Children may participate in exempt research depending on the research category. There are 6 categories of exempt research. Category 3 CANNOT involve children and Category 2 can ONLY involve children if participation is limited to educational tests or observations of public behavior when investigator(s) do NOT participate in the activities being observed. See our Exempt FAQs for more information on each exempt category. The research must also involve no more than minimal risk.

Investigators conducting exempt research involving children (aside from category 4 where no consent is required), should provide adequate information about the study to the child and their parent/guardian. Child assent is a written or verbal process where a child decides whether they want to participate based on information provided to them at their reading/comprehension level. If a child does not want to participate in an exempt study, then their dissent should be respected. If children, whether some or all, are incapable of assenting (as determined by the IRB considering their age, maturity, and psychological state), then only parental/guardian consent would need to be obtained. The IRB does not provide an age range for requiring written assent. Investigators should determine children’s capability of assenting based upon the population being studied. In general, written assent would be utilized with children who have reached an age where they can read. Some researchers choose to provide a more detailed written assent form for children who have reached adolescence. 

Most exempt research does not require a written signature; however, parental/guardian consent forms should include a written signature section or other form of documentation of consent when a study involves direct research interactions with their child. If obtaining written signatures from parents is not necessary, for example an observational-only study with no recording of the child’s personally identifiable information, the IRB will determine the requirement to obtain parental consent and the requirement to document parental consent, for example a parent notification letter.

Unless a waiver of consent is requested by the investigator and approved by the IRB, a parent/guardian must consent for their child to participate in research.

Whether consent must be obtained from one or both parents depends on the level of risk of the study and whether there is a potential for direct benefit to the child.

  • Minimal risk studies – one parent consent is acceptable.

  • Greater than minimal risk studies with a potential for direct benefit – one parent consent is acceptable.

  • Greater than minimal risk studies without the potential for direct benefit – two parent consent is required UNLESS one parent is deceased, unknown, incompetent, *not readily available, or when only one parent has legal responsibility for the care or custody of the child.

* A parent who is not reasonably available is one whose whereabouts are unknown or there is no way to reach them by phone, mail, email, fax or any type of videoconferencing or has not responded to multiple contact attempts. Not available does not apply to situations when a parent is at work, traveling, caring for other children or living in another state or country.

Studies involving wards should follow MU HRPP/IRB policy regarding their inclusion and who can consent on their behalf. Please see our Additional Protections for Vulnerable Populations SOP for more information.

You can request a waiver of parental consent under two following conditions, and the IRB will determine whether it is appropriate.

  • The research is designed for conditions or for a population for which parental or guardian permission (consent) is not a reasonable requirement to protect the children (for example, neglected or abused children). (Not available for FDA regulated studies).

  • The study meets the general criteria for waiving consent pursuant to 45 CFR 46.116(d). 

You can also request a waiver of documentation of parental consent. This means you will obtain consent, but the parent is not required to sign a consent form. This may be applicable when there is no in-person interaction (i.e. phone interview, online survey), and no electronic signature is required. This option is not always available for FDA regulated studies.

It is important to review the IRB approval letter for the final IRB determination on parental/guardian consent.

See our Informed Consent FAQs for more information about types of consent and waivers.

The federal regulations require that you obtain the child’s assent to participate in research. Child assent is a written or verbal process where a child decides whether they want to participate based on information provided to them at their reading/comprehension level. If a child does not want to participate in an  study, then their dissent should be respected. If children, whether some or all, are incapable of assenting (as determined by the IRB considering their age, maturity, and psychological state), then only parental/guardian consent would need to be obtained. The IRB does not provide an age range for requiring written assent. Investigators should determine children’s capability of assenting based upon the population being studied. In general, written assent would be utilized with children who have reached an age where they can read. Some researchers choose to provide a more detailed written assent form for children who have reached adolescence. 

If children cannot assent, then a waiver of assent may be requested by the investigator and granted by the IRB under one of the following circumstances:

  • Assent from children is not possible because the capability of the child(ren) is so limited the child(ren) cannot reasonably be consulted.

  • 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.

  • Assent from children will not be obtained because the study meets the adult criteria for waiving consent pursuant to 45 CFR 46.116(d) (for minimal risk research procedures). 

Re-Consenting Upon Age of Majority: If the child will continue to participate in your study when they turn the legal adult age, consent must be obtained from the now adult. The IRB will request a plan for obtaining consent upon age of majority. Age of majority may differ by State or Country. In Missouri, the age of majority is 18 or 21 if DFS is the guardian.

Yes, we have several consent templates available on our Researcher Resources page. Please choose your templates based on the level of review your project will receive (Exempt or Expedited/Full Board) and whether your project involves biomedical or social, behavioral, educational (SBE) research.

Be sure to also choose an adult consent template when working with a population that may include 18-year-olds, even if most subjects in the population will be children.

  1. Research not involving greater than minimal risk to children. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

  2. Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child. The anticipated benefit must justify the risk and the relation of the anticipated benefit to the risk must be at least as favorable as that of alternative approaches.

  3. Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the child`s disorder or condition. The risk must represent only a minor increase over minimal risk, (This risk is slightly more than what the average healthy child would experience but is an experience or an expectation given their condition) the intervention or procedure must present experiences to the children that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations, and the intervention or procedure must be likely to yield generalizable knowledge about the children's disorder or condition which is a vital importance for understanding or amelioration of the disorder or condition.

  4. Research not otherwise approvable under one of the above categories, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The research uses minors that do not have the disease being studied and is greater than minimal risk. It presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health and welfare of minors but presents no direct benefits to the children. (Please note, research in this category must be reviewed by the HRPO and then submitted to the DHHS Secretary (conducted, funded, or otherwise subject to regulation by DHHS) or The Commissioner of Food and Drugs (if FDA regulated) for review and approval by a panel of experts following publication and public comment).

See OHRP FAQs on Research with Children for more information.

Clinical investigations involving children and FDA-regulated products are essential for collecting safety and effectiveness data of medical products. Children are considered a vulnerable population under the regulations and are therefore afforded additional safeguards when participating in clinical investigations.

Based on the principle of scientific necessity, children should not participate in clinical investigations unless their participation is necessary to answer an important scientific and/or public health question directly relevant to the health and welfare of children. When it is considered scientifically necessary to conduct a clinical investigation involving children, it is imperative that the clinical investigation be well-designed to collect interpretable data.

For children to be exposed to the level of risk described in Child Category 3 (50.53) in the previous question (greater than minimal risk and no prospect of direct benefit), the children should either have or be at risk for the specific disorder or condition that will be studied. See additional FDA guidance regarding risk categories for intervention or procedures without the prospect of direct benefit, and studies involving placebos and factors to consider when assessing risk to children in the placebo arm.

Child Category 4 (50.54) is an investigation that is not approvable under the other categories, and the IRB finds the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a problem affecting the health or welfare of children. Also, the FDA Commissioner, after consultation with a panel of experts in pertinent disciplines and following opportunity for public review and comment, determines certain conditions are met that allow the clinical investigation to proceed.