Reporting to the IRB Part 2
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1 Webinar Series Reporting to the IRB Part 2 Frequently Asked Questions December 4, 2013 Presented by: James MacFarlane Director of Board Services
2 About Schulman Associates IRB Established in 1983 US and Canadian boards fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) Superior audit history with FDA five consecutive audits with no findings. 21 CFR Part 11 compliant electronic systems Compliant with FDA and OHRP requirements
3 About Schulman Associates IRB Full board meetings five days a week Dedicated daily expedited review of qualifying minimal risk protocols Phase I Board with streamlined processes tailored to Phase I timelines Oncology Review Board for all phases of oncology research Customized services for institutions and AMCs Experienced primary points of contact for sponsors, CROs, institutions and sites
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5 About Today s Presenter James MacFarlane, BS, CIP Director of Board Services BS in History of Science and Medicine from Northern Kentucky University With Schulman since 2008 Responsible for direct support of board operations, including IRB liaison for informed consent development, safety reporting, and study change management Member of PRIM&R and Mensa
6 Introduction In this presentation, we will: Identify what noncompliance is, who can be noncompliant, and who is responsible for reporting. Discuss what the Board is reviewing, and what determinations the Board can make. Dissect some real life examples of noncompliance. Have an interactive, live Q&A sessions.
7 What is noncompliance? DHHS Common Rule b.5, Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the department or agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval. Noncompliance failure to adhere to the research protocol, federal regulations, relevant guidelines and/or the requirements and determinations of the Board FDA a.4, A PI must maintain accurate records of the protocol, with documents showing the dates of and reasons for each deviation from the protocol. ICH 4.5, Deviations are not permitted except with prior sponsor approval or immediate risk to subjects must be reported to IRB, sponsor and regulatory authorities
8 Who can be noncompliant? The principal investigator The PI shoulders responsibility for the oversight of the study. Investigation into potential noncompliance starts here. Research site staff Noncompliance failure to adhere to the research protocol, federal regulations, relevant guidelines and/or the requirements and determinations of the Board Sponsor staff Just about anyone who can have an impact on subject safety and data integrity
9 What to Report Serious or Continuing Noncompliance Not expressly defined in CFR As defined by Schulman: Serious Noncompliance An event that has a severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention.
10 Why Not Report Everything? Noncompliance Case Study A central IRB receives 50,000 deviations in a given year. Of these,103 are found to be serious or continuing. Thus,.002% were reported by the IRB to the appropriate regulatory agency. Did the other % of the deviations reported that year help or hinder the protection of human subjects?
11 Case Studies
12 Serious and Continuing Noncompliance: Example of a Reportable Event? Criteria for Serious or Continuing Noncompliance: Serious Noncompliance Severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention. A study coordinator manipulates data in order to avoid exclusion criteria and enroll subjects who should not be included in the research. Yes reportable event
13 Serious and Continuing Noncompliance: Example of a Reportable Event? Criteria for Serious or Continuing Noncompliance: Serious Noncompliance Severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention. A subject misses their week 4 study visit due to a family emergency. No not a reportable event
14 Serious and Continuing Noncompliance: Example of a Reportable Event? Criteria for Serious or Continuing Noncompliance: Serious Noncompliance Severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention. Research site staff draw blood samples from 8 subjects prior to written informed consent. Yes reportable event
15 Serious and Continuing Noncompliance: Example of a Reportable Event? Criteria for Serious or Continuing Noncompliance: Serious Noncompliance Severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention. A man goes to his Primary Care Physician for an annual flu shot; the site staff inadvertently give him an injection of study drug. Yes reportable event
16 Serious and Continuing Noncompliance: Example of a Reportable Event? Criteria for Serious or Continuing Noncompliance: Serious Noncompliance Severe, negative affect on subject safety or study integrity that occurs as a result of negligence, misconduct, or violation of the protocol, GCP, or Board requirements. Continuing Noncompliance A pattern of events that affect the safety of the study subjects or study integrity, likely to continue without intervention. A routine study EKG is performed 90 seconds outside of the protocol specified window. No not a reportable event
17 Questions We d now like to invite our attendees to present their own questions regarding noncompliance. We will spend the remainder of today s presentation discussing as many questions as we can. Each situation is unique. The more we talk about these, the better we become at identifying what is and what is not reportable. To submit your questions, please use the in-webinar question tool or webinar@sairb.com
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