Section XVII:

Special Requirements and Guidance for Investigators

WPP #: XVII-15

Title 15:

Involving Independent Investigators in VCU Human Research

Effective Date:

6-21-06

Revision History:

Objective

To describe the policy for VCU IRB review of research that involves individuals who are not representatives of VCU or any other institution or facility (independent investigators).

Description

In accordance with the terms of the VCU Federalwide Assurance, a formal written agreement is required to be in place prior to involving individuals (those who are not acting as agents/employees of VCU, the VCU Health System, or any other institution or facility) in VCU human subjects research if an independent investigator is “engaged,” and the research is (1) not exempt and (2) involves a DIRECT FEDERAL award made to VCU (or application for such)

  1. Applicability and Definitions:

    This policy applies to any VCU research activity involving human subjects (regardless of source or plans for funding) that is both:

    • not exempt under 45CFR46.101 (as determined by the VCU IRB), AND
    • involves an independent investigator (not acting on behalf of VCU or any other 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. Independent Investigator: an individual who is acting independently and not acting as an agent or employee of any institution or facility while carrying out his or her duties in the research protocol.
    5. Engagement in Research: For the purpose of this WPP: An independent investigator becomes "engaged" in human subjects research when he/she (i) intervenes or interacts with living individuals for research purposes; or (ii) obtains individually identifiable private information for research purposes [45 CFR 46.102(d)-(f)].
  2. Policy:

    First, the VCU Principal Investigator must determine if the independent investigator is engaged in the research. A careful review of Engagement of Institutions in Research will support that determination (Note: this reference material does have an institutional focus, but also pertains to individuals that are not affiliated with institutions). If questions remain as to the level of engagement, the investigator should contact the sponsor if the research is federally funded (the program director) and/or contact the VCU Office of Research Subjects Protections.

  3. Submission Process for Independent Investigators NOT ENGAGED in the Human Research:

    No additional requirements exist for involving independent investigators as long as they are determined to be NOT ENGAGED in the human subjects research.

  4. Submission Process for Independent Investigators ENGAGED in the Human Research:

    Principal investigators who plan to work with independent investigators, who are engaged in the human research, 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) a description of their role with human subjects/identifiable human data and (b) your oversight of their involvement.
    2. The VCU IRB will review your IRB application and your request to involve an independent investigator who will be engaged in the human subjects research activity.

    NOTE: If an independent investigator is “engaged,” and the research is (1) not exempt and (2) involves a DIRECT FEDERAL award made to VCU (or application for such), the independent investigator must sign a formal written agreement with VCU certifying terms for the protection of human subjects. For an agreement to be approved: (1) the PI must directly supervise all of the research activities, (2) agreement must follow the ORSP template, (3) IRB must agree to the involvement of the independent investigator, and (4) agreement must be in effect prior to final IRB approval.

Responsibility

It is the responsibility of the principal investigator to allow adequate time to negotiate an agreement with independent investigators in accordance with this policy and to complete the documentation process for the agreement.

It is the responsibility of the IRB to review requests for the involvement of independent investigators and determine the path that (1) ensures optimal human subject protections and (2) represents controlled institutional risk. The IRB will decide if any relationship, beyond an agreement or in addition to the template written agreement is necessary.

It is the responsibility of the ORSP to monitor this policy and facilitate agreements.

References

VCU Independent Investigator Agreement Template (ORSP Office)