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IRBMED Standard Operating Procedures | Research A to Z
Copy Generated on: July 3, 2020, 12:52 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.
Institutional Review Board (IRBMED)
Expect updated version in early 2020 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.
II. Organizational Entities that Support IRBMED
A. University of Michigan Office of Research
C. Other University of Michigan Institutional Review Boards
D. Other Research Review and Support Units
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
B. Organization and Personnel (Chairs, Members and Staff)
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
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
C. Student Practicum and Internships
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
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.
II. ROLES AND RESPONSIBILITIES OF INVESTIGATORS AND RESEARCH STAFF FOR THE PROTECTION OF HUMAN SUBJECTS
C. STUDIES REGULATED BY THE FOOD AND DRUG ADMINISTRATION
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.
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.
II. RESEARCH INVOLVING INDs OR IDEs
C. Humanitarian Use Devices (HUD)
III. Expanded access
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.
III. Conflict of Interest of IRB Members, Consultants, And Staff
Part 10 – Sponsored Projects
This section describes policies and procedures for the administration of sponsored project agreements for human subjects research.
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
III. FINDERS FEES AND BONUS PAYMENTS
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.
III. Other reportable events (adverse events, Unanticipated Problems Involving Risks to Subjects or Others) and Suspension or Termination of IRB Approval
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
Last Updated: February 19, 2020 12:00 PM
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