Research group updates ethics training

Focus: Community obligations, informed consent

The new edition of a widely used human subjects protection curriculum has an increased emphasis on community engagement and the importance of ongoing informed consent, says one of its developers.

Changes to the Research Ethics Training Curriculum (RETC) for Family Health International (FHI) came in response to feedback from people around the world who've used it since its introduction in 2001, says Roberto Rivera, MD, a senior advisor for FHI, which conducts research throughout the developing world in areas that include reproductive health and infectious diseases. "We've trained hundreds of people ourselves, and people have used the [first edition of the] curriculum by the thousands," he says. "We were constantly receiving feedback from the people using it, so we had many ideas that we wanted to incorporate in a new edition."

The new RETC has been recognized with an Award for Excellence in Human Subjects Protection from the Health Improvement Institute (HII). In 2005, FHI won two awards from the HII: one for the first edition of the RETC and one for an ethics training curriculum for community representatives.

Rivera says the original RETC was developed to train personnel who participate in its international research projects. Since that time, it has come to be used by other organizations including the Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). In addition, Rivera says, many U.S. institutions use the RETC to provide an international component for their ethics training.

"They use the CITI as the primary tool, and then they use our curriculum for people who are going to do international research," he says. The CITI Program is a subscription service providing research ethics education to all members of the research community. To participate fully, learners must be affiliated with a CITI participating organization.

Community and consent

When it came time to update the curriculum, Rivera says his group made several changes but he sees two as particularly important:

Community impact.

The first edition of the RETC interpreted the basic Belmont principles — respect for persons, beneficence, and justice — only as they applied to individuals, Rivera says.

"This is still the most common perception of these three principles: that they apply to a particular person — respect for a person, benefits and risks for the person, justice for the person," he says. "In this [new] edition, we tried to make an important point that equally important is the community. You owe respect not only to the person, but to the community where the research is being conducted. You have to think of the benefits and risks that are going to come out of the research for the community. The community has to be justly treated."

In accordance with that principle, the curriculum has a new section on community participation, looking at the role of the community engagement in research projects, Rivera says.

Informed consent.

Rivera says that informed consent is too often seen as a single interaction between participants and researchers. The new edition looks at informed consent more as a process, he says.

"It's not one point in time, it's something that begins before the research is initiated," he says. "You have to collect information that is necessary to develop the informed consent. After you obtain consent, you have to maintain communication with the participant regarding informed consent issues."

In addition, he says, the developers of the new RETC have expanded the case studies section, a selection of real studies that raise particular ethical questions for students to discuss, to include examples from outside FHI. They now include studies reviewed by research ethics commissions in countries such as Colombia, Indonesia, and India. "Someone might say that the [FHI cases] aren't the best cases to talk about the research that they do or the ethical issues that they encounter," Rivera says. "So now we have a variety of case studies."