Section VIII:

General Functions of the VCU IRB

WPP #: VIII-8

Title 8:

Suspensions and Terminations of Previously Approved Research

Effective Date:

04-22-14

Revision History:

06-20-00; 07-26-00; 09-20-01; 06-07-04 as VI-2; 04-30-06; 06-21-06; 01-3-08

Policy Statement

The VCU IRB has the authority to suspend or terminate approval of research that is associated with serious or continuing noncompliance with regulations and/or VCU IRB requirements or that has been associated with serious harm or risk to participants. Any suspension or termination of approval shall include a statement of the reasons for the IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, regulatory authorities, and the department or agency supporting the research [in accordance with 45 CFR §46.113, 21 CFR §56.113, 45 CFR §46.103(b)(5)(ii), and 21 CFR §56.108(b)(3)].

Definitions

  1. Suspension of previously approved research: The suspension of previously approved research is defined as temporarily discontinuing approved interventions with human participants for research purposes. Options include: 1) suspension of new enrollment but continuation of previously enrolled participants, 2) suspension of research activities at a particular performance site under VCU jurisdiction, 3) suspension of a particular activity within the approved research protocol, or 4) suspension of all research interventions.
  2. Termination of previously approved research: The termination of previously approved research is defined as indefinitely (possibly permanently) discontinuing any interventions with human participants for research purposes.

Procedures and Guidance

  1. Circumstances Alerting the IRB to Consider Suspension or Termination:

    Circumstances (including allegations with supporting evidence) that may result in suspension or termination of previously approved research:

    1. When research is not conducted in compliance with IRB requirements. If such noncompliance is determined to be serious or continuing, the IRB will take action to protect human subjects, which may include suspension or termination.
    2. When research is associated with serious unanticipated risk or harm to participants or others. If the IRB determines that the risk or harm of the unanticipated problem seriously threatens the health status or well-being of subjects or others, the study may be suspended or terminated.

    Alternatively, when the conduct of the research rises to the level of either of the above two circumstances, the investigator may voluntarily stop research activities, thereby preventing an imposed suspension or termination, until such time as the circumstances are resolved. Upon favorable IRB evaluation of the circumstances, the investigator may be permitted to continue research activities with or without modification. If the IRB’s evaluation is not favorable, suspension or termination of research activities may by issued by the IRB.

  2. Suspension/Termination Procedure and Documentation:

    VCU utilizes one of the following three methods for suspending or terminating previously approved research. Each method allows for the group or individual to take swift and immediate action in order to ensure the immediate protection of research participants:

    • Administrative Suspensions and Terminations can be put into effect by the Director of the ORSP and/or the Vice President for Research. The preceding events and the imposed action are reviewed for on-going status at the next convened IRB meeting.
    • Expedited IRB Suspensions and Terminations can be put into effect by the Chairperson (or Vice Chairperson). The preceding events and the imposed action are reviewed for on-going status at the next convened IRB meeting.
    • IRB Full Board Suspensions and Terminations are put into effect by board action within a board meeting, where the board members vote to take this action.

    In all cases, regardless of the point of origin of the suspension or termination, the following procedure, which is overseen by the ORSP, applies:

    Every effort should be made to contact the principal investigator promptly (including the use of phone, fax, and email). Official written notice of the suspension or terminations must be provided to the principal investigator shortly after informal communication of same. If a suspension or termination is imposed by Administration, the IRB Chair/Vice-Chair, or the convened IRB, the Chair/Vice-Chair together with ORSP ensure that the PI is quickly informed according to the criteria below:

    1. Effective date of suspension or termination;
    2. Reason for suspension or termination;
    3. Corrective actions necessary, request for corrective actions, or instructions for closure of the study, as appropriate;
    4. Who the notice is copied to (including OSP, Departmental Chairperson or Dean, IRB, ORSP Director, and federal oversight agencies as required); and
    5. Specific instructions pertaining to currently enrolled research participants, including language to ensure that:
      1. Current participants are notified that the study has been suspended and/or terminated;
      2. Procedures to ensure that withdrawal of enrolled participants considers the rights and welfare of participants;
      3. When follow-up of participants for safety reasons is permitted/required by the IRB, the participants should be so informed; and
      4. When follow-up of participants is permitted/required by the IRB for safety reasons, any unanticipated events/outcomes should be reported to the IRB and the sponsor.

    Suspension imposed on some or all of the research protocol may be lifted when, and if, the IRB finds that subjects are adequately protected from risk in order to continue in the study safely. Suspension may also be lifted when, and if, the IRB finds that the corrective action plan has been adequately addressed such that subjects are fully protected and events preceding the suspension are unlikely to recur.

  3. Suspensions or Terminations Imposed by External IRBs:
    1. Western IRB: Suspensions or terminations imposed by Western IRB (WIRB) on VCU investigators and protocols will be communicated with the VCU Office for Research Subject Protections (ORSP). ORSP determines the extent to which the VCU IRB and/or Administration become involved in deliberations related to suspensions or terminations for protocols reviewed by WIRB. ORSP is responsible for appropriate reporting to regulatory entities and others if not already done so by WIRB. See VCU IRB WPP#: VI-3: Investigations and Reporting of Unanticipated Problems, Serious or Continuing Non-Compliance, Suspensions, and Terminations.
    2. NCI Central IRB: Suspensions or terminations imposed by NCI Central IRB (CIRB) on VCU investigators and protocols will be communicated with the VCU Office for Research Subject Protections (ORSP). ORSP determines the extent to which the VCU IRB and/or Administration become involved in deliberations related to suspensions or terminations for protocols reviewed by CIRB. CIRB is responsible for reporting to appropriate regulatory authorities and sponsors.

References

45 CFR §46.103(b)(5)(ii)
45 CFR §46.113
21 CFR §56.108(b)(3)
21 CFR §56.113
FDA Guidance for IRBs, Clinical Investigators and Sponsors: IRB Continuing Review After Clinical Investigation Approval
AAHRPP Tip Sheet: Suspensions and Terminations of Previously Approved Research
VCU IRB WPP#: VI-3: Investigations and Reporting of Unanticipated Problems, Serious or Continuing Non-Compliance, Suspensions, and Terminations