As a cutting-edge field like genetics evolves, new ethical issues and guidelines to deal with them arise constantly. But soon, Medical Center researchers and officials may be able to learn all the most recent research regulations online.
The Medical Center received a $597,000 federal grant to develop a web-based ethics training program. The program will help keep medical investigators and Institutional Review Board members, who oversee whether Medical Center research--particularly on human subjects--is conducted ethically, up to date with ethics regulations.
In response to the frequently changing ethical guidelines, the School of Medicine began making research ethics training mandatory for IRB members and investigators in 1999. The new program, Accessible Genetics Research Ethics Education, aims to make acquiring that training more convenient. AGREE is based on a proposal by Dr. Jeremy Sugarman, director of the Center for the Study of Medical Ethics and Humanities.
"AGREE is an extension of existing ethics training," said Linda Lee, associate director of the Clinical Research Training Program who is working on needs assessment and program evaluation for AGREE.
"AGREE will meet the needs of anyone who is involved in genetic research including clinicians, physicians and Ph.D. investigators," Lee explained.
Online modules that specialize in ethics training are already available for use, but AGREE will expand the variety of topics currently available, officials said.
"AGREE is much more focused on genetics research," said Dr. John Falletta, senior IRB chair and professor of pediatrics. AGREE will not only broaden the range of genetic topics covered in online modules but will also explain genetics and genomics issues in greater depth, he said.
In the recent past, IRB members were trained about ethical issues in live lectures. One problem with that type of training is that it is not possible to hold training sessions at times that are convenient for all individuals at once.
This problem, among others, led Sugarman to develop the more flexible web-based training option.
For years, enhancing the quality of learning opportunities for IRB members has been an issue, Falletta said. "[IRB members] are expected to have all the same training as investigators and also specific training that pertains to human research protections," he said.
AGREE provides a systematic way to train IRB members and investigators, Sugarman said.
As of now, the logistics of the website have yet to be determined. Sugarman said he plans to put together two focus groups composed of IRB members and investigators--potential users of AGREE.
Once program development is complete, the online programs will be accessible only to members of the Duke community.
"One thing in the proposal involves possibly broadening the audience through a second website... for a small fee," Lee said.
A wide range of people are contributing to the development of the program.
"An expert advisory panel helped to identify content areas and pinpoint cutting-edge issues," Lee said. The panel is composed of 14 Duke faculty members with areas of specialty ranging from philosophy to human genetics to family medicine.
"We need diversity," Sugarman said. "The diverse faculty reflect the range of people who play a role [in the development of the program]."
Falletta indicated the program will be helpful to researchers. "AGREE will provide one more source of information for IRB members, investigators, and their key personnel," he said. "I expect AGREE to enhance the knowledge of all learners. The result will not be a quantum leap, but it will be a leap."
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