Poster Presentation

Friday, July 13, 2007
9:30 AM - 10:15 AM

Friday, July 13, 2007
3:15 PM - 4:00 PM
This presentation is part of : Poster Presentation III
Developing an Institutional Review Board for International Healthcare Non-Governmental Organizations
Ellen L. Palmer, Nursing, The University of Texas at Arlington School of Nursing, Arlington, TX, USA
Learning Objective #1: 1. Discuss the rationale for and list the steps in formation of an Institutional Review Board for international non-governmental organization in international health-care.
Learning Objective #2: 2. Review an example of a new Institutional Review Board and a request for research protocol approval for non-governmental organization in healthcare.

An Institutional Review Board (IRB) for an International Non-Governmental Organizations (NGO) is needed in developing countries. As documented in the current list of International Compilation of Human Subjects Research Protections complied by Office for Human Research Protections Department of Health and Human Services on October 1, 2005 and 2007 no ethical guidelines exist for conduct of human subjec research in the country of Haiti and other developing countries.  Although there are general guidelines such as those released from Council of International Organizations for Medical Sciences (CIOMS), countries are under no obligation to enforce them.  This presentation reviews the steps in the educational process for the development of an IRB for a NGO in a developing country.  Presentation includes: review the concept of IRBs; how to justify and establish an international ethical IRB; review other international research rules; specific organization utilization of research ethics for an IRB; required membership of the IRB committee; creation of a set of operating procedures and policies to which the new IRB will function; and a plan to implement an IRB.

An IRB has been created and implemented for Grace Children’s Hospital in Port-au-Prince, Haiti, providing health care for tuberculosis, HIIV/AIDs and respiratory infections in children for over 35 years. This program has established a precedent for the conduct of investigator and others engaged in human subject research in a country without guidelines.  Further it has created a portal through which an organization can begin to receive resources that require ethical standards. The review of a sample research protocol with a checklist for new IRB reviewers will be presented.