How do you overcome cultural differences and teach health care professionals around the world to accept and practice a uniform code of ethics? That was the challenge addressed by PERC—Promoting Enhanced Research Capacity for Global
Health—a distance-accessible international training program aimed at teaching best practices to clinical research coordinators and giving them the necessary skills to share that training with their colleagues.
The principal investigator for PERC was Lynda Wilson, PhD, RN, FAAN, assistant dean for international affairs and deputy director of the Pan American Health Organization/World Health Organization Collaborating Center for International Nursing. Wilson’s research team included Marti Rice, PhD, RN, FAAN, Carolynn T. Jones, MSPH, RN, Cynthia I. Joiner, PhD, MPH, MSN, RN, Jennifer K. Laborde, MN, RN, KIMBERLY McCall, PhD, MPA and Penelope Jester, MPH, RN.
The Project received funding through April 2011, with UAB nurse researchers now looking at ways to expand and build on the successful program they’ve developed.
“The lack of structured training programs often creates uncertainty among research coordinators, potentially compromised research, potential ethical breaches, and unsafe working environments,” Wilson explained. “So this is a major issue that has become even more critical as the number of worldwide clinical trials has increased.”
A clinical trial can involve anything from testing a new drug to finding ways to empower women to use condoms and microbicides for HIV prevention. Some of the trials being conducted in other countries are funded by the United States, with the federal government requiring that uniform standards be met. But in developing countries, despite minimal exposure, clinical coordinators often have no idea what those standards are, why they’re in place, or how to apply them in complex research settings. Cultural differences create still more issues, sometimes preventing patients from questioning physicians and fully understanding their rights as a clinical trial participant, explained Carolynn Jones, who developed the PERC curriculum, so a primary goal of PERC is to protect the rights of those participants.
The School of Nursing believes the best way to promote ethics and best practices is to train local coordinators to take ownership and protect their own populations. The school is dedicated to this educational leadership domestically and internationally. In tandem with the PERC award, the school launched a post-baccalaureate certificate and master’s degree in Clinical Research Management (CRM) in 2009 for both nursing and other health professionals across UAB.
“The role of a clinical research coordinator isn’t traditionally taught in undergraduate nursing programs, but it’s a huge role in the pharmaceutical industry and academic medical centers like UAB, where most clinical trials are conducted,”
Jones said. She developed the CRM courses and the distance-accessible curriculum for PERC, modeling it after four earlier programs she created, beginning in 2005.
Using a network of contacts from those earlier studies, Wilson’s PERC team received an overwhelming 690 applicants from 50 countries, eventually filtering those down to a sample of 166 English-speaking coordinators, with far-ranging backgrounds—physicians, nurses, pharmacists, midwives, and social workers.
To overcome spotty internet access in some countries, courses were offered in multiple formats—online, on CD-ROM, and in print. Each of the five interactive courses built on the others and included a community-building activity and social networking. Participants’ competencies were tested before and after each class, with noticeable improvement after their training. The data are still being analyzed, but the capacity-building activities of students in the two PERC offerings have reached an astounding 3,000-plus.
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