Joining an NIH Study Conducted by a Family Member

Immediate family members include parents, siblings, spouses, and children of the researcher who is doing the study.

Family members of NIH staff may join research conducted by the NIH. This is true even if the study might not benefit you directly.

If you are a family member, there are some risks you should think about before joining a study conducted by your relative.

NIH has rules to protect you. We refer to these as safeguards. These safeguards help make sure that you are not pressured to join a study. Other safeguards make sure that your information stays as private as possible.

You can learn more about these rules by reading Policy 404.

Sometimes family relationships can make it hard to say “no.” For example, a spouse may feel pressure to join a study, so their partner does not feel upset. Children may feel they cannot say “no” to joining a study conducted by their parent because they are minors.

The safeguards help protect you from feeling pressured.

• An Institutional Review Board (IRB) must review and approve the study. The IRB is a committee that makes sure the research is safe and fair before you join it.
• The person getting your consent to join the research cannot be your family member.
• A third person may watch the consent discussion to make sure there is no pressure placed on you. This person cannot be on the study team and cannot be your relative.
• A member of the study team who is not related to you may confirm that it is safe for you to join the study. They will also make sure you meet the study’s rules for who can join (called eligibility criteria).

• Privacy and confidentiality risks: Your family member and other NIH staff will see your medical or research records. These staff are authorized to see your private information. However, no system to protect your data is perfect. You should be aware that there could be a privacy breach.
• Your safety: When you join a study you must give complete and truthful health and social information. For example, pregnancy history or drug use. Leaving out these important details could put you at risk.
• Scientific Integrity: The outcome of the study should be based on correct data. This is called scientific integrity. For example, a family member doing the study could feel uncomfortable reporting your side effects because they are worried about affecting the results of the study. If you leave out important health information, you might affect the results of the study.

You cannot join the study if:

• You do not meet the study’s eligibility criteria.
• It is not safe for you.
• The IRB does not approve family members joining the study.

NIH follows federal laws to protect your privacy and your information. Authorized study team members can see your records. You should know that your information will appear in medical or research systems that other authorized staff NIH can access.

Before joining, talk with the study team about what information will be collected. Discuss any concerns you have with the Principal Investigator (PI) before you decide to join the study.

You can find out more information about research record confidentiality protections from the Patient Handbook or Medical Records.

If you have more questions, contact:

• Office of Human Subjects Research Protections (OHSRP) 301-402-3713 or irb@od.nih.gov (do not send any sensitive information).
• If your study is at the NIH Clinical Center: the Patient Representative at 301-496-2626.