Introduction

Under certain circumstances, employees may not feel free to refuse if asked to participate in research. Employees may feel pressure to participate in research, particularly if the workplace is one that encourages research participation. The perception of expectations to participate in research may be coercive. In rare occasions, pressure may be more pronounced, in that employees may fear that the lack of participation could result in negative consequences with respect to their employment.

Employees may be exposed to a greater risk of invasion of privacy than other research participants who have no association with the sponsoring institution. For example, co-workers and workplace friends of employees participating in research may have access to research data and may obtain and share personal information about research subjects.

Definitions

Active recruitment means approaching and interacting with potential participants with the goal of enrolling them in research.

Employee means an individual who is contracted to receive a salary or other compensation from the University of University, Primary Children’s Hospital, Veteran Affairs Salt Lake City Health Care Services, Shriner’s Hospital for Children, or any subsidiary thereof (hereafter referred to as employees) in return for services performed on a full-time, part-time, limited-time, temporary, contracted, or casual basis.

Direct supervision means having the authority to evaluate performance, recommend pay raises and/or promotions, or hire and fire employees.

Minimal risk means the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  CFR 45 Part 46.102

Passive recruitment means an invitation to participate in research using materials such as flyers, advertisements, and posters with the goal of appealing to potential participants to contact the research team for enrollment.

Guidance

Recruitment

Investigators and research staff may not directly invite employees to participate in research on a direct, personal basis.

Acceptable recruitment methods include passive recruitment methods. The posting of IRB-approved flyers and IRB-approved advertisements is acceptable. E-mails or letters may be sent to employees if they have previously agreed to receive invitations to participate in research.

Minimal Risk Research

Enrollment in research activities that have been designated “minimal risk” by an IRB is open to all employees. This includes research determined to be exempt by the University of Utah IRB.

Greater-than-Minimal Risk Research

Employees may not enroll in research that is designated “greater-than-minimal risk” by an IRB if 1) they are directly supervised by an investigator (principal or co-investigator) of the research; 2) their direct supervisor reports to an investigator (principal or co-investigator) of the research.

Restrictions on the enrollment of employees in greater-than-minimal risk research is not intended to bar an employee from participating as a research subject where it is in the medical best interests of the employee to do so. Investigators should notify and seek the approval of the IRB in such circumstances. The IRB chairs or their designee may approve the enrollment of an employee in such circumstances on a case-by-case basis.

An IRB has the authority to determine that employees may be enrolled in greater-than-minimal risk research in exceptional situations. The convened IRB must determine and document that the research is of significant importance and cannot be conducted without the enrollment of these employees.

Privacy and Confidentiality

The risk of a breach of confidentiality is greater when research participants are employees, particularly when those employees are known by the research staff. Whenever employees participate in research, regardless of level of risk or prospect of direct medical benefit, investigators must provide the IRB with specific plans for ensuring that the privacy and confidentiality of these employees will be respected. These plans must adequately address the special concerns raised by the workplace context.

Documents and References

Investigator Guidance Series: Advertisements: https://irb.utah.edu/guidance-series/advertisements/

Investigator Guidance Series: Recruitment Methods: https://irb.utah.edu/guidance-series/recruitment-methods/

IRB SOP 501: Vulnerable Populations: https://irb.utah.edu/guidelines/irb-standard-operating-procedures/

Points to Consider