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Brown Bag Series First Tuesday of each month (except July)

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1 Brown Bag Series First Tuesday of each month (except July)
Dartmouth Human Research Protection Program (HRPP) Brown Bag Series First Tuesday of each month (except July) Welcome and Introductions

2 HRPP Brown Bag Series Association for the Accreditation of Human Research Protection Programs AAHRPP Questions Topics for 2017

3 Association for the Accreditation of Human Research Protection Programs AAHRPP
AAHRPP: founded in 2001 by 7 non-profit organizations including AAMC, AAU, PRIMR, Consortium of Social Science Associations, National Health Council, Federation of American Societies for Experimental Biology, Association of Public and Land-grant Universities Concern: (in) consistencies of IRBs Concept: IRB vs. HRPP To date: 231 organizations (35 outside of USA)

4 The Value of Accreditation per AAHRPP website
Strengthen protections for research participants Earn respect and meet expectations of peer organizations Leadership role in collaborative efforts Competitive edge with sponsors Reduce risk of non-compliance Enhance standing with federal agencies Common commitment to continuous quality improvement

5 received 12/5/2016 Our site here at ‘institution x’ works with one of your researchers on a multi-site collaborative program.  I am writing in follow-up to the s from about a year ago, to ask if there is an update regarding your IRB’s AAHRPP accreditation.  The last information we have said you were in the process of reaccrediting. We would like to shift IRB oversight to your IRB, however our IRB won’t defer to other agencies unless that accreditation is in place. Thanks so much for your help.

6 AAHRPP Application Step one – completed December 1 (800 pages)
Respond to questions / gaps Step two Education sessions to prepare for : AAHRPP site visit (interview researchers, IRB members, staff, institutional officials) Respond to site visit questions AAHRPP Council review Timeframe ?

7 AAHRPP Application Domain I. Organization Domain II. IRB
Domain III. Researchers and research staff Institutional HRPP Policy HRPP website HRPP Overview HRPP SOPs

8 Dartmouth HRPP includes:
Committee for the Protection of Human Subjects Research Compliance Office; Conflict of Interest Committee SYNERGY (Clinical Translational Science Award - CTSA) Office of Sponsored Projects (OSP) Environmental Health & Safety (EHS) IBC, GTC Technology Transfer Office (TTO) Clinical Trials Office (CTO) Office of Clinical Research - Norris Cotton Cancer Center Privacy Officers Legal Counsel Investigational Pharmacy Department Chairs, PIs, Research Team; Research participants  Institutional Officials Goal is to strength communications between all stakeholders

9 Topics for 2017 AAHRPP : Discussion and Questions
Investigational drug management, Recruitment, Prioritize research studies, Quality Improvement, Education, Conflict of Interest, Rapport, Teach – Back, Funding advocacy, AAHRPP, HIPAA, External IRBs, Single IRB (NIH requirement), Research involving individuals lacking decision making capacity, Investigator Transfer Guidance, Community Based Research


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