International research group updates ethics training course

New FHI curriculum emphasizes community obligations, informed consent process

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

Roberto Rivera, MD, a senior advisor for Family Health International (FHI), says changes to its Research Ethics Training Curriculum (RETC) came in response to feedback from people around the world who've used it since its introduction in 2001.

"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, published in 2010, was recognized in December 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. FHI conducts research throughout the developing world in areas that include reproductive health and infectious diseases such as HIV, malaria and influenza.

Since that time, it has come to be used by other organizations, including the Centers for Disease Control and Prevention and the World Health Organization. In addition, Rivera says, many U.S. institutions use the RETC to provide an international component for their ethics training.

"They use the CITI (training program) as the primary tool and then they use our curriculum for people who are going to do international research," he says.

Community and consent

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

• Community impact — The first edition of the RETC interpreted the basic Belmont principles — respect, 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, 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."

International principles

While the curriculum looks at the requirements of U.S. federal regulations, Rivera says the developers sought to balance that with a focus on international ethical principles and the need for countries to develop their own regulations.

"We make the point that you cannot do research if you do not have regulations," he says. "It's the responsibility of national organizations to develop such regulations."

Rivera says there have been many examples of people around the world who have taken the RETC and used it to update or develop new research procedures and regulations in their own countries.

The first edition of the RETC was released in a CD-ROM format and translated into five languages — French, Spanish, Portuguese, Chinese and Swahili.

Currently, FHI is seeking funding to do the same for the second edition. However, it is now available on the FHI website ( in English.

Rivera says he's been surprised by how many people across the world have been able to access the curriculum on the Web. He noted that more than 160,000 computer users from more than 200 countries had visited the curriculum's webpage through 2009.

"The total number of page views through 2009 has been 13 million," he says. "This is good — it shows you that access to technology is not as limited as we used to think."