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• NIH staff and immediate family members of the study team are generally permitted to participate in human subjects research conducted by the NIH. This is true whether or not the research offers the prospect of direct benefit.
  
  
• NIH staff must be provided with the NIH Frequently Asked Questions (FAQs) for Staff who are Considering Participation in NIH Research to review prior to participating.
  
  
• NIH staff and immediate family members of the study team participating in NIH research, must comply with NIH Policy including:
  • Prohibitions or restrictions by the staff member's Institute or Center
  • NIH compensation requirements
  • NIH leave requirements.  (See NIH Manual Chapter: 2300-630-3 -Leave Policy for NIH Employees Participating in NIH Medical Research Studies. NIH login required)
    
    
• When NIH staff participates in research taking place within their own work units, or conducted by any of their supervisors, you must assure the subject that participation or refusal will not affect their employment, training, or position.
• Follow Policy 404, Research Involving NIH Staff as Subjects.
  
  

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• For research that offers the prospect of direct benefit to the subject (e.g., studies of potential therapeutic intervention for a condition from which the subject suffers), you are not required to obtain IRB approval for enrollment of NIH staff or the immediate family members of the study team.
  
  
• The NIH staff member must still be provided with the FAQs for Staff who are Considering Participation in NIH Research when the research offers no prospect of direct benefit and NIH staff, or immediate family of a study team member wants to participate. In this case, the IRB must approve inclusion of this population prior to enrollment, and the protocol must describe:
  • Whether staff or family members will be included in the research
  • The safeguards for this subject population (e.g., recruitment methods, consent monitoring, eligibility assessment)
  • Recruitment plan, including:
    • Solicitation of subordinates should not be direct, either orally or through individual mailings or email distribution.
    • Recruitment materials may be displayed only where public announcements are permitted.
      
      
• Prior to enrollment the NIH investigator must request NIH staff member to review the Leave Policy for NIH Employees Participating in NIH Medical Research Studies (NIH Policy Manual 2300-630-3). NIH login required
  
  
• If investigators at an NIH site will enroll NIH staff members on a protocol that is being reviewed by an external non-NIH IRB, information about NIH Policy 404, Research Involving NIH Staff as Subjects, will be included as local context information that is provided to that IRB.

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