April 2011 Volume 15.4 Compliance Office, N14, Rm. 10E, X3624 3624 Accreditation News Improving Lives through Research, Education and Community Outreach © 2008 LA Biomed All Rights Reserved 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.