Ethical issues and social injustice

CABs could pose new challenges

Research institutions occasionally have studies that involve a population or topic that brings up issues of social injustice, such as studies involving war refugee populations or pediatric HIV foster children. A typical response is to seek input from a community advisory board (CAB), but this might not answer all ethical dilemmas, an expert says.

"There can be problems with community advisory boards," says Ross McKinney, MD, professor of pediatrics and director of the Trent Center for Bioethics, Humanities, and Medical History at Duke University in Durham, NC.

"They're filled with people with the strongest opinions, and they might not share the community's opinions," McKinney says. "They may be a vocal subset; so how do you get a representative group of the community?"

McKinney has been involved with pediatric HIV/AIDS cases, and he has observed how CABs designed to represent HIV/AIDS populations, including the low-income, minority children he saw, were instead filled with non-minority members who came from middle- or upper-middle-class backgrounds.

"Our CAB had nice people who tended to be people who were more adherent with their treatment, more middle class, and who were better able to come to meetings," McKinney says. "It was very hard for a lot of our families on the margins to be involved."

The ethical dilemma with this community advisory board that did not truly represent the community being studied was that the members did not share the unrepresented group's concerns with imprisonment, homelessness and other major problems, he explains.

"Worrying about medication turns out to not be high on their priority list, and worrying about future medications is even lower on the list," McKinney says. "My general sense is if you want to get to the broad community, it is very hard to get that balanced community engagement from the CAB."

The studies typically did not have funding available to pay CAB participants enough to attract a wider range of members, but even if they did there are some ethical challenges with this approach, he says.

"Whenever you pay someone for their time it becomes trivial for the rich and important for the poor," McKinney says. "If you make it important for everybody, then you're paying people proportionate rates based on their day's wages; then one person receives a lot of money to attend the meetings."

Since funding for paying CAB members typically isn't available, investigators and IRBs have to make use of community advisors who sometimes have a superficial awareness of the community's true needs, he says.

This makes it important that researchers, social workers, and faculty who sit on the CAB help keep the board's focus within the scope of identified community concerns.

"You have to keep it within the scope of what is reasonable and possible," McKinney says. "Your worry is that you will steer them so much you will lose the point, but you have to keep people focused and note where there are differences in the board's opinions and what you've learned about the community's concerns."

There are other issues involving social injustice juxtaposed with ethical considerations that IRBs can encounter. McKinney offers these two case examples:

• Children in foster care: Occasionally, there are studies enrolling children who are in foster care.

"In the early days of HIV treatment, the only way you could obtain access to medications — and this still is the case with some cancer drugs — was to participate in research," McKinney says.

"When a child is in a foster care system it becomes a tremendous amount of work because of the regulatory burden to enroll a foster child," he explains. "The regulations require you to have the signature of the authorized head of the department of social services, a guardian ad litem or other advocate, both foster parents, and both parents, even if they didn't have custody."

The ethical dilemma from the IRB's perspective is that if investigators chose not to enroll this population or failed to obtain permission to enroll foster children because of incomplete paperwork, then the children were deprived of the only potential treatment that might save their lives.

"Don't they deserve access to the medication that in many cases was being studied just to prove the drug was bio viable in children, as well as adults?" McKinney asks. "In the case of the HIV drugs, we knew they worked."

This ethical dilemma also caused some long-term headaches for research institutions in New York, he notes.

Some institutions got into trouble because they forgot to have guardians ad litem sign the informed consent forms, he says.

"There was a lot of controversy over that 10 years ago," he says. "They had to dig through 15-year-old records to see if we had a foster kid and whether there was guardian ad litem or not."

• Parents' privacy versus public safety: The three worst privacy cases McKinney can recall involved adopted children who had contracted HIV at birth.

"The mothers did not want to tell the children they were HIV-infected because it would mean the children would understand that either the parents also were infected or that they were adopted," he explains.

The children were given treatment since birth, but they were told only that they had a blood disease. But the ethical dilemma arose when the children reached their teen years and showed signs of becoming sexually active.

"We had to tell the children they were HIV positive," McKinney says. "In the relative hierarchy of ethical priorities, the possibility that one person would endanger another person was a position we could not support."

The institution was not sued, but the children's mothers were angry, and the children lost respect and trust for their parents, he adds.

Although this particular case did not involve research, it illustrates what can happen in study situations if there are conflicts between what investigators, IRBs, and research institutions believe is the ethical and correct way to handle disclosure to participants who are minors and what the children's parents believe is best.

These types of cases also show how difficult it can be to handle enrollment and informed consent in the context of social injustice, McKinney notes.

"In the early days of HIV we were dealing with children from drug-abusing families or children who acquired HIV from child abuse," he says. "We had trouble dealing with families because of the drug use and all that came up with it, and sometimes there were adolescents who ended up in jail."