Document 6428819

April 2011 Volume 15.4
Compliance Office, N14, Rm. 10E, X3624
3624
Accreditation News
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Accreditation News – Some background
Before the accreditation process unfolds, this is a brief
background based on the slide presentation I will be giving to
various stakeholders over the next few months:
1. Terminology
The preferred term is Human Research Protection Program
(HRPP) which encompasses more than just the IRB/
Compliance Office.
The entire institution is considered involved in the HRPP
2. Why accredit?
Historical
z Closure of major institutions due to failure to properly
support their Human Research Protection Program
(HRPP) and/or implement their programs in a
systematic and consistent way
z Commercial IRB forced to close after federal “sting”
operation – suggests the need for standards
Philosophical
z Other medical and research operations are accredited
z JCAHO for hospitals
z AAALAC for animal research
z Why would human research protection be held to a
lower standard?
z Assurance system is not well policed by OHRP
Pragmatic
z Industry is moving toward only placing trials with
accredited organizations
z Anticipated CTSI award is partly dependent on all
HRPP’s within the consortium being accredited
Logistical
z Standardize operations to produce more consistency
in IRB review within and between institutions
z Streamline the review process by focusing the IRB on
its regulatory defined tasks
3. Benefits of Accreditation
High standards and protections.
An assurance of quality.
Improved efficiency, effectiveness.
A competitive edge.
Government recognition.
Public trust, confidence.
4. Who accredits?
z Association for the Accreditation of Human Research
Protection Programs (AAHRPP)
z Independent non-profit organization
z Founded by, among others, AAMC, AAU,
FASEB, PRIM&R
z Accreditation is voluntary
Training/tests available at www.labiomed.org, Training and Education.
z
Accreditation of Human Research Protection
Programs is the coming thing
z Currently over 223 HRPPs, covering over
1100 entities
5. Where changes have to be made
z IRB
z Compliance Office
z Grants & Contracts/Research Administration
z Financial Conflict of Interest
z Investigators
6. What will investigators have to do?
z Use a more comprehensive template in writing a
protocol
z But may avoid having to duplicate information in the
protocol in the initial application form
z For industry clinical trials, initial application can refer to
sponsor protocol (“see page 54”)
z For NIH or foundation grants, or investigator-initiated
submissions, Investigators will have to create a
protocol using the template
z Will need to meet time sensitive deadlines or have
human research privileges restricted.
7. Advantages to Investigators
z
z
z
z
z
Greater transparency
Greater likelihood of approval quickly after IRB review
Avoidance of the “gotcha” questions
Less ambiguity in negotiating contracts
Clear guidelines for investigators to follow (Investigator
Manual)
8. Other Issues
z
New human subjects training (CITI)
There will be more to the talk than just this summary, such as
the changes anticipated in the IRB and Compliance Office
operations, but if I told you about those, then you might not
come to the presentations.
I That’s not exactly what I meant
Pregnancy tests will not be conducted as exercise is not
contraindicated in early pregnancy and because early
pregnancy should not appreciably influence exercise
responses, pregnancy tests will not be conducted.
Yes, but let’s get this clear – will pregnancy tests be done or
not?
A Randomized, Parallel, Placebo-Controlled, Double-Blink
Phase IIA Study….
Must be one of those flash studies.