enter The Association for the Accreditation of Human Research Protection Programs AAHRPP Developed by UMIC University of Michigan IRB Collaborative AAHRPP 3 Developed by UMIC Association ID: 742660
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Slide1
1
Developed by:U-MIC
To start the presentation, click on this button in the lower right corner of your screen. The presentation will begin after the screen changes and you press enter.Slide2
The Association for the Accreditation of Human Research Protection Programs
(AAHRPP)
Developed by:U-MICUniversity of Michigan IRB CollaborativeSlide3
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)
reviews/accredits HRPPs
internationalindependentnonprofit
AAHRPP accreditationvoluntary
d
esigned to ensure excellent
, ethically sound
research Slide4
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)accredits public/private
entities engaged in human subjects
researchacademic institutionshospitalsgovernment agencies
private corporationsindependent IRBs
has accredited
o
ver 215 organizations
46 US states
other countries
University
of
Michigan
AAHRPP-accredited institution since 2008
currently seeking reaccreditationSlide5
AAHRPP
5
Developed by:U-MICAssociation for the Accreditation of HumanResearch
Protection Programs (AAHRPP)
Accreditation of UM HRPPaffirms UM’s commitment to excellence in
human subjects research
h
elps establish framework
for
a high-quality HRPP
Sponsors/other
research partners
consider
AAHRPP accreditation
before
pursuing research collaborations
providing research fundingSlide6
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)examines
policies, procedures, and practices within three categories of HRPP responsibility:
institutional leadershipinstitutional review boards (IRBs)researchers and research
staffwithin
these categories,
applies
fifteen standards
numerous elements
derived
from
federal regulatory requirements
key ethical principles
international guidelines
best
practicesSlide7
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of HumanResearch
Protection Programs (AAHRPP)
Category 1: Institutional leadershipAAHRPP considers HRPP’s integrated structure/functionHRPP resources
Category 2: IRBsAAHRPP evaluates the functioning of IRBs
ethical requirements
regulatory requirements
Are there processes in place to ensure the appropriate review of all research protocols involving human subjects?
Do policies and procedures safeguard the rights and welfare of human subjects in accordance with AAHRPP standards?
Category 3:
R
esearchers
and research staff
ethical/regulatory responsibilities
Are
researchers and research staff aware of the ethical and regulatory requirements that apply to their research?
Do they have sufficient education and training regarding human subjects protections?Slide8
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)UM’s most
recent
reaccreditation processinitiated June 2015self-assessmentu
pdates:HRPP Operations
Manual
IRB
Standard Operating
ProceduresSlide9
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)AAHRPP site visit
AAHRPP
typically selects 100+ individuals to interviewanyone whose duties relate to human subjects
researchinstitutional leadership
IRB
members/staff
principal
investigators/research
staff
othersSlide10
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)AAHRPP site visit
If you are selected for an AAHRPP
interview, you willbe notified in advance by UM site visit coordinators
receive additional informationbe asked by AAHRPP about
human subjects
protections
Be prepared
for
your AAHRPP interview.
You represent UM HRPP.
You play a
critical role in UM’s efforts toward
reaccreditation.
Make
sure you
understand
HRPP structure
your
role within
that structureSlide11
AAHRPP
11
Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)AAHRPP site
visit
Re-familiarize yourself with human subject protections–related policies/procedures that apply to your role. Ensure you are familiar with
practices related to recruitment and informed
consent
noncompliance
and adverse
event reporting
including
unanticipated problems involving risk to subjects or
others (
UaP
/UPIRSO)
p
rivacy/confidentiality
vulnerable
subjects
conflicts
of
interestSlide12
AAHRPP
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Developed by:U-MICAssociation for the Accreditation of Human Research Protection Programs (AAHRPP)AAHRPP site visit
Be
prepared to describe your education and training
PEERRSinformation
on IRB
and HRPP websites
IRB’s / other units’
c
ourses
s
eminars
consultations
Review
IRB website
HRPP
Operations
Manual
PEERRS modules
UM’s AAHRPP reaccreditation website
http
://
research-compliance.umich.edu/human-subjects/aahrpp-re-accreditation
AAHRPP website
http
://www.aahrpp.org
/
Slide13
For more information about AAHRPP accreditation
AAHRPPvisit@umich.edu
13Developed by:U-MICSlide14
Thank you.
Sana
ShakourAvery AvrakotosUniversity of Michigan AAHRPP Accreditation Committee
Judy
Birk
Cindy Shindledecker
Brian
Seabolt
University of Michigan Institutional Review Boards
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Developed by:
U-MIC