- Is permission (consent) required from both parents? (See Section I of Federal Guidance).
- If yes, and only Parent A is present, is the identity of Parent B known, and is Parent B alive? (If Parent B is unknown, or is deceased, permission of Parent A is sufficient).*
- If Parent B is known and alive, do the parents share legal responsibility for care/custody? (If, and only if, Parent A has sole custody and legal responsibility for the child, permission of Parent A is sufficient). *
- If the parents share legal responsibility, and only Parent A is present:
a. If Parent A can provide a phone number for Parent B, the investigator should telephone Parent B to discuss the study and to arrange to send consent forms for B’s signature. Parent B may receive the forms by mail or fax, and may mail or fax a signed consent form back to the investigator. The child may not be enrolled until the absent parent has returned the signed consent form to the investigator.
b. If no contact information is available for Parent B, or B does not respond to repeated attempts at phone contact (e.g., at least two messages over a 48 hr. time period), the investigator may consider Parent B to be unavailable, unless Parent B subsequently responds and refuses to give permission (at which point the child’s participation must end).
c. If Parent A has an address for Parent B, but no phone number, the investigator should send Parent B written notification that
i. Parent A is enrolling the child in a research study;
ii.The investigator has been unable to reach Parent B by telephone; and
iii.Parent B will be considered unavailable if he or she does not contact the investigator by a specified date (allow at least ten days from the date of the letter). The child may not be enrolled until the earlier of the date Parent B responds affirmatively or the date ten days after sending the notice with no response. If Parent B subsequently responds and refuses to give permission, the child’s participation must end.
5. Documentation. The investigator should document all attempts to contact the absent parent, along with the basis for any determination that consent of the absent parent is not required.
* See Section IV of the federal guidance for special rules pertaining to research involving fetuses, neonates and pregnant women.