SOPs

IRBMED Standard Operating Procedures

IRBMED
Aug 24, 2018 12:00 pm

The IRBMED Standard Operating Procedures serve as the method by which the IRBMED implements the governing rules of the HRPP Operations Manual (OM). The IRBMED Standard Operating Procedures serve as a reference for investigators, IRBs, administrators, and others.

University of Michigan
Medical School
Institutional Review Board (IRBMED)

Standard Operating Procedures

Expect updated version in early 2018 due to regulatory and policy changes.

  • Part 1 – Introduction, Purpose, and Ethical Principles

    This section describes the mission of the 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.

    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 HRPP and 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.

    I. KEY ORGANIZATIONAL REPRESENTATIVES

    II. Organizational Entities that Support IRBMED

         A. University of Michigan Office of Research

         B. The Academic Units

         C. Other University of Michigan Institutional Review Boards

         D. Other Research Review and Support Units

         E. Independence of Research Review Units and Response to Undue Influence

         F. Resources

    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.

    I. Rule making at the University of Michigan

    II. HRPP OPERATIONS MANUAL

    III. IRB STANDARD OPERATING POLICIES AND PROCEDURES

         A. General Provisions

         B. Organization and Personnel (Chairs, Members and Staff)

         C. IRB Review Policies and Procedures

         D. IRB Administrative Functions

         E. Quality Assurance and Quality Improvement

    IV. OTHER REVIEW UNIT STANDARD OPERATING POLICIES AND PROCEDURES

  • Part 4 – Activities Subject to the HRPP

    The conduct of human subjects 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 U-M’s HRPP or when the requirements of the HRPP are triggered, four questions must be answered. First, is it human subjects research under the Common Rule? Second, is it human subjects research under FDA regulations? Third, is U-M engaged in the research? And finally, when does the research begin and end? Analysis of these questions is described below and in the decision aids attached to the Appendix.

    I. Determining What is and what is not human subjects Research

    II. Determining Whether Research Involves Human Subjects

    III. Determining Whether the University is Engaged in Human SUBJECTS Research

    IV. Determining When HUMAN SUBJECTS Research Begins and Ends

    V. Authority to Make ReGULATED/not-REGULATED determinations (PER THE COMMON RULE AND FDA) and notification of decisions

         A. Authority to Make Regulated/Not-Regulated Determinations

         B. Illustrations

         C. Student Practicum and Internships

         D. Notification of Decisions

         E. Review of Emergency Use of Investigational Agents

         F. Review of Humanitarian Use Devices (HUD) Under a Humanitarian Device Exemption (HDE)

         G. 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

    University research generally must be approved or declared exempt by a University IRB. This section describes the scope of jurisdiction of the various University IRBs and policies on cooperative research and ceded review.

    I. University of Michigan IRB Jurisdiction

         A. IRBMED

         B. IRB–Health Sciences and Behavioral Science (IRB-HSBS)

         C. IRB-Dearborn

         D. IRB-Flint

         E. General Exceptions

    II. Cooperative Research

         A. Engagement in Human Research

         B. Default Position on Outside Entities Engaged in University Research: Avoiding Duplicate Review

         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. IRB-of-Record

         B. Responsibilities of the HRPP and Local IRB in Multi-Site Research

    IV. Unaffiliated Investigators

    V. RESEARCH INVOLVING COMMUNITY MEMBERS IN THE RESEARCH PROCESS

  • Part 6 – Roles and Responsibilities of Investigators and Research Staff

    Every person involved in human research plays a critical role in protecting the rights and welfare of research participants. This section describes the roles and responsibilities of investigators and research staff engaged in University research.

    I. ELIGIBILITY TO PERFORM RESEARCH AT THE UNIVERSITY OF MICHIGAN

    II. ROLES AND RESPONSIBILITIES OF INVESTIGATORS AND RESEARCH STAFF FOR THE PROTECTION OF HUMAN SUBJECTS

         A. Generally

         B. Key Responsibilities

         C. 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 (IRB) or other duly constituted committee approved by the University of Michigan Office of Research (UMOR), 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.

    I. HRPP PROTECTION EXTENDS TO ALL SUBJECTS

    II. Data and Safety Monitoring Plans and Boards

    III. Payment to Research Subjects

    IV. Vulnerable Subjects

         A. Research Involving Pregnant Women, 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 – Studies Regulated by FDA and Use of Investigational Articles

    The US 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.

    I. Introduction

    II. RESEARCH INVOLVING INDs OR IDEs

         A. Investigational Drugs and Biologics

         B. Investigational Devices

         C. Humanitarian Use Devices (HUD)

    III. Expanded access

         A. Investigational Drugs and Biologics

         B. Expanded Access to Investigational Devices

    IV. Emergency Use of investigational articles

    V. Planned Emergency Research Using investigational articles

    VI. FDA Sponsors and sponsor-investigators

    VII. Investigator and IRB REsPonsibilities for FDA-REgulated Research

         A. Ensuring Review by Appropriate IRB

         B. Verification of IND or IDE Acquisition Prior To Release of Final IRB Approval

         C. Oversight of FDA-Regulated Research

         D. Investigational Article Accountability

         E. Charging for Investigational Articles

         F. Records and Documentation

         G. Required Reporting

         H. ICH-E6 and GCP

         I. FDA Inspection of FDA-Regulated Research and Related Articles

         J. Additional Exceptions

  • 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.

    I. APPLICABLE POLICIES

    II. Conflicts of Interest of Investigators and Research Staff

         A. Identification and Disclosure of Outside Interests Related to Human Research

         B. Conflict of Interest Review and Management

         C. IRB Risk/Benefit Analysis

    III. Conflict of Interest of IRB Members, Consultants, And Staff

    IV. INSTITUTIONAL CONFLICTS OF INTEREST

  • Part 10 – Sponsored Projects

    This section describes policies and procedures for the administration of sponsored project agreements for human subjects research.

    I. ROLE OF THE OFFICE OF RESEARCH AND SPONSORED PROJECTS

    II. AGREEMENTS WITH SPONSORS

         A. Assurance of Compliance with Human Research Protection Requirements

         B. Medical Care for Research-Related Injury

         C. Communication of Findings that May Affect the Safety of Human Research Participants or their Willingness to Participate or Influence the Conduct of the Research

         D. Dissemination of Findings From the Research

    III. FINDERS FEES AND BONUS PAYMENTS

    IV. ADDITIONAL INFORMATION

  • Part 11 – Laws, Regulations, and Standards

    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 UM and the University’s implementation and educational activities to promote compliance with these regulations.

    I. LEGAL AND REGULATORY BODIES

    II. LAWS, REGULATIONS, AND STANDARDS COMMONLY APPLICABLE TO RESEARCH

         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. Document Control and Record Retention and Destruction

         G. State Professional Licensing Laws and Institutional Credentialing Policies

         H. Clinical Trials Disclosure Requirements

    III. ACCESS TO LEGAL COUNSEL

  • Part 12 – Quality Assurance and Research Compliance

    This section describes the University’s quality assurance, quality improvement, and enforcement activities.

    I. Quality Assurance: assessment and Improvement

         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. Actions of the Institutional Official

         G. Response to Determinations of Noncompliance

         H. Institutional Notification and Reporting Requirements

    III. Other reportable events (adverse events, Unanticipated Problems Involving Risks to Subjects or Others) and 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

  • Part 13 – Education and Training

    This section describes educational and training opportunities offered to IRBMED members, office staff, and researchers and study team members comprising the University research community.

    I. EDUCATION IN GENERAL

         A. Required Training

         B. Educational Initiatives for the Research Community

    II. TRACKING AND COMMUNICATING NEW DEVELOPMENTS

  • Definitions Appendix

Questions?

Contact us at irbmed@umich.edu or 734-763-4768 / (Fax 734-763-1234)
2800 Plymouth Road, Building 520, Room 3214, Ann Arbor, MI 48109-2800

A list of IRBMED staff is available in the Personnel Directory, or view the list of Regulatory Teams.

Edited By: bpsea@umich.edu
Last Updated: August 24, 2018 12:00 PM