Collecting Information About Participants' Family Members

A family member becomes a research subject if, for research purposes, you collect or record identifiable private information about that individual.

If the family member is considered a research subject, you must:

• Obtain the family member's informed consent before collecting the information, or
• Obtain IRB approval for a waiver of informed consent.

You generally must obtain informed consent from the family member when you are collecting identifiable private information, such as:

• Name
• Full date of birth
• Medical record number
• Social Security number
• Address
• Telephone number
• Other direct identifiers

Consent may also be required if information collected during the study could reasonably allow investigators to identify the family member, even if direct identifiers are not initially recorded. This is particularly important in studies involving rare diseases or other situations where re-identification may be possible.

Consent from the family member is generally not required if you record only relationship information and do not collect or record identifiable private information.

For example, it is generally acceptable to record that a participant's:

• Mother
• Father
• Brother
• Sister
• Grandparent
• Aunt
• Uncle

has a particular medical condition, provided the information cannot be linked to a specific identifiable individual.

Your protocol should clearly state that study staff will not attempt to identify or contact family members based on the relationship information collected.

Before collecting information about family members, ask yourself:

• Is the family member alive?

Federal human subjects regulations apply only to living individuals.

• Am I collecting identifiable private information about the family member?

If yes, the family member may also be a research subject.

If obtaining informed consent from family members is not practicable, you may request that the IRB approve a waiver of informed consent.

Your protocol should explain why the waiver is appropriate and address the criteria for waiver under 45 CFR 46.116(f), including:

• The research presents no more than minimal risk.
• The research could not practicably be carried out without the waiver.
• The research could not practicably be carried out without identifiable information.
• The waiver will not adversely affect the rights and welfare of the subjects.
• Subjects will receive additional information after participation, when appropriate.

Collecting information about a participant's family members does not automatically make those family members research subjects. The determining factor is whether you are collecting or recording identifiable private information about them for research purposes. If so, informed consent or an IRB-approved waiver is generally required.

If you are unsure whether information about family members makes them research subjects, or whether a waiver of consent may be appropriate, contact OHSRP before submitting your protocol.