OBJECTIVE:

To describe the policy for VCU IRB review of human subjects research taking place at, or otherwise involving, a non-VCU institution.  Note:  State law in Virginia places protections and/or restrictions on the conduct of the research, which are in addition to federal regulations.  Applicability of state law in states other than Virginia is based on the relevant law of the jurisdiction in which the research is being conducted.  See VCU IRB WPP #II-5 - State Law Applicability for Research Conducted In- and Outside of Virginia for specific considerations.

DESCRIPTION:

A.     Applicability and Definitions:

This policy applies to any VCU research activity involving human subjects (regardless of source or plans for funding) that involves a non-VCU institution.

1.       Research:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge [45CFR46.102(d)].  For additional information, see also the FDA definition of ‘clinical investigation.’

2.       Human Subject: a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information [45CFR46.102(f)].   For additional information, see also the FDA definition of ‘human subject.’

3.       VCU Research Activity:  any human subject research activity that is supported with VCU funds or by funds awarded/contributed to VCU and/or is conducted using VCU facilities, personnel/students, research subjects, data or other non-public resources.

4.       Non-VCU Institution:  an institution (or an employee or agent of the institution) that is not under the authority of VCU or VCU Health Systems and is located within the United States or a United States territory.  Examples include clinics, schools, other universities, consulting firms, or other institutions where activities include interaction or intervention with human subjects and/or the collection or analysis of identifiable data.  For non-VCU institutions that are located outside of Virginia, please see WPP II-5 :  State Law Applicability for Research Conducted In and Outside of Virginia.  For non-VCU facilities that are located outside the United States, please see WPP XVII-11: Involving Foreign Institutions/Sites in VCU Human Subjects Research.  Note:  For independent investigators (not acting as employees or agents of another institution) involved in VCU human research, please see WPP XVII-15: Involving Independent Investigators in VCU Human Subjects Research.

5.       Engagement in Research:  A non-VCU institution becomes "engaged" in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d)-(f)]. 

B.     VCU Policy:

The terms of the VCU Federalwide Assurance (FWA) form the foundation of the VCU IRB policy, as follows:

1.       If VCU is the prime awardee under a federal grant, contract, or cooperative agreement (supporting research to which the FWA applies), then VCU will ensure that all collaborating institutions engaged in such research operate under an appropriate OHRP-approved assurance for the protection of human subjects;

2.       If VCU is the coordinating center for federally conducted or supported research (to which the FDA applies), then VCU will ensure that all collaborating institutions engaged in such research operate under an appropriate OHRP-approved assurance for the protection of human subjects; and

3.       Regardless of the source of sponsorship, all investigators must follow additional requirements of the non-VCU institution (including additional IRB review, if required). 

If there are questions regarding this policy (after reviewing the OHRP Guidance Document, "Engagement of Institutions in Research,") the investigator should:

§         Contact the sponsor if the research is federally funded (the program director) and/or

§         Contact the VCU ORSP or the VCU OECO.  [Note that a telephone conversation often does not fairly represent the entire scope of the research activity.  If questions remain about whether a non-VCU institution is engaged in the research, the investigator may be requested to submit a written IRB protocol for consideration].

C.     Non-VCU Institutions NOT ENGAGED - Submission Process:

Principal investigators who plan to work with Non-VCU institutions that are not engaged in the human subject research activity (not intervening or interacting with living individuals for research purposes and not obtaining individually identifiable private information for research purposes) must meet the following additional VCU IRB requirements:

1.       Submit an application for VCU IRB review and approval and include in the VCU Research Plan/Synopsis a description of their role in the human subjects research, adequacy of the facility (in order to ensure human subject safety in the case of an unanticipated emergency), responsibilities of their agents/employees, and oversight that you will be providing in order to ensure adequate and ongoing protection of the human subjects.  You should only identify institutions that have agreed to participate

2.       Obtain a written letter of permission from an authorized individual at the non-VCU institution that authorizes the PI to perform activities at that location (this documentation need not be submitted to the VCU IRB, but must be made available upon request).

3.       Follow any additional requirements of the non-VCU institution.

D.     Non-VCU Institutions ENGAGED - Submission Process:

Principal investigators who plan to work with Non-VCU institutions that are engaged in the human subject research activity must meet the following additional VCU IRB requirements:

1.      EXEMPT Research*

a)      Submit an application for VCU IRB review and approval and include in the VCU Research Plan/Synopsis a description of their role in the human subjects research, adequacy of the facility (in order to ensure human subject safety in the case of an unanticipated emergency), responsibilities of their agents/employees, and oversight that you will be providing in order to ensure adequate and ongoing protection of the human subjects.

b)      Obtain a written letter of permission from an authorized individual at the non-VCU institution that authorizes the PI to perform activities at that location (this documentation need not be submitted to the VCU IRB, but must be made available upon request).

c)      Follow any additional requirements of the non-VCU institution including additional IRB review if required.

2.      EXPEDITED and FULL BOARD Reviews*

a)      Submit an application for VCU IRB review and approval and include in the VCU Research Plan/Synopsis a description of their role in the human subjects research, adequacy of the facility (in order to ensure human subject safety in the case of an unanticipated emergency), responsibilities of their agents/employees, and oversight that you will be providing in order to ensure adequate and ongoing protection of the human subjects.  You should only identify institutions that have agreed to participate.

b)      It should also be noted that VCU strongly recommends that a single consent document be given to the research participant, whenever possible.  In the case of more than one IRB reviewing the research, every effort should be made to develop a single consent document that fairly and completely represents the decisions of each IRB involved that explains the involvement of each institution.  The consent form must name the VCU PI.

c)      Obtain a written letter of permission from an authorized individual at the non-VCU institution that authorizes the PI to perform activities at that location (this documentation need not be submitted to the VCU IRB, but must be made available upon request).

d)      Follow any additional requirements of the non-VCU institution including additional IRB review if required.

e)      If the research project involves a DIRECT FEDERAL award to VCU (or application for such), OHRP requires that the non-VCU institution have a Federalwide Assurance (FWA) or obtain one naming their own IRB or a central IRB.  NOTES:

i)           In rare cases, it may not be practical for the non-VCU institution’s IRB to review the research (thus, they plan to 'defer' to the VCU IRB).  If this is the case, the PI must contact ORSP to begin the agreement process between VCU and the non-VCU Institution (which must have or obtain an FWA).   Historically, justifications are only considered in this case where the risk level is low or VCU personnel oversee research activities at the non-VCU institution.

ii)         In certain instances, a federally-sponsored protocol may describe collaborations with un-named investigators or institutions (who will be engaged in the research activity in a one-time, short-term capacity).  In this rare case, the investigator should contact the ORSP, which, together with the OECO, will coordinate a plan for compliance that ensures maximized protections for the research participants. 

NOTE: *As a reminder, although the investigator may request an Exempt or Expedited review, the IRB may upgrade the review based upon level of risk and/or other factors.

E.     Helpful Links/Notes:

1.       OHRP has published "Steps for Filing A Domestic Federalwide Assurance" (to assist the non-VCU Institution in obtaining their own FWA).

2.       Allowing another institution to rely upon the VCU IRB requires knowledge of the local research context. VCU will consider geographic proximity and similarities of communities in the decision to allow for a deferral.

3.       As VCU considers requests of deferrals on a case-by-case basis (as authorized under the authority of the VCU Signatory Official).

4.       VCU has drafted its own specialized IRB Authorization Agreement (available by contacting the ORSP). 

5.       VCU is not currently considering requests for the VCU IRB to defer to another institution’s IRB, except under the limited circumstance described in Section “F:  Deferral Process” of this WPP.

F.     Deferral Process:

1.      Requests for the VCU IRB to review on behalf of a Non-VCU Institution:

a)      VCU may permit the non-VCU institution to defer to the VCU IRB if all 3 conditions, below, are met:

i)           The research must involve no greater than minimal risk. [If the research involves greater than minimal risk, the principal investigator/research staff must be either conducting the research activities or directly supervising the research activities (of the employees/agents of the non-VCU institution)];

ii)         A written agreement must be negotiated between VCU and the non-VCU institution (as a formal documentation of deferred responsibilities); and

iii)        The non-VCU institution must amend their FWA to list the VCU IRB.

b)      In order to request that an agreement for deferral be considered, the PI should contact the VCU ORSP as soon as possible and begin preparing a written request that includes the elements described below.  The written request should be submitted with the VCU IRB application, including:

i)           Is the proposed human research activity (that involves a non-VCU institution) conducted under the direct supervision of the VCU PI/research staff (as part of their VCU employment responsibilities)?  Describe the level of VCU PI oversight of the research activities conducted at the non-VCU institution.

ii)         Identify the source(s) of all funding (i.e., grant issued by ____, unrestricted gift from ____, contract with ____, VCU departmental funds, Non-VCU institutions funds).  Which institution is managing the funds (i.e., VCU, VCU Health System, Non-VCU Institution).

iii)        Describe your understanding of the local research context or how the knowledge will be obtained (i.e., use of consultants).

iv)       Does the non-VCU Institution have an FWA?  If yes, provide the FWA Number and effective dates.

v)         Does the non-VCU institution have adequate resources to conduct the research?  Please describe these resources.

vi)       If the research is ongoing at another institution (such as in the case of a multi-center study) provide a report on research results to date and summary of all unanticipated problems and/or serious adverse events and other reportable adverse events.  

c)      The VCU IRB will review the material and make a recommendation to VCU Signatory Official (or designee) regarding approval.

NOTES:  VCU administration will not approve an IRB authorization agreement without a favorable recommendation by the VCU IRB.  The principal investigator should be aware that the agreements process requires additional effort and required paperwork at the Federal-level in accordance with the terms of the VCU Federalwide Assurance.  An agreement is rarely less time consuming than dual IRB review and, in most cases, affords no advantage in terms of human subject protections. 

2.      Requests for a Non-VCU IRB to review on behalf of VCU:

a)      Approval of this type of long-term arrangement is extraordinarily rare and will only be considered by the VCU Signatory Official (or designee) when both of the following conditions are met:

i)           The research began at another institution, prior to employment of the PI at VCU, and remains active only at that other institution AND

ii)         Any funds supporting the research remain under the control of the non-VCU institution.

b)      In order to request that an agreement for deferral be considered, the PI should contact the VCU ORSP as soon as possible and begin preparing a written request that includes the elements described below:

i)           Provide the name of the institution that would provide the IRB oversight for this research.  Also list the institution’s FWA number/expiration date and IRB registration number(s).

ii)         Is the proposed human research activity (that causes the non-VCU institution to be engaged in the research) conducted under the direct supervision of the VCU PI/research staff?

iii)        Does the activity involve VCU property or facilities (e.g., hospitals, outpatient clinics)?

iv)       Does the proposed activity involve the use of VCU patients (including tissues, medical information, or other VCU non-public information) for the purpose of research?

v)         Identify the source(s) of all funding.

vi)       Identify the institution and division that is managing the funds (i.e., VCU Grants and Contracts Accounting, VCU Health System, or Non-VCU Institution).

vii)      If you are currently employed part-time outside VCU, indicate what part of the research is being conducted at VCU and what part is being conducted at the other institution.

viii)    If this activity began at another institution, indicate the name of that institution and the date of original and most recent IRB approval (at that institution).  Please explain if this is a different institution than that noted in question number 1, above.

ix)       Did this activity involve subject recruitment, which began prior to your becoming employed by or enrolled in VCU?

RESPONSIBILITY:

It is the responsibility of the principal investigator to: (1) plan for the involvement of non-VCU institution(s) in VCU human research AND (2) obtain ALL necessary permissions and documents in accordance with the VCU Federalwide Assurance.  In addition, the principal investigator must be prepared to (1) ensure that adequate resources will be available at the non-VCU institution to conduct the research safely and effectively in full accordance with the approved protocol; (2) ensure that all persons interacting with human subjects and/or their identifiable data are adequately trained in the protection of human subjects, regardless of their employment status with VCU; (3) make every effort to ensure that any non-VCU institution whose IRB is reviewing research that is associated with VCU is registered with the U.S. Office for Human Research Protections; (4) ensure that the VCU IRB receives complete reports of all IRB-reportable events occurring both at VCU and at the non-VCU institution; (5) ensure that applicable state law relative to research outside of Virginia is incorporated into the research design, especially as it applies to enrollment and informed consent; and, (6) ensure the consent documents fairly and accurately represent the involvement of VCU in the research and the decisions of all responsible IRBs reviewing the research.

It is the responsibility of the IRB to review requests for the involvement of non-VCU institutions and determine the path that (1) ensures optimal human subject protections and (2) represents controlled institutional risk.  It is the responsibility of the OECO, the ORSP, and the Associate Vice President for Research to monitor this policy and facilitate agreements.

REFERENCE:

45CFR46.101-102

XVII-11 Involving Foreign Institutions/Sites in VCU Human Subjects Research

WPP XVII-15: Involving Independent Investigators in VCU Human Subjects Research

Engagement of Institutions in Research

VCU Federalwide Assurance

OHRP List of Approved Assurances

OHRP Assurance Process

ORHP Registration of an Institutional Review Board (IRB)