AAHRPP Accreditation

Karen L. Smarr, PhDHuman Research Compliance OfficerTruman VA Hospital, Columbia, MO

Cincinnati, OH March 19, 2007

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

VA HRPP

Why accreditation??? Why AAHRPP???

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

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

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

How to Understand What AAHRPP accredits?

• Organization• Research Review Unit• Investigator

HumanResearchProtectionProgram

A shared responsibility

AAHRPP Accreditation Standards Domains

• Organization• Research Review Unit• Investigator

• Sponsored Research• Participant Outreach

Obligations of

Obligations to

How does accreditation work?

Application

Site Visit

Council onAccreditation

Self Evaluation

Expert site visitorsTailored to setting

DeterminesAccreditation category

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

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

Categories of Accreditation• Full AAHRPP accreditation• Qualified AAHRPP accreditation• Accreditation-pending• Accreditation withheld

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.

Sample Interview Questions

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

Investigator Oversight

• Roles and communication with co- or sub-Investigators

• Staff qualifications

• Delegation of authority

• Daily management

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

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

Study Personnel Training

• Facility training requirements

• Training records

• Where do you go for information

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?

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)

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

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

Subject Recruitment• Recruitment (privacy concerns)• Enrollment (coercion and undue

influence concerns)• Inclusion/exclusion criteria

determination• Vulnerable subjects, e.g. prisoners• Acceptable advertisements and

incentives

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

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

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

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.

Difference between AEs and Unanticipated Problems

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.

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.

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

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

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

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

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