Transcript Introductions & Recognitions

Tips for the AAHRPP
Site Visit Interviews
May 18 – 20, 2011
Tips for the Interview
• Be straightforward. A candid account of your
knowledge and experience is all that is
expected of you.
• It’s okay to say “I don’t know.”
• If you don’t know the answer, tell how you
would find the right answer; who would you ask
or where would you look?
Tips for the Interview (cont.)
• When discussing problems, also include ways
that problems have been addressed (corrected).
• Note plans for improvement.
• Mention efforts at quality improvement.
Tips for the Interview (cont.)
AAHRPP’s focus will be on:
– Your emphasis and dedication to ethics
(related to human subject protection)
– Not on the perfect execution of rules and
regulations
Tips for the Interview
(IRB Members)
• Focus on philosophical aspects of your role first,
then know the regulatory details (e.g. what you
are reviewing/performing is sound, purposeful,
and has value, before the nuts and bolts of
compliance assessment)
Tips for the Interview (cont.)
• Be aware that the site visitors work in a
university setting, therefore may ask questions
that seem foreign to you because of their
perspective
• Site visitors may ask for anecdotes or examples
of situations that illustrate how you do things.
Final points to consider
• This is not an audit.
• Interviews are only a small portion of the overall
assessment of the HRPP.
• AAHRPP recognizes that the HRPP at our
institution is continuing to evolve and grow, and
that we are committed to protecting human
subjects.
What interviewees need to know?
• Basic principles of human subjects protection.
• Federal Regulations – Common Rule and FDA
regulations – Federalwide Assurance: what they
mean, where to find them, how to apply them.
• MMC HRPP Policies and Procedures and where
to find them
What interviewees need to know?
•
Your role(s) in the Human Research Protection
Program.
•
The roles of other members of the HRPP (e.g. PIs, IRB
Members, Staff, CRCs, CTSS, Pharmacy)
•
Where to obtain answers for ethical/regulatory
behaviors expected of you in conducting research
duties: policies, guidance and forms, IRB Office,
Contract Office, Legal Affairs, Radiation Safety, the
HRPP website (www.mmc.org/hrpp)
What interviewees need to know?
•
Do you have adequate resources to perform
your duties?
•
Do you have positive or negative feelings
about the IRB?
•
Is there any message that you would like us to
relay to the Organization?
What interviewees need to know?
• How to report trouble, non-compliance, adverse
events, unanticipated problems, etc.
• How to handle participant complaints
• Where to go for advice (e.g. IRB Chair, IRB Staff,
IRB Members).
• How to keep compliant research records and
documentation and justify decisions
What interviewees need to know?
• Understand what constitutes a conflict of interest at all
levels (e.g. IRB, investigator, institution, administration).
How do you handle a conflict of interest?
• Describe the human subjects education you’ve had and
how you use it in your research
• When was the first time you heard of the Belmont
Report?
• What is the process for prior scientific review in your
department?
• Know the ethics of recruitment and inclusion/exclusion
criteria
Partnering for Protections
When you partner with an Accredited Organization, you will know:
•
They meet high standards, since they have submitted to a thorough review ensuring that they have
written down all required policies and procedures, and have submitted to intensive interviews that
evaluate how they actually implement those procedures in practice.
•
They are operating at the optimal level of quality, efficiency, and effectiveness, since the
accreditation process requires that they constantly improve their research capability. The result: more
investigators from Accredited Organizations had no action indicated after FDA inspections in 2008 than
those from non-accredited organizations. And no IRB with an Accredited Organization received a
warning letter from FDA.
•
They are in compliance with laws and world-wide standards, including U.S. federal regulations, or
other countries’ laws, or the ICH-GCP (E6) Guideline. AAHRPP site visitors are experts who probe into
how your partners meet regulations, laws, and guidelines of the countries where they work.
•
You can simplify coordination of your investigators across sites with one, comprehensive set of
industry standards, worldwide, because AAHRPP standards are already recognized as a gold standard
for promoting research integrity, consistent regulatory guidance, coordinated regulatory oversight,
quality of data, and the strongest transnational standards governing research.