A Clinic on Employee ParticipationA Clinic on Employee Participation

Timely recruiting is a key concern for the industry, because clinical trial delays can significantly impact a company’s bottom line. One industry source reported that “drug companies stand to lose between $600,000 and $8 million each day clinical trials delay a drug’s development and launch.”¹ Another reported that “every day of delay in [clinical trial] approval costs the sponsoring company $1.3 million.”²

Given the stakes involved, executives for medical technology companies should understand the pros and cons of us using employees in clinical trails. This article discusses the benefits and risks associated with employee-participants, and outlines a few best practices to consider when trying to minimize the inherent risks.

Benefits of Employee-Participants

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 the lack of awareness of the trial, lack of access to the trial site, time constraints, as well as 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 it’s 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 likely that employees may be less suspicious of clinical trials that are sponsored by their employer instead of an unfamiliar research organization.

Considering the potential benefits, it can be tempting for device companies to invite employees to participate in clinical trials without considering some of the negative consequences of doing so. While the law does not explicitly prohibit employees from participating, recruiting employees presents its own set of risks. These include questions of undue influence and confidentiality concerns. Company executives must understand the risks and think carefully before inviting employees to participate in clinical trials.

Two Big Drawbacks

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 involuntary prisoners. In order to ensure that participation is voluntary, the clinical trial investigator is required to inform candidates of the potential risks associated with participating in the trial and obtain their consent. FDA regulations outline the circumstances under which such consent is to be obtained:

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

Company executives must be aware of the following two principal drawbacks to employee participation in clinical trials:

Coercion and Undue Influence. While all clinical trial participants are at risk of being coerced or unduly influenced, that risk is higher 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 an individual in a position of authority extends the invitation. He may also feel pressured 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 a supervisor will grant favors, offer a promotion, or award a bonus for participation. On the other hand, an employee may be concerned that he will be demoted, penalized, or have benefits withheld if he does not participate. These perceptions may unduly influence an employee’s decision to take part.

Breaching Confidentiality. 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 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 the possibility that confidentiality will be breached, there is a greater risk of a 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 nonauthorized hands.

Suggestions for Minimizing Risk

There are a variety of ways in which employer-sponsors can minimize risks associated with employee-participants. The following are 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, the most important being the prevention of costly delays. But device company executives need to be mindful of the inherent risks of this strategy and minimize them by following the best practices here. Doing so protects both the welfare of the employees and the integrity of the clinical trial itself.

References

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, emphasis added.
4. 45 CFR 46.117(7).
5. 21 CFR 50.25(a).
6. 45 CFR 160, 164.
 

Roshelle Davis is the staff attorney for the Medmarc Insurance Group (Chantilly, VA.) She may be reached at 703/652-1332 or [email protected].