Section X:

Monitoring Activities

WPP #: X-1

Title 1:

Terms of Approval

Effective Date:

09-24-14

Revision History:

06-07-04; 12-06-04; 06-21-06; 11-1-06; 03-01-11; 05-14-14

Policy Statement

In addition to continuing review and review of proposed modifications to research, a formal statement of conditions of approval is provided with each initial letter of approval from the VCU IRB. The conditions of approval serve to ensure that investigators understand their ongoing responsibilities for keeping the IRB informed of the status of the research.

Principal investigators must ensure that conditions of approval are met and report any deviations from conditions promptly to the IRB.

Description and Procedures

Conditions of Approval for Exempt Studies:

  1. Conduct the research as described in and required by the Protocol.
  2. Provide non-English speaking patients with a translation of the approved Consent Form in the research participant's first language. The Panel must approve the translation.
  3. The following changes to the protocol must be submitted to the IRB panel for review and approval before the changes are instituted. Changes that do not meet these criteria do not have to be submitted to the IRB.  If there is a question about whether a change must be sent to the IRB please call the ORSP for clarification.

    THESE CHANGES MUST BE SUBMITTED:

    1. Change in principal investigator
    2. Any change that increases the risk to the participant
    3. Addition of children, wards of the state, or prisoner participants
    4. Changes in survey or interview questions (addition or deletion of questions or wording) that change the level of risk or adds questions related to sexual activity, abuse, past or present illicit drug use, illegal activities, questions reasonably expected to provoke psychological anxiety, or would make participants vulnerable, or subject them to financial, psychological or medical risk
    5. Changes that change the category of exemption or add additional exemption categories
    6. Changes that add procedures or activities not covered by the exempt category(ies) under which the study was originally determined to be exempt
    7. Changes requiring additional participant identifiers that could impact the exempt category or determination
    8. Change in inclusion dates for retrospective record reviews if the new date is after the original approval date for the exempt study. (ex: The approval date for the study is 9/24/10 and the original inclusion dates were 01/01/08-06/30/10. This could be changed to 01/01/06 to 09/24/10 but not to end on 09/25/10 or later. )
    9. Addition of a new recruitment strategy
    10. Increase in the planned compensation to participants
  4. Monitor all problems (anticipated and unanticipated) associated with risk to research participants or others.
  5. Report Unanticipated Problems (UPs), following the VCU IRB requirements and timelines detailed in VCU IRB WPP VIII-7) and outlined below.
  6. Promptly report and/or respond to all inquiries by the VCU IRB concerning the conduct of the approved research when so requested.
  7. The VCU IRBs operate under the regulatory authorities as described within:
    1. U.S. Department of Health and Human Services Title 45 CFR 46, Subparts A, B, C, and D and related guidance documents.
    2. U.S. Food and Drug Administration Chapter I of Title 21 CFR 50 and 56 (for FDA regulated research only) and related guidance documents.
    3. Commonwealth of Virginia Code of Virginia 32.1 Chapter 5.1 Human Research (for all research).

Conditions of Approval for Expedited and Full Review Studies:

  1. Conduct the research as described in and required by the Protocol.
  2. Obtain informed consent from all subjects without coercion or undue influence, and provide the potential subject sufficient opportunity to consider whether or not to participate (unless Waiver of Consent is specifically approved or research is exempt).
  3. Document informed consent using only the most recently dated consent form bearing the VCU IRB "APPROVED" stamp (unless Waiver of Consent is specifically approved).
  4. Provide non-English speaking patients with a translation of the approved Consent Form in the research participant's first language. The Panel must approve the translated version.
  5. Obtain prior approval from VCU IRB before implementing any changes whatsoever in the approved protocol or consent form, unless such changes are necessary to protect the safety of human research participants (e.g., permanent/temporary change of PI, addition of performance/collaborative sites, request to include newly incarcerated participants or participants that are wards of the state, addition/deletion of participant groups, etc.). Any departure from these approved documents must be reported to the VCU IRB immediately as an Unanticipated Problem (see #7).
  6. Monitor all problems (anticipated and unanticipated) associated with risk to research participants or others.
  7. Report Unanticipated Problems (UPs), including protocol deviations, following the VCU IRB requirements and timelines detailed in VCU IRB WPP VII-6).
  8. Obtain prior approval from the VCU IRB before use of any advertisement or other material for recruitment of research participants.
  9. Promptly report and/or respond to all inquiries by the VCU IRB concerning the conduct of the approved research when so requested.
  10. All protocols that administer acute medical treatment to human research participants must have an emergency preparedness plan. Please refer to VCU guidance here.
  11. The VCU IRBs operate under the regulatory authorities as described within:
    1. U.S. Department of Health and Human Services Title 45 CFR 46, Subparts A, B, C, and D and related guidance documents.
    2. U.S. Food and Drug Administration Chapter I of Title 21 CFR 50 and 56 (for FDA regulated research only) and related guidance documents.
    3. Commonwealth of Virginia Code of Virginia 32.1 Chapter 5.1 Human Research (for all research).

References

VCU IRB WPP VII-6 Required Reporting of Unanticipated Problems Involving Risk or Harm to Subjects or Others
VCU Human Research Policies and Guidance