In this series of Ampersand posts, PRIM&R touches base with those who presented programmatic and research-based findings at past PRIM&R conferences.

Spotlight on an abstract from the 2009 Advancing Ethical Research Conference.

Title: Implementation and Outcomes of a Research Ethics Education Program for Cardiovascular Investigators

Authors: David Solomon, PhD and Sara L. (Sally) Tobin, PhD, MSW

Affiliation: University of Texas Health Science Center at Tyler

Abstract summary: Human subjects protection education that is tailored to specialized researchers and suited to their particular interests or research context may serve to improve their ability to address human subjects protection issues that arise in their practice. In light of this hypothesis, the authors developed a research ethics training program specifically for cardiovascular investigators. The program included modules on different topics including, statistical analysis, emergency research, subject advocacy, pediatric research, genetic research, and subject recruitment. Topics were contextualized to cardiovascular research, but framing principles are widely applicable. Our intended outcome was a transportable, modular program of research ethics education that met the expressed needs of prospective constituents comprised of cardiovascular researchers and others (e.g., IRB members.) Course participants expressed a high degree of satisfaction with our educational content, our delivery methods, and indicated that educational objectives were met. Our methods and instruments are easily replicated by others who are interested in developing specialized educational programs in human subjects protection. Educational materials are currently being prepared for online dissemination at no cost to end-users.

PRIM&R Staff (PS): In the months since you presented this abstract at PRIM&R’s 2009 Advancing Ethical Research Conference, how has your program changed or evolved?

Howard Stone, JD, LLM (HS): Since the presentation, we’ve made a number of refinements and updates to the research ethics training program. These include the addition of newly reported scientific findings that will be included in a bibliography accessible to program participants; reformatting of videotaped instructional modules for improved online access; and development of pre and post-program questions to help measure participants’ baseline and acquired knowledge in regard to specific program content.

PS: What challenges have you faced in implementing this program?

HS: Perhaps the most significant challenge that we have faced in implementing our research ethics program is in developing and delivering an onsite, traditional format one-day course that will help meet the diverse needs of cardiovascular investigators whose own experience and prior training in human subject protection vary greatly. While our national needs assessment helped us identify subject areas of interest and general background of prospective research ethics program participants, participants’ uneven experience and expertise in research ethics had to be ascertained contemporaneously with each course in order for program faculty to most effectively tailor their training modules to participants’ knowledge gaps and interests.

For questions or comments about this program, please contact Howard Stone.

Interested in submitting an abstract to present at PRIM&R’s next animal or human research ethics conference? Please e-mail us for more information.