IDU researchers face myriad of ethical dilemmas

IRBs may raise the wrong concerns

HIV researchers who work with study participants who are injection drug users (IDUs) sometimes find themselves facing challenges that wouldn't be issues in the typical HIV trial.

For example, research has overwhelmingly shown that the most effective prevention method for IDUs is a needle exchange program, and yet investigators are prohibited from spending federal research funds on needle exchange.

"It's sad that despite overwhelming evidence that these programs reduce HIV, there's still a federal ban," says Kaveh Khoshnood, PhD, an assistant professor of epidemiology and public health in the Yale School of Public Health in New Haven, CT.

This prohibition posed a major ethical problem during a study protocol in which investigators were collecting used syringes and testing them for HIV and hepatitis infection, Khoshnood notes.

When the study subjects turned in their used syringes, they asked researchers, "I'm giving you my syringe, so what am I going to do?" Khoshnood recalls.

This was an unanticipated ethical dilemma that arose, and investigators were put in a bind; the study was federally funded, so they couldn't use the research grant to fund clean needles that would be given back to the study participants.

"If we left them in a situation where for their next drug injection, they're without a syringe, then they'd borrow one from someone else," Knoshnood explains. "That's a tricky issue."

Ethically, once they were aware of the fact that the research study could be placing trial subjects at a greater risk of becoming infected with HIV or hepatitis, investigators were ethically bound to do something about it. Yet, their most logical course of action was prohibited by the study sponsor.

So they found a way around the federal ban by using both personal and, where it was available, state and local funds to buy clean needles for an exchange, Khoshnood says.

"In some site there were needle exchange programs offered by the state," he adds. "In one location, needle exchange was not allowed, so investigators decided to use their personal funds to make sure drug users have access to clean syringes."

This was the only way they could make sure they didn't break the law or endanger the life of their study subjects, he says.

Khoshnood first became interested in the ethical issues surrounding studies with IDU populations after years of HIV prevention research.

"I've been doing HIV prevention research for about 15 years, and to be honest, in the beginning I wasn't really thinking about ethical issues because we felt the research was so important," Khoshnood says.

"Then I began noticing ethical issues and feeling frustrated that I didn't have answers to questions and couldn't identify in the literature discussions about these issues," Khoshnood says. "A lot of ethical issues that came up with this population is because they're involved in illegal behavior."

There are less dramatic concerns when dealing with an IDU study population, as well.

For instance, any breach of confidentiality has greater implications among IDUs than it does for most other potential research participants.

If a drug user's family finds out about his or her IDU status, then it could have severe economic and emotional repercussions. Or if an injection drug using woman participates in a study and becomes pregnant, any disclosure of her pregnancy and drug use could result in her being arrested and charged with endangering her unborn child in some states, Khoshnood says.

IRBs sometimes fail to anticipate those examples of ethical concerns, but they likely will ask researchers about others, including the informed consent process and the payment of subjects for their participation.

Research subjects who are obviously high from a drug or are going through withdrawal symptoms may have an impaired ability to consent to a study, Khoshnood says.

But if the subject's drug use does not impair his or her ability to think and function, then the ability to provide informed consent may not be compromised, he adds.

"The way we deal with this is pragmatic," Khoshnood says. "If someone is so high they can't think straight, we say, Thanks for coming today, but today is not a good day for us to do this. Why don't you come back tomorrow?'"

An IRB might think that anyone who at any time is using an illegal substance is not able to provide acceptable informed consent, but Khoshnood disagrees with this philosophy.

"An IRB member's opinion about drug users' capacity to consent is not based on science," he says.

IRB members may put all illicit drugs into the same category when the pharmacology is quite varied, he adds.

Likewise, all drug users are not the same. Some have fulltime jobs and homes and families, Khoshnood says.

"Clearly, they're making decisions every day," he adds. "They're driving buses and taking care of us in hospitals, educating our kids, and they're everywhere."

When Khoshnood has asked IRB members whether they have any experience with protocols that enroll drug users, they typically say they don't receive these protocols very often.

"What they fail to recognize is that if they're looking at a chronic pain protocol, they will be enrolling drug users in that study whether it's explicitly stated or not," Khoshnood says. "Many of the research protocols submitted to the IRB may not have drug use in the title or in the protocol, but our experience is that drug users end up in all kinds of studies."

IRBs also may have some preconceived opinions about how IDUs are compensated for their study participation.

Many IRBs express discomfort with an investigator making cash payments to IDU subjects, even when the amount is minimal, Khoshnood says.

Since they often don't express the same discomfort with paying college students cash, even when the money could be used to buy beer on the weekend, this would seem to be part of the stigma or prejudice against IDU populations.

"If you offer someone hundreds of dollars to do a research interview, then, yes, it could be undue inducement," Khoshnood says. "The main concern is when individuals may offer to participate in a study that involves significant risk against their better judgment because of the cash payment."

But this is not a problem unique to drug users, he notes.

"I feel like this statement about drug users being desperate and shouldn't participate in a study that pays cash speaks more to the discomfort of IRB members," Khoshnood says.

It's also unrealistic of IRB members to think they can control a drug user's motivations by having the researcher offer gift certificates instead of cash for participation, he adds.

"They can exchange gift certificates for money, but only 60-70 percent of the value, so you're short-changing them," Khoshnood says.

"I have no problem with giving cash payments to people with drug abuse issues," he adds. "I do have problems if it's an excessive amount and if the protocol is more than minimal risk."

Also, it's not a fair assumption that all drug users will enroll in research solely for the compensation, Khoshnood says.

One study in Australia found that drug users provided varied reasons for participating in research, he says.

While some said the money was a significant factor, others said they would participate because they wanted to give something back to society, and still others cited a desire to have access to medical care, Khoshnood says.

Resource:

1: Barratt MJ, et al. Positive and negative aspects of participation in illicit drug research: implications for recruitment. Int J Drug Policy. 2007;18:235-238.