Do the Regulations require the same elements for assent as they do for consent?
No, assent is not consent. At a minimum, the child should understand the purpose of the research (in age-appropriate terms), an explanation of the procedures, that their participation is voluntary and that they have the right to withdraw (change their mind) at any time. Assent must be affirmative. Failure to disagree is not evidence of assent. Children should not be asked to make risk-benefit assessments, nor should they have to deal with financial aspects (additional costs).
Should children be told how much money they will be paid?
It is respectful to be honest with all participants, especially children. If they are going to be compensated, they should be told how much and the basis for payment. Children younger than 9 can not understand payment based on effort and should receive a flat payment (if any). Children 9 and up can understand the concept of being paid more for more work/effort etc.
How must assent be documented (does the child need to sign the assent form)?
It is up to the IRB to decide whether or not assent must be documented and if it must be documented, the way in which it will be documented.
There is quite a bit of variability between IRBs ranging from no documentation - to documentation in the medical record - to documentation on the consent form - to documentation on an assent form. The CHOP IRB prefers that investigators document assent on the consent form using a separate assent documentation page that follows the consent signature/parent permission page. The CHOP IRB usually (but not always) makes the child's signature on the form optional. The Assent documentation page (available on the Consent Template page) includes a section for the investigator to indicate that the child was incapable of providing assent.
When does the IRB require children to sign the assent form or assent section of the consent form?
It is up to the IRB to determine whether or not the child must sign the form. The CHOP IRB takes into account the nature of the research, ages of the participants and other factors that might make signature more or less compelling.
When can the IRB waive the requirement for assent?
The IRB may waive assent for children in cases where the IRB determines that the child or children are incapable of providing assent. For example, an oncology study may be too complex for children younger than 12 or 14 to understand but a study limited to collecting a blood sample might be understandable to a 6 or 7 year old.
The IRB can also waive the requirement for assent under the following circumstances:
- the intervention offers a prospect for direct benefit (e.g., a Phase III clinical trial) approved under 45 CFR 46.405/21 CFR 50.52);
- the benefit related to the intervention is important for the child's health (e.g., a novel chemotherapy drug or drug to treat a serious illness); and
- the intervention is only available in the context of the research (new drug or treatment regimen). See the IRB's webpage on Waiver of Assent for more information.
What if my study enrolls children ages 2 - 17 years; do I need assent of everyone?
Only children capable of providing assent should be both involved in the discussion and asked to provide assent. The IRB expects that the investigator will submit a proposal describing which age groups will be able to provide assent and which will not. This should be based on the type and complexity of the research and the population being enrolled. Children too young to assent should still have the research explained to them in terms appropriate to their level of understanding and maturity.