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- Operations Manual - Part 1
Introduction, Purpose, and Ethical Principles
The purpose of the Human Research Protection Program (HRPP) is to protect the rights and welfare of human subjects participating in research conducted at the University of Michigan (U-M) or elsewhere by University faculty, staff, students, and trainees. Its goals are to promote compliance with relevant legal requirements and ethical standards at all levels, while also addressing the needs and concerns of researchers and enhancing support of their endeavors.
The Vice President for Research (VPR), who serves as the Institutional Official (IO) for human research oversight, has established, developed, and implemented the HRPP as an integrated system consisting of research leadership, administration, and oversight functions. The oversight component includes education and training; quality assurance and compliance; research review units, including institutional review boards (IRBs); and other organizations charged with responsibility for protecting human subjects, investigators, sponsors, and research participants. Together, these individuals and organizations promote excellence in all aspects of human research.
Ensuring success of the HRPP is a joint responsibility. The program is directed by the U-M Office of Research (UMOR), but its implementation requires the active participation and collaboration of many stakeholders. On the administrative side, these include all of the University’s executive officers, including the Provost, Chief Financial Officer, Executive Vice President for Medical Affairs, the Chancellors, and leadership of the schools and colleges whose faculty, staff, students, and trainees conduct research. On the day-to-day operational level, the plan’s success requires support from the faculty, staff, students, and trainees involved in the research enterprise.
A. Types of Human Research Conducted
The U-M supports a broad range of human research including, but not limited to biomedical research and clinical trials, education and behavioral research, research with vulnerable populations, and genomic research.
B. Categories of Participants
Participants in research conducted by the faculty, staff, students, and trainees at the University include a diverse group of individuals from the local community and throughout the United States and the world. They reflect the communities in which research is conducted and include individuals who represent different racial, ethnic, and cultural backgrounds and who may speak languages other than English. Some are healthy adults. Others are members of specifically identified and protected vulnerable subject populations (such as children, pregnant women, and prisoners) and other groups of individuals entitled to special safeguards (such as those who are cognitively impaired or economically or educationally disadvantaged).
A. Institutional Authority
The Bylaws of the Board of Regents of the University of Michigan assign to the VPR general executive responsibility for the research programs of the University, including maintenance of appropriate liaisons between the University and government agencies and other organizations supporting University research.
As the University’s “Institutional Official” (IO), the VPR has established and maintains a federalwide assurance (FWA) between the University and the United States Department of Health and Human Services (HHS), through its Office for Human Research Protections (OHRP). In that assurance, the University pledges to comply with federal regulations for all federally supported research. In addition, the VPR has established and maintains a Department of Defense Addendum to the FWA. By signing this addendum, the University agrees to the special terms and conditions for IRB review of projects funded by the DOD.
The IO, on behalf of the University, has established Institutional Review Boards (IRBs) to assist in the review, approval, and monitoring of human research and to ensure compliance with applicable laws, regulations, and University policies. The University has established eight IRBs in three operational offices. The IRB offices are responsible for the day-to-day operations of the IRBs. They function in coordination with University officials and other review committees but at all times maintain their independence to appropriately review, approve, and monitor human research. Individuals who are responsible for University business are prohibited from serving as members or ex-officio members of the IRBs.
B. Limitations on Institutional Authority
All human research conducted by the University must be approved by an IRB or granted an exemption as specified in the IRB’s standard operating procedures. Research that has been reviewed and approved by a University IRB or external IRB may be subject to further review and disapproval by other review bodies or officials (including the IO); however, no person or organization may override an IRB’s disapproval determination.
The VPR has issued Standard Practice Guide (SPG) 303.05. This document establishes the University policy that all human research, regardless of funding source, will be guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects Research (the "Belmont Report") and will comply with applicable University policies and federal, state, and local laws and regulations.
The Belmont principles and their application to human research are summarized below:
Table 1: Ethical principles guiding human research at the University of Michigan. Adapted from OHRP, Institutional Review Board Guidebook (Glossary).
|Respect for Person||Respect for persons requires that protocols (including the informed consent process) be designed to promote personal capacity to consider alternatives, make choices, and act without undue influence or interference from others. The principle is reflected in federal regulations and University policy through requirements that legally effective informed consent be sought and obtained, unless specific requirements for waiver of informed consent are met and appropriately documented; and that subjects with diminished capacity and others who are vulnerable to coercion or undue influence receive special protection or consideration.|
Beneficence entails an obligation to protect individuals from harm. The principle can be expressed in two general rules: (1) do no harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm. It is reflected in federal regulations and University policy through a requirement that principal investigators design and IRBs approve protocols only under circumstances where the benefits to the subjects and the importance of the knowledge to be gained justify the risks to the subjects sufficiently to warrant a decision to allow the subjects to accept those risks.
|Justice||Justice requires fairness in distribution of burdens and benefits. The principle often is expressed in terms of treating persons of similar circumstances or characteristics similarly. It is reflected in federal regulations and University policy through requirements that selection of subjects is equitable and is representative of the group(s) that is intended to benefit from the research.|
Additional ethical codes and guidelines, such as the Nuremberg Code, the Declaration of Helsinki, reports of the Presidential Commission for the Study of Bioethical Issues, and ethical codes of professional societies may also govern University research.
IRB and other HRPP unit administrators, members, and staff have numerous interactions with investigators and others in the performance of their assigned roles. The University will investigate and resolve any reported attempt to inappropriately pressure (i.e., to exercise undue influence upon) an IRB or other HRPP unit administrator, member or staff representative because of that individual’s role. “Undue influence” refers to interference with the normal functioning and decision-making of an IRB or other HRPP unit, or to influence an IRB or other HRPP faculty or staff member, outside of established processes or through normal and accepted methods, in order to secure a particular determination or outcome.
Any attempt to exercise undue influence over the IRB or any other HRPP unit should be reported as follows:
- An IRB or HRPP unit staff or faculty member who experiences undue influence should first report the occurrence to the IRB or unit chair or director, who will attempt to mediate or resolve the concern, in consultation with an IRB or unit chair, the HRPP Director, the Deputy Institutional Official (DIO) or the IO as necessary or appropriate.
- An IRB or HRPP unit chair who experiences undue influence should first report the occurrence to the HRPP Director, who will attempt to mediate or resolve the concern, in consultation with the DIO and/or IO as necessary or appropriate.
- Any individual who believes that undue influence is being exerted by an official in one of the above reporting chains, or who believes that the undue influence has not been appropriately or timely resolved, should report to the next higher level in the reporting chain and ultimately to the Office of the Vice President and General Counsel or the Health System Legal Office.
- In addition individuals who wish to report an incident of undue influence and remain anonymous may report through the Compliance Hotline.
Resolution of incidents involving undue influence depends on the circumstance, but may include disciplinary actions following University standard procedures addressing non-compliance with policy or procedures as described in the Faculty Handbook and OM Part 12.