Assent - Under Age 18

Children Age 7 – 17

Federal regulations require the researcher to obtain assent or agreement from a child before participation in a research project. Assent is required for minors aged seven years or older unless the child’s decision-making capacity is impaired. The PI certifies by obtaining assent that the research has been explained to the child and that the child is willing to participate. Assent differs from obtaining a parent or guardian’s permission for participation.

The assent forms should be written at the 6th grade level. Visuals, illustrations, or diagrams are helpful to enhance understanding.  Research reviewed by the WVU IRBs requires both an Assent Form and a Parental\LAR Consent Form. 

 Click here for the  IRB approved forms.

Age Range	Assent Required?	Parental Consent Required?	Comments
Birth to Age 6	No	Yes	Including the child in the consent process with the parents is recommended for verbal assent as this shows; respect for persons.
Ages 7-11	Yes	Yes	For More than Minimal Risk research, a separate Assent form is required. If the child has diminished capacity, follow the guidance above for Birth to Age 6.
Ages 12-17	Yes	Yes	For More than Minimal Risk research, a separate Assent form is required.

Birth to Age 6

Based on age and cognitive level, a simplified oral explanation should be offered before research‐related procedures are conducted. For example: “We have to take a little bit of blood from your arm. That means that you will feel a little needle stick. It will only hurt for a minute. Your mom, dad, or guardian will be with you the whole time and can hold your hand.”

Ages 7-11

The Assent form should be simple enough for the child to understand what he/she is agreeing to do.  If the child has diminished capacity, follow the guidance above for Birth to Age 6. An Assent form written at a 6th grade level and a Parental Consent form are required. 

Ages 12-17

For adolescents between the ages of 12 and 15, ensure that the readability of the Assent form is age-appropriate.  An Assent form written at a 6th grade level and a Parental Consent form are required.  If consenting participants ages 15-17, the Assent form could be similar to the Parental Consent form. 

Minors Turning 18 During Participation

Federal regulations require informed consent to be viewed as an ongoing process throughout a research project. If a child is enrolled in research with parental\guardian permission and turns 18 during participation, the participation is no longer regulated by the requirements of 45 CFR part 46.408, regarding parental or guardian permission and minor assent.

Legally effective informed consent must be obtained as described n 45 CFR 46.116, for the now-adult participant for any ongoing interactions or interventions, unless the IRB waives informed consent. The parental permission and minor assent previously obtained is not equivalent to legally effective informed consent required for adult participants.

If the research does not require ongoing interactions or interventions with the participant and continues to meet the regulatory definition of “human subjects research” (for example, the continued analysis of specimens or data for which the participant’s identity is readily identifiable), legally effective informed consent must be obtained. The IRB may consider, if appropriate, a waiver under 45 CFR 46.116(d) of the requirements for obtaining informed consent for continued participation.

Emancipated Minors

Under some circumstances, a minor can consent as an adult without parental consent. West Virginia law states that minors over the age of 16 and legally married before the age of 18 are considered emancipated by operation of law and can provide consent on their behalf for research. Proof of marriage is required.

All other minors over the age of 16 must have a Judgement of Emancipation from a court of law to be considered “emancipated” (i.e., a minor who has a child).

Subpart D - Parental Signature Requirements

This table includes guidance for federal OHRP and FDA regulations, the Category of research, and the parental signature requirement for each Category. Note, if more than one parent signature is required, add a signature line to the form template.

Category	Determination	Details	Parental Signature Requirement
1	OMR	Adequate provisions are made for soliciting the Assent of children and Parental\LAR consent (46.408, 21 CFR 50.55).	One parent is sufficient
2	MMR with the prospect of direct benefit to the participant	The risk\benefit is justified. Adequate provisions are made for obtaining the Assent of the children and Parental\LAR consent ( 45 CFR 46.408).	One parent is sufficient
3	MMR with no prospect of direct benefit but likely to yield generalizable knowledge	The risk is an increase over only minimal risk. The risk of the intervention or procedure is reasonably commensurate with those inherent in actual, or expected medical, dental, psychological, social, or educational situations. Generalizable knowledge is likely from the research which is of vital importance for the understanding or amelioration of the disorder or condition.  Adequate provisions are made for obtaining the Assent of the children and Parental\LAR consent (45 CFR 46.408).	Both parents unless one is deceased, unknown, incompetent, or not reasonably available, only one parent has legal responsibility for the care\custody of the minor.