Attachment D - Parental Permission in Research involving Children

Parental Permission in Research involving Children, Focusing on 
“Not Reasonably Available”
SACHRP Recommendation, October 17, 2018
1. Parental Permission in Research Involving Children
HHS and FDA regulations for the protection of human subjects (45 CFR Part 46, Subpart D, 21 CFR Part 50 Subpart D) require that when research involves children, the IRB must ensure that “adequate provisions are made for soliciting the permission of each child’s parents or guardian (46.408 (b); 50.51). The permission in writing of one or both parents is required for the child to participate unless the IRB has waived the requirement for parental permission or a method other than written permission is approved. The responsibility of the institutional review board is to review the research in light of the regulatory requirements and determine the most appropriate category to support approval of the research. An IRB may approve research involving children that falls into one of these three categories: research no greater than minimal risk (46.404, 50.51(a)); research greater than minimal risk but presenting the prospect of direct benefit (46.405, 50.52); or research greater than minimal risk, with no prospect of direct benefit, but likely to yield generalizable knowledge about the underlying condition or disorder (46.406, 50.53). HHS must consult with a panel of experts for review of research that does not fit into one of these three categories but presents the opportunity to understand, prevent or alleviate a serious condition affecting the health or welfare of children (46.407, 50.54).    
Once the IRB determines which regulatory provision applies to the research under review, reference is then made to 46.408 and/or 50.55 which sets out the requirements relating to the permission of the parent or guardian. The permission of one parent is sufficient for the first two categories (46.404, 46.405, 50.51,50.52). For research falling under 46.406/50.53, if permission is to be obtained from parents, permission must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 
Both IRBs and investigators have expressed confusion about how the term “reasonably available” should be applied and interpreted. We start with the premise that determining whether one parent is reasonably available necessarily begins from the assumption that both parents are known and legally competent, and both have legal responsibility for the care and custody of the child.
There exists a broad, varied and inconsistent spectrum of opinion as to what may be considered an appropriate determination whether a parent is or is not reasonably available. Generally, IRBs do not review the circumstances of whether a second parent is reasonably available for each enrolled subject; this is a task for the investigator. The IRB determines the requirement for parental permission at the time of IRB review of the research, based on the regulatory category that is most appropriate to the nature of the research under review and with regard to the entire population of prospective subjects. It is not until the investigator meets the parent (s) and child and discusses the particulars of the research and enrollment that information about the availability of both parents becomes apparent. While the IRB may certainly be consulted by investigators for guidance on a particular situation, it is ultimately the responsibility of the investigator to adequately assess, document and decide whether a parent is not reasonably available given the specific facts and circumstances of each situation, including the level of that second parent’s participation in the life of the child.
When the IRB requires that permission be provided by two parents, and both parents provide permission, there is no issue. The problem arises when both parents are known and competent and have legal responsibility for the child but the permission of the second parent is not obtainable. Here, the absence of permission by a second parent could be because the second parent:
1. does not want to participate in the informed consent process;
2. is not reasonably available; or
3. is reasonably available to provide permission for the child’s participation but is not reasonably available in terms of providing a signature.
In this recommendation, we provide guidelines on how to determine whether a parent is not reasonably available, and on management of situations in which a parent may be reasonably available to provide permission but not reasonably available to provide a signature.
2. OHRP Guidance on Not Reasonably Available
An OHRP Q&A provides the general guidance for permission from parents: 
Do both parents need to provide permission for their child to participate in research? 
It depends. In general, permission should be obtained from both parents before a child is enrolled in research. However, the Institutional Review Board (IRB) may find that the permission of one parent is sufficient for research to be conducted under 46.404 or 46.405. When research is to be conducted under 46.406 and 46.407 permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 
Reasonably available is not defined in regulation or regulatory guidance. There are varying IRB interpretations that result in either the ability to more easily enroll children with one parent’s permission or more stringent interpretations that impose more limitations on the ability to enroll children in research.  Since subpart D was developed, the concept of reasonably available has been affected by the advent of new forms of communication that can lead to more easily reaching and communicating with a parent who might otherwise not be available for discussion about a child’s participation in research. These methods include, but are not limited to: video-conferencing, e-consent, communication via an app, as well as scanning or faxing documents. These tools enable communication, permission and documentation of consent without requiring a parent to be physically present. That said, not all individuals will have access to these mentioned forms of communications or other appropriate ones not herein listed.
3. Overarching Principles 
Families present in a variety of configurations and experiences. Researchers should be sensitive to this variability in making determinations about whether a second parent is “reasonably available” to consent. In some cases, such as cases of domestic violence or abandonment, it may be inappropriate, or disrespectful to the first parent, to solicit consent from the second parent. Researchers may need to inquire about parental relationships – including whether two parents live in the home or are otherwise involved in the child’s life (e.g., participates in decisions about health, education, etc., visits regularly, provides financial support) in making their evaluation. In doing so, they must rely on the information provided by one parent.
When an IRB determines that the permission of both parents, if reasonably available, is required, the permission process with each parent can occur independently, at different times, and by different methods prior to involvement of the child in research. 
When children are in the shared legal custody of two parents or guardians, each parent’s right of decision-making is to be respected. If one parent agrees to be contacted and declines to give permission, in other words affirmatively says no to participation by the child in research, that does not mean the parent is not reasonably available. It means that parent has decided not to provide permission, and that therefore, the child should not be enrolled in the research.
The term reasonably available should be applied both to (1) locating a parent and (2) the mechanism that can be used to secure that parent’s permission. For example, parents may be reasonably available because they have been located; however, there may be no reasonably available mechanism to obtain the second parent’s signature on a permission form. 
4. Application of “Reasonably Available” to Locating a Parent
Overall, if a parent's role in the care of and/or decision-making about the child, even if limited, is such that his or her involvement and location may be readily ascertained, the parent is considered reasonably available and attempts at contact should be pursued. “Not reasonably available” is not intended to mean that a parent is temporarily unavailable, unless there are specific circumstances where time is of the essence. There are numerous specific situations that could support a determination that a parent is not reasonably available. In general, however, a parent who is not reasonably available is one whose whereabouts are unknown; who should not be contacted because of the nature of the relationship between the parent and child; whom there is no way to reach by phone, mail, email, fax or any type of videoconferencing; or who has not responded to multiple contact attempts.  “Not reasonably available“ does not apply to situations when a parent is at work, traveling, not immediately available by electronic means, or living in another state or country, without more to justify the investigator’s inability to reach the parent and seek permission. 
Examples of situations when one may reasonably conclude that a parent is not reasonably available could include the following situations:
The parent is incarcerated and not contactable. 
The parent is on active military duty and not contactable. 
The parent’s whereabouts are unknown. 
The parent is known and contactable but chooses not to be involved in the child’s care. 
The parent is known but, upon inquiry, there is reason to believe that requesting permission would be inconsistent with the parent/child relationship, such as where there is reason to believe there is or has been domestic violence or other situations involving harm to the health or welfare of the child.
5. Application Of “Reasonably Available” to Documentation of Permission by a Parent 
A determination that a parent is “not reasonably available,” per the regulations, may include circumstances in which a parent is available to participate in the consent process and has given permission for the child’s participation, but is not able to provide a valid signature. A second parent’s inability to provide a signature must not be used as a reason not to involve that parent in the consent process, or as a reason not to respect that parent’s decision. SACHRP recommends that OHRP and FDA produce joint guidance that describes types of documentation that would satisfy the requirements of 45 CFR 46.117 / 21CFR50.27 in addition to the traditional mechanism of physically signing a document.    However, SACHRP recommends that a parent’s inability to provide a signature or other accepted form of permission in writing, confirming the decision to permit the child to enroll in the research would be acceptable under the regulations as an application of the “not reasonably available” criterion, and thus would not require a waiver of documentation of informed consent. This analysis permits recognizing the importance of obtaining permission from both parents if available, without violating 45 CFR Part 46.117(c), which would not allow a waiver of documentation of consent in a situation involving greater than minimal risk research.
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