1. AAHRPP Accreditation Karen L. Smarr, PhD Human Research Compliance Officer Truman VA Hospital, Columbia, MO Cincinnati, OH March 19, 2007

2. AAHRPP Accreditation Process Background (Accreditation and AAHRPP) How to Approach the AAHRPP Application Understanding AAHRPP Accreditation AAHRPP Standards and Domains How to Get AAHRPP Accreditation AAHRPP Site Visit and Reviewer Questions AAHRPP Draft Report and Response

3. VA HRPP Why accreditation??? Why AAHRPP???

4. Background 1999 – Kiser testimony to Congress  VA would become the driving force to establish an accreditation program 2000 – 5-year $5.8 million contract to NCQA  72 VA facilities accredited 2005 – 5-year $4.9 million contract to AAHRPP  3 VA facilities accredited

5. What’s so different about AAHRPP? NCQA  Quantitative model  Focused on policies and procedures, and documentation  Involved primarily the research office, IRB, and research pharmacy AAHRPP  Qualitative model  Focuses on policies and procedures, and PRACTICES  Involves entire Human Research Protection Program (HRPP) – institutional officials, research office, IRB, investigators, sponsored programs, and subjects

6. Approach to AAHRPP Accreditation: Application Process Do Not Underestimate Time Commitment  Begin Early- Allow at least 4-6 months  Allow Time for Input/Review by Team Organization and Communication Key Request Guidance/Assistance from COACH and AAHRPP staff Be Familiar with policies and procedures (P&P) and practices Anticipate delays and modification of P&P, and creation of new P&P Focus on Final AAHRPP Accreditation

8. How to Understand What AAHRPP accredits? Organization Research Review Unit Investigator Human Research Protection Program A shared responsibility

9. AAHRPP Accreditation Standards Domains Organization Research Review Unit Investigator Sponsored Research Participant Outreach Obligations of Obligations to

10. How does accreditation work? Application Site Visit Council on Accreditation Self Evaluation Expert site visitors Tailored to setting Determines Accreditation category

11. Self-evaluation 77 elements Review of all HRPP policies and procedures Overview of HRPP program Range of pages in a completed self-evaluation application – 350 to 1500

12. Site Visit Process 2 – 6 site visitors 2 – 4 days Records review Interviews  Front-line  Management  Senior Management Exit briefing Draft report sent in 30 days

13. Categories of Accreditation Full AAHRPP accreditation Qualified AAHRPP accreditation Accreditation-pending Accreditation withheld

14. Domain III: Investigators What is AAHRPP looking for?  Competent, informed, conscientious, compassionate, and responsible investigators and research staff who provide the best protection for research participants.

15. Sample Interview Questions

16. General Tips Be honest If you don’t know something, say who you would go to for the answer This is not the place to pick or air battles

17. Investigator Oversight Roles and communication with co- or sub- Investigators Staff qualifications Delegation of authority Daily management

18. Relationship with the IRB This is a general area of just what it is like to work with the IRB  Communication  Work load  Review process

19. Study Resources Access to a population that would allow recruitment of the required # of participants Sufficient time Adequate numbers of qualified staff Adequate facilities A process to ensure legally-effective informed consent Availability of medical or psychological resources that participants may require

20. Study Personnel Training Facility training requirements Training records Where do you go for information

21. Submitting a Protocol What is human subjects research? When do you need IRB review? When can you start your study? What changes can you make to your protocol without IRB review?

22. Study Design Sound study design  Answers the research question  Adequately powered  Control groups Monitoring the rights and welfare of participants  Safety checks (lab, xray, physical exam, etc.)  Reporting mechanisms  Data Safety and Monitoring Board (DSMB)

23. Conflict of Interest Articulate what is a conflict of interest  Any interest of the investigator that competes with the investigator’s obligation to protect the rights and welfare of research participants Disclosure statements Evaluation by your institution

24. Risk Evaluation Risks of medical treatment vs. risks of research How do you minimize risks?  Avoiding unnecessary procedures  Using procedures already being performed for diagnostic or treatment purposes  Safety monitoring

25. Subject Recruitment Recruitment (privacy concerns) Enrollment (coercion and undue influence concerns) Inclusion/exclusion criteria determination Vulnerable subjects, e.g. prisoners Acceptable advertisements and incentives

26. Informed Consent Process vs. paper  Persons providing consent  Any waiting period  Steps to ensure sufficient opportunity to consider participation  Minimize possibility of coercion or undue influence  Language used and understood  Assessment of decision-making capacity and communication with a legally-authorized representative

27. Disclosures in Consent Form Study procedures Risks Circumstances under which participation might be terminated Consequences of withdrawal Additional costs Confidentiality of records Liability Conflict of interest

28. Subject Questions and Complaints What is a complaint? Who else should you tell? Contact numbers for subjects:  Research staff  If research staff can’t be reached, call…  Someone other than research staff  Where to voice concerns/complaints

29. Unanticipated Problems Involving Risks to Subjects or Others OHRP considers unanticipated problems, in general, to include any incident, experience, or outcome that meets all of the following criteria:  unexpected (in terms of nature, severity, or frequency) given the research procedures and the subject population being studied;  related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by participation in the research); and  suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

30. Difference between AEs and Unanticipated Problems

31. Examples An investigator conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. The data are stored on a laptop computer without encryption, and the laptop computer is stolen from the investigator’s car on the way home from work. This is an unanticipated problem that must be reported because the incident was  unexpected (i.e., the investigators did not anticipate the theft);  related to participation in the research; and  placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized.

32. Examples As a result of a processing error by a pharmacy technician, a subject enrolled in a multi-center clinical trial receives a dose of an experimental agent that is 10-times higher than the dose dictated by the IRB-approved protocol. While the dosing error increased the risk of toxic manifestations of the experimental agent, the subject experienced no detectable harm or adverse effect after an appropriate period of careful observation. This constitutes an unanticipated problem for the institution where the dosing error occurred that must be reported because the incident was  unexpected;  related to participation in the research; and  placed subject at a greater risk of physical harm than was previously known or recognized.

33. Data Safety and Monitoring Plans This is more than adverse event reporting  Timing and collection of safety data  Monitoring of the safety data  Who does the monitoring? Risks include more than physical risks  Psychological, social, economic and legal

34. Case History (Research Records) Case report forms Supporting data Medical records Progress notes Signed and dated consent form Documentation that consent was obtained prior to subject participation

36. Post AAHRPP Site Visit Take a Break from AAHRPP Activities 30 days Before Draft Report Arrives Review Notes from Site-visit Meet with Team and Discuss strategies Begin Communicating with AAHRPP

38. Receipt of Draft Report Review Carefully Report Compare to Site Visit Notes Compare to Your Draft Response Electronically Communicate with AAHRPP  Element number in message line  One element per message  Include observation from draft report Anticipate Several Communications per Element

39. Communication Key Institutional Official Regarding Response and Timeline Distribute Policies and Procedures to PI’s and research team Discuss with IRB Institution’s Response, Implications, and Timeline