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Federal regulations for the protection of human subjects require (or permit the IRB to require) the permission of both parents for the participation of vulnerable subjects in the following research under the following circumstances (with exceptions as indicated):
A. For any proposed study involving children, the IRB will determine whether the consent of both parents is necessary as an additional protection for child subjects. This determination may be made even in cases where the permission of both parents is not required by regulation. The IRB will notify the investigator whenever it determines that permission must be obtained from both parents.
B. If the research presents more than minimal risk and offers no prospect of direct benefit to child participants (i.e., the research is categorized as 45 CFR §46.406/407 or 21 CFR §50.53/54).
Exception: Permission of one parent is sufficient if the other parent is deceased, unknown, incompetent, not reasonably available, or does not have legal responsibility for the care and custody of the minor child. (See Obtaining the Permission of Both Parents for Certain Research: Steps to Follow.)
C. If the research is DHHS-regulated, involves a pregnant woman and/or fetus, and offers the prospect of direct benefit solely to the fetus (45 CFR §46.204 (e)).
Exception: The father’s consent need not be obtained if he is unable to consent due to unavailability, incompetence, or temporary incapacity, or the pregnancy resulted from rape or incest.
D. If the research is DHHS-regulated and involves a non-viable neonate (§46.205(c)(5)).
Exception: The consent of one parent is sufficient if the other parent is unable to consent because of unavailability, incompetence, or temporary incapacity, and the father’s consent need not be obtained if the pregnancy resulted from rape or incest. Note that consent may not be waived or altered for minimal risk research involving a nonviable neonate.
II. May the IRB Waive Parental Permission?
Under regulations applicable to DHHS-funded research, 45 CFR §46.408(b), the IRB may waive the requirement for parental permission if the IRB determines that such permission is not a reasonable requirement to protect the child subjects (e.g., the subjects are abused or neglected children) and the waiver is not inconsistent with applicable laws (e.g., the IRB may not waive the permission requirement for a procedure for which parental consent is required under state law). Note that FDA regulations do not permit such a waiver of parental permission.
III. Required Form of Permission
Where the permission of both parents is required by regulation as described in Section I, and has not been waived by the IRB as described in Section II, such permission must be obtained in writing. As a general rule, the IRB expects investigators to involve both parents in a face-to-face consent discussion and to obtain the signatures of both parents on the consent form. If only one parent is present, the investigator must attempt to arrange for a consent discussion with the absent parent, and should document this attempt.
When relying upon one of the exceptions listed in Section 1 to obtain permission from only one parent, the investigator should document the factual basis for the exception (e.g., reason why the second parent cannot provide permission) in detail in the research record.
A. Is the absent parent alive or legally responsible?
When only one parent is present, the investigator should ask whether the other parent is living, and if so, whether the parents share ccustody and legal authority to make decisions on behalf of the child.
- If the parent who is present responds that the other parent is deceased, unknown, or does not share custody and legal decision-making authority, permission from the custodial parent who is present with the child is sufficient, unless the investigator has evidence that would lead a reasonable person to question whether that parent’s response is credible. (In the latter case, the investigator should consult with legal counsel before enrolling the child).
B. Is the absent parent incapacitated or incompetent?
The investigator should apply the same “reasonable person” standard if the parent who is present responds that the other parent is available but unable to give permission due to incapacity or incompetence.
- If the investigator is uncertain whether the parent who is not present truly lacks capacity (e.g., the parent is institutionalized or hospitalized but has not been declared incompetent), the investigator should follow the process described below for parents who are “not reasonably available.”
C. Is the absent parent legally responsible and competent, but unavailable?
- If the parent who is present (Parent A) can provide a phone number for the parent who is absent (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.
- 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).
- If Parent A has an address for Parent B, but no phone number, the investigator should send Parent B written notification that
- Parent A is enrolling the child in a research study;
- The investigator has been unable to reach Parent B by telephone; and
- 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.
- Parent A is enrolling the child in a research study;
D. What if the investigator is unable to contact the absent parent?
If the absent parent cannot be reached by telephone and the investigator has made repeated attempts over a reasonable time period (e.g., multiple attempts over a period of at least 48 hrs.), and no other contact information (e.g., address) is available, the investigator may determine and document that the parent is “not reasonably available.”
V. When Neither of the Parents has Custody of the Child.
If neither of the parents has custody, the investigator should determine whether another individual or entity (e.g., Department of Social Services) has been awarded a guardianship that includes authorization to consent for the child to participate in medical research (or in the case of kinship caregivers and where the research involves medical treatment, whether the relative can provide a copy of the kinship care affidavit filed with DSS). In the absence of such a guardianship order (or kinship care affidavit), permission must be obtained from the court with jurisdiction over the child.
VI. Research Involving Pregnant Women, Fetuses, or Nonviable Neonates
In addition to the exceptions listed in Section I, above, the permission of the father is not required for research involving pregnant women, fetuses, or nonviable neonates, if the pregnancy was the result of rape or incest. The investigator may rely upon the mother’s rrepresentations about rape or incest unless the facts and circumstances would cause a reasonable person to doubt the mother’s credibility (in which case, the investigator should consult legal counsel before enrolling the subject).
VII. If Parents Disagree
If the investigator has succeeded in contacting the absent parent and that parent does not give his/her permission, or fails to sign and return the consent form, the child (or pregnant woman, fetus, or neonate, except in cases of rape or incest) may not be enrolled in the study, even if the parent who is present (or the pregnant woman, except in cases of rape or incest) has given permission.
VIII. Embryonic Stem Cell Research
Although DHHS does not presently fund research involving the creation of new embryonic stem cell lines, and FDA regulations requiring informed consent apply only to clinical investigations of therapeutic products or other “test articles,” the Institute of Medicine has recently published voluntary ethical guidelines for such research. The IOM recommends that informed consent be obtained from any donor whose gametes will be used to create embryos for research. In addition, the IOM guidelines recommend that embryos (“blastocysts”) not be used in research without the consent of all gamete donors.