1. The IRB and Human Subjects Research Protection Eric Felde, CIP Research Compliance Consultant Office of Research Compliance Indiana University

2. Where we came from…

3. …and why it matters Human subjects protection began as an attempt to avoid the worst case scenario Context drives regulation Technology outpaces regulatory framework - Genomic research - Data confidentiality

4. Independent review Voluntariness Coercion Informed consent: process & elements Justice Lack of subject understanding Beneficence Risks justified by benefits Failure to treat Minimization of risk Harm Independent review Scientific validity Unverified results Belmont Report Common Rule Belmont Report Common Rule

5. Belmont Report Respect for Persons JusticeBeneficence Common Rule Criteria for approval -Minimization of risk -Risk/benefit ratio -Consent -Increased protections for vulnerable populations

6. Role of the IRB: Protect Human Subjects Approve, require modifications in, or disapprove research activities Conduct initial and continuing review of ongoing research Approve any changes in research activities prior to changes being initiated Evaluate adverse events, protocol deviations, and noncompliance May suspend or terminate IRB approval Provide confirmation that IRB review is not required when needed 6

7. IRBs at Indiana University 7 Serve Bloomington and Indianapolis campuses, IU Health, Eskenazi, VA, and Regenstrief Six IRBs – each meets monthly 4 Biomedical IRBs 2 Social/Behavioral IRBs IRB Executive Committee – policy and oversight Members: Physicians Nurses Attorneys Psychologists Social Workers Statisticians Dentists Pharmacists Physiologists Non-IU-affiliated individuals Non-scientists Representatives for vulnerable populations

8. 8 RESEARCH Systematic investigation to develop or contribute to generalizable knowledge HUMAN SUBJECT Research about a living individual either through intervention/ interaction or identifiable private information IRB Review Human Subjects Research - DHHS Human Subjects Research - FDA RESEARCH Any experiment involving a test article HUMAN SUBJECT An individual who is or becomes a subject in research, either as recipient of test article or as a control IRB Review

9. Review IRB or IRB member Full Board studies Most drug and device studies Invasive procedures X-rays in excess of standard of care Surveys/interviews including very sensitive questions and collecting identifiers Expedited studies Non-invasive collection of biological specimens Minimal risk clinical procedures (blood draws, MRI, ECG, EEG, EMG, moderate exercise, etc.) Use of data collected for non- research purposes FDA regulated research using de-identified human specimens Human Subjects Office staff Exempt studies Surveys, interviews with adults Collection of existing data when recorded without identifiers Non-Human Subjects Research Non-FDA regulated research using de-identified human specimens Non-Research Student Project Class project involving surveying adolescents about illegal behavior 9

10. IRB Role: Post Approval Review study: - renewal - amendments - adverse events and noncompliance

11. Where we are today 30 years later… New technologies: imaging, mobile, big data Precision medicine Research in clinical care settings Increasing willingness to participate in and even seek out research

12. Where we are today (in research) Increased visibility -Media (including social) -CT.gov Privacy of personal information Save everything: data, tissue Consent waived for most research without subject intervention

13. Where we are today (in research compliance) Collaborative reviews Flexibility Balance between institutional review and research

15. Where we’re going New regulations New goals Bring human subjects protections in line with current practices and technology Simplify, and reduce inappropriate burdens

16. A New Common Rule Improve informed consent – content and organization – to facilitate understanding Almost always require informed consent for secondary use of biospecimens – regardless of identifiability Mandate single IRB review of multi-site research conducted at U.S. institutions Eliminate continuing review for certain minimal risk research

17. A New Common Rule Require privacy safeguards Exclude certain activities from coverage Extend the scope of rules to cover clinical trials – regardless of the source of funding Expand the categories of research that are exempt from the rules, better calibrating the level of review to the level of risk

18. The future of human subjects research Driven by advances in clinical care and technology Requires collaboration on all levels

19. Eric Felde, JD, CIP Research Compliance Consultant, Human Subjects Office Office of Research Compliance Indiana University efelde@iu.edu 317.278.7816