As an industry we hope that all research volunteers are enrolling in clinical trials out of the goodness of their heart and to advance medicine. A 2015 CISCRP Perceptions & Insights Study found that, of the top perceived benefits of participating in a clinical study, only 5% of respondents perceived monetary compensation as a top benefit. While it’s great the percentage isn’t any higher, the reality is there are financially motivated people who participate in clinical trials. Some of them even make a career out of it.
The professional research participant
Referring to research participants as “subjects” isn’t always appreciated. The term “guinea pig” seems even more offensive, yet there are people who don’t mind the label and even describe themselves that way.
There are thousands of healthy volunteers who enroll in Phase I trials. These studies are conducted to determine the metabolic and pharmacologic actions of drugs in humans, as well as the side effects associated with various doses. Some Phase 1 volunteers complete one trial ever, while others make a career path out of it. These “serial” research participants can become addicted to the easy money they earn from participating in one trial after another. Years may pass and, without any traditional jobs to add to the resume, they keep on going. For people in this unconventional line of work, retirement often comes at 45, the typical cut-off age for studies.
Should participating in clinical trials be treated like a job? After all, in the US, compensation for studies adding up to more than $600 is taxable income that you have to report to the IRS. Additionally, these self-proclaimed professional “guinea pigs” seek out trials that take place at sites with the best facilities and amenities such as video games, pool tables, etc. You could argue this isn’t so different from job seekers who want a company culture that allows you to have fun.
In the book, The Professional Guinea Pig: Big Pharma and the Risky World of Human Subjects, author Roberto Abadie examined the experiences and views of a group of Phase 1 volunteers. His research took place in Philadelphia from 2003-2004 for 18 months. Some of the individuals he studied had participated in more than 80 Phase 1 studies, earning an annual income of $20,000. Often bouncing from city to city, trial to trial (or what they considered job to job), professional research subjects would migrate to locations where clinical trials were booming.
The impact of money on enrollment decisions
The FDA website states people should not be tempted to enroll in a clinical trial simply based on the promise of money. However, Phase 1 studies typically attract low-income earners or financially motivated participants. Whether it’s a broke college student or an unemployed person desperate for cash, they’re typically in it for the money. One could argue that Phase 1 trials exploit vulnerable populations and take advantage of cheap labor. In an article published to The Atlantic titled, “The Life of a Professional Guinea Pig,” a Phase 1 participant makes the point, “Who has a month or three weeks to just check in to a trial site or live there for that amount of time? Homeless people, undocumented people, people who are either temporarily or long-term unemployed, people who are out of jail who can’t get regular work.”
The FDA makes it clear that payment to research volunteers for participation in studies is considered a recruitment incentive. They also state that financial incentives are most often used when there are no real health benefits to participants to compensate them for their time and for any discomfort they may experience. As so, the IRB reviews everything to make sure nothing is coercive or presents undue influence. Yet, Abadie believes the industry has become dependent on the routine participation of experienced study volunteers and argues that financial incentives compromise the ethical imperative for informed consent to be freely given by research participants. Ultimately, he confirms the need to reform policies regulating the participation of paid volunteers in Phase I clinical trials.
In his research, Abadie evaluated how monetary compensation affects a Phase 1 volunteer’s perception and disposition to enroll in a trial. While the participants seemed to understand the risks they’d face for participating, Abadie found the risks were discounted or ignored by research volunteers who were in need of money. Almost every participant he interviewed admitted to participating in at least one study they thought was too risky in exchange for the thousands of dollars they’d receive. While people have the right to participate in a study for money, if a participant’s focus is primarily financial, it can lead to problems.
Deceptive and dishonest participants
The research participants interviewed believe lying is a prerequisite to getting into a study. Since there’s nothing that tracks trial participation industry-wide, it’s hard to detect and determine the extent of this fraudulent practice. Cheating the system can have serious effects on the integrity and validity of data, potentially compromising an entire study.
Abadie learned about the online communities and sites such as get paid guinea pig or Just Another Lab Rat! that list locations of trials and provide tips on how to be a successful professional research subject. Sometimes, users will provide information about the eligibility criteria or answers to successfully pass the phone screening questions. Some participants don’t always obey the 30-day “wash-out” periods between trials, or they won’t adhere to study requirements for taking medications. Others will go as far as lying about participating in more than one trial at a time. This dishonesty may not only hurt that participant’s health but jeopardize the safety of any patient who may use the treatment in the future.
How common is dual enrollment in clinical trials?
A 2007 Johns Hopkins survey of research volunteers published in Clinical Pharmacology & Therapeutics, found that 10% of the sampled group admitted to participating in more than one study at a time. Additionally, a 2013 PubMed paper titled, “Concealment and fabrication by experienced research subjects.” examined the prevalence of deception and how subjects used it to enroll in multiple studies. This study surveyed 100 participants who had participated in at least two studies in the past year. Of the participants surveyed, the study found:
- 75% kept health information from researchers to avoid exclusion from enrollment in a study
- 32% concealed health problems
- 28% lied about their use of prescribed medications
- 25% admitted to exaggerating symptoms so they would qualify for a trial
- 20% lied about their recreational drug use
- 14% pretended to have a health condition in order to qualify
How can we prevent ineligible participants from enrolling in studies?
Unfortunately, we can’t rely on everyone to tell the truth. Seeing as there are no clinical trial background checks enacted on participants across sites, how can we make it easier to know when participants are enrolling in studies they shouldn’t be? Abadie proposed a centralized registry of Phase I volunteers to prevent them from participating in more than one trial at a time or enrolling too soon after their last protocol ended. In the past, bar-coding systems were developed based on a participant’s DNA but they never fully caught on. Verified Clinical Trials is currently working on an initiative to stop dual enrollment using a HIPAA compliant clinical trials participant database registry. It uses an IDmetric process to halt concurrent enrollment.
Phase 1 trials are without a doubt one of the most important steps in bringing new treatments to market. The industry must be aware of financially motivated misbehavior and do everything possible to detect deception and protect both research participants and data quality. Meanwhile, professional research subjects will continue their work in the field, hopefully being completely honest and not jeopardizing trial data.
Do you have any tips on how to identify serial subjects and ideas on how to prevent dual enrollment? Share your thoughts in the Comments. And discover an ethical way to pay study participants with Forte’s participant payment system.
Editor’s note: This article was originally published on November 4, 2015