alexa Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research
ISSN: 2155-9627

Journal of Clinical Research & Bioethics
Open Access

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Review Article

Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research

Tal Burt1*, Yogendra KGupta2, Nalin Mehta2, Nagendra Swamy3, Vishwas Sovani4 and Marjorie A Speers5

1Duke Clinical Research Unit & Duke Clinical Research Institute, Durham, NC, USA

2All India Institute of Medical Sciences, New Delhi, India

3Manipal Health Enterprises, Karnataka, India

4Revogenex Inc., Duluth, GA, USA

5Association for the Accreditation of Human Research Protection Programs, Washington, DC, USA

*Corresponding Author:
Tal Burt
Duke Clinical Research Unit & Duke Clinical Research Institute
Box 3854, DUMC, 40 Duke Medicine Circle, Durham, NC 27710, USA
Tel: 919-668-4650
Fax: 919-684-1674
E-mail: [email protected]

Received date: May 08, 2014; Accepted date: September 04, 2014; Published date: September 07, 2014

Citation: Burt T, Gupta YK, Mehta N, Swamy N, Vishwas, et al. (2014) Ethics Standards (HRPP) and Public Partnership (PARTAKE) to Address Clinical Research Concerns in India: Moving Toward Ethical, Responsible, Culturally Sensitive, and Community-Engaging Clinical Research. J Clin Res Bioeth 5:195. doi:10.4172/2155-9627.1000195

Copyright: © 2014 Burt T, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

 

Abstract

Like other emerging economies, India’s quest for independent, evidence-based, and affordable healthcare has led to robust and promising growth in the clinical research sector, with a compound annual growth rate (CAGR) of 20.4% between 2005 and 2010. However, while the fundamental drivers and strengths are still strong, the past few years witnessed a declining trend (CAGR -16.7%) amid regulatory concerns, activist protests, and sponsor departure. And although India accounts for 17.5% of the world’s population, it currently conducts only 1% of clinical trials. Indian and international experts and public stakeholders gathered for a 2-day conference in June 2013 in New Delhi to discuss the challenges facing clinical research in India and to explore solutions. The main themes discussed were ethical standards, regulatory oversight, and partnerships with public stakeholders. The meeting was a collaboration of AAHRPP (Association for the Accreditation of Human Research Protection Programs)—aimed at establishing responsible and ethical clinical research standards—and PARTAKE (Public Awareness of Research for Therapeutic Advancements through Knowledge and Empowerment)—aimed at informing and engaging the public in clinical research.The present article covers recent clinical research developments in India as well as associated expectations, challenges, and suggestions for future directions. AAHRPP and PARTAKE provide etiologically based solutions to protect, inform, and engage the public and medical research sponsors.

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