Chapter 48

Planned Deviations

Please note that planned deviations should be submitted to WCG IRB as a change in research for federally funded research and FDA drug and biologic studies. If the research is federally funded, conducted under an FWA, or is a clinical investigation of a drug or biologic, then all planned protocol deviations must be submitted to WCG IRB for review and approval prior to implementation except where necessary to eliminate apparent immediate hazards to the human research participants [(DHHS (FDA 21 CFR § 56.108(a)(4) ; ICH 3.3.7].  

However, if the research is a clinical investigation of a device and the research is not federally funded and not conducted under an FWA, then only planned protocol deviations that may adversely affect the rights, safety or welfare of participants or the integrity of the research data should be submitted to WCG IRB for review and approval prior to implementation except where necessary to eliminate apparent immediate hazards to the human research participants [DHHS 45 CFR § 46.108(a)(3)(iii); FDA 21 CFR § 56.108(a)(4); ICH 3.3.7].   

These different requirements regarding planned protocol deviations are necessary because the Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) drug and biologic divisions have adopted the regulatory interpretation that every planned protocol deviation is a change in research that needs prior IRB review and approval before implementation; however, the FDA device division operates under a distinct regulation (See 21 CFR 812.150(a)(4)).

Investigator Noncompliance

WCG IRB expects PIs to conduct research activities in accordance with the IRB’s requirements, as set forth in this Guide and in compliance with all federal, state, and local regulations. We define investigator noncompliance as the failure to follow the applicable regulations and/or the requirements and determinations of the IRB.

Examples of Noncompliance

The following are examples of investigator noncompliance. This list is not meant to be all-inclusive. Please reference the Promptly Reportable Information form. The actions of anyone in the Human Research Protection Program may result in noncompliance if one of the following occurs:

  • Performing human participant research without first obtaining IRB approval or an IRB declaration of exemption.
  • Deviating from or violating the provisions of an IRB-approved protocol when the deviation harms a participant or placed participant at risk of harm.
  • Failing to secure IRB approval of a protocol due for periodic continuing review prior to its expiration date.
  • Permitting a protocol’s IRB approval to lapse without stopping all research-related activities and submitting a Principal Investigator Closure Report to the IRB or, in the event of an overriding safety concern or ethical issue such that it would be in the individual participant’s best interest to continue study participation, arranging with the IRB to continue those activities.
  • Failure to report complaints or results of audits to the IRB.
  • Failure to follow the regulations or the requirements and determinations of the IRB.

If evidence is received by the IRB to indicate potential noncompliance, the Board reviews this information and determines appropriate actions, including, but not limited to:

  • Temporary suspension or termination of all or some previously approved research activities (suspensions and terminations of previously approved research are reported to applicable regulatory authorities in accordance with federal regulations.)
  • Determination of serious or continuing noncompliance (in accordance with federal regulations, serious and/or continuing noncompliance is reported by the IRB to the applicable regulatory authorities.)
  • Request for the conduct of an investigator site visit.
  • Communication with the PI to document the issues and to provide the opportunity to respond.
  • Request for additional information from the PI, submitting body, or other source.
  • Other actions as determined by the Board.

WCG IRB reserves the right to visit your site and/or interview your sponsor or others as needed to assess possible noncompliance issues.

Suspensions and Terminations

Federal regulations require that an IRB have the authority to suspend or terminate approval of research or investigators. WCG IRB may suspend or terminate approval of previously approved research or investigators under the following circumstances:

  • When research is not conducted in compliance with federal, state, and local requirements and in accordance with our requirements, or
  • When the risk-to-benefit ratio no longer justifies continuing the study (based on information received by the IRB related to safety or other unanticipated risks to research participants or others).

When suspensions or terminations occur, the PI is required to send the Board a written course of action that will be undertaken to ensure the protection of the rights and welfare of each enrolled research participant. Additionally, if the suspension or termination is for investigator noncompliance, we reserve the right to initiate immediate review of all the PI’s active studies.

The IRB reserves the right to suspend or terminate activity for all other approved studies until a convened Board has made a determination. If the IRB terminates or suspends approval of the clinical trial, the Investigator must promptly notify the sponsor.

In accordance with federal requirements, suspensions or terminations of previously approved research or investigators are reported by the IRB to the sponsor and to the appropriate regulatory authorities