Part 5  - IRB Jurisdiction and Cooperative Research (January 2008)

WHICH UNIVERSITY OF MICHIGAN IRB

The University has registered nine IRBs under its Federalwide Assurance with the U.S. Department of Health and Human Services.  Two (IRB-Health and IRB-BehavSci) are operated by the Office of the Vice President for Research and review health, behavioral, and social science research outside the University of Michigan Health System.  One IRB (IRB-Flint) reviews research from the UM-Flint campus; another (IRB-Dearborn) reviews research from the UM-Dearborn campus.  Five IRBs (collectively referred to as IRBMED) review Health System research. 

The IRBs serve the institution as a whole: approval by one constitutes approval under the University’s HRPP.  The IRBs are specialized in terms of span of expertise, however, reflecting the types of studies each regularly reviews; the membership of each committee is diverse and promotes complete, adequate, fair and balanced review of research activities commonly conducted within its associated segment or discipline of the University.  Given this structure, investigators and others may need help determining which IRB should be consulted if there are questions about research under development and about to which IRB an application should be submitted.  Default IRB jurisdiction is summarized in Table 5 below.

Table 5: Default Jurisdiction of the University of Michigan’s Institutional Review Boards

Trigger	IRB-Flint	IRB-Dearborn	IRB-BehavSci	IRB-Health	IRBMED
PI’s primary appointment/ affiliation	Flint	Dearborn	College of Architecture and Urban Planning ISR Law School LS&A Office of the Provost Office of the Vice President for Student Services School of Art and Design School of Business Administration School of Education School of Information School of Music School of Natural Resources and Environment	College of Pharmacy Division of Kinesiology School of Dentistry School of Nursing School of Public Health School of Social Work	University of Michigan Health System fMRI
Facilities or Private Information	Flint (if any UMHS, defer to IRBMED)	Dearborn (if any UMHS, defer to IRBMED)
Biomedical Research	YES (Limited)	NO	NO	YES (Limited)	YES

Faculty, staff members, students and other trainees from units not listed in Table 5 should consult with the HRPP Office for information on the traditional IRB for their units.

The guidance below describes in further detail default IRB jurisdiction and principles underlying common exceptions to those defaults.  It also describes the procedures to follow in determining jurisdiction in unusual cases.  Special circumstances, such as the need for additional expertise during IRB review or the involvement of University of Michigan Health System patients or facilities, may warrant the transfer of oversight of a project from the IRB that would normally review and monitor it to another University IRB.  For any transfer, the receiving IRB will be provided with all information associated with the review in the project’s previous home.  Each IRB is authorized, in its discretion, to invite individuals with special expertise who have no disqualifying conflicts of interest to assist in the review of issues that require expertise beyond or in addition to that available on the IRB.  These individuals may not vote with the IRB. 

It is expected that the rules below will cover virtually all situations and clarify which IRB to use.  In rare instances in which the rules below do not clearly define which IRB to use and the chairs cannot agree on jurisdiction, the matter may be referred to the IRB Council for a determination.

IRB-Flint

All research in which a UM-Flint faculty or staff member or student or other trainee is the principal investigator and all research using UM-Flint facilities or private information should be reviewed and, if approved, monitored, by IRB-Flint.  There are five exceptions to this rule:

Exception 1: In those instances in which the proposed research uses patients or facilities in the University of Michigan Health System (other than patients of the UM-Flint Urban Health and Wellness Center), the research will be reviewed and, if approved, monitored by the IRBMED.  Research using UM PREMIER CARE, MHMC, MHIC, or M-CAID data will be reviewed by IRBMED or IRB-Flint, depending on the principal investigator’s primary appointment.

Exception 2: Research involving investigational drugs, biologics or significant risk devices will be reviewed and, if approved, monitored by the IRBMED.

Exception 3: In any other instances in which the IRB-Flint does not have the appropriate breadth of expertise to review a research proposal, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the IRB-Flint in consultation with the other IRBs.

Exception 4: In those instances in which conflicts of interest preclude a quorum for review, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the UM-Flint, if without a disqualifying conflict, in consultation with the other IRBs.  If the chair has a disqualifying conflict of interest, the selection will be made by the Vice President for Research or designee.

Exception 5: In those instances in which another IRB or a Flint faculty or staff member or trainee requests review by an IRB other than the IRB-Flint, the IRB-Flint chair will review the reasons for such a request; if appropriate, consult with the other IRBs; and decide which IRB shall review the proposal.  In extraordinary circumstances, the Vice President for Research may overrule a chair’s refusal to agree to such a proposal.

The IRB may, in its discretion, invite individuals with special expertise and no disqualifying conflicts of interest to assist in the review of issues that require expertise beyond or in addition to that available on the IRB.  These individuals may not vote with the IRB. 

IRB-Dearborn

All research in which a UM-Dearborn faculty or staff member or student or other trainee is the principal investigator and all research using UM-Dearborn facilities or private information should be reviewed and, if approved, monitored, by IRB-Dearborn.  There are five exceptions to this rule:

Exception 1: In those instances in which the proposed research uses patients or facilities in the University of Michigan Health System, the research will be reviewed and, if approved, monitored by the IRBMED.  Research using UM PREMIER CARE, MHMC, MHIC, or M-CAID data will be reviewed by IRBMED or IRB-Dearborn, depending on the principal investigator’s primary appointment.

Exception 2: In any other instance in which a UM-Dearborn faculty or staff member or student proposes bio-medical research, the research will be reviewed and, if approved, monitored by the IRBMED or the IRB-Health. The selection of IRB will be a joint determination by the chairs of the IRB-Dearborn, the IRBMED, and the IRB-Health.

Exception 3: In those instances in which the IRB-Dearborn does not have the appropriate breadth of expertise to review a research proposal, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of the alternative IRB will be made by the chair of the IRB-Dearborn in consultation with the other IRBs.

Exception 4: In those instances in which conflicts of interest preclude a quorum for review, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the UM-Dearborn, if without a disqualifying conflict, in consultation with the other IRBs.  If the chair has a disqualifying conflict of interest, the selection will be made by the Vice President for Research or designee.

Exception 5: In those instances in which another IRB or a UM-Dearborn faculty or staff member or student requests review by an IRB other than the IRB-Dearborn, the IRB-Dearborn chair will review the reasons for such a request; if appropriate, consult with the other IRBs; and decide which IRB shall review the proposal.  In extraordinary circumstances, the Vice President for Research may overrule a chair’s refusal to agree to such a proposal.

The IRB may, in its discretion, invite individuals with special expertise and no disqualifying conflicts of interest to assist in the review of issues that require expertise beyond or in addition to that available on the IRB.  These individuals may not vote with the IRB. 

IRB-BehavSci

All research from the following Ann Arbor units in which a faculty or staff member or student or other trainee is the principal investigator shall be reviewed and, if approved, monitored by the IRB-BehavSci:

1. College of Architecture and Urban Planning;
2. Institute for Social Research;
3. Law School;
4. LS&A;
5. Office of the Provost;
6. Office of the Vice President for Student Services;
7. School of Art and Design;
8. School of Business Administration;
9. School of Education;
10. School of Information;
11. School of Music; and
12. School of Natural Resources and Environment. 

The school/college of affiliation of a principal investigator will be deemed to be the school or college with which he or she has a primary appointment.  There are five exceptions to this rule:

Exception 1: In those instances in which the proposed research uses patients or facilities in the University of Michigan Health System, the research will be reviewed and, if approved, monitored by the IRBMED.  Research using UM PREMIER CARE, MHMC, MHIC, or M-CAID data will be reviewed by IRBMED or IRB-BehavSci, depending on the principal investigator’s primary appointment.

Exception 2: In any other instances in which a faculty or staff member or student proposes bio-medical research (including any research subject to FDA regulation), the research will be reviewed and, if approved, monitored by the IRBMED or the IRB-Health.  The selection of IRB will be a joint determination by the chairs of the IRB-BehavSci, the IRBMED, and the IRB-Health.

Exception 3: In those instances in which the IRB-BehavSci does not have the appropriate breadth of expertise to review a research proposal, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the IRB-BehavSci in consultation with the other IRB's.

Exception 4: In those instances in which conflicts of interest preclude a quorum for review, the research will be reviewed and, if approved monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the UM-BehavSci, if without a disqualifying conflict, in consultation with the other IRB's.  If the chair has a disqualifying conflict of interest, the selection will be made by the Vice President for Research or designee.

Exception 5: In those instances in which another IRB or a faculty or staff member or student requests review by an IRB other than the IRB-BehavSci, the IRB-BehavSci chair in consultation with the IRB staff will review the reasons for such a request; if appropriate, consult with the other IRBs; and decide which IRB shall review the proposal.  In extraordinary circumstances, the Vice President for Research may overrule a chair’s refusal to agree to such a proposal.

IRB-Health

All research from the following Ann Arbor units in which a faculty or staff member or student or other trainee is the principal investigator shall be reviewed and, if approved, monitored by the IRB-Health:

1. College of Pharmacy;
2. Division of Kinesiology;
3. School of Dentistry;
4. School of Nursing;
5. School of Public Health; and
6. School of Social Work.

The school/college of affiliation of a principal investigator will be deemed to be the school or college with which he or she has a primary appointment.  There are five exceptions to this rule:

Exception 1: In those instances in which the proposed research uses patients or facilities in the University of Michigan Health System, the research will be reviewed and, if approved, monitored by the IRBMED.  Research using UM PREMIER CARE, MHMC, MHIC, or M-CAID data will be reviewed by IRBMED or IRB-Health, depending on the principal investigator’s primary appointment.

Exception 2: In those instances in which the proposed research involves FDA-regulated drugs, biologics or devices (including but not limited to research involving INDs and IDEs), the research will be reviewed and, if approved, monitored by the IRBMED. See Part 8 of this Operations Manual for additional information on FDA-regulated research.  This exception does not apply to dental research or to any research involving non-significant risk devices as determined by IRB-Health under procedures approved by the Vice President for Research.

Exception 3: In any other instances in which the IRB-Health does not have the appropriate breadth of expertise to review a research proposal, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise. The selection of alternative IRB will be made by the chair of the IRB-Health in consultation with the other IRB's.

Exception 4: In those instances in which conflicts of interest preclude a quorum for review, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise. The selection of alternative IRB will be made by the chair of the IRB-Health, if without a disqualifying conflict, in consultation with the other IRB's. If the chair has a disqualifying conflict of interest, the selection will be made by the Vice President for Research or designee.

Exception 5: In those instances in which another IRB or a faculty or staff member or student requests review by an IRB other than the IRB-Health, the IRB-Health chair in consultation with the IRB staff will review the reasons for such a request; if appropriate, consult with the other IRBs; and decide which IRB shall review the proposal.  In extraordinary circumstances, the Vice President for Research may overrule a chair’s refusal to agree to such a proposal.

IRBMED

All research proposed by a faculty member from the Medical School, or by a staff member or student or other trainee affiliated with the University of Michigan Hospitals and Health Centers, shall be reviewed and, if approved, monitored by the IRBMED. The school/college of affiliation of a principal investigator will be deemed to be the school or college with which he or she has a primary appointment.  In addition, all research using the patients or facilities of the University of Michigan Hospitals and Health Centers shall be reviewed and, if approved, monitored by the IRBMED.  There are three exceptions to these rules:

Exception 1: In those instances in which the IRBMED does not have the appropriate breadth of expertise to review a research proposal, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the IRBMED chair in consultation with the other IRBs.

Exception 2: In those instances in which conflicts of interest preclude a quorum for review, the research will be reviewed and, if approved, monitored by an IRB with the appropriate expertise.  The selection of alternative IRB will be made by the chair of the IRBMED, if without a disqualifying conflict, in consultation with the other IRBs.  If the chair has a disqualifying conflict of interest, the selection will be made by the Vice President for Research or designee.

Exception 3: In those instances in which another IRB or a faculty or staff member or student requests review by an IRB other than IRBMED, the IRBMED chair will review the reasons for such a request; if appropriate, consult with the other IRBs; and decide which IRB shall review the proposal.  In extraordinary circumstances, the Vice President for Research may overrule a chair’s refusal to agree to such a proposal.

Ensuring Adequate IRB Capacity

The Vice President for Research may, as necessary for efficient operation of the HRPP to protect the rights and welfare of human subjects participating in University research, increase or decrease the number of IRBs registered under its FWA; designate external IRBs (under written agreements or memoranda of understanding) to review and monitor individual projects or categories of projects otherwise subject to University HRPP oversight; or modify the scope of any University IRB’s jurisdiction. Designation of external IRBs to review and monitor categories of federally funded projects requires amendment to the University’s FWA.

COOPERATIVE RESEARCH

Researchers at the University of Michigan frequently interact with entities or individuals outside the University.  The types of relationships are too numerous to list, but they may include:

• Purchasing goods;
• Contracting for commercial services or seeking professional services or opinions;
• Establishing research collaborations by subcontract from or to the University;
• Serving as the coordinating site for a multi-center clinical trial being conducted elsewhere;
• Serving as one of many subordinate (for example, enrolling) sites in a multi-center clinical trial;
• Conducting research at clinics, schools, etc., where the outside site provides only access;
• Conducting research at clinics, schools, etc., where the outside site has or will have name-linked research data;
• Conducting research in another country, but not in partnership with an established entity in that country;
• Establishing relationships with individuals, such as volunteer research assistants, who will provide services but not have access to name-linked research results; and
• Establishing relationships with individuals, such as volunteer research assistants, who will have access to name-linked research results.

The University’s (and its researchers’) regulatory obligations and alternatives for addressing them differ depending on the relationship with the entity or individual outside the University in the context of the research project.  In analyzing the many types of relationships that exist between the University and its researchers, on one hand, and outside entities or individuals, on the other, a primary distinction is between those that are “engaged” in human research versus those that are not engaged.  This distinction is important because each engaged institution is responsible for safeguarding the rights and welfare of human subjects and for complying with applicable laws and regulations (including the Common Rule, as appropriate) and with its own HRPP policies and procedures.  IRBs generally are free, however, through their standard operating procedures, to impose special requirements or restrictions on involvement in human subjects research that does not rise to the level of engagement.

The Vice President for Research has implemented the policies described below and in Part 3 of this Operations Manual to ensure that the University can fulfill its affirmative obligation to assure appropriate oversight of research in which the University is “engaged” and also, under certain circumstances, of other “engaged” entities associated with University research.

Engagement in Human Research

A performance site becomes “engaged” in human research when its employees or agents intervene or interact with living individuals for research purposes, or obtain individually identifiable private information for those purposes.  A performance site is always deemed to be “engaged” in human research when it receives a direct grant or other award to support the research.  A performance site is “not engaged” in human research if its employees or agents do not intervene or interact with living individuals for research purposes, or obtain individually identifiable private information for those purposes.

See Part 4 of this Operations Manual and the chart below for assistance in determining whether an investigator or institution is “engaged” in research; see also http://www.hhs.gov/ohrp/humansubjects/assurance/engage.htm for additional guidance.

OHRP issued additional draft guidance for public comment on December 8, 2006 (See FR Vol. 71, No 236, pg. 71169).  It is expected that when the new guidance is finalized it will be incorporated into this Operational Manual.

Table 6 - Engagement in Research Activities

Category	Description of UM Activities	UM Engaged?	Other Site Engaged?
Funding Only/No Direct UM Involvement	UM receives a direct grant or award to perform human subjects research, even if all of the activities are performed off-site by subcontractors or collaborators and UM itself never intervenes or interacts directly with human subjects and never receives identifiable private information.	YES	YES
Pre-Research Activities	UM performs a feasibility study to determine whether sufficient data or prospective participants exist to formulate a hypothesis or conduct a study.	MAYBE	n/a
	UM performs a small pilot study to work out details of an anticipated future research project.	YES
	UM intervenes or interacts with individuals who meet study eligibility criteria to develop study protocol.	YES
PR/Publicity/Pre-Screening Activities	UM informs potentially eligible subjects about research occurring elsewhere and provides them with information about how to contact the researchers.	NO	YES
	UM sends letters to prospective subjects describing a study and letting them know they may later be contacted to participate.	YES	MAYBE
Study Recruitment/Informed Consent	UM informs prospective subjects about the availability of research conducted elsewhere; provides prospective subjects with written information about research (including the relevant informed consent document and other IRB-approved materials); provides prospective subjects with information about contacting investigators for information or enrollment; or obtains and appropriately documents prospective subjects’ permission for investigators to contact them.  Generally, a UM clinician may discuss the study with the prospective subject as the subject’s clinician but not as a researcher or part of the study team.	NO	YES
	UM faculty, staff, trainees, or agents conduct the consent interview, obtain subject signature on the consent form, or otherwise act as authoritative representatives of the investigators.	YES	YES
	UM researchers obtain permission from a school or nursing home to observe, audio/videotape, or distribute surveys/questionnaires for research purposes.  The students or residents are consented by the UM researchers to participate in the project.	YES	NO
Data/Specimen Repositories	UM data steward queries UM database on behalf of external researchers.	NO	YES
	UM releases information and/or specimens to investigators at other site in non-identifiable (i.e., non-linkable) form, when the information and/or specimens were originally obtained for non-research purposes.	NO	NO
	UM receives information or specimens for research from established repositories operating in accord with an FWA, OHRP guidance on repositories, and a written agreement unequivocally prohibiting release of identifying information to UM investigators.	NO	YES
	UM obtains, receives, or possesses identifiable (directly or with links/codes) private information from another site for research purposes.	YES	YES
Multi-Site Research – UM Statistical Center	UM obtains, receives, or possesses identifiable (directly or through links) private information to operate a “statistical center” for multi-site collaborative research.	YES*	YES
Multi-Site Research – UM Operations/ Coordinating Center	UM obtains, receives, or possesses identifiable (directly or through links) private information to maintain an operations center or coordinating center for multi-site collaborative research.	YES	YES
Medical Care/ Standard Clinical Practice	UM provides unforeseeable but medically appropriate clinical treatment incident to a patient’s participation in a clinical trial elsewhere, e.g., when patient suffers an adverse event that is treated at UM by her regular health care provider.	NO	YES
	Patient is hospitalized at UM and attending physician decides continued participation on protocol at outside institution is ok.	NO	YES
Medical Care/ Little or No Direct UM Involvement/ Data Not Collected for Study	UM administers test article and performs normal monitoring, but does not perform data collection.	NO	YES
	UM performs blood draw for a genetics study occurring at another institution but sends the samples to the other institution for analysis.	NO	YES
	UM provides pre- and/or post-test genetic counseling to study participants regarding tests conducted by and results reported from other institution.	NO	YES
Subinvestigators	UM consents prospective subjects (even if for “someone else’s study”).	YES	YES
	UM performs physicals or other eligibility testing to be sent to investigators at another site.
	UM collects and reports data to investigators at another site.
Contracted Medical/ Professional Services	UM performs physicals or other eligibility testing to be sent to investigators at another site.	NO UM must adhere to commonly recognized professional standards for maintaining privacy and confidentiality.	YES
	UM performs and/or analyzes blood draw for genetics study occurring at other institution and furnishes the results to the investigator.
	UM collects and reports data to investigators at another site.
Consulting Services (See “multi-site research” above for additional details.)	Consultant does not obtain, receive or possess identifiable private information (e.g., the consultant analyzes data that cannot be linked to individual subjects, directly or through a coding system, by any member of the research team).	NO	YES
	Consultant accesses or uses identifiable private information while visiting the research team’s institution.	NO But consultant’s activities become subject to the other institution’s HRPPP.	YES
	Consultant obtains coded data for analysis at UM (and there is not a written agreement unequivocally prohibiting release of identifying codes to the consultant).	YES	YES

   Documentation of permission must be HIPAA-compliant if the UM investigator is affiliated with a unit covered by HIPAA.
*  If UM has no other interaction or intervention with subjects, and the principal risk associated with institutional activities is limited to the potential harm resulting from breach of confidentiality, then the UM IRB need not review each underlying collaborative protocol.  However, the IRB should determine and document that: (i) the statistical center has sufficient mechanisms in place to ensure the privacy of subjects and confidentiality of data are adequately maintained; (ii) each collaborating institution holds an FWA or other appropriate assurance; (iii) each protocol is reviewed and approved by the IRB at the collaborating institution prior to enrollment of subjects; and (iv) informed consent is obtained from each subject in compliance with the Common Rule.
 

Default Position on Outside Entities Engaged in University Research: Duplicate Reviews

The University’s default position on research performed at multiple locations is that each must review and approve its own participation in the research.  Table 7 below summarizes the necessary approval mechanism at the other site(s).  When the overall principal investigator of research conducted at multiple locations is affiliated with the University, or the University is otherwise involved as the primary or coordinating center, the PI must assure the University IRB reviewing the research that each performance location involved in the research has been properly approved at that location before the research is initiated there and must notify the University IRB if any lapse or other change in approval status occurs.  The IRB may take any steps it deems appropriate to verify the information provided by the PI.

Table 7: Acceptable Human Research Oversight Mechanisms

Other Site’s Engagement	Human Research Oversight Mechanism
Engaged Site with Federal Support or Direct Federal Grant	Federal registration of assurance (FWA or SPA/MPA with a non-HHS federal agency), whether U.S. or international; and Registered IRB (if applicable).  Note that for some projects sponsored by non-HHS federal agencies, the IRB may not be registered.  In that case, another oversight mechanism acceptable to the UM IRB will be appropriate.  Examples of such mechanisms are described in the cell below. Registered IRB may be a non-UM, OHRP-registered IRB or, with a proper memorandum of understanding and amendment to UM’s FWA, depending on the circumstances, the UM IRB may be used.
Engaged Site without Federal Support or Engaged Site with non-HHS Support Where the Federal Agency (e.g., National Science Foundation) Provides a Written Determination That an FWA or International Assurance (IA) is Not Required	No FWA or IRB required (but existence of FWA and IRB or similar assurance mechanism and ethics board is preferred); and Site must provide human research oversight acceptable to the IRB as documented in its SOPs. Examples of acceptable oversight mechanisms include OHRP-registered IRBs, research ethics boards, independent ethics committees, or (with proper MOU and amendment to UM’s FWA, depending on the circumstances) UM IRBs
Non-Engaged Site	Appropriate approval (as determined by the UM IRB) for conduct of research in the non-engaged site must be secured.  Appropriate approval locus or mechanism is site-specific.

The University does entertain requests to avoid duplicate reviews.  The circumstances under which the University will agree to serve as IRB-of-Record for other engaged sites or to cede review of University research to other IRBs are described below in section III.

Researcher and IRB Responsibilities with Regard to Performance Sites not Engaged in Research

When a performance site is not engaged in research, it is the responsibility of the principal investigator to assure that the site’s facilities and resources are appropriate for the nature of the activities that will be conducted there.  It is also the responsibility of the principal investigator to notify the IRB promptly if a change in research activities changes the performance site’s engagement in research.

IRBs may ask investigators to submit statements from entities providing research services or site access but not “engaged” in research to provide evidence of permission by those entities for their involvement.  The investigator may begin research activities at each site as it is approved by the IRB.  Performance sites may be added to a research study with the submission of an amendment and the appropriate documents to the IRB for review and approval prior to beginning research activities at the new performance sites.

Special University IRB Responsibilities for Multi-Site Research in Which the University is Involved

Generally

IRBs whose jurisdiction typically extends to research in which the University is one of multiple engaged sites must have a method to: (i) determine when other IRBs are involved; (ii) define their respective responsibilities in connection with the research; (iii) communicate as appropriate with the other involved IRBs; and (iv) notify investigators of any special expectations with regard to the conduct of multi-site research.  This may be accomplished through any combination of standard operating procedures, application forms, formal and informal guidance, inter-institutional agreements, and other communications.  For example, the University IRB should determine prior to the initiation of research how it will solicit and review reports of unanticipated problems involving risks to subjects or others, regardless of location, when those risks may have an impact on any matter within that IRB’s jurisdiction.

University of Michigan as a Coordinating Center

[RESERVED]

COORDINATED OR JOINT REVIEW

For federally funded research, an institution with an FWA that is participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.  The University permits similar arrangements for non-federally-funded research.  In either case, the Vice President for Research or designee must approve the arrangement for either individual studies or categorically (e.g. facilitated review).  Any coordinated or joint review effort requires a written agreement among the involved institutions, regardless of whether they maintain FWAs.

Note:  See http://www.fda.gov/oc/ohrt/irbs/research.html and http://www.fda.gov/oc/ohrt/irbs/nonlocalreview.html for additional guidance on cooperative research and reliance on non-local IRBs for approval of FDA-regulated research and http://www.hhs.gov/ohrp/humansubjects/guidance/hsdc93-01.htm regarding NIH research.

IRB-of-Record

An IRB is considered the IRB of record when it assumes IRB responsibilities for another institution and is designated to do so through an approved Assurance with OHRP.   In limited circumstances, the University will consider becoming the IRB-of-Record for the engagement in research by an outside entity or ceding authority for review and oversight of University research, in whole or in part, to an outside IRB.  Such a review-sharing arrangement requires a formal agreement between the institutions approved by the Institutional Official(s) or their designee.  The University’s Institutional Official is the Vice President for Research (VPR).  The VPR has delegated authority for approving IRB authorization agreements to the Associate Vice President for Research and Deputy Institutional Official.

IRBs have a central role in determining whether proposed arrangements preserve and promote protections for human participants in research for which they have responsibility, and, thus, are acceptable.  The University typically will accept or cede IRB responsibilities for a single specified research project only.  When research is federally-funded, the institution ceding review must amend its FWA to list the IRB-of-Record as a reviewing IRB.

Statement of Principles

Under certain circumstances the University will agree to become the IRB-of-Record for research conducted at another entity or allow another institution's IRB to serve as IRB-of-Record for University research.  The University will not normally provide IRB-of-Record services for research in which the University is not engaged or in which its investigators are not otherwise involved.  Nor will the University provide IRB-of-Record services for research over which the University does not feel it can appropriately address the local context or otherwise exercise adequate oversight. 

When an outside entity engaged in research centered at UM (or with an overall principal investigator affiliated with UM) does not have an IRB, the UM may refer the outside entity to an independent IRB or one associated with another entity. 

Procedures for a UM IRB to Become IRB-of-Record for Another Institution

Requests for UM IRB-of-Record services may become known in a number of ways.  They may arise by request from an outside entity to DRDA, to one of the IRBs, or to the Office of the Vice President for Research.  They also may arise by petition from a UM investigator as the investigator pursues a research design with external collaborators or performance sites.

Unless it is obvious which UM IRB would most appropriately provide IRB-of-Record services if approved, requests should be forwarded to the Associate Vice President for Research and Deputy Institutional Official.  The Deputy Institutional Official will make an initial determination of the most appropriate UM IRB to provide IRB-of-Record services and will forward the request to that IRB.  The DIO also may notify the appropriate Conflict of Interest Review Committee of the receipt of the request.

If the request is received directly by an IRB and it is obvious that that particular IRB has the expertise sufficient to review the project, the IRB may proceed directly with the next steps.  Upon receiving a request for IRB-of-Record services, the IRB reviewing the request must decide whether it wishes to accept the obligation.  In such a review the IRB should consider any relevant information including, for example:

• The time and resources required to accept the review, given other demands;
• The expertise required for initial and continuing review;
• The ability to comply with requirements for “local” knowledge of the research context at the outside organization and any research sites;
• The resources, ability, and willingness of the outside organization, the principal investigator and the research sites to handle complaints, review adverse events, and to monitor compliance with applicable laws and regulations and IRB requirements; and
• The ability and willingness to comply with any additional requirements the outside organization may impose on the UM review.

The IRB will notify the Deputy Institutional Official of its decision to accept or reject responsibility as the IRB-of-Record.  If the IRB has rejected that responsibility, the DIO or the IRB will so notify the outside entity.  If the IRB agrees to accept the responsibility, the Deputy Institutional Official will prepare a recommendation based on the IRB’s willingness to provide services and any other relevant institutional-level factors, including the ability to manage any potential conflict of interest.  The Vice President for Research has final approval authority.  An arrangement to accept responsibility as IRB-of-Record must be documented in a written agreement under which the respective responsibilities of the two organizations will be described.  An inventory of such agreements will be maintained centrally.

Procedures for Ceding Authority to Another IRB

Although inquiries may arise first in OVPR or DRDA, requests to cede UM-IRB authority to the IRB associated with another entity, to a commercial IRB, or to a central IRB generally arise in UM-IRB offices in the context of IRB review of projects under their jurisdictions.  Requests typically involve oversight of a single project.  Any transfer of oversight of a federally supported project, whether for a single project or a category of projects, requires formal amendment to the University’s FWA to add the outside IRB.

First review of a request to cede authority resides with the UM IRB with jurisdiction. Among the considerations involved in review of a request to cede authority are the following:

• The impracticability of direct review through the UM IRB;
• The appropriateness of the outside IRB to review local context; qualifications of the IRB to which the review will be ceded (with due consideration given to such objective factors as accreditation status); and level of confidence in its review and determinations; and
• The proposed arrangements for the UM Institutional Official and IRB with jurisdiction to monitor the outside review and oversight.

The UM IRB with jurisdiction will notify the Deputy Institutional Official of its decision or recommendation.  If the UM IRB with jurisdiction has declined the request to cede authority, the DIO will so notify the requestor.  If the UM IRB with jurisdiction recommends approval, the DIO will further review the request.  If the DIO disapproves the cession, he or she will so notify the requestor.  If the DIO approves the cession, he or she will arrange for a formal agreement between the University and the entity in which the outside IRB resides, under which the respective responsibilities of the two organizations will be described. 
             

Responsibilities of the HRPP and Local IRB in Multi-Site Research

Even when the University or another institution serves as IRB-of-Record for multi-site research, each organization remains responsible for maintaining a system to protect human research participants.  The ceding institution retains ultimate responsibility for safeguarding the rights and welfare of human research subjects involved at its performance site and for educating members of its research community to establish and maintain a culture of compliance with applicable laws and regulations and with institutional policies relevant to the protection of human research participants.  The ceding institution also remains responsible for implementing appropriate oversight mechanisms to ensure compliance with the determinations of the reviewing IRB.  Thus, for example, a UM performance site may be subject to not-for-cause compliance reviews and for-cause inspections through the University’s HRPP even if oversight of the project has been ceded to an outside IRB.

UNAFFILIATED INVESTIGATORS

Researchers engaged in federally-funded UM-initiated or UM-centered research who are not employees of the University and not agents of an outside entity providing IRB review must sign an “Individual Investigator Agreement” to assure that they understand their obligations as performers of human research (The IRB may grant an exception in cases involving literacy or technology constraints).  For non-federally-funded research unaffiliated investigators generally are required to sign an “Individual Investigator Agreement,” but may be granted an exception by the IRB in limited cases.  See the flow diagrams for IRB authorization agreements and individual investigator agreements.