Federal regulations require the reporting of serious and continuing noncompliance to the IRB, institutional officials and certain federal agencies and department heads. UW-Madison has developed this guidance on reporting noncompliance to assist investigators and research staff in meeting their obligations under the federal regulations.
Noncompliance is any failure to follow (1) federal regulations, state laws or institutional policies relevant to human subjects research, or (2) the requirements and determinations of the reviewing IRB.
Serious noncompliance is non-compliance that affects the rights and welfare of participants or that may put participants at risk of harm.
Continuing noncompliance means multiple or repeated instances of noncompliance, particularly after written notice from the IRB that the investigator must take action to correct noncompliance. The multiple or repeated instances of noncompliance may occur on one protocol or on more than one protocol and may occur simultaneously or over a period of time.
Some protocol exceptions and deviations may be reportable as noncompliance.
See, UW-Madison’s Noncompliance Policy posted on the HRPP Policies webpage: http://www.grad.wisc.edu/research/hrpp/HRPPpolicy.html. See, also, Health Sciences IRBs Guidelines for Reporting Protocol "Exceptions" and "Deviations" in Clinical Trials posted on the HS IRB webpage:
http://info.gradsch.wisc.edu/research/hrpp/hsirbs/2.deviations.html.
Investigators or research staff members who uncover noncompliance in the course of conducting research have an obligation to report the noncompliance to the IRB that approved the research in which the noncompliance occurred. Reports can be made to the reviewing IRB office, director or chair. Contact information for each IRB office is on the Human Research Protection Program’s website (http://info.gradsch.wisc.edu/research/hrpp/irblinks.html)
Reports of noncompliance may also come from other sources such as participants, sponsors, patient advocate offices or family members. In some instances, IRB office staff or IRB members may discover noncompliance in the course of reviewing a protocol. All reports regardless of their source are handled in the same way by the IRB.
The IRB offices will assist those making reports to assure all necessary information is supplied.
Reports of noncompliance should be made within 48 hours of receiving notice of the alleged noncompliance, if the alleged noncompliance requires immediate intervention to prevent serious harm to participants or others. In all other cases, reports of noncompliance should be made within fourteen (14) business days after discovery of the alleged noncompliance.
Reports of possible noncompliance are first screened by the IRB director who refers those reports requiring immediate action to the IRB chair. All other reports are referred to the full IRB for review at their next meeting.
When a report is sent to the IRB, the IRB evaluates the report and determines whether the noncompliance is serious or continuing. The IRB will also make a decision as to what the appropriate remedies should be, including whether research should be suspended or terminated, and whether the noncompliance needs to be reported to federal departments and agencies, such as Office of Human Research Protection (OHRP), the VA or the Food and Drug Administration (FDA), and to UW-Madison officials.
Generally, if the event is determined to be serious or continuing noncompliance, the IRB will give the investigator an opportunity to present written information or to appear in person at the IRB meeting before it makes its final decision.
The investigator may appeal the IRB decision to the Human Research Protection Advisory Committee within 10 business days from receipt of notice of the decision. The appeal must be made in writing and must explain the basis for the appeal. The investigator’s appeal will be considered at an Advisory Committee meeting, and the Advisory Committee will notify the investigator, the IRB and the UW-Madison Institutional Official of the final outcome.
The IRB chair may immediately suspend research if a report of noncompliance suggests immediate intervention is necessary to protect research participants. The IRB may also suspend research pending a final decision by the IRB as to whether the noncompliance is serious or continuing. If federally funded research is suspended by the IRB or the IRB chair, the IRB or chair will immediately report the suspension to the UW-Madison Institutional Official.
If the IRB decides that a report constitutes serious or continuing noncompliance, when required by the UW-Madison policy and federal law, the Institutional Official will report the noncompliance to the OHRP, the VA, the FDA and any other federal department or agency that funds or supports the research in which the noncompliance occurred.
See, also, UW-Madison’s Noncompliance Policy, Suspension and Termination of Research Policy and Reporting to Federal Authorities Policy posted on the HRPP Policies page: http://www.grad.wisc.edu/research/hrpp/HRPPpolicy.html.