Can employees be enrolled into research?
-Regulatory Affairs, Medical Device Company
For supervisors including their employees in their research, involvement brings in the main issues of coercion or undue influence during the consent process. For all co-workers, including supervisors, there is the added issue of awareness of research data of which they would not otherwise have knowledge.
For research that involves those potential issues, David Resnik identifies in his article, “Employees as Research Participants: Ethical and Policy Issues” several possible solutions for these ethical issues.
To support voluntary participation by minimizing the possibility of coercion or undue influence, Resnik recommends:
- Not allowing the direct supervisor to be involved in recruitment, consenting or the conduct of the study;
- Being explicit in the consent process that the employee’s decision does not affect performance evaluations, employment status or benefits
To help protect the privacy of the participant, consider conducting private aspects of the research offsite or at off hours.
To further protect the confidentiality of employee participant data collected as part of the research, Resnik suggests:
- Describing in both the research plan and informed consent document who will have access to stored data and specimens, for example, using of coded data or restricting the supervisor’s access to the employee’s identified data.
- Including in the consent form a description of how privacy and confidentiality will be protected and any limitations on those protections for the employee.
The strategies to mitigate these risks are dependent on the design of the study and the specific application of risks of participation. There is no one-size-fits all answer to the question; so, it would be important to work close collaboration with the IRB to ensure that study-specific employee risks are addressed.
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- Resnik, D. Employees as Research Subjects, Ethical and Policy Issues, IRB Ethics and Human Research, January 2016