Accreditation of human research protection program: An Indian perspective

Bairy, KL and Pereira, Pratibha (2012) Accreditation of human research protection program: An Indian perspective. Perspectives in Clinical Research , 3 (2). pp. 80-84.

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With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can have, that subjects are duly compensated, and credible data generated. Most importantly, each institution/hospital should have a strong Human Research Protection Program to safe guard the trial subjects. In order to look at research with a comprehensive objective approach, there is a need for a formal auditing and review system by a recognized body. As of now, only the sponsors are monitoring/auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the Ethics Committee. This challenge can be addressed by going for accreditation by a reputed association that encompasses-the institutions, the ethics committees, and researcher/research staff. Starting their journey for the accreditation process in late 2010, Kasturba Medical College and Hospital [KMC], Manipal, and Manipal Hospital Bangalore [MHB] received full Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation in Dec 2011-a first in India. This article delves into the steps involved in applying for AAHRPP accreditation from an Indian Perspective, the challenges, advantages, and testimonials from the two hospitals on the application experience and how the accreditation has improved the Human Research Protection Program at these hospitals.

Item Type: Article
Uncontrolled Keywords: Accreditation, Association for the Accreditation of Human Research Protection Programs, ethical clinical trials, human research protection, subject protection
Subjects: Medicine > KMC Manipal > Pharmacology
Depositing User: KMC Manipal
Date Deposited: 24 May 2012 04:01
Last Modified: 24 May 2012 04:01

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