
VI. Advertising Materials
Part 8 – Use of Test Articles and Humanitarian Use Devices - The US Food and Drug Administration (FDA) enforces the Food, Drug and Cosmetic Act and other laws and regulations governing the use of drugs, biologics, and devices for treatment and in research studies. This section describes when or under what circumstances an Investigational New Drug (IND) application or Investigational Device Exemption (IDE) is needed, and describes IRB responsibilities with respect to protocols involving investigational test articles. (PDF Version)
I. Determination that an IND or IDE is Required
A. Investigational Drugs and Biologics
B. Investigational Devices
C. Humanitarian Use Devices (HUD)
II. Withholding Final Approval Pending Verification of IND or IDE Acquisition
III. Institutional or Employee Sponsorship of INDs and IDEs
IV. Early and Expanded Access to Test Articles
A. Investigational Drugs
B. Investigational Devices
C. Continued Access
D. Humanitarian Use Devices (HUD) under a Humanitarian Device Exemption (HDE)
E. Additional Exceptions
V. Charging for Test Articles
A. Investigational Medical Devices and Radiological Health Products
B. Charging for Investigational Drugs and Biologics
VI. Electronic Records and Electronic Signature Articles
Part 9 – Conflicts of Interest and Commitment - Conflicts of interest and commitment in research can adversely impact the integrity of research results and the confidence of prospective volunteers in the research enterprise. The University seeks to identify, disclose, and avoid or manage conflicts to avoid these negative repercussions. (PDF Version)
I.. Applicable Policies
Additional Local Considerations
II. Conflict of Interest of Investigators and Research Staff
A. Identification of Significant Financial or Outside Management Interests in Human Research That Could Form the Basis of a Conflict of Interest
B. Conflict Review and Management
III. Conflict of Interest of IRB Members, Consultants, Staff, Guests and Convened Board
IV. Institutional Conflicts of Interest
Part 10 – Sponsored Research - This section describes policies and procedures for the administration of sponsored project agreements for human subjects research. (PDF Version)
I. Role of the Division of Research Development Administration
II. Agreements with Sponsors
A. Human Research Protection Program
B. Medical Care for Human Research Participants with a Research-Related Injury
C. Communication of Findings That May Affect the Safety of Human Research Participants or Their Willingness to Continue in the Research Study
D. Communication of Findings That May Directly Affect the Medical Care of Research Participants
III. Dissemination of Findings from the Research
IV. Additional Information
Part 11 – Standards, Compliance, and Education - The University of Michigan and its faculty, staff, and trainees are committed to complying with the laws and regulations that govern the conduct of human research and to upholding the highest ethical standards. This section describes selected laws and regulations impacting human research conducted at the University of Michigan and the University’s implementation and educational activities to promote compliance with these regulations. (PDF Version)
I. Introduction
II. Governing Laws, Regulations, and Other Standards
III. Other Related Laws, Regulations, and Standards
A. Informed Consent and Legally Authorized Representatives
B. Confidentiality of and Access to Research Records and Other Information
C. Research Involving Prisoners and Other Detained Persons
D. Research Involving Pregnant Women, Fetuses, and Neonates
E. Stem Cell Research
F. Data and Specimen Repositories
G. Document Control and Record Retention and Destruction
H. State Professional Licensing Laws and Institutional Credentialing Policies6
I. Registration of Clinical Trials
J. Lotteries
K. Screening Logs
L. Electronic Records and Electronic Signatures
M. Research Involving Human Specimens
IV. Education and Training for the Research Community
A. Educational Initiatives for the Research Community
B. Tracking and Communicating New Developments
Part 12 – Quality Assurance and Research Compliance - This section describes the University’s quality assurance, quality improvement, and enforcement activities. (PDF Version)
I. Quality Assessment, Improvement, and Assurance
A. Performance Measurement and Quality Assessment
B. Quality Improvement
II. Compliance Oversight
A. Response to Complaints or Allegations of Noncompliance
B. Noncompliance Review Procedures
C. How Compliance Concerns are Brought Forward
D. Receipt and Initial Handling of Allegations of Noncompliance
E. Chair and Board Considerations and Determinations
F. Detailed Procedures for Investigating Allegations of Noncompliance
G. Response to Determinations of Noncompliance
H. Institutional Notification and Reporting Requirements
III. Procedures for Review and Reporting of Unanticipated Problems Involving Risks to Subjects or Others, Serious or Continuing Noncompliance, or Suspension or Termination of IRB Approval
A. Background
B. Roles and Responsibilities
IV. Questions and Contact Information
A. IRBMED Director and Office
B. Questions Concerning University Policies and Procedures
Definitions Appendix (PDF Version)
Posted 11-22-10, Revised 5-25-12, 10/18/2012, 1/26/2013
