Recruiting participants for clinical trials is frequently the source of costly delays for medical technology and life sciences companies. Increasing the success rate of participant enrollment and retention has become an industry priority, and sponsoring companies have devised a variety of strategies to optimize recruitment. One of these recruitment strategies for achieving adequate enrollment numbers is to invite employees to participate.

Roshelle Davis

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:

• Review recruitment strategy with the institutional review board (IRB). The IRB is responsible for reviewing clinical trials to safeguard the rights and welfare of the participants. While employees are not considered by statute to be a “vulnerable population,” i.e., people who need special protection to be included as subjects, the IRB may have some input regarding how to safeguard against some of the unique risks associated with employee-participants. IRBs also ensure that there are no conflicts of interest with researchers and employees that could adversely affect the rights and welfare of the participants.
• Do not personally solicit individuals for participation. When informing potential employee-participants about clinical trials, do not target or single out individuals for participation. Employees who are personally invited to participate are at a greater risk of feeling unduly pressured to do so—especially if solicited by a supervisor or coworker. Additionally, while the protocol’s inclusion/exclusion criteria may eventually preclude certain individuals from taking part, all employees should be granted the opportunity to consider it. Accordingly, advertisements or information regarding the trial should be placed in common areas or sent via mass e-mail when appropriate.
• Put the onus on employees to inquire about the study. Advertising efforts and materials should be designed so that the employee initiates contact with the clinical trial investigator, not the other way around. Inviting potential employee-participants to make first contact also reduces the risk of an employee feeling coerced or unduly influenced to participate.
• Make sure there are no benefits or detriments—real or perceived—to participating in the trial. There should be no employment benefits or detriments—outside of those related to the trial itself—associated with participating in the trial. Participation should not positively or negatively affect an employee’s job status, promotion potential, compensation package, bonus potential, or vacation time. Likewise, employers should be careful that nothing is said to employees that would lead them to believe such benefits or detriments exist.
• Do not share confidential employment records with researchers. Any information researchers have about employee-participants should be obtained the same way the information from a nonemployee would be obtained. Researchers should not have access to an employee’s employment file containing private information regarding his work performance and history.
• Do not share research data with employees who are not involved in the research. Unauthorized employees who are not involved in administering the clinical trial should not be allowed to access data about employee-participants obtained through the research process.
• Safeguard electronic data. Private information about employee-participants that is stored electronically can be readily accessible and easily shared. Such information should be password-protected and accessible only to authorized individuals.
• Safeguard tangible data. Private information that is kept as a hard copy should be kept in a secured facility, such as a locked room or cabinet that is accessible only to authorized individuals.
• Safeguard an individual’s personal information even if he or she is ineligible or drops out. Researchers should outline procedures in the research protocol for securing or destroying private data that are no longer useful or relevant to the study.

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 rdavis@medmarc.co.