Unique approach assesses social risks to participants

Developer warns it's not answer for every study

Researchers at Temple University in Philadelphia, PA, have developed a novel approach to assessing the potential social risks to participants in a research study before the study commences.

The approach, called rapid policy assessment and response (RPAR), also has been used for non-research health interventions in dealing with groups such as drug users and sex workers. It pulls together analysis of existing laws in the study population with a rapid collection of data about how those laws are implemented on the ground, potentially affecting patients or subjects.

In a recent article in The American Journal of Bioethics, author Scott Burris describes its use as an assessment tool prior to an HIV prevention drug trial. Burris, JD, a professor of law at Temple, says he was hired by the HIV Prevention Trials Network (HPTN) to conduct an assessment of the social risks that might be faced by drug users in Thailand and China who were recruited to participate in a trial of the opiate addiction treatment suboxone.

The assessment confirmed what many researchers knew anecdotally — that drug users in both countries faced serious social risks. In China, drug users are often assigned to detoxification and "re-education" camps. In Thailand, they face pressure to enter treatment facilities and even the possibility of extrajudicial killings.

But the assessment also concluded that if researchers implemented thoughtful protections and coordinated with authorities, those risks might be minimized and in fact, participation in a study could actually protect participants.

Expensive approach

Burris, who has studied IRBs and has been critical of what he calls the overregulation of research, doesn't believe that this intensive RPAR approach is necessary or even preferable for most studies. For one thing, it's expensive — the process conducted for the HPTN cost about $135,000.

"I never did this as a way of saying this should be the new norm," he says. "If it did become the norm, we would be adding yet another layer of burden on our research system via the IRB.

"I did it to say that there may be situations in which the social risk question is more than usually piquant, in which there may be a real reason to be concerned. And then we don't have to speculate — on a major project that has sufficient resources, it can sometimes be possible to investigate further."

When asked by the HPTN to assess the potential risks to participants in the suboxone trial, Burris' group first reviewed the laws in each country as they pertained to injection drug users, HIV and health care. This was carried out by lawyers in both countries. Then, independent researchers at both sites looked at how those laws were actually enforced in China and Thailand, and how that enforcement could affect drug users who might be recruited to the trial.

The RPAR assessment itself was approved by IRBs at Temple and other universities where the RPAR researchers were based. Its protocol provides for ongoing monitoring, particularly collecting adverse event reports related to social risks.

The report showed that the Chinese and Thai governments imposed heavy punishments on drug users and had interfered with or opposed needle-exchange programs in the past. But it also highlighted examples of health researchers and officials who had been able to carry out projects with drug users by negotiating with police, for example, to keep them from waiting at treatment centers to arrest patients.

Added risk

Burris says one important focus of the assessment was to determine how much additional risk study participants would be exposed to, beyond the intrinsic risk of being a drug user in these cultures.

"One can say that anytime you're working with drug users in research, drug users are exposed to all sorts of social risks associated with their drug use," Burris says. "So the question that arises is would participating in the research exacerbate that risk?"

"Not surprisingly, we found that assuming that the work is done with a reasonable amount of circumspection, concern for confidentiality and appropriate consultation with authorities, we thought it was pretty unlikely that there would be a marginal addition to risk," he says. "Indeed, we found it appeared it could actually be protective in some way."

He says that the message for IRBs isn't to start requiring researchers to do the intensive assessment his group did in this trial. In fact, researchers may be able to thoroughly examine issues of social risk by a less involved process, such as a more formalized desk review of existing data.

"For IRBs, I think the question is has the researcher thought through the issues, and collected the necessary information to make a reasonably good judgment and then in fact, made a good judgment?" Burris says.

"As a general matter, IRBs will do better in assuring that the researcher has thought things through, than in trying to imagine it through themselves," he says. "In research like ours, researchers have usually done research like this before, while IRB members typically don't have a clue — they've never been there, never dealt with drug users. You have to be cautious in substituting the IRB's judgment for that of the researchers."

Reference

  1. Burris S, Davis C. Assessing social risks prior to commencement of a clinical trial: Due diligence or ethical inflation? Am J Bioeth 2009 Nov;9(11):48-54.

For more information about rapid policy assessment and response, please visit www.rpar.org.