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103.7 Organization Policy on Investigator Non-Compliance

August 2013

The Organization has granted the responsibility for review of all human subjects research to the JHM IRBs.  The JHM IRBs may approve applications that meet the criteria set forth in government regulations, Organization policies, and other federal, state, and local laws and regulations.  IRB approval notices to the Principal Investigator (PI) detail any special conditions or requirements for conduct of the research and provide a time limit on the approval period.  The PI is responsible for conducting the approved research in accord with the IRB’s requirements, as well as in accord with all ethical standards, Organization policies, and federal or state laws or regulations applicable to the research study.   It is the obligation of the PI and study team to submit a written report to the IRB if non-compliance occurs during the conduct of the research. 

The Organization defines non-compliance to be:

  • Failure on the part of the PI, any member of the study team, or any other individual involved in research’s review or oversight to follow the terms of the JHM IRB’s approval; or
  • Failure of the PI, any member of the study team, or any other individual involved in research’s review or oversight to abide by applicable laws or regulations or Organization policies, including failure to submit human subjects research or changes to the approved research for IRB review and approval prior to commencing the research or changes to it.

Non-compliance varies in nature, severity, and frequency.  The IRB must review written reports of non-compliance.  The IRB will determine whether each report represents either:  a) an instance of minor non-compliance with the IRB’s approval determinations; b) an instance that is serious non-compliance; or c) a pattern of continuing non-compliance with the IRBs’ determinations.

Minor non-compliance is defined by the Organization to be reported incidents, or events, which are not serious or continuing non-compliance. 

Serious non-compliance is defined by the Organization to be failure to comply with laws or regulations, Organization policies, or the requirements or determinations of the IRB when that failure actually or potentially increases risk to participants or adversely affects the rights and welfare of the participants.  A single instance of non-compliance may be determined by the IRB to be serious non-compliance.

Continuing non-compliance is defined by the Organization to be a pattern of behavior or minor non-compliance issues that, if unaddressed, may compromise the integrity of human research protections applicable to the study.

Written reports of non-compliance may originate from a PI, study team, monitoring staff, other Organization staff or offices, sponsors, or collaborators.  All written reports, regardless of origin, will be reviewed by the IRB at a convened session.

The Institutional Official (IO), IRB, or other Organization offices or staff may be notified informally or may receive a non-written allegation of non-compliance.  An allegation of non-compliance is defined by the Organization as an assertion by a second party of an incident of non-compliance that should be reviewed.  The IO or IRB may authorize OHSR senior staff or monitoring staff to conduct a fact finding effort to determine whether the allegation has a basis in fact.  An allegation determined to have a basis in fact and to meet the Organization definition of non-compliance must be forwarded to the IRB for review.  An allegation determined not to have a basis in fact will be forwarded to the IO for response to the source of the allegation.  An allegation for which OHSR staff cannot adequately determine the facts will be forwarded to the IO or other Organization officials for a determination on the appropriate mechanism for additional fact finding about the allegation.

The IRB will review written reports of non-compliance or allegations of non-compliance that have a basis in fact.  The IRB is authorized to collect additional information before making a determination.  The IRB may collect information using a variety of methods, such as, but not limited to, communicating directly with the PI and study team, or requiring the PI and study team to meet with the IRB.  The IRB may request an audit by the OHSR Compliance Monitoring Staff, or ask the General Counsels’ Office to conduct an investigation.

The IRB may determine the non-compliance reported is:  minor non-compliance, serious non-compliance, or continuing non-compliance.  An IRB finding of minor non-compliance may include a determination of what appropriate corrective action, if any, should be implemented by the PI and study team.  The IRB may require a range of actions to correct minor non-compliance.  The IRB may determine a corrective action plan should include, as appropriate:

  • Additional training of the PI or the study team
  • Additional supervision of the PI
  • A limit on the number of research activities conducted by the PI
  • A limit on the number of participants who may be enrolled by the PI

In cases where the IRB makes a determination that non-compliance is not serious or continuing, the IO is authorized to take additional action, which may include suspending or terminating the research in accord with Organization policy.

When the IRB determines there has been serious or continuing non-compliance, the IRB will determine what steps must be taken, if any, to protect enrolled participants.  The IRB will determine the elements of a corrective action plan to address the non-compliance and prevent recurrence.  The IRB may take the following actions in the case of serious or continuing non-compliance:

  • Modify the study protocol
  • Modify information that must be disclosed in a consent document
  • Provide information about the non-compliance to current study participants, when such information may affect willingness to continue participation
  • Require re-consent of all participants
  • Modify the continuing review schedule
  • Monitor the research activities
  • Monitor the consent process
  • Suspend the conduct of research until corrective actions are implemented
  • Terminate the research

An IRB determination of serious non-compliance or continuing non-compliance must be reported to the IO.  Reports to the IO will be sent within 30 business days of the IRB’s determination of serious or continuing non-compliance.

The IO is authorized to determine whether a corrective action plan recommended by an IRB should include additional measures.  The IO is not authorized to change the IRB’s determination of serious or continuing non-compliance. The IO will report the IRB’s determination of serious or continuing non-compliance in accord with Policy No. 103.6(a). 

For cases of serious or continuing non-compliance, the IO may take action to restrict or prohibit the ability of an investigator to conduct human subjects research at JHM.  A decision by the IO to restrict or prohibit the conduct of research will be provided to the invstigator in a meeting with the IO. 

The investigator will be informed that she/he may appeal the decision.  An appeal should be filed in writing with the Dean of the Medical Faculty and CEO of JHM within 10 calendar days, and the investigator may request a meeting to discuss the appeal.  The Dean of the Medical Faculty and CEO of JHM will inform the investigator of the outcome of the review of the appeal.

In addition to the FDA and DHHS reporting requirements, the Department of Defense (DoD) has specific requirements for serious or continuing non-compliance.   After all appeal options have been exhausted by the investigator, if the research is supported by or conducted in conjunction with the DoD, then the IO would report the serious or continuing non-compliance to the Director, Defense Research and Engineering (DoD Directive 3216.02, April 24, 2007).

If the research study was reviewed by the IRB under ICH-GCP guidance (E6), the PI must promptly notify the sponsor and provide the sponsor with the IRB suspension or termination notification (see, 4.12.3 at http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm073122.pdf).



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