265597 Navigating international IRB partnerships: What you need to know

Wednesday, October 31, 2012

Janet Archer, BSc, Msc , Public Health Research, Social & Scientific Systems, Durham, NC
Mwenda Kudumu, BS , Public Health Research, Social & Scientific Systems, Durham, NC
Robert Yates , Social & Scientitic Systems, Silver Spring, MD
The role of the institutional review board (IRB), known internationally as “Ethics Committees,” is to provide ethical and regulatory oversight of research that involves human subjects in order to protect the rights, welfare, and well-being of research participants; comply with laws and regulations; assess risk; and adhere to the Belmont Report. However, laws and the standard of human rights differ greatly between countries. When working with international IRBs researchers might have to educate the local IRB on US federal requirements such as annual review, ethics or data safety monitoring, standard format and language. A primary step in conducting international epidemiologic or field research using US federal funds is to identify an in-country IRB that is registered with the Office of Human Research Protection (OHRP) and is associated with an institution with Federal Wide Assurance (FWA). In addition, multi-site studies often have several IRBs with different consent and regulatory requirements. Ensuring that the associated institutions and IRBs comply with the OHRP guidelines, adhere to each other's specifications, and consider the nuances of the local language and cultural can be challenging. The authors have conducted studies in China, Mexico, Norway, Nigeria and South Africa. Case studies will be used to illustrate strategies for effectively navigating international IRBs. Challenges such as identifying qualified translators to translate study documents into rarely-spoken languages, classifying the IRB of record, maintaining multiple IRBs' schedules, and determining the order of submission will be discussed.

Learning Areas:
Diversity and culture
Ethics, professional and legal requirements

Learning Objectives:
1. Identify challenges of working with international IRBs. 2. Discuss case studies to demonstrate effective strategies for resolving international IRB issues.

Keywords: Epidemiology, Ethics

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: I am familair with the subject content and have worked in the research area for 10 years. I have an MS.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.