Literature DB >> 23099599

Review of multinational human subjects research: experience from the PHFI-Emory Center of Excellence partnership.

Hemalatha Somsekhar1, Dorairaj Prabhakaran, Nikhil Tandon, Rebecca Rousselle, Sarah Fisher, Aryeh D Stein.   

Abstract

Public Health Foundation of India (PHFI), New Delhi, India and Emory University, Atlanta, USA, are lead partners in the National Heart, Lung and Blood Institute/UnitedHealth funded Center of Excellence (COE) in Cardio-metabolic Risk Reduction in South Asia which provides a vehicle for the development of collaborative research projects. With funding from the National Institutes of Health/ Fogarty International Center, a project was commenced to ensure seamless, thorough and efficient review of this collaborative research. The primary activities of the project are: 1) fact-finding activities which included conduct of a case study and review of policies and procedures of the involved ethics review committees (ERCs); 2) training workshops for COE ERC members and staff and 3) piloting of parallel review of continuing reviews and amendments. A process of parallel review of collaborative research has now been initiated and projects are now submitted simultaneously to the Emory institutional review board (IRB) and PHFI institutional ethics committee (IEC).

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Year:  2012        PMID: 23099599      PMCID: PMC3491753          DOI: 10.20529/IJME.2012.086

Source DB:  PubMed          Journal:  Indian J Med Ethics        ISSN: 0974-8466


  5 in total

1.  How many committees does it take to make a project ethical?

Authors:  Robert H Gilman; Catherine Anderton; Margaret Kosek; Hector H Garcia; Carlton A Evans
Journal:  Lancet       Date:  2002-09-28       Impact factor: 79.321

2.  Ethics review procedures for research in developing countries: a basic presumption of guilt.

Authors:  Robert H Gilman; Hector H Garcia
Journal:  CMAJ       Date:  2004-08-03       Impact factor: 8.262

3.  The paradoxical problem with multiple-IRB review.

Authors:  Jerry Menikoff
Journal:  N Engl J Med       Date:  2010-10-13       Impact factor: 91.245

4.  Institutional review boards: consideration in developing countries.

Authors:  J W Pape
Journal:  Emerg Infect Dis       Date:  2001       Impact factor: 6.883

Review 5.  Reporting of informed consent, standard of care and post-trial obligations in global randomized intervention trials: a systematic survey of registered trials.

Authors:  Emma R M Cohen; Jennifer M O'Neill; Michel Joffres; Ross E G Upshur; Edward Mills
Journal:  Dev World Bioeth       Date:  2008-04-28       Impact factor: 2.294

  5 in total

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