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Compliance In Focus
Posted by Toni Hegyi on Fri, Dec 18, 2015

Enrolling Employees or Clinic Staff: Is it Acceptable?

Little discussion can be found around the question of whether or not employees of an institution should be Enrolling_Employees_or_Clinic_Staffpermitted to participate as subjects in human research conducted by the institution they work for. To date, there is no specific guidance (protection/provisions) provided by the federal regulations governing research with human subjects. The Office for Human Research Protections (OHRP) presents consideration around students, employees, and normal volunteers in Chapter VI, “Special Classes of Subjects,” of its IRB Guidebook. Similarly, the Centers for Disease Control and Prevention (CDC) offers guidance for employee participation in research. While the enrollment of employees is allowed, there is a potential for fundamental ethical provisions to be compromised. Both the study sponsor and the Institutional Review Boards (IRB) or Independent Ethics Committees (IEC) have a responsibility to address the management of these issues:

  • Coercion - Employees may feel pressure to participate and under certain circumstances, may not feel free to refuse. Regardless of how subtle (or overt), employees may fear adverse affects to their relationship with the employer. Conversely, they may also volunteer out of the belief that it will place them in good favor with their employer (eg. participation will result in promotion, recommendations, or the like). 
  • Confidentiality – Employees may be at a higher risk for invasion of privacy than research participants who have no affiliation with the research institution. Collection of sensitive data such as mental health, sexual activity, and illicit drug and alcohol use can be a risk to subjects. There is the potential for coworkers and/or workplace friends of employees participating in research to obtain access and share personal information. 
  • Policies on Illness or Injury During Research – What happens if a participant (employee) gets ill or injured as a result of the research? Will medical treatment be made available? Will there be penalty or loss of benefits that they would otherwise be entitled?
  • Prohibition of Enrollment of Employees – For those individuals who are motivated by a genuine interest in participating in research, not allowing them the option would restrict their autonomous preferences. Furthermore, institutions that prohibit employee participation run the risk of individuals outside the institution questioning why they should volunteer when the institution protects its employees from the risks of the research. 
  • Reduced Employee Performance- an employee who is enrolled in a study may experience an inability to fulfill the responsibilities of their job as a result of participation.

Special consideration needs to be taken to assure policies are developed that adequately address the concerns:

  • Regardless of the level of risk, employees should not be directly solicited to enroll in research, either orally or through individual mailings or email. Acceptable methods of recruitment include flyers and other recruiting materials (approved by an IRB) displayed in the workplace where public announcements are permitted.
  • Investigators should provide the IRB with specific plans for ensuring the privacy of employees that participate in research. 
  • Policies should be clearly spelled out in the informed consent for issues such as injury or sickness as a result of the research.
Do you have experience with employee participation in research? How did the institution manage it? Were there policies in place to address the issues?

Misconduct in Research | Free Download | IMARC Research photo credit: Jaehee fielding questions via photopin (license)

Topics: Clinical Research, IRB, Enrolling Employees,, Clinical Staff,

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