Section VII:

General Operations

WPP #: VII-1

Title 1:

Authority of the IRB and Scope of Review

Effective Date:

08-06-14

Revision History:

06-07-04; 12-06-04; 04-30-06; 06-21-06; 02-05-07; 2-25-14; 05-20-14

Policy Statement

The VCU IRB is granted authority through the Terms of the Federalwide Assurance (per 45 CFR 46.103), by way of the VCU Institutional Official to OHRP, to review and act upon human subjects research, in which VCU is engaged. The VCU IRB has the responsibility and authority to review all research projects involving human subjects before the involvement of human subjects may begin, as well as to provide ongoing oversight to research as described below.

Description and Procedures

  1. Authority of the VCU IRB (including all IRBs upon which VCU relies):

    Authority to Act on Proposed Studies: The VCU IRB has the responsibility and authority to review all research projects involving human subjects before the involvement of human subjects may begin; require from investigators revisions in research protocols and informed consent documents as a condition for initial or continuing approval; approve new research projects and the continuation of previously approved projects; and disapprove the initiation of new research projects. In addition, the VCU IRB has the responsibility and authority to review and take appropriate actions regarding conflict of interest issues.

    Authority to Require Progress Reports and to Oversee the Study: The VCU IRB has the responsibility and the authority to review progress of studies by conducting continuing review at least annually and to require verification of compliance with approved research protocols and informed consent procedures through means such as audit, monitoring, observation or third party review. The authority to review progress of studies includes the authority to review any planned changes in approved projects prior to the implementation of those changes and the authority require prompt reporting to the IRB of any unanticipated problems occurring in, or related to, approved protocols.

    Authority to Suspend or Terminate Approval of Research: The VCU IRB has the responsibility and the authority to suspend or terminate approval of any study that it has originally reviewed and approved if

    1. the study no longer meets the criteria for IRB approval under 45 CFR 46.111 and 21 CFR 50.111,
    2. in response to an unanticipated problem involving risks to human subjects or others, or
    3. in response to serious or continuing noncompliance with any federal regulation or serious or continuing noncompliance with the requirements or determinations of the IRB.

    Such actions will be determined at a convened meeting of the full panel with a quorum present and will be incorporated into the minutes of the meeting.

    Authority to Restrict a Research Activity: Each IRB Panel has the responsibility and the authority to restrict any study that it has originally reviewed and approved if it determines to warrant such action. If one aspect of a study fails to comply with federal regulations, IRB requirements, or IRB determinations, the panel should restrict the study so as to restrict the activity found in noncompliance until it is brought into compliance. The panel may also request that a monitoring visit be conducted by the ORSP.

    Authority to Monitor Research Activity: The IRB has the authority, at any time, to monitor study conduct and/or the informed consent process for any research activity being conducted under the auspices of VCU. The IRB may perform this oversight activity directly or request that such observation be conducted by another entity or individual.

    Authority to Act Independently: All IRBs designated to review and approve research on behalf of VCU have the authority to make independent decisions regarding study activity including approval, disapproval, suspension, termination, and noncompliance decisions. In the case of an approval decision, should the Vice President for Research conclude that a project does not fully comply with the policies or obligations of VCU, the project may be administratively disapproved, suspended, or terminated on behalf of the institution. In the case of a decision by the IRB to disapprove, suspend or terminate a project, the decision may not be reversed by the Vice President for Research or any other officer/agency of VCU [45 CFR 46.112].

    If an IRB panel or IRB member feels subjected to undue influence when making decisions regarding research activity, the Vice President for Research Policy: Policy for Managing Undue Influence in Research Committees and Groups should be followed.

  2. Scope of Review

    IRB review is conducted to ensure proposed research involving human subjects meets the criteria for IRB approval in accordance with 45 CFR 46.111 and 21 CFR 56.111. Specifically, to approve a study, the IRB must find:

    1. Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
    2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies that subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
    3. Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons.
    4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with and to the extent required by part 50.
    5. Informed consent will be appropriately documented, in accordance with and to the extent required by 50.27.
    6. Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
    7. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
    8. When some or all of the subjects, such as children, prisoners, pregnant women, handicapped, or mentally disabled persons, or economically or educationally disadvantaged persons, are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.
    9. The principal investigator is qualified to conduct the proposed research.

    Additionally, the IRB must find that the following criteria are fulfilled in certain circumstances:

    1. When research is federally funded, the subparts of 45 CFR 46 must be met:
      1. Subpart B – Pregnant Women, Human Fetuses, and Neonates
      2. Subpart C – Prisoners
      3. Subpart D – Children
    2. When research is FDA regulated, Subpart D – Children, must be met.
    3. When research is subject to federal agency or department requirements, additional requirements must be met:
      1. Department of Defense – Directive 3216.02
      2. Department of Education – 34 CFR 97 Protection of Human Subjects
      3. National Institute of Justice – Human Subject Protection
    4. When research is subject to the following ancillary committee reviews, documented approval must be provided prior to obtaining IRB approval:
      1. Institutional Biosafety Committee
      2. Radiation Safety Committee
      3. Protocol Review and Monitoring Committee (oncology related studies)
  3. IRB Actions Regarding Inadequate Protocol Submissions

    The IRB is charged to review protocols according to criteria listed above. On occasion, it may be difficult for an IRB reviewer to adequately assess those criteria because the quality of the submission is inferior. Poor quality may be indicated by, and include, the following: 1) inadequate or insufficient information to determine the criteria are met, 2) insufficient scientific justification for the research protocol or plan, or 3) improper or incorrect supporting documentation to the protocol or research plan.

    When an IRB reviewer is of the opinion that review of the inadequate protocol is an impractical or inefficient use of time, the IRB reviewer should contact the IRB chair. If the IRB chair agrees with the initial impression of the reviewer, the IRB chair may send correspondence to the PI describing the situation and indicating that the submission must be re-worked and re-submitted prior to review. In addition, the IRB Chairperson also may choose to copy the PIs department chair or dean (whoever signed the IRB application) and copy the Associate Vice President for Research.

References

U.S. Department of Health and Human Services Title 45, Part 46, Subparts A, B, C, and D

U.S. Food and Drug Administration Chapter I of Title 21 CFR 50

U.S. Food and Drug Administration Chapter I of Title 21 CFR 56

Department of Defense – Directive 3216.02

Department of Education – 34 CFR 97 Protection of Human Subjects

National Institute of Justice – Human Subject Protection