Employees in Clinical Trials Boost or Bust the Prospects of a Company?
[Thursday, July 23, 2020] Sinopharm, the Chinese government owned company announced that 30 of its employees, including some in senior management roles, were the first to receive its experimental Covid vaccine. And this would be legal even in the US. It is often assumed, incorrectly, that the regulations prohibit employee participation in company-sponsored clinical trials. On the contrary, under the US laws employees can enroll in clinical trials sponsored by their employers, like anyone else. But companies are expected to create clear policies to assure non-coercion, privacy and confidentiality of information, informed consent, integrity of the study blinding, and mitigation of bias. Even US Federal government agencies, such as NIH, have policies defining how and when federal employees can participate in NIH-funded clinical trials. Similarly, academic centers also allow employee participating in ongoing clinical trials. There are also numerous reports of patients sponsoring trials on themselves. Employees could be much more familiar with the background of the research behind the product being tested and have a better appreciation of the risks and concerns with the trial compared to the other potential study participant being recruited. However, there are obvious concerns about the employees being coerced into enrolling in company-sponsored trials. It is critical for any trial to assure non-coercive and voluntary nature of all the participants. It is generally assumed that employees would feel coerced by their bosses or may be pressured by their peers to participate in company-sponsored trials. But this could be mitigated with clear policies and independent assessments of recruitment and retention practices. Simple things like non-solicitation of employees to participate, offering equal opportunity to all employees who meet the study’s inclusion and exclusion criteria to participate, assuring that there are no benefits or detriments to enrolling in trials, and maintaining strict confidentiality of data and medical information could alleviate any concerns from IRBs. And, of course, employees should be treated like any other study participant when it comes to study procedures. Two major concerns with SinoPharm’s employee trial were that employees were given the experimental vaccine before regulatory approval which was likely illegal, and that the trial was not open to the public, but only the employees, adding to concerns regarding bias in any results obtained. Not to encourage the improper practices by SinoPharma, if done properly, employee participation in employer-sponsored trials offer several advantages. But it carries the risk of stigma and perception of inappropriateness which need to be addressed, particularly if the same employees later end up doing testimonials to recruit additional participants. Employees should have as much opportunity as any other individual to enroll in a trial that they believe in. It is legal, ethical, and fair that everyone who wants to, is eligible for, and is willing to follow the protocol, gets to participate in any clinical trial. |
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