Building an IRB to ensure rights of subjects in a developing nation

Team uses experience setting up IRB in Haiti as basis of handbook

Medical research in developing countries often is conducted by Western institutions, using their own IRBs to ensure the rights of participants who could be half a world away.

It's a process that can fail to take local input into account, and that fails to give credit to the institutions on the ground who are committed to providing care in these countries, says Ellen L. Palmer, RN, MSN, PhD, an assistant professor of nursing at the University of Texas in Arlington and board member of International Child Care (ICC), a Christian health development agency that operates a hospital and clinics in Haiti and the Dominican Republic.

Palmer and Cheryl Rowder, RN, PhD, CCRC, an associate professor of nursing at the University of Mary Hardin-Baylor in Belton, TX, are collaborating to change that model, starting an IRB at an ICC hospital in Port-au-Prince, Haiti. In the process, they're literally writing the book on how to start up IRBs in developing countries.

While many smaller countries currently don't have regulations requiring human subjects protection for research conducted within their borders, Palmer foresees a time in the not-too-distant future when all international research projects will require local IRB approval.

"The United Nations and World Health Organization — and some of our big grants in the future — are going to require that," she says. "I think we're going to have to show that we have in place some kind of ethical committee, rather than work off the [IRB] from the country that comes in."

The IRB Palmer and Rowder are creating will be based at Grace Children's Hospital, ICC's 40-year-old tuberculosis hospital in Port-au-Prince that serves as the command center for all of the organization's Haitian clinics. The hospital provides TB, HIV, and AIDS treatment services to children and adults, as well as a nutrition clinic and other health services.

While some clinical trials have been conducted at Grace, much of the research involves measuring the effectiveness of various treatments for disease or nutritional interventions rather than testing new drugs.

Palmer says that while outside groups come to the hospital to look at data, Grace currently does not have a system in place to initiate or review research locally.

"My concern is that without [the hospital], they wouldn't have a place to do the research," Palmer says. "And we don't get the credit — 'we' meaning me as a Caribbean Haitian. Seeing that our organization is there for them to do their research, I don't think we get the recognition we deserve."

Unique issues

Palmer has volunteered in Haiti for more than 30 years and currently serves on ICC's U.S. board (in addition to clinics in Haiti and the Dominican Republic, ICC has offices in Columbus, OH, and Mississauga, Ontario).

She pitched the idea of an IRB associated with Grace Children's Hospital to the ICC board and began working on the project in November 2006. She tapped Rowder, who has conducted clinical research and helped create a university IRB in the United States, to provide her expertise in dealing with IRB policies and procedures.

Rowder says she has drawn upon her experiences with IRBs — both good and bad — to help come up with an effective plan for a new IRB at Grace. Because Haiti has no human subjects protection regulations, she's using modified forms and policies from American IRBs while addressing some of the ethical issues that are unique to international research in developing countries.

For example, Rowder says, an IRB in a developing country would have to consider whether to allow placebos to be used for research on diseases for which the country currently has no standard of care, although a treatment may be available elsewhere.

"To say we're going to have a placebo group, even though there's a known treatment in another country, when it doesn't exist in this country — that's a pretty major ethical issue," Rowder says.

An IRB also must weigh whether proposed research will provide real benefit to its local population, especially if the treatments being tested ultimately wouldn't be affordable there.

"Institutions need to know how to evaluate a project and the impact it's going to have on their population — whether it's appropriate for their population and whether they're actually going to gain anything," Rowder says.

The IRB's membership will include several ICC leaders, including Harry Geffrard, the organization's national director in Haiti, and Jean Marius Lafond, a maxillofacial surgeon in Haiti and president of ICC's board in that country.

Palmer says the Methodist Church in Haiti will provide members that will offer an ethical perspective, and says she knows of people who can serve as community members of the IRB.

"There are wonderful people in these countries just waiting for people like Cheryl and I to come through and help them write the manual, and get this started," Palmer says.

Although these types of projects in developing countries always require the consent of the government, Palmer foresees no difficulty in getting approval from the Haitian government, thanks to ICC's long track record in that country.

"I have no doubt that they'll agree," she says. "We have the credibility and reliability with the Ministry of Health. There are several people down there at the medical university in Port-au-Prince who want to talk to me. They realize we need to do this."

Trust essential

Palmer says that kind of trust relationship can be essential in countries where there has been past exploitation.

"The reason I'm able to do this is that I've been there for many years," she says. "They're trusting me. They trust that I'm not going to put something out to make them look bad."

Rowder says her years of working with IRBs have helped her come up with the multitude of templates that will be needed for the Grace Children's Hospital IRB. But the training manual will be of prime importance, because many of the people who will be involved in this process know little about IRB review.

"It's going to require something almost like an introduction to research," Rowder says.

The IRB manual and supporting documents all will be translated into Spanish and French, and back-translated into English to double-check the accuracy of the translations.

One vital factor in creating an IRB that is responsive and builds good relationships with researchers is the selection of an administrator who can keep in contact with researchers, monitor projects, and keep the IRB organized, Rowder says. But she also wants to ensure that researchers can communicate directly with the IRB if they have problems.

"That's one of the biggest stumbling blocks, if the researcher is having difficulty with the administrator and there's no way for them to speak to the chair of the IRB or to present their quandary to the IRB — that can really be an issue," she says. "There have to be open lines of communication and real assistance to researchers. Some of them are going to be new to this, and other groups will be used to it already and will pick right up on using the templates.

"But I think it really can hinge on having a really good administrator," Rowder says.

That IRB's records probably will be kept at the ICC's Ohio office, because communications and other systems in Haiti sometimes can be sketchy, Palmer says.

Palmer estimates that the committee will be put in place in March 2008. She and Rowder already have arranged for a nursing research project to be used as a trial run for the new IRB.

"We want to put in an application to show how this works," she says.

In the meantime, they say they've received a lot of interest about their project, particularly the manual they're creating on how to develop an IRB. The manual should be completed in the next year.

Palmer says that when she created a poster presentation for Sigma Theta Tau's International Nursing Research Congress in Vienna, Austria, last summer, "I was busy every minute I was there with inquiries about how to do this. I'm much aware that it's needed."

Palmer says that in the future, she'd like to look for grants that could help start an IRB process in different countries.

"It isn't meant to be tied just to Haiti."

[Editor's note: For information about the manual that Palmer and Rowder are creating on starting IRBs in developing countries, contact Palmer at ellenlpalmer@tx.rr.com or Rowder at cherierowder@yahoo.com.]