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Weigh the vulnerability of clinical research subjects
Economic, power vulnerability exist
Investigators and clinical trial associates sometimes miss the more subtle signs of vulnerabilities among potential study participants.
There are times when participants are vulnerable for economic reasons or for coercive pressures that the investigator has not fully considered.
Even when physicians who also are investigators ask their patients to consider participating in a study, this can be a situation involving vulnerability, says Helen McGough, who works with the Collaborative IRB Training Initiative (CITI) as a writer and editor of modules. McGough is retired from the office of research at the University of Washington in Seattle, WA, and she speaks about vulnerability and research at national conferences, including the recent PRIM&R conference on advancing ethical research, held Nov. 17-19, 2008, in Orlando, FL.
"I think researchers don't recognize that potential subjects may view the invitation to participate in research as weighted," McGough says. "If I say, 'No,' what will my doctor think of me?"
Patients have more invested in their relationship with their doctors than do the doctors, particularly if they have a life-threatening illness, she adds.
"If I have a condition that's life-threatening, then I'm a lot more vulnerable than I am with male pattern baldness," McGough says.
Vulnerability associated with powerlessness can be associated with various aspects of life, depending on a potential subject's physical health, psychological/social conditions, language differences, cultural orientation, or it can be an entirely individual matter, she says.
It's investigators' responsibility to be aware of subjects' vulnerabilities, even when the participants are unaware that they are vulnerable to making a decision without fully understanding their options, says Monika Markowitz, PhD, director of the office of education and compliance oversight in the vice president's office of research at Virginia Commonwealth University in Richmond, VA. Markowitz also spoke about vulnerabilities at the PRIM&R conference.
For example, a student might enroll in a study that is not specifically targeting college students. And the student might be limited in providing informed consent because his status as a student could mean that he doesn't fully appreciate the risks to which he is susceptible, Markowitz suggests.
The student might feel pressure to please his professor, so he volunteers for a study he has heard that the professor is leading, she adds.
"It's a matter of considering the individual and having more focus on the circumstances that an individual brings to a project," Markowitz says.
Sometimes research subjects decide to participate for reasons related to their vulnerability, which poses an ethical dilemma to researchers.
"How do you make sure people understand they really are under no obligation to take part in this research, especially if they have no other choices?" McGough says. "They could be so sick that they are easily pressured into thinking the research is the only opportunity for them to receive care."
And yet if the study might offer them direct benefit, their vulnerability could be balanced by fairness and equity in research.
"I have an acquaintance who participated regularly in studies of experimental antidepressants," McGough says. "She suffered from depression and had no money, so her way of obtaining care was to enroll serially in clinical research trials of antidepressants."
This woman's economic vulnerability made it difficult for her to fully weigh the risks of clinical trials since she put so much weight on the potential benefits of receiving treatment she otherwise could not obtain.
But whether this vulnerability meant she should be disqualified from a clinical trial is an ethical question IRBs and investigators need to fully consider.
"Given our society and the way our current government is structured, there are a lot of people who don't have access to care," McGough says. "So clinical trials can be a win-win situation."
There are caveats to this approach: for instance, if CT sites discover that some participants are enrolling for these economic reasons, then they should be extraordinarily careful that the participants meet all of the exclusion/inclusion criteria for the study, McGough says.
The key is to make sure the informed consent is clear about the participant's right to not enroll or drop out of the study at any time and about how an investigational treatment is different from standard medical care.
Also, there are vulnerable populations beyond what are outlined in federal regulations.
For example, a study that enrolled gay and lesbian couples for research about domestic violence would involve a double vulnerability, perhaps, Markowitz says.
"So investigators need to be very aware of the possible vulnerability, and IRBs need to help them ensure as much as possible that risks are understood and that consent is informed and voluntary," Markowitz says.
"Investigators also need to think about vulnerabilities in an ongoing way, so that part of what they consider is what is necessary to provide ongoing protections for privacy and confidentiality," she adds.