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Bioethics in research: strengthening the foundation
March / April 2014 | Volume 13, Issue 2
Opinion by Fogarty Director Dr Roger I Glass
No research on human subjects can be conducted without an effective local system in place to ensure the protection of human subjects. And yet many low- and middle-income study sites lack the capacity to address this critical need. In recognition of this issue, Fogarty hosted the first Global Forum on Bioethics in Research in 1999. The following year the Center launched its International Research Ethics Education and Curriculum Development program. Several other NIH institutes, which appreciated the value of this endeavor to their own programs, joined this initiative. Over the past decade, this program has grown to address the urgent need to train a cohort of bioethicists in low-resource settings where research is conducted and encourage them to build academic programs and national structures for biomedical review and research ethics.
I'm pleased this program is being featured in two sets of papers written by many of its principal investigators and published in the Journal of Empirical Research on Human Research Ethics. (Access the full collection of papers, Ethics of Clinical Research: Multinational Research and Capacity Building, from the NIH Clinical Center Department of Bioethics.) The timing of this series could not be better: 2014 will mark the fiftieth anniversary of the publication by the World Medical Association of the Declaration of Helsinki, the document that first outlined many of the central principles for the ethical conduct of biomedical research.
This collection on international research ethics education comes at a critical point for the global health community. The past decade has witnessed a major increase in funding for biomedical research globally and a clear shift toward the conduct of more clinical trials in low- and middle-income countries (LMICs). This shift recognizes that biomedical research anywhere can help people everywhere and that many health problems of global concern can best be addressed by conducting studies in countries where these problems are most prevalent.
For example, much of our understanding of the treatment and prevention of HIV/AIDS has come from research in countries where this problem is most devastating, especially in sub-Saharan Africa. The testing of new drugs and regimens, and the development of strategies to prevent transmission of the disease - prevention of mother-to-child transmission (PMTCT), circumcision, counseling of discordant couples and treatment as prevention - have all benefited from extensive research conducted in areas where the disease has the greatest prevalence and the most devastating impact.
Major funding for these studies has come from international donors, which raises concerns about who controls the research agenda, who benefits from the research, and whether the pressure to achieve expeditious results might trump concerns for the safety and well-being of the populations being studied. Researchers also face unique challenges in low-resource settings, for example, creating a meaningful informed consent process among low-literacy populations and providing ancillary care to study participants who lack access to adequate health care. NIH-supported research, no matter where it takes place, must adhere to the same high ethical standards. Our ability to address many critical health concerns can only advance by globalizing our research agenda and extending our ability to assess and understand the underlying ethical issues. International training and research in research ethics is essential.
While many other research sponsors have recognized and joined the global effort to support training and research in research ethics in LMICs, funding and support have not kept pace with the growth of global health research. Consequently, these efforts at training and research in research ethics remain a critical need but an orphan child.
While this collection highlights some of the key features and findings of the Fogarty program, it also provides clear directions to advance research ethics education for the future. Unquestionably, as clinical research and trials increase in LMICs, the need for skilled local experts to independently assess and address thorny ethical issues will remain key. Fogarty, along with its many partners at NIH, is committed to being part of this continuing and essential process.
This is a condensed version of the editorial, "International Research Ethics Education," published by the Journal of Empirical Research on Human Research Ethics (JERHRE).
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