Extending Human Research Protection Standards Globally

Posted in GUMC Stories  |  Tagged medical ethics

JAN 8, 2016–Many in the U.S., especially in the health science community, understand why the Tuskegee syphilis experiment was infamous. For 40 years, until 1972, African-American men in rural Alabama participated in a U.S. Public Health Service study designed to research the natural progression of syphilis. Men were told they were receiving free health care from the U.S. government but were not treated for the disease.

To train scientists online about the rules and practices that govern the protection of human and animal subjects, the NIH uses the Tuskegee experiment and the comparable studies carried out by American researchers in Guatemala in the late 1940s as examples of violations of human subjects’ protection.

“These are excellent and tragic examples of a complete lack of ethical protection of participants in a study — but why would they be used to illustrate the point with populations outside of the U.S.?” asks Irene Jillson, PhD, an associate professor at the Georgetown University School of Nursing & Health Studies.

Moreover, as research methods become increasingly sophisticated and biomedical research grows globally, modern medical science needs  standards for human subject protection that can be, to the maximum extent possible, universal, she says. Increasingly, efforts to harmonize varying views focus on the highest ethical standards for protecting human subjects and research integrity.

To make available training related to research ethics more relevant to audiences in the Middle East and North Africa (MENA) region, Jillson is working with colleagues there,  as well as with researchers at the University of Miami on a different approach — one that recently received funding from the U.S. State Department.

Making The Lessons Relevant

International researchers frequently seek NIH funding for studies that cannot be conducted in the U.S., such as research on malaria, which doesn’t exist here. Or they partner with U.S. investigators on joint research projects. But in both cases, the studies must have approval from an institutional review board (IRB), which requires all researchers, including those overseas, to complete an online protection of human subjects course, or comparable training.

The Collaborative Institutional Training Initiative (CITI) Program at the University of Miami offers online courses on human subjects protection, responsible conduct of research, good clinical practices, and laboratory animal welfare and others. Since 2000, the CITI courses have been used both  in the U.S. and globally, providing training for millions of researchers, IRB staff, clinicians and others. In many countries where  research ethics education is not mandatory, CITI is being adapted or translated to provide an inexpensive tool for research ethics education, Jillson says.

The University of Miami has already translated the CITI course into more than 10 languages, including Chinese, Japanese, Korean, Portuguese and Spanish; it has also been adapted culturally and contextually for researchers in Latin America and the Caribbean.

Jillson is leading an effort to make CITI relevant to researchers in the Arabic-speaking countries in the MENA region by adapting the courses to fit the context, culture and language of researchers there. With her longstanding collaboration with researchers in the region, and experience designing and launching courses in global health ethics, global health systems and politics and global health research, Jillson is well placed to do this research.

Insisting on Global Ethical Standards

The need to ensure ethical treatment and human protection in all research studies, not just those sponsored by the NIH, is now critically important because medical research is increasingly being conducted outside the U.S., Jillson says. For that reason, researchers are increasingly required to comply with the international ethical research standards, including those based in part on NIH requirements.

“Collaborative global research is exploding exponentially,” Jillson says. “Neither infections or chronic health issues know global boundaries, but it is also true that clinical studies are expanding dramatically in resource-poor countries.

“There have been some well known ethical issues raised in some of this international research,” she adds. “There are some companies whose sole purpose is to recruit human subjects for studies in countries where the costs are less and regulatory hurdles are fewer, so the degree to which they are protecting subjects has been called into question. These countries are responding — India, for example, is developing stringent IRB requirements for all clinical research. Scientists are starting to insist on NIH standards when doing business with pharma.”

Respecting Medical Collaboration

Jillson and her collaborators are bringing together specialists throughout the MENA region to work through the cultural context issues that will make the CITI course most effective there. Clinical and basic researchers will meet with bioethicists next year in Morocco to hammer out the adaptations.

“There are many issues to discuss, such as how Islamic law may impact clinical studies and distinctions between Sunni, Shia and Christian ethical perceptions of research ethics,” she says. “Many researchers in these countries are familiar with the need for ethical human protection and have received training in research ethics, including training through NIH, Department of State and European funding.”

Jillson adds that the U.S. State Department funds this work because they “see this as an extraordinary opportunity to engage people in the region in the issue of bioethics — a respectful way of collaborating in health and medical research and ensuring that researchers in the region have ownership in developing content that reflects their values, their culture, and their context — thereby making it more meaningful, useful, and likely more used.”

Renee Twombly
GUMC Communications