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Operations Manual - Part 2 - Organization of the HRPP

[Operations Manual Table of Contents]

I. KEY ORGANIZATIONAL REPRESENTATIVES

An organizational chart identifies key officials and units in the Human Research Protection Program (HRPP) and illustrates their relationships with one another. The chart displays the incumbent in each role as of the most recent update of this Part of the HRPP Operations Manual (OM).

II. ORGANIZATIONAL ENTITIES THAT SUPPORT THE HRPP

Numerous organizational entities contribute to the operation of the University’s HRPP. These include:

In addition to the entities listed above, other key executive and administrative offices – including the Provost, the Executive Vice President for Medical Affairs, the Chancellors of the Flint and Dearborn Campuses, and the General Counsel – all help contribute to the operation of the HRPP. The decentralized organization and shared support system of the HRPP contributes to the program’s success by promoting local review and accountability and expert analysis of research proposals and IRB applications. The inherent complexity is managed through a number of mechanisms, including convened standing coordinating committees, overlapping membership on local committees, and informal associations among individuals with HRPP responsibilities.

A. The U-M Office of Research (UMOR)

The mission of UMOR is to nurture excellence in research, scholarship, and creative activity by the University’s faculty, staff, and students; promote the integration of the research, education, and service missions of the University; facilitate the sharing of knowledge and expertise with the larger society; and promote responsibility in the conduct and administration of these activities. To this end, UMOR establishes the institution's research policies, administers a number of freestanding research units, assists in the creation and incubation of new initiatives, and provides a voice for U-M scholars and scientists in communicating with the public, private industry, and government.

The Vice President for Research (VPR) serves as the University’s “Institutional Official” (IO). In that capacity, the VPR sets the tone for an institutional culture of respect for human subjects and bears ultimate accountability for the proper conduct of human research at the University. The VPR’s primary activities as IO are described further below.

1. Policy Implementation, Communication, and Education

The VPR reviews and approves all HRPP policies and represents the HRPP to internal and external stakeholders. In this capacity, the VPR:

  • Defines the scope of the University’s Federalwide Assurance (FWA) and obligates the University to comply with its terms;
  • Retains authority to make exemption determinations in specific instances or for defined categories of activities and to make categorical determinations of what does nor does not constitute human research. See Part 5 of this OM for additional details;
  • Makes, or delegates authority to make, decisions on IRB authorization agreements, collaborating institution agreements, and individual investigator agreements;
  • Is responsible for all budgets within UMOR, including its various administrative and research units;
  • Manages all UMOR units.

As the IO, the VPR promotes communication among research administrators, deans, department chairs, investigators, clinical care staff, human subjects, and other stakeholders to maintain a high level of awareness regarding the ethical conduct of research and the safeguard of the rights and welfare of subjects. This is accomplished in a number of ways, including:

  • Sponsorship of committees, forums, and other formal and informal opportunities for researchers to air their goals and concerns and to provide input into institutional policy;
  • Maintaining access to the University’s FWA, as well as to pertinent federal and state laws, regulations, policies, and guidelines related to the involvement of human subjects in research, and to institutional policies and procedures;
  • Educating members of the research community to maintain a culture of compliance with regulations and institutional policies relevant to the protection of human subjects.

2. Recordkeeping and Reporting

The VPR establishes policies and procedures requiring that IRB records are maintained as required by applicable laws and regulations and that they are accessible to authorized regulators and sponsors. Records for projects that rely on an outside IRB for review and oversight are maintained by the outside IRB in accordance with the U-M IRB Authorization Agreement process.  

The policies also establish requirements to the IRB any changes to an already approved protocol, except when necessary to eliminate apparent, immediate hazards to the subject(s). In addition to reporting changes, investigators are required to promptly report to the IRBs, appropriate University officials, federal regulators, and private sponsors, as required: (i) unanticipated problems involving risks to subjects or others; (ii) serious or continuing noncompliance with federal regulations or IRB requirements; and (iii) any suspension or termination of IRB approval for research. See Part 12 of this OM for more information about reporting concerns.

3. Monitoring and Oversight

The VPR designates IRBs to review research covered by the FWA, as well as other research subject to the HRPP, and delegates additional authority to the IRBs and other units to act on other related issues. In collaboration with other University executive officers, the VPR provides sufficient resources, space, and staff to support the IRBs' review, monitoring, and recordkeeping duties.

The VPR ensures that appropriate oversight mechanisms are implemented to promote compliance with applicable laws, regulations and IRB determinations. For research supported by the United States Department of Health and Human Services (HHS) that is performed primarily under the direction of the University, the VPR also takes steps to ensure that any cooperating performance sites have approved assurances from the Office for Human Research Protections (OHRP). The VPR requires that cooperative IRB review arrangements be documented in writing consistent with OHRP guidance. For federally-sponsored research, the VPR also requires that unaffiliated investigators relying on the University's assurance have documented, as provided by OHRP guidance, their commitment to the University's human subjects protections requirements and to the IRB's determinations. See Part 5 of this OM for additional information on required assurances and registrations and for a discussion on IRB-of-Record arrangements and the University's policy on unaffiliated investigators.

4. Organization

Multiple individuals, units, and functions within UMOR assist in the development, implementation, and enforcement of University policies and procedures for the HRPP.

a. Leadership of the Human Research Protection Program (HRPP)

The Associate Vice President - Research Policy and Compliance serves as the Deputy Institutional Official (DIO) and advises the IO on all aspects of human research, including policy changes. The DIO acts on behalf of the IO and serves as the designated contact person for OHRP under the University’s FWA. The DIO signs Certificates of Confidentiality on behalf of the University.

The Director of the Human Research Protections Program (HRPP), reporting to the DIO, provides oversight for the HRPP, develops and maintains this OM, works with the IRB Council to draft institutional policies for effective and efficient administration of the HRPP, and coordinates policy implementation initiatives as necessary and appropriate. 

The HRPP Director promotes consistency and addresses identified inconsistencies among various University policies, procedures, and guidance affecting human subjects research.  The HRPP Director facilitates communication and coordination throughout the HRPP, chairs the IRB Council, and serves as a liaison between the HRPP and individual review units, organizations, and functions, including the Institutional Biosafety Committee, the Department of Occupational Safety and Environmental Health, the Conflict of Interest Review Committees, the Radiation Policy Committee, the General Counsel’s Office, campus and health system compliance structures, and academic misconduct investigations and proceedings.

The HRPP Director’s administrative responsibilities include overseeing the HRPP function; signing IRB authorization agreements, collaborating institution agreements, and individual investigator agreements; and performing other tasks as delegated by the IO or the DIO. The HRPP Director and staff maintain the HRPP web site.

b. Office of Research and Sponsored Projects

The Office of Research and Sponsored Projects (ORSP) assists faculty and staff members in all aspects of externally sponsored research projects and other scholarly activities – including the identification of a potential sponsor, preparation of a proposal, identification and resolution of various administrative, contractual and regulatory compliance issues, negotiation of funding agreements and submission of the documents required to close out the project.

ORSP submits sponsored research proposals to external funding entities, negotiates the terms of those agreements consistent with the mission and goals of the HRPP and law and policy applicable to the University, and arranges for the establishment of appropriate financial accounts when a project is awarded. ORSP obtains and records information about the proposal and project activity, including whether a research proposal involves human research and the status of the IRB approval, through the campus-wide eResearch Proposal Management (eRPM) system and utilizing a proposal approval form (PAF).

The PAF in eRPM asks the PI to attest to project team disclosures about whether they or any of the key investigators on the project (or their spouses, domestic partner, and/or dependent children) have outside financial or management interests that may create potential conflicts of interest.  eRPM displays disclosure status information used by ORSP.  ORSP project representatives monitor any proposal that is flagged for conflict of interest review and will not establish financial accounts without confirmation of review and approval by the appropriate Conflict of Interest Review Committee and by the Board of Regents, (if required).

ORSP requires that all Principal Investigators and Co-Investigators complete a web-based curriculum called the Program for the Education and Evaluation in Responsible Research and Scholarship (PEERRS) prior to initiation of a sponsored human research project. PEERRS serves as a tool to demonstrate and certify basic foundational knowledge of responsible research conduct. Additional information about PEERRS and other educational initiatives is provided in Part 3 of this OM.

c. Office of Research Compliance Review 

The mission of the Office of Research Compliance Review (ORCR) is to promote the protection of human subjects participating in research through compliance with the laws, regulations, and University policies affecting the University’s HRPP. This mission is fulfilled by conducting inspections of allegations and instances of noncompliance; initiating and conducting not-for-cause reviews of research protocols; initiating periodic reviews of HRPP subsystems, including the IRBs; and assisting with AAHRPP accreditation activities.

d. IRB Council

The IRB Council advises the IO and DIO with regard to HRPP and IRB policies and procedures. The IRB Council includes representation from a broad base of the research community, as described in Table 2 below. Ex officio consultants include the representatives from ORCR, a representative of Information and Technology Services (ITS), and representative(s) from the University’s Office of the General Counsel.  Additional individuals may participate as invited guests at the discretion of the chair. 

Table 2: IRB Council Membership

Position (#Members) Description

Deputy Institutional Official (DIO) (1)

Associate Vice President for Research-Research Policy and Compliance

Chair (1)

Assistant Vice President for Research-Regulatory and Compliance Oversight

IRB Chairs

The chairs, co-chairs, and vice chairs of all of the U-M IRBs

IRB Leadership

The unit leadership of the IRBs:

  • IRBMED: Associate Dean, Regulatory Affairs (Medical School)
  • IRB-Health Sciences and Behavioral Sciences: Assistant Vice President, Regulatory and Compliance Oversight (UMOR)

  • IRB-Flint: Director of Research

  • IRB-Dearborn: Compliance Consultant

IRB Executive Directors or Other Key Administrators

  • IRBMED: Senior Director of Research (Medical School); Director of Regulatory Affairs (Medical School); Director of IRBMED

  • IRB-Health Sciences and Behavioral Sciences: Director

ORSP

Associate Director

Faculty Researchers (5)

  • Nominations solicited from the Research Associate Deans or others

  • Appointments are made by the Vice President for Research (VPR)

  • Term is 3 years, renewable at the discretion of the VPR.

  • Number of appointments is roughly proportional to human subjects activity within each IRB jurisdiction (currently 2 for IRBMED, 2 for IRB-Health Sciences and Behavioral Sciences, and 1 for IRB-Flint and IRB-Dearborn on a rotating basis)

Ex Officio Consultants

  • ORCR representative

  • eResearch Director

  • MICHR Director and other representative

  • Legal Counsel

  • Provost's Office Representative

Invited Guests

Anyone invited by the chair or (with the chair's permission) any member or consultant of the Council

The IRB Council and its members are encouraged to seek the broadest possible input from the U-M research community and bring those perspectives to the deliberations of the Council. Specific functions of the IRB Council include:

  • Providing advice on the need for, prioritization of, and development of Operations Manual (OM) policies, procedures, or guidance;
  • Reviewing OM policies, procedures, or guidance emerging from the eResearch process and elsewhere, and recommending specific revisions or recommending adoption thereof;
  • Advising on whether policies should appear in the central OM or in individual IRB or other review unit Standard Operating Procedures (SOPs);
  • Advising on the procedures developed by the various IRBs for developing and updating local policy;
  • On a continuing basis, reviewing the adequacy of existing training and quality assurance functions and recommending improvements;
  • Coordinating the development of information technology sufficient to update compliance files and to provide dynamic linkages among compliance partners;
  • Performing other tasks as requested by the chair or the VPR.

The VPR generally will solicit IRB Council input but may develop and implement institutional policies and approve IRB and other review unit SOPs prior to Council review or recommendation, in order to ensure the efficient operation of the HRPP.

e. eResearch

To support the management of research information at the University, UMOR and Information and Technology Services (ITS) Research, Teaching, and Administration maintain an electronic administrative system called eResearch. eResearch supports efforts of faculty, staff, and students to comply with federal, state, and University requirements aimed at ensuring the safety and privacy of persons who volunteer to participate in research studies. eResearch also supports the administrative functions involved with conflict of interest management, grants, and sponsored projects. Regular updates are made to eResearch with input from administrative and academic units that support the HRPP. Requested changes are prioritized and approved via eResearch governing committees. Major changes must be approved by the DIO for the HRPP. Final authority to implement changes belongs to the Assistant Vice President for Research for Regulatory and Compliance Oversight and is delegated to the ITS Assistant Director for Research Administration Systems.

f. Research Associate Deans 

The Research Associate Deans (RADs) of the schools and colleges gather every other month at meetings convened by the Associate Vice Presidents for Research. The meetings facilitate communication between central administration and faculty through their RADs as well as providing a forum for RADs to share initiatives and experiences in the development, conduct, and administration of research in their own units. The Associate Vice President for Research represents any issues and concerns related to the operation of any component of the HRPP that are brought forwarded by the RADs. The RADs also review and provide feedback concerning policy and procedure initiatives.

B. The Academic Units

The University's schools, colleges, departments, and other academic units whose appointed faculty and staff conduct human subjects research are responsible for ensuring that sufficient resources (including facilities and equipment, personnel, regulatory support, and other financial and non-financial support) are allocated to sponsored and non-sponsored research activities to protect human subjects participating in those activities. For sponsored activities, the academic units certify compliance with this requirement through eRPM.

In addition, the academic units are permitted and encouraged to develop, implement, and enforce local policies and procedures governing University research, so long as those policies are consistent with the requirements of this OM and applicable University policies. Academic unit policies and procedures may address issues such as the following:

  • Mentoring programs for new faculty and continuing education for experienced faculty, to ensure familiarity with best research practices and with applicable regulatory and institutional requirements;
  • Administrative requirements designed to ensure that limited financial, facility, staff, and participant resources are appropriately allocated to individual projects or groups of projects;
  • Substantive peer review requirements designed to promote sound research design and scientific integrity in any University research.

All sponsored projects must be approved both at the local academic unit level and through ORSP. This is accomplished through eResearch.  In addition, through eResearch, the academic units may require that any individual projects or categories of projects, regardless of sponsorship, be approved at the unit level before they are initiated. IRBs may withhold approvals pending confirmation of approval or receipt of additional information (or both) from the academic unit and from other review units at the University or at other performance sites.

C. The Institutional Review Boards (IRBs)

Each of the University's IRBs sits within an administrative structure that provides the resources for and oversees the general operation of the IRB. The Medical School provides resources and administrative support for IRBMED. UMOR provides resources and administrative support for the IRB Health Sciences and Behavioral Sciences. The U-M Dearborn Office of the Provost provides resources and administrative support for the IRB-Dearborn. The U-M-Flint Office of Research provides resources and administrative support for the IRB-Flint.

The business functions of the administrative units are separated from the ethics review function. The administrators of the units supporting each IRB are not involved in the day-to-day operations of the IRB review process.

1. Authority of the University of Michigan Institutional Review Boards

Except for research that is specifically exempted in accordance with applicable laws and regulations and Part 4 of this OM, the University's IRBs review and monitor all University research involving human subjects, regardless of funding source. In addition, the specific types of human subjects research that must also be reviewed and approved by other departments, divisions or units of the University are described in section D below. Depending on the nature and scope of a project, a University IRB may withhold its approval pending confirmation of approval by, or receipt of additional information from, any of these units or from review units at other performance sites. Further, the University IRB’s have the right to observe or have a third party observe the consent process and the conduct of research.

Each University IRB also has the authority to suspend or terminate approval of research that is not being conducted in accord with the IRB's requirements or that has been associated with unexpected serious harm to subjects or others. Any suspension or termination of approval must be imposed in compliance with the IRB's SOPs and, at a minimum, include a statement of the reasons for the IRB's action. Promptly following any such suspension or termination, the IRB must report its action to the IO or DIO, or their designee, who then follows the procedures outlined in Part 12, Section III of this OM. If the suspended or terminated research is regulated under the Common Rule or Food and Drug Administration (FDA) regulations, the IO or DIO then reports the suspension or termination to the relevant agencies, sponsors or other authorities as required by applicable laws, regulations or contractual commitments.

2. Primary Responsibility to Human Subjects

Each IRB's first and most important function is to protect the rights and welfare of human research subjects. The safeguarding of subject rights and welfare must at all times take precedence over the goals and requirements of any research endeavor overseen by the IRB. IRB members and staff, as well as researchers submitting applications to the IRB, all must be informed of and understand this obligation.

3. Standard Operating Policies, Procedures and Guidance

Each of the University's IRBs has developed and documented its own SOPs, together with related guidance, that are consistent with the requirements of Part 3 of this OM. Having separate IRBs allows each to tailor its activities to the specific types of research it oversees, to the ethical issues raised by that research, and to the local context. Separate and specific IRBs also facilitate more targeted and effective education and training for IRB members and staff and for the researchers and others who interact with the IRB.

The administrative units overseeing the operations of the IRBs are responsible for the development, maintenance, review, and updating of IRB-specific SOPs. IRB SOPs and any substantive amendments may be implemented only upon the approval of the VPR or designee.

D. Other Research Review Units

1. UMHS Clinical Engineering 

UMHS Clinical Engineering (formally named Biomedical Engineering Unit) is responsible for the technical and engineering support of most of the medical equipment at the University of Michigan Health Systems (UMHS), with certain exceptions for specialized services.

2. Comprehensive Cancer Center

(a) Clinical Trials Office 

The Cancer Center Clinical Trials Office (CTO) serves as the centralized core facility of all clinical research trials conducted by investigators at the University of Michigan Comprehensive Cancer Center (UMCCC). The CTO offers a broad range of support services inlcuding regulatory and data management services.

(b) Protocol Review Committee

The Protocol Review Committee (PRC) is a multidisciplinary committee that provides peer review of the scientific merit, prioritization, and progress of all cancer clinical trial studies.

(c) Tissue Procurement Service

The Tissue Procurement Service ensures that relevant ethical and administrative guidelines are followed in the procurement and distribution of human tissue for research purposes.

3. Conflict of Interest Committees

The UMOR Conflict of Interest Committee reviews potential conflicts of interest in research outside of the Medical School.

The UMMS Conflict of Interest Review Board addresses potential conflicts of interest in research performed by Medical School faculty, staff, and trainees, and their affiliated co-investigators in other schools and colleges as appropriate.

4. Michigan Institute for Clinical and Health Research 

The Michigan Institute for Clinical and Health Research (MICHR) is an institution-wide institute aimed at providing education, resources, infrastructure, consultation, and guidance in the development and conduct of clinical and translational research at the University of Michigan. MICHR is the recipient of the NIH-funded Clinical and Translational Sciences Award (CTSA). MICHR is also the home of the former General Clinical Research Center, now called the Michigan Clinical Research Unit (MCRU).

5. Institutional Biosafety Committee 

The Institutional Biosafety Committee (IBC) oversees all recombinant and synthetic DNA research at the University of Michigan, including human gene transfer trials. The IBC also oversees research with select agents and toxins that are regulated by HHS and the U.S. Department of Agriculture (USDA), as well as other biological agents that require biosafety level three (BSL3) containment.

6. Investigational Drug Service 

All investigational drug protocols conducted by Medical School faculty or using UMHS facilities must be reviewed by the Research Pharmacy prior to submission to the IRBMED. The Research Pharmacy is responsible for: (i) assuring appropriate storage and handling of all investigational drugs; (ii) assuring inventory accountability of all investigational drugs; (iii) serving as a central source of information for all investigational drugs used for humans; (iv) dispensing medications only for protocols that have approval of the IRBMED and only in a manner consistent with the requirements of those protocols; and (v) distributing appropriate information about investigational drugs and their use in particular study protocols to individuals with direct care responsibilities for patients enrolled in those studies.

7. Radiation Safety Service 

The Radiation Safety Service (RSS) oversees the use of radioactive materials and radiation-producing devices at the University, and promotes radiological safety through safety training, professional guidance, and technical support, in accordance with federal and state regulations and the University’s Byproduct Material License.

8. Research Centers

A number of other centers distribute resources or provide other support on a merit basis, or perform functions such as peer review and research oversight. These include, but are not limited to, the U-M Office of Research, the Alzheimer’s Disease Research Center, the Institute for Research on Women and Gender, and the Michigan Diabetes Research and Training Center.

9. Additional Units Suppoting the HRPP

A variety of additional administrative units and functions contribute to the operation of the University's HRPP.  Examples include:

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

Although the research review units, and in particular the IRBs, are accountable to the VPR for appropriate conduct of research and for protecting human subjects they maintain their independence by formulating their own policies and procedures and, in some cases, through independent funding and oversight mechanisms. Specific procedures for reporting and responding to allegations of noncompliance, including exercise of undue influence of any HRPP unit administrator or staff member, are described in Part 1 and Part 12 of this OM. In addition, all faculty, staff, and trainees have access to advice and assistance outside of their units and traditional lines of supervision through the Provost's Office, the Office of the Vice President and General Counsel, and other central University offices.

F. Resources

Resources for the HRPP components are provided through the annual budget review processes in the administrative units in which the components reside. 

The need for study-specific resources is evaluated at the local level. Investigators and sponsoring units are responsible for ensuring that sufficient resources are allocated to all projects, whether sponsored or investigator-initiated. These include staffing and personnel (in terms of availability, number, expertise, and experience); psychological, social, and medical services (including counseling or social support services that may be required because of participation in a study); psychological, social or medical monitoring (including counseling or social support services that may be required because of participation in a study); psychological, social or medical monitoring, ancillary care, equipment needed to protect participants, and resources for participant communication (such as language translation services).

The need for incremental or off-cycle resources may emerge as a result of special or unusual demands on the offices, either as reported by the offices or by quality assurance/review activities, or by Executive Officer deliberations. Requests for incremental or off-cycle resources may be made to the responsible unit at any time, or to the VPR, or through the VPR to the Provost.