LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER NEW ORLEANS

1. LOUISIANA STATE UNIVERSITYHEALTH SCIENCES CENTER NEW ORLEANS

2. Office of Research ServicesPh. 504-568-4970 Suite 206, Resource Bldg. • Kenneth Kratz, PhD –Director • Staff: • Nicole Hammill – Pre-award (Grants and Contracts) • Rose Castay – IACUC/IBC • Charlene Walvoord – IRB • Sylvia Young – IRB • Dyan Melson - IRB • Office Responsibilities: • Pre-award Sponsored Research - Proposal and Contract Review, Negotiation, and Routing • Institutional Animal Care and Use Committee (IACUC) • Institutional Review Board (IRB) • Institutional Biosafety Committee (IBC)

3. Office of Research Services Staff Nicole Hammill Rose Castay Dyan Melson Lynn Arnold Charlene Walvoord

4. LSUHSC-NO IRB STAFF Chair - Dr. Kenneth Kratz Coordinators - Ms. Charlene Walvoord Ms. Lynn Arnold Ms. Dyan Melson

6. Human Subjects Protection Program(HSPP)

7. Institutional Review Board(IRB)PurposeTo protect the welfare of humans participating in research studies

8. National Research Act (1974) National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research“Ethical Principles and Guidelines for the Protection of Human Subjects of Biomedical and Behavioral Research” (The Belmont Report - Federal Register 1979) Code of Federal Regulations - 1981 Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) - Title 45, Part 46 Food and Drug Administration (FDA) - Title 21, Chapter 1, Parts 50, 56, 312, 600, 812

9. The Belmont ReportOffice of the SecretaryDept. of Health and Human Services Ethical Principles and Guidelines for the Protection of Human Subjects of Research The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979

10. Basic Ethical Principles 1. Respect for Persons - Respect for persons incorporates at least two ethical convictions: First, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. 2. Beneficence - Persons are treated in an ethical manner not only respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being: (1) do not harm and (2) maximize possible benefits and minimize possible harms. 3. Justice - Who ought to receive the benefits of research and bear its burdens? This is a question of justice in the sense of “fairness in distribution” and “fairness in who will contribute”.

11. Applications 1. Respect for persons captured in “Informed Consent” Information Comprehension Voluntariness 2. Beneficence captured in “Assessment of Risks and Benefits” The Nature and Scope of Risks and Benefits The Systematic Assessment of Risks and Benefits 3. Justice captured in “Selection of Subjects”

12. Human Subjects ResearchLSUHSC-NO Training Requirements(CITI)

15. Institutional BiosafetyCommittee (IBC)

18. HIPAA Health Information Portability and Accountability Act (Privacy and Security Rules)

23. Institutional Review Board(IRB)

24. Institutional Review Board (IRB) Human Subjects Research “Human subjects”means a living individual about whom an investigator (whether professional or student) conducting research obtains: 1.) Data through intervention or interaction with the individual or 2.) Identifiable private information The term “research” designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships

25. LSUHSC-NO IRB Committee of 11 members: • Medical personnel of various disciplines • Scientists of various disciplines • Non-scientist • Unaffiliated member from community

26. Initial Board Actions on New Studies Exempt Expedited Full Board Review Potential recommendations from the Board are: Approval:No further changes needed. Modifications Required to Secure Approval:Moderate revisions are necessary. Withheld: Extensive revisions needed. Modifications must be re-submitted for Full Board Review. Disapproval:The scientific or ethical problems posed by the study are of grave concern to the Board. A new proposal must be submitted to the Board.

27. Responsibilities of the IRB: Review new applications and consent forms for approval Conduct continuing reviews (projects approved no more than one year) Review adverse event reports Review amendments to protocols and consent forms Responsibilities of Investigator to IRB: Respond to IRB requests in a timely fashion Submit adverse event reports Submit continuing re-approval documents Submit all amendments to protocols Submit all proposed advertising Copy all communications to FDA or OHRP

31. 1) Exempt Status

32. 2) Expedited Review

33. 3) Full Board Review

34. 4) Demographics

35. 5) Conflict of Interest

36. 6) Waivers

37. 7) Consent Form

38. Common mistakes made by P.I.s on IRB applications: Difference between QA and Research. Who can be a PI (Faculty/individuals in training)? Minimal Risk Studies 1. Confusion between “retrospective” and “prospective” studies. 2. Issue of “practicability” in waiver applications. 3. Difference between “de-identified” and “anonymous”. Greater than Minimal Risk Studies 1. Underestimating the risk in drug studies.  2. “n”  -  Must have a statistical section with justification of “n”. 3. Protocol writing. 4. Data Monitoring Board. 5. Informed consent document problems.

39. Association for the Accreditation of Human Research Protection Programs(AAHRPP)

40. AAHRPPAccreditation Domains I. Organization (2 Standards with 24 Elements) II. IRB (5 Standards with 25 Elements) III. Researcher and Research Staff (8 Standards with 11 Elements)

41. I I I I > December 2009 April 2010 June 2010 March 2012 Pre-paid Fee AAHRPP Commence Submit Step 1 App. Annual Meeting Self-Study > I I I July 2012 September 2012 December 2012 Submit Step 2 App Site Visit Full Accreditation Proposed Time-line for LSUHSC-NO Human Research Protection Program AAHRPP Accreditation Process

43. HRPP Institutional Review Board Policy and Procedure Guidebook Updates

44. Safety Reporting and Compliance • Section 4.6 (Continuing Review) Post Approval Monitoring • Section 4.7 Unanticipated Problems Involving Risk to Subjects and Others (previously referred to as adverse event reporting)

45. Post Approval Monitoring • Purpose • Extension of the LSUHSC-NO HRPP formal procedures to monitor compliance and UPs in research studies • Exercise to assist the IRB in the review of internal QA practices of Investigators • Exercise to assist investigators in reviewing and improving practices regarding their studies

46. Post Approval Monitoring

47. Implementation Effective March 2012 Studies are randomly selected each yearly quarter for participation Comprehensive study self-assessment 7 working days Post Approval Monitoring

48. Post Approval Monitoring • Evaluation Results • Final evaluation results are disseminated to the Principal Investigator by the Chair • Possible Review Outcomes • No deficiencies • Deficiencies – Corrective Action Plan • Deficiencies – Directed or Non-Directed Audit

49. Post Approval Monitoring • On-Site Audits • Collaborative effort with the Office of Compliance Program Privacy Officer • Directed and non-directed audits • All study material must be made available for review

50. Unanticipated Problems • Rationale for the Change • Alignment with current regulatory guidance • Reduce the burden of reviewing external reports that do not aid in the protection of human subjects