Part 1 - Introduction, Purpose and Ethical Principles (January 2008)

This section describes the mission of the University of Michigan, the purpose of the University’s Human Research Protection Program (HRPP) and authority under which it operates, and the scope of research conducted at the University.

MISSION STATEMENT AND ORGANIZATIONAL SUMMARY

The mission of the University of Michigan is to serve the people of Michigan and the world through preeminence in creating, communicating, preserving and applying knowledge, art, and academic values, and in developing leaders and citizens who will challenge the present and enrich the future.  See the University of Michigan Mission Statement.

The Vice President for Research has developed and implemented a Human Research Protection Program (HRPP), an integrated system consisting of research leadership, administration, and oversight functions, including education, 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.

The purpose of the HRPP is to protect the rights and welfare of human subjects participating in biomedical and behavioral research conducted at the University of Michigan or elsewhere by University faculty, staff and trainees.  Its goals are to promote compliance with relevant legal requirements and ethical standards at all levels, while addressing the needs and concerns of researchers and enhancing support of their endeavors.

Ensuring success of the HRPP is a joint responsibility.  The program is led by the Office of the Vice President for Research (OVPR), 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 and trainees conduct research.  On the day-to-day operational level, the plan’s success requires buy-in from the faculty, staff, and trainees involved in the research enterprise.  These individuals coordinate their efforts through a Human Research Coordinating Council (HRCC). The HRCC is discussed further in Part II of this Operations Manual.

Note: For additional details on the history and purpose of the HRPP, see “Plan for Insuring Adequate Protection of Participants in Clinical Trials, Jan. 15, 2004.”  This is an early constituting document for the HRPP and while it does not fully and accurately reflect the current organization, standards or thinking, it does describe the genesis and early development of the program.  The document was presented to The Regents of the University of Michigan, whose acceptance established a commitment to the program and its essential objectives at the highest levels of the institution.

SCOPE OF HUMAN RESEARCH AT THE UNIVERSITY

Types of Human Research Conducted

The Vice President for Research maintains a research web site where extensive information concerning research conducted at the University and by its faculty may be found.  A summary of important research projects and strategic research directions for schools and colleges at the University appears at that site.

Categories of Participants

Participants in research conducted at the University or by its faculty, staff and trainees 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 representing different racial, ethnic and cultural backgrounds and who 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.

INSTITUTIONAL AUTHORITY

The Bylaws of the Board of Regents of the University of Michigan assign to the Vice President for Research 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.  The Vice President for Research, in turn, has established the HRPP.

As the University’s “Institutional Official” (IO), the Vice President for Research 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.

The Vice President for Research, on behalf of the University, is authorized to establish and has established Institutional Review Boards (IRBs) to assist in complying with applicable laws, regulations and University policy in the review, approval and monitoring of human research.  As of August 2006, the University had established nine IRBs in four 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.

LIMITATION ON INSTITUTIONAL AUTHORITY

All human research conducted by the University must be approved by an Institutional Review Board or granted an exemption by a University IRB (through its members or staff, as specified in the IRB’s standard operating procedures) or the Vice President for Research.  Research that has been reviewed and approved by a University IRB may be subject to further review and disapproval by other review bodies or officials (including the Vice President for Research); however, no person or organization may override an IRB’s disapproval determination. 

PROTECTION FROM UNDUE INFLUENCE

IRB and other HRPP unit chairs, 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 an IRB or other HRPP unit chair, member, or staff representative because of that individual’s role, i.e., to exercise undue influence.  “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 member who experience undue influence should first report the occurrence to the IRB or unit director, who will attempt to mediate or resolve the concern, in consultation with an IRB or unit chair, Deputy Institutional Official, or Institutional Official as necessary or appropriate.
  
  
• An IRB or HRPP unit member who experiences undue influence should first report the occurrence to the appropriate IRB or HRPP unit chair, who should notify the IRB or unit director.  Together they will attempt to mediate or resolve the concern, in consultation with the Deputy Institutional Official or Institutional Official as necessary or appropriate.
  
  
• An IRB or HRPP unit chair who experiences undue influence should first report the occurrence to the Deputy Institutional Official, who will attempt to mediate or resolve the concern, in consultation with the Institutional Official as necessary or appropriate.
  
  
• Any individual who believes that undue influence is being exerted by an official in one of the above reporting chain, 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.

ETHICAL PRINCIPLES

The Vice President for Research has issued Standard Practice Guide (SPG) 303.05.  This document establishes that it is 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 Office for Human Research Protections, Institutional Review Board Guidebook (Glossary).

Principle	Application
Respect for Persons	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 of others.  The principle is reflected in federal regulations and University policy through requirements that legally effective informed consent be sought 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	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 are intended to benefit from the research.

Additional ethical codes and guidelines, such as the Nuremberg Code, the Declaration of Helsinki, reports of the President’s Council on Bioethics, the National Bioethics Advisory Commission, and ethical codes of professional societies may govern University research.