Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-6

Title 6:

Involving Non-VCU Institutions in VCU Human Subjects Research

Effective Date:

09-24-14

Revision History:

6-21-06; 11-1-06; 1-15-08; 05-30-14

Policy Statement

When VCU investigators are involved in research with collaborating institutions, VCU will ensure the following:

  1. If VCU is the prime awardee under a federal grant, contract, or cooperative agreement [supporting research to which the Federalwide Assurance (FWA) applies], then VCU will ensure that all collaborating research sites 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 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; 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).

Definitions

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)].

Independent Investigator: Individuals involved in the conduct of VCU Research who are not acting as employees or agents of another institution. See WPP XVII-15: Involving Independent Investigators in VCU Human Subjects Research for more information.

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.

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 by a VCU faculty, staff or student using VCU facilities, personnel/students, research subjects, data or other non-public resources.

Procedures and Guidance

  1. 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:
    • Submit an application for VCU IRB review and approval and include in the Research Plan a description of the non-VCU institution’s role in the human subjects research, adequacy of the facility to support the research and to ensure human subject safety in the case of an unanticipated emergency, responsibilities of their agents/employees, and oversight that the VCU investigator will be providing in order to ensure adequate and ongoing protection of the human subjects. Only institutions that have agreed to participate should be identified in the VCU IRB submission.
    • 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 should be maintained in the investigator’s research records and must be made available upon request).
    • Follow any additional requirements of the non-VCU institution.
  2. 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
      • Submit an application for VCU IRB review and approval and include in the Research Plan a description of the non-VCU institution’s role in the human subjects research, adequacy of the facility to support the research and to ensure human subject safety in the case of an unanticipated emergency, responsibilities of their agents/employees, and oversight that the VCU investigator will be providing in order to ensure adequate and ongoing protection of the human subjects.
      • 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 should be maintained with the investigator’s research records and made available upon request).
      • Follow any additional requirements of the non-VCU institution including additional IRB review if required.
    2. EXPEDITED and FULL BOARD Research
      • Submit an application for VCU IRB review and approval and include in the Research Plan a description of the non-VCU institution’s role in the human subjects research, adequacy of the facility to support the research and to ensure human subject safety in the case of an unanticipated emergency, responsibilities of their agents/employees, and oversight that the VCU investigator will be providing in order to ensure adequate and ongoing protection of the human subjects.
      • 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 should be maintained in the investigator’s research records and made available upon request).
      • Follow any additional requirements of the non-VCU institution including additional IRB review if required.
      • VCU strongly recommends that a single consent document be given to the research subject, 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 explains the involvement of each institution and represents the decisions of each IRB involved. The consent form must name the VCU PI.
      • If the research project involves a DIRECT FEDERAL award to VCU (or application for such), the non-VCU institution must already hold a Federalwide Assurance (FWA) or obtain one.
  3. IRB Reliance Arrangements (IRB Deferral)

    In some cases, it may be duplicative or it may not be practical for both VCU and the non-VCU organization to obtain separate IRB approval. In this situation, either entity may decide to rely on the IRB review of the other:

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

      When the non-VCU organization wishes to rely on the VCU IRB, this should be indicated in the IRB submission. The IRB will consider the request. If accepted, the ORSP will work with the VCU investigator to establish the appropriate signed agreements.

      To facilitate an efficient reliance decision, the VCU investigator should address all of the following when completing the VCU IRB submission:

      • Describe the level of VCU PI oversight of the research activities conducted at the non-VCU institution.
      • Describe your understanding of the local research context of the non-VCU organization or how the knowledge will be obtained (i.e., use of consultants).
      • Does the non-VCU Institution have an FWA? If yes, provide the FWA Number and effective dates.
      • Describe the resources available at the non-VCU institution to conduct the research.
      • 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.
      • If a VCU researcher is the lead researcher of a multi-site study, applications should include information about the management of information that is relevant to the protection of human subjects, such as interim results and protocol modifications.

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

    2. Requests for VCU to rely on the IRB of a non-VCU Institution:

      In some cases, the VCU IRB may elect to rely on the IRB of a collaborating organization. The VCU investigator may make this request via an abbreviated submission in the submission system. Such requests will be carefully considered when the other IRB demonstrates equivalent standards to those of the VCU IRB. If the request is accepted, the VCU investigator will need to provide to the VCU IRB the approved IRB application, approved informed consent document(s), and IRB approval letter. ORSP will work with the VCU investigator and the other organization to enter into the appropriate signed agreements.

  4. Helpful Links/Notes:
    • OHRP has http://www.hhs.gov/ohrp/assurances/assurances/file/index.htmlssist the non-VCU Institution in obtaining their own FWA).
    • 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 and/or request information from the other organization pertaining to local context.
    • VCU considers requests for IRB deferrals on a case-by-case basis (as authorized under the authority of the VCU Signatory Official).
    • VCU has drafted its own specialized IRB Authorization Agreement template (available by contacting the ORSP).
  5. VCU Principal Investigator Responsibilities for Collaborative Research

    When collaborating with non-VCU organizations, it is the responsibility of the VCU principal investigator to 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;
    • 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;
    • 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;
    • the VCU IRB receives complete reports of all IRB-reportable events occurring both at VCU and at the non-VCU institution;
    • 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
    • the consent documents fairly and accurately represent the involvement of VCU in the research and the decisions of all responsible IRBs reviewing the research.

References

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
OHRP List of Approved Assurances
OHRP Assurance Process