This document describes how the UW-Madison complies with DHHS and FDA regulations reporting requirements for unanticipated problems involving risks to participants or others for studies that fall under UW-Madison IRB purview.
- Study teams must notify the UW-Madison IRB promptly of any potential unanticipated problems occurring in their research that could pose risks to participants or others.
- For purposes of this policy, promptly means study teams must report potential unanticipated problems to the reviewing IRB within:
- One (1) business day of receiving notice of the problem when immediate intervention is required to prevent serious harm to participants or others.
- Ten (10) business days after the study team receives notice of the problem for any potential unanticipated adverse device effect occurring on the study.
- Fourteen (14) business days from the date the study team is notified of the problem for all other potential unanticipated problems.
- An unanticipated problem involving risks to participants or others is a problem that is unanticipated and reasonably related to the research.
- A problem is considered unanticipated if it is reasonably related to the research and unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the study-related documents, such as the IRB-approved research protocol and informed consent document, and the characteristics of the participant population being studied.
- However, it is considered unanticipated and must be reported to the IRB when a participant is incarcerated while participating in a study that is not approved to enroll incarcerated individuals.
- In multi-center trials, an unanticipated problem involving risks to participants or others occurring at a non-UW-Madison research site must be reported to the UW-Madison IRB if a) the potential unanticipated problem poses risks to UW-Madison participants or b) the UW-Madison IRB is serving as the reviewing IRB for the site at which the potential unanticipated problem occurred.
- Potential unanticipated problems can also be reported by other individuals not involved with the research project, but who have relevant information, including IRB members or staff; participants or potential participants and their family members; members of staff of another IRB; patient relations offices at University of Wisconsin Hospital and Clinics, University of Wisconsin Medical Foundation, or the VA; and sponsors and other auditors.
- The report can be made to the IRB Office by phone or email and may be made anonymously.
- The IRB Office will ask the reporter to provide the following information:
- Detailed information about the possible unanticipated problem, including relevant dates.
- How the person reporting obtained the information provided in the report.
- Information about any injury, potential harm, or risk to the participant or others.
- How the reporter may be contacted for further information, if needed.
- Any other relevant information requested by the IRB Office.
- Upon receipt of a report of a possible unanticipated problem from someone other than the investigator or study staff, the IRB director (or designee) will notify the principal investigator on the study when appropriate.
- IRBs process reports of potential unanticipated problems in accordance with their Standard Operating Procedures (SOPs).
- Reports of potential unanticipated problems may be triaged by experienced IRB staff to determine whether the problem likely constitutes an unanticipated problem.
- If IRB staff determines that the report constitutes a potential unanticipated problem, IRB staff will refer the report to the IRB Chair (or designee) or convened IRB.
- After reviewing the report, the IRB Chair (or designee) or committee will determine whether further consultation is needed to assess whether the problem posed risks to participants or others.
- If IRB staff thinks that a reported problem may require immediate intervention to protect participants or others from serious harm, IRB staff will immediately forward the report to the IRB chair (or designee).
- If the IRB chair (or designee) determines that the report (i) does not constitute an unanticipated problem or (ii) does not require any action and that the research may continue without change, the IRB chair (or designee) will promptly notify the study team in writing when appropriate.
- The IRB chair (or designee) may consult with other IRB members if special expertise is needed to assess whether the problem posed risks to participants or others.
- If a report suggests that participant safety is at risk, the IRB chair may immediately suspend the protocol pursuant to the UW-Madison Suspension and Termination of Research Policy.
- Any report that appears to constitute a potential unanticipated problem will be referred to the convened IRB for review at the next available IRB meeting for scheduling.
- If a report did not come from the study team, IRB staff may provide the study team with an opportunity to respond to the report before forwarding it to the IRB.
- When appropriate, the IRB chair (or designee) may make recommendations to the convened IRB as to what actions should be taken in response to the report.
- The IRB will review reports of potential unanticipated problems referred to it by the IRB chair (or designee).
- All IRB Members have access to the complete protocol file, including the unanticipated problem report, in the electronic submission system.
- If a report suggests that participant safety is at risk, the IRB may immediately suspend or terminate the research, pursuant to the UW-Madison Suspension and Termination of Research Policy.
- Before making a determination that the problem constitutes an unanticipated problem involving risks to participants or others, the IRB may invite the study team to present additional materials.
- After reviewing a report, the convened IRB will make determinations on the following issues:
- Whether the reported problem constitutes an unanticipated problem involving risks to participants or others according to the definition in this policy
- What action in response to the report is appropriate
- Whether suspension or termination of approval is warranted (See, Suspension or Termination of Research Policy), and
- Whether further reporting to university officials, federal agencies and department heads is required pursuant to the UW-Madison Reporting to Federal Authorities Policy.
- Regardless of whether the IRB determines that the problem is an unanticipated problem involving risks to participants or others, according to the definition in the policy, the IRB may take any of the following actions:
- Modifying the consent document and/or process
- Monitoring of the research and/or consent process
- No action
- Other actions appropriate for the local context
- Providing additional information to past and/or current participants (e.g. whenever the information may relate to the participant’s willingness to continue participation)
- Reconsidering approval
- Referral to other organizational entities (e.g., legal counsel, risk management, institutional official)
- Requirement that current participants re-consent to participation
- Requiring additional training of the investigator and/or study staff
- Requiring modifications to the protocol
- Revising the continuing review timetable
- Suspending the research
- Terminating the research
- After making its determinations, the IRB will:
- Notify the investigator in writing of its decisions.
- If the IRB determines the problem constituted an unanticipated problem, it 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, and Deputy Institutional Officials
- Deferring institution if the continuing or serious noncompliance involves or may affect that institution’s investigator(s) or participants
- 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
Adopted By: All Campus IRB
Adoption Date: November 10, 2005
Revised: April 10, 2008
Revised: December 4, 2008
Revised: September 10, 2009
Revised: November 5, 2009
Revised: December 3, 2009
Revised: March 1, 2012
Revised By: Cross-Campus Human Research Protection Program Committee
Revision Date: November 11, 2015
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