Research Knowledge Base
This policy defines noncompliance that must be reported, specifies reporting deadlines, and describes how the reports will be evaluated and determinations made. It also defines when and how institutional officials and appropriate federal departments/agencies will be notified.
- Study team noncompliance means any failure by the study team to follow (1) federal regulations, VA guidance (when applicable), state laws or institutional policies relevant to human participants research, or (2) the determinations of the reviewing IRB as documented in the approved IRB application and supporting materials.
- Serious noncompliance includes failure to follow federal regulations, VA guidance (when applicable), state laws or institutional policies relevant to human participants research or any determinations of the reviewing IRB and involves one or more of the following:
- substantive harm or genuine risk of substantive harm to the safety, rights and welfare of research participants or others,
- decreases potential benefits, or
- compromises the integrity of the human research protection program.
- 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, or from the Institutional Official (IO) that the IRB or individuals within UW-Madison must take action to correct noncompliance.
- Continuing noncompliance may occur on one or more than one study and may occur over a period of time.
- All noncompliance should be reported to the IRB except the items outlined in the:
- Health Sciences IRBs’ Guidelines for Reporting Study "Exceptions" and "Deviations" in Clinical Trials; or
- Education and Social/Behavioral Science IRB’s Deviations Document.
- Initial reports of noncompliance should be made to the IRB that has been involved in reviewing the research study or exemption. When no application has been submitted to an IRB, the report should go to the IRB that normally would have jurisdiction over the study or exemption.
- If the alleged noncompliance requires immediate intervention to prevent serious harm to participants or others, initial reports of noncompliance should be made within one (1) business day of discovery of the alleged noncompliance.
- In all other cases, initial reports of noncompliance should be made within fourteen (14) business days after discovery of the alleged noncompliance.
- If additional time beyond the above reporting deadlines is needed to investigate and identify causes of the noncompliance, study teams must still adhere to the deadlines and inform the IRB that investigation is ongoing.
- In addition to study teams, noncompliance can be reported by IRB members or staff (e.g., when discovery is made during a study review or investigation of a participant complaint); Human Research Protection Program (HRPP) compliance monitors or other Office of Research Compliance staff (e.g., as result of a compliance monitoring activity); participants, potential participants or others, such as family members; members or staff of another IRB; UW Health or the VA research or patient relations offices; sponsors and other auditors; and others not involved with the research project but having information about possible noncompliance.
- The written reports filed by individuals other than investigators or study staff should include:
- Detailed information about the alleged noncompliance, including relevant dates.
- How the person reporting obtained the information provided in the report.
- Information about any injury, potential harm, or risk to the subject or others.
- How the reporter may be contacted for further information, if needed.
- Any other relevant information.
- The IRB staff (or IRB designee) reviews each report of noncompliance in accordance with its standard operating procedure and, if necessary, conducts an investigation of the report.
- If the IRB staff (or designee) thinks that the report may require immediate action to protect participants, they will promptly refer the report to the IRB chair or to the IRB director, if the director is not the individual initially reviewing the case.
- If the IRB staff (or designee) or IRB chair determines that the report may constitute serious or continuing noncompliance, as defined in this policy, the IRB staff (or designee) or IRB chair will forward the issue to the convened IRB for review.
- The convened IRB will review reports of noncompliance referred to it by the IRB staff or IRB chair to determine whether the report constitutes serious or continuing noncompliance and any appropriate remediation measures, such as changes to the protocol, suspension, termination, reporting to federal agencies and department heads, and other corrective actions as appropriate.
- The IRB will notify the investigator and institutional official in writing of its decisions.
- If the IRB determines the noncompliance to be serious and/or continuing, the IRB may notify any of the following individuals, institutions or organizations:
- The chair of the investigator’s department and/or research unit
- Other administrative officials as relevant, such as the dean and/or division head, director of Research and Sponsored Programs
- Deferring institution if the continuing or serious noncompliance involves or may affect that institution’s investigator(s) or subjects
- Other campus IRBs or oversight entities, such as the Data Safety Monitoring Board, HIPAA Privacy and Security Officers, and Auditing and Monitoring Programs
- Any other individuals, institutions, or organizations as appropriate
- In noncompliance cases that are likely to be complicated or sensitive, the IRB Chair, IRB Director, IRB, or IO may convene an advisory committee to consider the case and make recommendations to the IRB regarding how to proceed, including the type of information and action required or whether a formal investigation is warranted.
- If a research study has been ceded to an external IRB, that Reviewing IRB would be responsible for assessing the report of potential noncompliance unless the Reviewing IRB and the UW-Madison have made alternative arrangements (e.g., the local IRB office or post-approval monitoring program instead could have responsibility for receiving and assessing the reports).
- Written agreements with external IRBs obligate those IRBs to promptly report any findings of serious and/or continuing noncompliance to the appropriate point of contact at the UW-Madison.
- IRB or institutional noncompliance means any failure to follow federal regulations, state laws or institutional policies relevant to human participants research.
- When apparent serious noncompliance by a UW-Madison IRB is discovered, a report documenting the specific regulations, laws or policies that were not followed should be made to the Institutional Official.
- The IO may appoint an ad hoc committee to investigate the report, make the same findings required for study team noncompliance, including whether noncompliance occurred, and, if so, whether the noncompliance was serious or continuing, what remedies are required, and what reporting is necessary.
- The ad hoc committee reports its decisions to the IO for further reporting pursuant to the UW-Madison Reporting to Federal Authorities Policy.
- When apparent serious noncompliance by components of UW-Madison HRPP outside of the IRB or study teams is discovered, a report should be made to the Vice Chancellor for Research and Graduate Education (or his/her designee).
- The Vice Chancellor for Research and Graduate Education (VCRGE, or their designee) may appoint an ad hoc committee to investigate the report, make the same findings required for study team noncompliance, including whether noncompliance occurred, and, if so, whether it was serious or continuing, what remedies are required, and what reporting is necessary.
- The ad hoc committee reports its decisions to the VCRGE for further reporting pursuant to the UW-Madison Reporting to Federal Authorities Policy.
- The same protections specified in the Reporting of Suggestions and Concerns Regarding HRPP Performance and Function Policy apply to individuals making reports of potential noncompliance.
- If a report contains facts that suggest there was research misconduct as that term is defined in the UW-Madison Research Misconduct Policy, the report must be forwarded promptly to the Research Integrity Officer.
Adopted By: All Campus IRB
Adoption Date: December 8, 2005
Revision Date: May 5, 2006
Revised: April 10, 2008
Revised: December 2008
Revised: November 5, 2009
Revised: May 6, 2010
Revised: October 7, 2010
Revised: March 1, 2012
Revised By: Cross-Campus HRPP Committee
Revision Date: August 28, 2015
Revision Date: October 13, 2015
Revision Date: May 31, 2017
Revision Date: April 26, 2018
Revision Date: January 3, 2019
Copyright © 2017 University of Wisconsin System Board of Regents
- Health Sciences IRBs Protocol Exceptions and Deviations Guidance
- Common Rule (45 CFR 46)
- Reporting to Institutional and External Authorities
- Suspension and Termination of Approved Research
- Misconduct in Scholarly Research
- VA Research - Policy and Guidance
- Reporting of Suggestions and Concerns Regarding HRPP Performance and Function
Keywords: noncompliance serious continuing report