SUNY DOWNSTATE MEDICAL CENTER UNIVERSITY HOSPITAL OF BROOKLYN POLICY AND PROCEDURE Subject: Human Research Protections Program No. IRB-01 Prepared by: Danielle Lewis, MD, MPH Kevin L. Nellis, MS, CIP Approved by: Richard Rosenfeld, MD President of the Medical Board Michael Lucchesi, MD Chief Medical Officer Patricia Winston, MS, RN UHB CAO/COO William P. Walsh, MBA, MSW UHB Sr. VP & Managing Director Page 1 of 104 Revision Date: 01/19/2018 Original Issue Date: 03/30/2017 Supersedes: 12/05/2017 Effective Date: 01/19/2018 The JC Standards: IM.01.01.01, IM.01.01.01, LD.04.01.01, LD.04.02.03, MM.03.01.01, MM.06.01.05, RC.02.01.01, RI.01.01.01, RI.01.03.05,PI.03.01.01 Issued by: Research Foundation for SUNY – Downstate Medical Center; Office of Research Administration – Institutional Review Board
See definitions in IRB guidance documents for a description of each event. *Government inspection (or audit) Report findings within 24 hours, if any serious or continuing non-compliance was found or proposed; otherwise report at the time of continuing review or study closure. If the IRB is not aware of the government inspection, the study team should alert the IRB when the inspection is scheduled or if an inspector arrives unannounced, so the IRB may help as needed. *Privacy Violation (or Breach). Immediately report this to IRB and Privacy Officer. *Information (Data) Security Violation (or Breach). Immediately report this to IRB and Data Security Officer. Incarceration of a research participant. Immediately, if participant is actively incarcerated; otherwise within 5 days. If an already-enrolled research participant becomes incarcerated, all research interventions and interactions cease (except those required for the well-being of the research participant) until the IRB has made the prisoner determinations. Any FDA Actions or changes to a HUD. Immediate. Serious Adverse Event. An AE or SAE may also meet the definition of an UPIRPO, UAE, or UADE, as described below. 24 hours, if in a Clinical Trial an internal AE meets the following criteria: serious (or alarming) AND CAUTION: If the IRB approves a protocol that has more strict SAE reporting requirements (e.g., required by the sponsor), the PI must report those SAEs
unanticipated (unexpected), AND would have implications for the conduct of the study (e.g., requiring a significant and usually safety-related, change in the protocol such as revising inclusion/exclusion criteria or including a new monitoring requirement, informed consent, or investigator’s brochure). to the IRB as described in the IRB approved protocol. The term “alarming” is not defined by the FDA, so it is up to the PI’s or Sponsor’s discretion on how to interpret this term. An individual AE occurrence ordinarily does not meet these criteria because, as an isolated event, its implications for the study cannot be understood. Reporting requirements to the sponsor of AEs for clinical trials conducted under IND are stricter. Consult with the sponsor or see *Research related injury involving provision of healthcare. 24 hours, if serious. Report within the current approval period, if minor. The PI or IRB may consult with general counsel regarding recommended action. *Apparent Non-Compliance. 24 hours, if serious or continuing. Report within the current approval period, if minor (e.g., protocol deviation). Any employee or agent is expected to report any apparent non-compliance to the IRB or to the Compliance Hot Line at 877-349-SUNY (7869) or via the . You may make an anonymous report using the web based system, if desired. Only a convened (full) board may confirm a determination of “serious” or “continuing” Determinations “serious” or “continuing” non-compliance
participants to inform them of the new information. If the change to the risk/benefits ratio is adverse, the informed consent should be amended and submitted to IRB for approval. The informed consent should be updated and the IRB may require that the currently enrolled research participants be re-consented, acknowledging receipt of this new information and for affirming their continued participation. Changes Initiated to Eliminate an Apparent Immediate Hazard days. 5 days. Include an amendment, to propose any additional or permanent changes. Expanded Access, Emergency Use, or Compassionate Use of an Unapproved Drug, Unapproved Biologic or Unapproved Device. Notify IRB Chair as soon as possible. Notify the IRB within 5 days of drug administration or device use. Requires approval of the Department Chair and Medical Director before administration. Protocol Deviations (including minor modifications made without IRB approval), Violations, or Complaints. *Must be reported to the full board if the event meets the requirements to be reported within 5 days. 5 days, if it adversely affects: the rights, safety, or welfare of the research participant; or the research participant’s willingness to continue participation; or the integrity of the research data, including information security requirements. Otherwise report to IRB before continuing review or project closure. Include an amendment, to propose any additional or permanent changes, as a corrective action. Any complaints involving translations or interpretations must also be reported to patient relations.
*Termination or *Suspensions of research, Administrative Hold, FDA Clinical Hold, Enrollment Hold. 5 days. Either the termination of IRB approval or the suspension of IRB approval requires the prompt reporting by the Institutional Official to OHRP to the FDA for a clinical investigation that is FDA regulated, to the US DOJ when the research is federally supported or conducted by the US DOJ, to the NYC H+H when the research is conducted at Kings County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. All Local Unanticipated Problems Involving Risks to Participants or Others (UPIRPO). *Must be reported to the full board if the event meets the requirements to be reported within 5 days. See also SAE. 5 days, if serious; otherwise, within 30 days. If the IRB concurs or determines that an event is an UPIRPO, it requires prompt reporting by the Institutional Official to OHRP, to the US DOJ when the research is federally supported or conducted by the US DOJ, to the NYC H+H when the research is conducted at Kings County Hospital, to an external institution when the research is conducted at an external site, and to the sponsor when applicable. Unexpected AE (UAE). See also SAE and UPIRPO. 5 days, if serious; otherwise, within 30 days.