HRPP Policy - Reporting to oversight agencies

The following IRB determinations prompt additional reporting requirements to relevant institutional, organizational, and federal officials:

• unanticipated problem involving risks to subjects or others (UPIRTSO)
• serious and/or continuing noncompliance
• IRB suspension of research (some or all research activities)
• IRB termination of research

Notifications include the IRB’s determination, surrounding circumstances, reason for the determination, and relevant subsequent actions and information.

When members of the IU Human Research Protection Program (HRPP) become aware of any of the following, the Association for the Accreditation of Human Research Protection Programs (AAHRPP) must be notified as soon as possible, but not later than 48 hours:

• Any negative actions by a government oversight office, including OHRP determinations, FDA Warning Letters, FDA 483 Inspection Reports with official action indicated, FDA Restrictions placed on IRBs or investigators, and corresponding actions taken under non-US authorities related to human research protections
• Any litigation, arbitration, or settlements initiated related to human research protections
• Any press coverage (including but not limited to radio, TV, newspaper, online publications) of a negative nature regarding the HRPP.

When the IRB makes any of the determinations described in section 2.1 above, the determination is reported to appropriate entities within 21 days, unless a different timeframe is outlined below. In some cases, the 21-day timeframe may be extended based on circumstances surrounding the event, such as an outstanding corrective action that could affect the report. Such extensions and the reason will be documented by the University Director, HRPP.

• The Principal Investigator (PI)
• Institutional official or designee, Indiana University
• If IU faculty, the PI’s department chair or division chief
• If event involved personnel conducting the research on behalf of an affiliate organization, the affiliate’s organizational official or designee, as applicable
• If issue of legal liability, IU Office for the Vice President & General Counsel or counsel for engaged institutions
• If the IU IRBs are serving as the IRB of record for external sites or research personnel, the relying institution(s)
• If the research is under the oversight of an external IRB, the reviewing IRB
• If subject to DHHS regulations, the Office for Human Research Protections (OHRP)
• If the research is federally funded and all study activities were suspended or terminated, IU Director of Grant Services
• If subject to Food and Drug Administration (FDA) regulations, the FDA
• If subject to Department of Defense (DOD) regulations, the DOD human research protection officer, within 30 days after the IRB’s determination

Research subject to VA regulations

IRB determinations described in section 2.1 above must be reported within five (5) business days of the date of the determination to the facility director, associate chief of staff for research, and Research and Development Committee. Additional reporting is required to the Research Compliance Office (RCO) if the apparent serious or continuing non-compliance was identified by an RCO audit, regardless of outcome.

IRB determinations related to local research deaths, apparent UPIRTSO, apparent serious and/or continuing noncompliance, and other events involving VA HRPPs must be reported in accordance with the IU HRPP Policy on Reportable Events, section 3.3.