Research Involving NIH Staff or Immediate Family Members of the Study Team

• Tell you that your participation or refusal to participate will not affect your employment, training, or position at the NIH.
• Make sure, as much as possible, that someone who does not supervise you will obtain your consent.
• Have a third party, such as a consent monitor, present to observe the consent process. This process helps minimize the risk of undue pressure when an investigator on the research team is also your supervisor.

• At the NIH CC, use a consent monitor from the CC Department of Bioethics Consultation Service or a Clinical Research Advocate from the NIMH Human Subjects Protection Unit (HSPU). 
• Use another party independent of the research team, such as an IC monitor. 
• If a consent monitor is not available, have another qualified investigator on the study who is independent of your work unit and not your supervisor. If no such person exists, any qualified investigator on the study can observe consent. 

For research that offers direct benefit to the subject and is minimal risk, you do not need IRB approval for enrollment of NIH staff or immediate family members of the study team. However, you must provide the NIH staff member with the FAQs for Staff who are Considering Participation in NIH Research before they participate. 

When the research offers no direct benefit and NIH staff or immediate family of a study team member wants to participate, you must obtain prospective approval from the IRB. 

When the research offers no direct benefit and NIH staff or immediate family of a study team member wants to participate, the IRB must approve inclusion of this population before enrollment. The following must be described in the protocol: 

• Whether NIH staff or immediate family members of the study team will be recruited or allowed to enroll in the research. 
• The safeguards for this subject population (such as recruitment methods, consent monitoring, eligibility assessment). Include any additional safeguards required by the IRB. 
• The recruitment plan, including these requirements: 
• Do not directly solicit subordinates, either orally or through individual mailings or email distribution. 
• Display recruitment materials only where public announcements are permitted. 
• That you will provide the staff member with the FAQs for Staff who are Considering Participation in NIH Research to review before they participate. 

You must submit a modification if your research did not plan to recruit or enroll this population and you later want to enroll NIH staff or immediate family members of the study team. You must describe the safeguards in the protocol, and the IRB must approve the modification before you start enrollment.