Organization of the HRPP (June 2012)
Operations Manual - Part 2
This section describes the organization of the University of Michigan's Human Research Protection Program (HRPP) and the roles and responsibilities of the various units that guide and support the program.
I. KEY ORGANIZATIONAL REPRESENTATIVES
An organization chart identifies key organizational officials and units in the 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.
II. ORGANIZATIONAL ENTITIES THAT SUPPORT THE HRPP
Numerous organizational entities contribute to the operation of the University's HRPP. These include:
- the Office of the Vice President for Research and its central operating units including OVPR's human research protection staff, the Division of Research Development and Administration, and the Office for Human Research Compliance Review, and coordinating committees, such as the Human Research Coordinating Council and the IRB Council;
- the schools, colleges and other academic units to which faculty, staff and trainees engaged in human research are appointed;
- the IRBs;
- other research review units with responsibility for monitoring specific categories of research;
- other support units and committees, such as the Michigan Institute for Clinical & Health Research, the Center for Statistical Consultation and Research, and the Research Administrators' Network; and
- key executive and administrative offices and functions including the Provost's office, the Executive Vice President for Medical Affairs, the Chancellors of the Flint and Dearborn Campuses, and the Office of the Vice President and General Counsel.
The HRPP structure is, thus, decentralized and seemingly complex. Decentralization contributes to the system's success by promoting local review and accountability and expert analysis of research proposals and IRB applications. The 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. Office of the Vice President for Research
The mission of the Office of the Vice President for Research (OVPR) is to nurture excellent 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 and knowledge and expertise with the larger society; and promote responsibility in the conduct and administration of these activities. To this end, OVPR 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 UM 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" and, in that capacity, 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 Institutional Official 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 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 human research/not human research determinations. See Part 5 of this Operations Manual for additional details.
- Makes or delegates authority to make decisions on IRB Authorization Agreements and Independent Investigator Agreements.
- Is responsible for all budgets within OVPR, including its various administrative and research units.
- Manages all OVPR units including the Division of Research Development and Administration and the Office for Human Research Compliance Review.
As the Institutional Official, the VPR promotes communication among research administrators, deans, department chairs, investigators, clinical care staff, human subjects, and other stakeholders to maintain a high level awareness regarding the ethical conduct of research and safeguarding the rights and welfare of subjects. This is accomplished in a number of ways, including: (i) sponsoring committees, forums and other formal and informal opportunities for researchers to air their goals and concerns and to provide input into institutional policy; (ii) maintaining access to the University's FWA; copies of pertinent federal and state laws, regulations, policies, and guidelines related to the involvement of human subjects in research; and institutional policies and procedures; and (iii) 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 ensures that IRB records are maintained as required by applicable laws and regulations and that they are accesible to authorized regulators and sponsors. When the University relies on another IRB for review and oversight of a project, the records may be maintained at the other IRB's site. See the standard University of Michigan IRB Authorization Agreement. The VPR also establishes and enforces policies and procedures to ensure that changes in approved research, during the period for which IRB approval already has been given, are not initiated without IRB review and approval, except when necessary to eliminate apparent, immediate hazards to the subject(s); and to ensure prompt reporting to the IRBs, appropriate University officials, and federal regulators and private sponsors, as required, of: (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 operations Manual 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 executive officers, the VPR provides sufficient resources, space and staff to support the IRBs' review, monitoring and record keeping duties.
The VPR ensures that appropriate oversight mechanisms are implemented to ensure compliance with applicable regulations and IRB determinations. The VPR also ensures that any coorperating performance sites in HHS-conducted or supported research performed primarily under the direction of the University have appropriate OHRP-approved assurances and provide certifications of IRB approval to the appropriate federal authorities. The VPR requires that coorperative IRB review arrangements be documented in writing consistent with OHRP guidance. 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 Operations Manual for additional information on required assurances and registrations and for a discussion on IRB-of-Record arrangements and the University's policy on unafilliated investigators.
Several functions within the Office of the Vice President for Research (OVPR) assist in developing, implementing and enforcing the HRPP and related University policies and procedures. OVPR also administers two the IRB Health Science and Behavioral Sciences. In addition, OVPR sponsors various committees, task forces and working groups to facilitate communication and coordination among various HRPP units and consistency, as appropriate, in implementation of the HRPP across the organization.
(a) Human Research Protection Program
The Associate Vice President with responsibility for research risks oversees the Human Research Protection Program (HRPP) for Research and serves as the Deputy Institutional Official (DIO). This individual advises the Institutional Official on all aspects of human research, develops and maintains this Operations Manual, formulates institutional policies for effective and efficient administration of the HRPP, and otherwise undertakes policymaking and policy implementation initiatives as necessary and appropriate. The DIO acts on behalf of the Institutional Official to conduct noncompliance reviews and serves as the designated contact person for OHRP under the University's FWA.
The DIO promotes consistency and addresses identified inconsistency among various University policies, procedures, and guidance affecting human research. The DIO 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 Occupational Safety and Environmental Health, the Conflict of Interest Review Committees, the Radiation Policy Committee, the General Counsel's Office, and the campus and health system compliance structures.
The DIO's administrative responsibilities inclue overseeing the HRPP function, signing, on behalf of the Institutional Official, IRB authorization agreements and individual investigator agreements and certificates of confidentiality and performing other tasks as delegated by the Institutional Official. Information about the HRPP is available through the HRPP Portal.
(b) Office of Research and Sponsored Projects (ORSP)
The Office of Research and Sponsored Projects (formerly Division of Research Development and Administration, DRDA) assists faculty and staff members in all aspects of externally funded research projects and other scholarly activities - from the identification of a potential sponsor and the preparation of a proposal, through various administrative activities (related to budgets, personnel, space, sub-contracts, reporting and accountability, patents and negotiations with the sponsor) during the course of the project, to the submission of the documents required to close out the project.
ORSP submits sponsored research proposals to external agencies, negotiates the terms of those agreements consistent with the mission and goals of the HRPP, and establishes appropriate financial accounts when a project is awarded. ORSP uses theelectronic Routing and Proposal Management (eRPM) information system to solicit information on whether a research proposal involves human subjects. No sponsored project involving human subjects is established without confirmation that IRB approval has been received and other regulatory requirements for the protection of human subjects have been met.
eRPM also elicits disclosures from investigators about whether they or any of the key investigators on the project (or their spouses or dependent children) have outside financial or management interests that may create a conflict of interest. ORSP project representatives monitor any proposal flagged for conflict of interest review and will not establish financial accounts without confirmation that Conflict of Interest Review Committee approval (and approval by the Board of Regents, if required) has been received.
ORSP implements the OVPR requirement that PIs 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 basic foundation and certification for responsible research conduct. Additional information about PEERRS and other educational initiatives is provided in Part 11 of this Operatons Manual.
(c) Office of Human Research Compliance Review
The mission of the Office of Human Research Compliance Review (OHRCR) is to ensure the protection of human subjects participating in research and compliance with the laws, regulations and University policies affecting the University's Human Research Protection Program. This 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 IRBs, and assisting with AAHRPP accreditation activities.
(d) Committees and Working Groups
Human Research Coordinating Council
The Human Research Coordinating Council (HRCC) was created to guide the establishment of the HRPP. The HRCC remains on stand-by to assist with priority setting, reviewing the adequacy of the communication and other linkages among human research compliance realms, and between each realm and the faculty, and recommending improvements.
The Vice President for Research or designee chairs the Council. The membership consists of:
- Associate Vice President for Research Ð Compliance
- Associate Vice President for Research Ð Life Sciences
- Assistant Dean for Research Regulatory Affairs, Medical School
- A representative of the UMHS Compliance Committee
- Chairs of all IRBs
- Chairs of the two UM Conflict of Interest Review Committees
- Chair of the Institutional Biosafety Committee (IBC)
- Biosafety Officer, OSEH
- Chair of the Subcommittee on Human Use of Radiation (SHUR)
- Director of the Office of Human Research Compliance Review (OHRCR)
- Executive Director of ORSP
- Executive Director of Audits
- A representative from the General Counsel's Office
- A representative from the Office of the Provost
- A representative from the Graduate School
- The Chief Financial Officer or designate
- An individual with professional experience in applied ethics
OVPR is the host office for HRCC and, as such, provides staff support for the Council. The HRCC meets as needed.
The HRPP receives policy support from the IRB Council. The IRB Council provides representation from a broad base of the research community, as described in Table 2 below. Ex officio consultants include the Director of the Office for Human Research Compliance Review, a representative of eResearch, and the HRPP legal counsel. Additional individuals may participate as invited guests at the discretion of the chair.
Table 2: IRB Council Membership
|Institutional Official (1)||Vice President for Research|
|Chair (1)||Associate Vice President for Research and Deputy Institutional Official|
|IRB Chairs||The chairs, co-chairs, and vice chairs of all of the UM IRBs|
The unit leadership of the IRBs:
|IRB Executive Directors or Other Key Administrators||
IRBMED: Senior Director of Research (Medical School); Director of Regulatory Affairs (Medical School); Director of IRBMED
|ORSP||Senior Associate Director|
|Faculty Researchers (5)||
|Ex Officio Consultants||
|Invited Guests||Anyone invited by the chair or (with the chair's permission) any member or consultant of the Council.|
The IRB Council advises the Institutional Official and Deputy Institutional Official with regard to HRPP and IRB policies and procedures. The IRB Council and its members are encouraged to seek the broadest possible input from the UM 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 Operations Manual (OM) policies, procedures, or guidance
- Assisting the Vice President for Research in prioritizing the need for OM policies, procedures, or guidance
- Providing advice on the development of OM policies, procedures, or guidance
- Reviewing OM policies, procedures, or guidance emerging from the eResearch process and elsewhere, recommending specific revisions, or recommending adoption
- Advising on whether policies should appear in the central OM or in individual IRB or other reivew unit SOPs
- Advising on the procedures developed by the various IRBs for development and updating of 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 Vice President for Research
The IRB Council serves a consultative role only. The Vice President for Research generally will solicit IRB Council input but to ensure the efficient operation of the HRPP may, prior to Council review or recommendation, develop and implement institutional policies and approve IRB and other review unit SOPs.
eResearch - Regulatory Management
To improve the management of research information at the University the Office of the Vice President for Research and Information and Technology Services (ITS) Administrative Computing have developed an electronic administrative system, called eResearch. One of eResearch's central goals is to support 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 and for grants and contract management functions. Faculty and staff from all three UM campuses, as well as representatives of IRBs and other HRPP review committees, have been involved in its development. Implementation has been phased in since 2005.
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 from the central administration to the faculty through their Associate Deans and provide a forum for Research Associate Deans to share initiatives and experiences in the development, conduct, and administration of research in their own units. The RADs bring to the IRB Council through the Associate Vice President for Research issues and concerns related to the operation of any component of the HRPP. They 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 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 wih 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 they are consistent with the requirements of this Operations Manual and applicable University policy. Academic unit policies and procedures may address issues such as:
- Mentoring programs for new faculty and continuing education for experienced faculty to ensure familiarity with best research practices and with applicable reegulatory 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 the Division of Research Development and Administration. This is accomplished through eRPM. See the eRPM instructions for additional information. 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 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. The Office of the Vice President for Research provides resources and administrative support for the IRB Health Sciences and Behavioral Sciences. The UM-Dearborn Office of Research and Sponsored Programs provides resources and administrative support for the IRB-Dearborn. The UM-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 Operations Manual, the University's IRBs review and monitor all University human research, regardless of funding source. In addition, certain types of research involving human subjects must be reviewed and approved by other departments, divisions, or units of the University in section D are described 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.
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 Standard Operating Procedures 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 Institutional Official or Deputy Institutional Official, or their designee, who then follows the procedures outlined in Part 12, Section III of this Operations Manual. Suspensions or terminations in research regulated under the Common Rule or FDA regulations are reported by the Institutional Official or Deputy Institutional Official to the relevant agencies, sponsors, or other authorities as required by applicable laws, regulations, or contractual commitments.
2. Primary Responsibility to Human Subjects
The Institutional Revew Board'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 Standard Operating Policies and Procedures (SOPs), together with related guidance in may cases, consistent with the requirements of Part 3 of this Operations Manual. 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 update of IRB-specific SOPs. IRB SOPs and any substantive amendments may be implemented only upon the approval of the Vice President for Research or designee.
D. Other Research Review Units
Additional organizational units throughout the Unviversity play critical roles in protecting the rights and welfare of human subjects. They are described below. Each unit is responsible for developing and implementing policies and procedures necessary to support its functions and for educating its members and staff, as well as affected investigators and others whose activities it regulates, as necessary to ensure compliance.
1. Biomedical Engineering Department
The Biomedical Engineering Department is responsible for the technical and engineering support of most of the medical equipment at the University of Michigan Hospitals and Health Centers (UMHHC), with certain exceptions for specialized services.
2. Comprehensive Cancer Center
Clinical Trials Office
The Cancer Center Clinical Trials Office (CTO) assists investigators by providing centralized data managment support for clinical research studies conducted by University of Michigan Comprehensive Cancer Center investigators.
Protocol Review Committees
The Protocol Review Committee (PRC) is responsible for all clinical therapeutic research protocols that involve the treatment of cancer.
The Cancer Prevention and Control PRC (CPC PRC) is responsible for clinical protocols involving cancer prevention or behavioral studies.
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 OVPR Conflict of Interest Committee reviews research outside of the Medical School.
The UMMS Conflict of Interest Review Board addresses 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 (MICHR)
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 Biosafey Committee (IBC) oversees recombinant DNA research at the University of Michigan as well as research with Select Agents not created using recombinant DNA techology.
6. Investigational Drug Service
All investigational drug protocols conducted by Medical School faculty or using UMHHC facilities must be reviewed by the Investigational Drug Service (IDS) prior to submission to the IRBMED. The IDS 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 appoval of the IRBMED and 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) promotes radiological safety and provides oversight for the safe use of radioactive materials and radiation-producing devices 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 and perform functions such as peer review and research oversight. These include, but are not limited to the Office of the Vice President for Research, the Alzheimers Disease Research Center, the Institute for Research on Women and Gender, and the Michigan Diabetes Research and Training Center.
E. Roles and Responsibilities of Other Units Supporting the HRPP
A variety of additional administrative units and functions contribute to the operation of the University's HRPP. Examples include:
- Biomedical Research Council
- Michigan Institute for Clinical and Health Research
- Life Sciences Institute
- Michigan Center for Oral Health Research
- Research Administrators' Network
- UMHS Compliance Program
- UMMS Office of Research
- IRBMED Leadership Group
F. Independence of Research Review Units and Response to Undue Influence
The research review units, and in particular the IRBs, are accountable to the Vice President for Research for appropriate conduct and protecting human subjects, but 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, icluding exercise of undue influence, are described in Part 12 of this Operations Manual. 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.
Resources for the HRPP components are provided through the annual budget review processes in the administrative units in which the components reside. For example, each IRB sits within an administrative structure that provides the resourcs for and oversees the general operation of the IRB: the Medical School provides resources and administrative support for the five IRBMEDs; the Office of the Vice President for Research provides resources and administrative support for the IRB-Health Sciences and Behavioral Sciences; the UM-Dearborn Office of Research & Sponsored Programs provides resources and adminstrative support for the IRB-Dearborn; and the UM-Flint Office of Research for the IRB-Flint.
The need for study-specific resources is evaluated at the local level. Investigators and sponsoring units are responsible to ensure 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, 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 Vice President for Research, or through the Vice President for Research to the Provost, who is the Unviersity's chief budget officer.