Sift through ethical issues of subject recruitment
Sift through ethical issues of subject recruitment
Expert offers advice
Clinical research sites and principal investigators should not wait for an IRB to weigh the ethical considerations of their subject recruitment practices. Everyone involved in human subjects research needs to consider whether a particular practice is appropriate or not, an expert suggests.
"I think what's most challenging is finding potential subjects who are willing to participate in a study and who also know what they're getting into," says Lindsay McNair, MD, MPH, senior medical director of clinical research at Vertex Pharmaceuticals Inc. in Cambridge, MA. McNair spoke about enhancing subject recruitment at the recent PRIM&R "Advancing Ethical Research Conference," held Nov. 17-19, 2008, in Orlando, FL.
"We need to make sure subjects are appropriately informed and understand that this is research," McNair says.
McNair has worked in all facets of research, including working as an investigator at an academic research institution, serving on the IRB at the Boston University Medical Center in Boston, MA, and working in the pharmaceutical industry for 10 years.
What she's learned is that CR volunteers have various levels of understanding depending on the particular disease being studied and other features.
"With some diseases, people are extremely well informed about their illness, and in some case they're not so well informed," McNair says.
"From the site's perspective, especially when there are new drugs in development, it's a hard thing for a research team to separate [doctors] wanting to get access to potential new therapies for their patients from the issue of conducting research and not knowing which new therapies will become available," McNair says.
Another problem for sites is the result of optimism about new studies.
"Often when a study starts out no one thinks they're going to have difficulties recruiting subjects until study recruitment is slowing down and measures are put into place to find more subjects," McNair says.
This means that sites need to vigilant in updating their recruitment activities in correspondence with the IRB, or else they risk falling out of compliance.
"IRBs don't always know that additional measures are added," McNair notes.
"So the question is how IRBs can make sure they know what's going on to recruit subjects and how sponsors can be educated about what IRBs find appropriate and inappropriate," she adds.
McNair offers these examples of inappropriate recruitment practices:
• Finder's fees: "Offering a financial amount for referral to a study and offering financial or tangible rewards to study teams that recruit more subjects or recruit above a certain number of subjects are what most sponsors realize are inappropriate," McNair says. "These create a conflict of interest for the study team, although not everyone thinks about it this way."
For instance, a sponsor might think that it would be a good incentive to offer sending a study coordinator to a research conference/meeting if the coordinator's study recruits 10 more patients, she suggests.
"To them that sounds like an appropriate incentive, but the IRB might consider that a conflict of interest," McNair says. "So it's not that the sponsor doesn't care about what's ethical, but it doesn't occur to them to think about it in that way."
• Sliding-up scale of payments per subjects: It's also inappropriate to pay sites according to the number of subjects enrolled in the trial, if that amount escalates after a certain level, McNair says.
"Say you offered $2000 for the first 10 subjects and $4000 for each subject above that -- that would clearly be inappropriate," McNair says.
This is a recruitment practice that is clearly appropriate to use:
• Referrals without incentives: Study listings on standardized Web sites like clinicaltrials.gov are clearly appropriate, so long as they have IRB-approved wording. These types of recruitment practices do not have incentives tied to them, McNair says.
There are some ethical issues to consider with these types of recruitment postings, however, she notes.
Although clinicaltrials.gov is great for information about protocols, there are potential problems with how people might use it, McNair says.
"When you post inclusion/exclusion criteria, could a subject come to your site and lie about their history because they know the inclusion/exclusion criteria?" McNair says. "They might say, 'No, I never had an alcohol problem or seizure disorder,' because they saw that they would be excluded from the study if they have it."
Or potential subjects who screen fail at one site might go to another site listed on the Web site and not tell them how they had failed the other site's screening, she adds.
These are the kind of issues that IRBs and researchers should think about, McNair says.
For instance, they could abbreviate their study listings to not provide explicit inclusion/exclusion details, she adds.
"They could include enough information so that subjects will know if the study fits them but not enough information that they could fudge any part of their medical history," McNair explains.
And then there are sponsor recruitment methods that fall in a gray area:
• Charting recruitment progress: "Some sponsors put out newsletters with charts of who has enrolled the most patients and who has enrolled the fewest," McNair says. "Is that appropriate? Or does it create competition between sites, potentially creating a conflict of interest?"
For example, if the study coordinators all know each other, then creating a chart that lists top enrollers would create a competition and give public recognition to some sites, McNair explains.
Some people might say that this would be enough of an incentive for some study coordinators to create a conflict of interest in their motivations for enrolling subjects, she adds.
"Others might say the more people they enroll, the more recognition they should receive," McNair says.
Clinical research sites and principal investigators should not wait for an IRB to weigh the ethical considerations of their subject recruitment practices. Everyone involved in human subjects research needs to consider whether a particular practice is appropriate or not, an expert suggests.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.