Office for Human Research Protections Noncompliance in Clinical

Office for Human Research Protections Noncompliance in Clinical Research Settings & Protecting Participants Lisa Buchanan, MAOM Division of Compliance Oversight 1

Office for Human Research Protections What is the Office for Human Research Protections (OHRP)? • Provides leadership in protection of rights, welfare, and wellbeing of subjects involved in research conducted or supported by U. S. Department of Health and Human Services • Provides clarification and guidance • Develops educational programs and materials • Maintains regulatory oversight • Provides advice on ethical and regulatory issues pertaining to biomedical and behavioral research 2

Office for Human Research Protections HHS Regulations on Human Research Protections 45 CFR Part 46 • Subpart A – “The Common Rule” – IRB & Informed Consent • Subpart B – Pregnant women and fetus • Subpart C - Prisoners • Subpart D – Children • Subpart E – IRB Registration

Office for Human Research Protections Determining Applicability of Regulations Prerequisite: • Research involving human subjects conducted or supported by HHS (or other Federal Departments or Agencies) that is not otherwise exempt • Non-exempt human subject research covered by Assurance of Compliance OR 4

Office for Human Research Protections Federalwide Assurance (FWA) • Required when institutions are engaged in non-exempt human subject research conducted or supported by a federal department/agency • Documentation of institution’s commitment – to protecting the rights and welfare of human research subjects; – comply with applicable regulations • Designate the IRB(s) to be used to review applicable human subjects research 5

Office for Human Research Protections Signatory Official • Assures that human subjects research to which the FWA applies is conducted in accordance with the terms of assurance. • Generally, someone at the level of President, Chief Executive Officer (CEO), or Vice President of a company, or at the level of President, Provost, Chancellor, Vice President, or Dean of an academic institution, unless another official has been specifically delegated with this authority.

Office for Human Research Protections Signatory Official • I recognize that providing research investigators, IRB members and staff, and other relevant personnel with appropriate initial and continuing education and training about human subject protections will help ensure that the requirements of this Assurance are satisfied. • Acting officially in an authorized capacity on behalf of this Institution and with an understanding of the Institution’s responsibilities under this Assurance, I assure protections for human subjects as specified above. • The IRB(s) upon which this institution relies will comply with the Terms of the Federalwide Assurance when reviewing research covered by this Assurance and possess appropriate knowledge of the local context in which this Institution’s research will be conducted.

Office for Human Research Protections Institutional Official Responsibilities Two of the nine: – Setting the “tone” for an institutional culture of respect for human subjects, – Ensuring that investigators fulfill their responsibilities 8

Office for Human Research Protections Human Protection Administrator • The human protection administrator (HPA) should have comprehensive knowledge of all aspects of your institution’s system of protections for human subjects, as well as be familiar with the institution’s commitments under the FWA, and play a key role in ensuring that the institution fulfills its responsibilities under the FWA.

Office for Human Research Protections Top 10 Compliance Risks 10

Office for Human Research Protections Top 10 Compliance Risks 1. Inadequate IRB staff and resources 2. Inadequate IRB documentation 3. Failure to conduct auditing 4. Inadequate written procedures 5. Inappropriate IRB reporting lines 6. Inadequate communication 7. Inadequate resources for researchers 8. Insufficient support from leadership 9. Inadequate education 10. Failure to utilize regulatory flexibility 11

Office for Human Research Protections Reduce Risks? • Top to bottom – SO –Researchers –IRB –Staff Everyone in the human research protections program (HRPP) must know their role and responsibilities • Education and Training 12

Office for Human Research Protections Reporting Requirements & Compliance Oversight Procedures 13

Office for Human Research Protections Reporting Requirements - § 46. 103(b)(5) • Unanticipated problems involving risks to subjects or others – Unanticipated problems vs. adverse events – Guidance available at: http: //www. hhs. gov/ohrp/policy/Adv. Evnt. Guid. htm • Suspension or termination of IRB approval • Serious or continuing non-compliance 14

Office for Human Research Protections Most Adverse Events are not Unanticipated Problems Do Not Report AE that are not UP to OHRP Report all UP 15

Office for Human Research Protections What is an Unanticipated Problem? Incident, experience, or outcome that is: • Unexpected (nature, severity, frequency) • Related or possibly related to research, AND • Suggests greater risk of harm than previously known or recognized 16

Office for Human Research Protections Compliance Procedures • OHRP receives allegation of noncompliance • OHRP initiates evaluation • FWA-holding institution responsible • May lead to restriction or suspension of FWA 17

Office for Human Research Protections OHRP Contact Information • • • OHRP website: http: //www. hhs. gov/ohrp/ OHRP telephone: 1 -866 -447 -4777 OHRP e-mail: ohrp@hhs. gov 18

Office for Human Research Protections for protecting Human Subjects ! 19