Using employees as participants in a clinical trial is one solution for keeping trials on schedule. However, their participation and recruitment is fraught with the potential for inappropriate influence and coercion. This Loss Control Column explores those dangers and how to avoid them.
Clinical trial delays can significantly impact a company’s bottom line. One industry source reported that, “Drug companies stand to lose between $600 thousand and $8 million each day clinical trials delay a drug’s development and launch.”1Another reported that, “Every day of delay in [clinical trial] approval costs the sponsoring company $1.3 million.”2
Challenges in recruiting trial participants are frequently the source of some of these delays. In fact, difficulties in recruitment are one of the major reasons for failure of clinical trials. Since participant enrollment has a direct relationship to the successful launch of a new product, increasing the success of participant enrollment has become an industry priority, and sponsoring companies have devised a variety of strategies to optimize recruitment. One of the strategies companies sometimes consider is to invite employees to participate in the clinical trials of a product.
Inviting employees to participate in clinical trials can be a practical recruitment strategy. Some of the challenges when recruiting participants from the general population include lack of awareness of the trial; lack of access to the trial site; time constraints; and fear, distrust, or suspicion of the research itself. These obstacles may be less challenging with employee-recruits. For example, it generally requires less effort and expense to inform employees of the trial. They typically have greater access to the trial—especially if the trial is performed onsite—and thus have fewer transportation issues. Their proximity to the site may result in fewer time constraints and less interference with work or home responsibilities. It is also plausible that employees may be less suspicious of clinical trials that are sponsored by their employer as opposed to an unfamiliar research organization.
Considering the potential benefits, it can be tempting for employers to invite employees to participate in clinical trials without considering some of the potential consequences of doing so. While the law does not explicitly prohibit employees from participating, recruiting employees presents its own set of risks that should be carefully considered before implementing such a strategy. The remainder of this article discusses some of those risks, encouraging sponsors to think carefully before inviting employees to participate in their clinical trials.
One of the fundamental principles of modern clinical trial practice is that human trial subjects must participate on a voluntary basis. This has been an internationally recognized requirement of clinical trials since the scientific community learned of the horrific experiments that the Nazis performed on prisoners against their will. To help ensure that participation is voluntary, the clinical trial investigator is required to inform participants of the potential risks associated with participating in the trial and obtain their consent to participate. Food and Drug Administration (FDA) regulations outline the circumstances under which such consent is to be obtained, stating, “An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.”3
While all clinical trial participants are at risk of being coerced or unduly influenced to participate in a trial, the risk is increased with employee-participants. By virtue of the employment relationship, a sponsor-employer has a real or perceived degree of power over employee-participants that does not exist in a normal sponsor-participant relationship. Thus a sponsor-employer runs the risk of appearing to coerce or unduly influence employees to participate in a clinical trial. For example, an employee may feel obligated to participate if he or she is personally invited to participate by an individual in a position of authority. The employee may also feel pressured to participate by fellow coworkers who choose to participate in the trial.
Similarly, employees may choose to participate in a study because of employment benefits they think they may receive. For example, an employee may be under the impression that he or she will be favored by a supervisor, receive a promotion, or be awarded a bonus for participating in the clinical trial. On the other hand, an employee may be concerned that he will be demoted, penalized, or have benefits withheld for not participating. These perceptions may unduly influence an employee’s decision to participate.
Protection of an individual’s privacy is one of the great challenges in clinical research. Indeed, there are a number of laws and regulations that have been designed to protect a clinical trial participant’s private health information.
The Common Rule from the U.S. Department of Health and Human Services requires that there be “adequate provisions to protect the privacy of subjects and to maintain the privacy of subjects and to maintain the confidentiality of data.”4 The FDA requires statements in the informed consent form “that describe the extent to which confidentiality of records that can identify the participant in the research will be maintained.”5 The Health Insurance Portability and Accountability Act (HIPAA) supplements these protections, requiring covered entities to take specific measures to safeguard the privacy of individually identifiable protected health information (PHI).6
While clinical trial participation always involves a risk that confidentiality will be breached, there is a greater risk of breach with employee-participants. Throughout the course of a clinical trial, researchers often obtain private health information that an employee would not otherwise share with his employer. For example, the trial’s screening process may include an inquiry into an individual’s history of mental health, sexual activity, or use of illegal drugs. The ramifications of a confidentiality breach of this information within the company could be devastating to an employee. In addition, when studies are conducted in the workplace, the proximity of the trial itself may increase the risk of sensitive information falling into non-authorized hands.
There are a variety of ways in which sponsor-employers can minimize risks associated with employee-participants. The following contains a few best practice suggestions that a sponsor may consider when creating a risk management strategy.
Inviting employees to participate in clinical trials has its benefits, but also its risks. Companies should be mindful of these risks and do what they can to minimize them. Doing so helps to protect the welfare of the employees as well as the integrity of the clinical trial itself.
1 T. A. Caulfield, “Legal and Ethical Issues Associated with Patient Recruitment in Clinical Trials: The Case of Competitive Environment,” Health Law Review 13, (2005): 58-61.
2 H. Brody, Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry (Lanham: Rowman & Littlefield Publishers, Inc.: 2007):at 342.
3 21 CFR 50.20, bold added.
4 45 CFR 46.117(7).
5 21 CFR 50.25(a).
6 45 CFR 160, 164.
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