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Special Cases and Considerations of Informed Consent

 

 


Department of Health and Human Services regulations for the protection of human subjects require that informed consent information be presented "in language understandable to the subject" and, in most situations, that informed consent be documented in writing (45 CFR §46.116 and §46.117).

Where informed consent is documented in accordance with §46.117(b)(1), the written consent document should embody, in language understandable to the subject, all the elements necessary for legally effective informed consent. Subjects who do not speak English should be presented with a consent document written in a language understandable to them. This procedure is strongly encouraged whenever possible.

Alternatively, §46.117(b)(2) permits oral presentation of informed consent information in conjunction with a short form written consent document (stating that the elements of consent have been presented orally) and a written summary of what is presented orally. A witness to the oral presentation is required, and the subject must be given copies of the short form document and the summary.

When this procedure is used with subjects who do not speak English, (i) the oral presentation and the short form written document (see HRP-507 TEMPLATE CONSENT DOCUMENT: Short Form ) should be in a language understandable to the subject; (ii) the IRB-approved English language informed consent document may serve as the summary; and (iii) the witness should be fluent in both English and the language of the subject.

At the time of consent, (i) the short form document should be signed by the subject (or the subject's legally authorized representative); (ii) the summary (i.e., the English language informed consent document) should be signed by the person obtaining consent as authorized under the protocol; and (iii) the short form document and the summary should be signed by the witness. When the person obtaining consent is assisted by a translator, the translator may serve as the witness.

The IRB must receive all foreign language versions of the short form document as a condition of approval under the provisions of §46.117(b)(2). Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.

It is the responsibility of the IRB to determine which of the procedures at §46.117(b) is appropriate for documenting informed consent in protocols that it reviews.

Source

If you are proposing research that will involve subjects whose primary language is not English and need assistance developing a consent process and forms that meet these requirements, please contact the HSPP for assistance.

The IRB must determine, to the extent required by 45 CFR 46.116, that adequate provisions are made for soliciting the assent of the children -- when in the judgment of the IRB the children are capable of providing assent -- as well as the permission of the parents (45 CFR 46.408). Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research (45 CFR 46.402(c)).

By regulatory definition, children are “persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted” (45 CFR 46.402(a)). In the United States the legal age of adulthood is a matter of state and local law. This means that who is legally considered a child may vary from state to state; in a large majority of states 18 years of age is the legal age of adulthood, but this is not true in every state, locality, or territory. State law also may address specific circumstances in which a person younger than the age of adulthood is legally authorized to consent to medical procedures: for example, some states allow children younger than the legal age of adulthood to consent to the provision of contraceptive services. Certain states provide a mechanism for the emancipation of minors, through which a child younger than the legal age of adulthood may gain certain civil rights, which might include the legal ability to consent to research participation.

The definition of children also takes into account the particular interventions or interactions involved in the proposed research (e.g., surveys, blood tests). For example, in some places individuals who are 16 years of age may legally consent to certain clinical interventions or interactions. If the involvement of human subjects in a proposed research activity consists of these interventions or interactions, then those individuals may be considered as adults for that purpose. If a proposed activity includes an intervention or interaction for which the subject has not yet reached the legal age of consent, however, that person must be considered a child.

Under 45 CFR 408(b) the IRB may find that the permission of one parent is sufficient for research to be conducted under 45 CFR 46.404 or 45 CFR 46.405. Where research is conducted under 45 CFR 46.406 or 45 CFR 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.

Although the regulations state that children are unable to provide legally effective informed consent to participate in research, some might be able to give their assent. Assent means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (45 CFR 46.402(b)).

If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted regarding assent, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under certain circumstances in accord with 45 CFR 46.116 and 45 CFR 46.408(a).

Source

In general, the HSPP recommends the following:


For children one month to 7 years of age, child assent is often waived or a simple verbal assent process may be provided.  Simply failing to object does not mean that a child is providing assent, or agreement, to participate in a study.  For some children in this age group, simple tasks or procedures of a study can be verbally explained in a way they might understand (e.g. "We are going to play a game about colors.  Do you want to play?").  Then, the researchers can use verbal responses ("yes", "no", etc.) and/or non-verbal cues (joining the play group, pulling away from the play group, etc.) to appropriately assess assent.  In general, researchers should defer to the responses of young children as to whether or not they want to engage in the research activities.  Children should not be coerced into participation by the researchers or their parents.

In your submission packet:  For children in the age group, the IRB would expect to see some discussion of whether or not there will be any assent process and your reasoning.  If there will be a verbal assent process, please provide a copy of your verbal script for review (i.e. the language the researchers will use to explain the study procedures to children) and explain how, when, and where the assent process will occur in conjunction with the parental consent process.


For children 8 to 12 years of age, child assent should often be provided and may be verbal or written depending on the research procedures involved and the level of understanding of the targeted population.  A verbal script or written form should be provided for IRB review.  The IRB would expect that the language used in either the script or the written form would be appropriate for the targeted age group and would focus on the research tasks or procedures that the child will undertake in the study.  There are a number of readability measures online that can help researchers assess the language being used in this process.  Consider using a readability checker like http://www.read-able.com or a list of possible word substitutions (such as Wikipedia's list of plain English words and phrases) to bring readability down to the appropriate level.  In some studies, child assent in this age group may be documented with a written name/signature.  For some procedures, children may feel more engaged in the process of assent by signing their name.  However, researchers should ensure that this is not the only sign of agreement and they have appropriately discussed the research together with the child.

In your submission packet:  For children in this age group, the IRB would expect an explanation of your proposed assent process in your research protocol.  If assent will not be sought from participants, this should be appropriately explained and justified.  The details of assent should be included, such as whether assent will be a verbal process or use a written form, whether or not assent will be documented and by whom, and how, when, and where assent will be conducted (e.g. with the parent or separately).  Provide the IRB with a copy of any verbal script or written assent form for review.


For children 13 to 17 years of age, child assent should most often be provided.  In many cases, children in this age group are able to read and discuss research participation provided that the information is presented in a way or at a level that they can best understand.  When enrolling children across this age group, assent forms or scripts should be designed for the youngest potential participants (e.g. 13 years).  Children in this age group can be provided with a separate assent form or can read and sign the consent form in conjunction with their parent/guardian if the consent form is at a reading level both parent and child can understand.  Assent should be documented when appropriate for your study.

In your submission packet.  For children in this age group, the IRB would expect an explanation of your proposed assent process in your research protocol.  If assent will not be sought from participants, this should be appropriately explained and justified.  The details of assent should be included, such as whether assent will be a verbal process or use a written form, whether or not assent will be documented, and how, when, and where assent will be conducted (e.g. with the parent or separately).  Provide the IRB with a copy of your verbal script, written assent form, or combined consent/assent form for review.


This information is provided for general guidance and your proposed assent process should be tailored to your study and your targeted population.  Some additional considerations:

  • For children with diminished capacity (e.g. cognitive impairment, certain disabilities or health conditions, etc.), age alone may not be a good indication of their ability to understand and agree to participate in a research study.  The researchers should adapt their proposed assent process to the needs of the targeted group.
  • For studies that involve procedures over time, assent may need to be sustained.  That is, the assent process (like the consent process) may need to occur more than once so that children who are participating in research remain informed about the study and continue to provide agreement to be involved as subjects.
  • As these age groups are recommendations, and not mandates on how assent should occur, you should consider the best assent process for your targeted group and research protocol. 
    • If your study will involve children from various age groups (e.g. 6 to 14 year olds) or a range within a group (e.g. 3 to 7 year olds), you may need to include several different assent processes in your submission packet.  For example, if your study targets 3 to 7 year old children, you might propose that a verbal assent process be used with 5 to 7 year olds, but request that assent be waived for children under 5.
    • Similarly, if your study design involves a sample of 12 to 17 year olds, it might not be in the best interest of the subjects, or the researchers, to propose separate assent processes for 12 years olds and for 13 to 17 year olds. It may be possible to design one assent process that can be used, and understood, by all the children in this age grouping.
  • Some studies propose to enroll children who are 17 years old at the time of recruitment and assent, but the research procedures take place over time.  If any child reaches the age of majority (18 years of age) during the course of the research (where they are actively participating in the study and/or providing identifiable private information to the researchers), he/she must be consented (give his/her own permission) as an adult in order to continue in the study.
  • The definition of "child" is not the same for every situation and circumstance.  The age of majority may differ depending on the state or country the researchers are working in.  Some children may have gained the legal status of adult (i.e. emancipation of minors) and can therefore consent to participate in a study without the additional consent of a parent or guardian.  Researchers should provide information to the IRB in their submission packets on the details of the targeted population and any anticipated special considerations.
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