Award-winning training program available to all
February 1, 2006
Award-winning training program available to all
Five key areas covered in curriculum
Clinical trial sites and research institutions seeking improvements to their staff and IRB training programs might learn something from the best practices developed by Family Health International (FHI) of Research Triangle Park, NC. Human Improvement Institute of Bethesda, MD, presented two of its 2005 Awards for Excellence in Human Research Protection to FHI for the organization’s best practices in education and training. The winning programs were the Research Ethics Training Curriculum and the Ethics Training Curriculum for Community Representatives.
The Research Ethics Training Curriculum was designed as an educational program for the people who do research, including investigators and clinical trials staff, says Roberto Rivera, MD, director of the Office of International Research Ethics at FHI.
"We provide basic training to every person who has direct participation in a trial, and it would include principal investigators, nurses, social workers, and others who have a function in the research by counseling people, obtaining informed consent, and by being responsible for the follow-up of subjects," Rivera says.
The training curriculum meets all requirements by NIH and OHRP for providing basic training on research ethics to everyone who conducts research, Rivera notes. "Our policies say the same as the federal regulations, and the person who does the training is a key researcher," Rivera says.
The basic research ethics training covers the core areas of research ethics, including these:
- principles of research ethics;
- foundations of research ethics;
- responsible conduct of research, including informed consent (see sample page from this section);
- supervision of research;
- special issues in research.
"Once we determined the content areas, we wanted to develop something that could be used as a tool that you could use for self-training and also for group training," Rivera says.
The result is a user-friendly training tool that is available on CD-ROM and the Internet at FHI’s web site: www.fhi.org. It can be located by putting "ethics training" in the web site’s search engine.
Each version has PowerPoint slide copies with narrative text, and group presenters can expand the narrative text according to their own knowledge and skills.
The curriculum is designed to be presented in a four- or five-hour training session if used individually or as a self-study program, and the group training version could be covered in one eight-hour session or in two four-hour sessions.
For those who use the training on-line, it has interactive case studies.(See sample case studies from training tool.)
The training tool, which FHI makes available to the public has had more than 300,000 visits, and it has been downloaded as a PDF file more than 10,000 times, Rivera says.
The tool includes 25 multiple choice questions for participants, and it has a reader’s evaluation of the curriculum. Participants who submit documentation of having taken the training course could receive a signed certificate from FHI. The training is available in Spanish, French, and Portuguese on the web site. It’s also available in Mandarin Chinese on a CD-ROM, and it’s being translated into Swahili, Rivera says.
"One thing we had in mind for the training was to have something that would be globally accepted," Rivera says. "We wanted a program that addressed research ethics without any direct reference to particular interests or regulations."
When investigators conduct research internationally, they often hear from local collaborators, "Why do you tell me I have to do things this way? Why do you want me to do things the way the U.S. government regulations say things have to be done?" Rivera says.
"It’s a prevalent attitude, so we developed it to have in mind an international audience that would find the training acceptable," Rivera says.
While the training programs at NIH and the CDC are useful for U.S. investigators who wish to make certain they follow federal regulations, they are not as useful for an international audience, Rivera says.
Since FHI’s goal was to have a globally-accepted training program, when the training curriculum was completed, FHI sent it to be reviewed by international experts, Rivera says.
"We have a number of reviewers from international organizations, like the World Health Organization and local people who are responsible for research ethics programs in their respective countries," Rivera says. "We asked them to be sure they believe it is internationally correct and that it is something that addresses the subjects in a manner that is acceptable for an international audience."
The reviewers returned many comments about terminology, informed consent, and other items, he notes.
"They care very strongly about informed consent and thought we were presenting it more like a form, so they wanted us to look at developing it as a process," Rivera says. "They wanted more focus on why you have to do research this way and not just because it’s a regulatory requirement."
After incorporating the reviewers’ concerns, FHI came out with a new version of the training program and then conducted field testing with the program, Rivera says.
"What we do commonly is select reviewers who may be members of research ethics committees and then ask the person to conduct training in their location," Rivera explains.
"Since they reviewed the training material they know how to do it, and they tell the audience that they are field testing a training instrument, and they want to hear what parts the trainees don’t understand."
The field testers completed a structural template, send it to FHI, and that information was incorporated in the final version of the training program, Rivera says.
"It’s a long and painful and costly process," Rivera says. "But it works, and that’s the only way of doing it."
Each training program took about a year to complete, he adds.