Spring 2009, Issue 10
Special Protections for Minors in Research Studies
Research studies that involve minors (younger than 18 years old) must adhere to special federal regulations for the safety and welfare of minors. The following details focus on all types of research conducted in the United States, and as such apply to both the Health Sciences Institutional Review Board (Boston and Grafton campuses) and the Social, Behavioral, and Educational Research (SBER) IRB (Medford/Somerville campus). For information on conducting international research with minors, please contact your IRB office.
Federal regulations require that investigators obtain informed consent from potential study participants. Informed consent regulations and terminology for studies involving minors differ from those for studies involving adults.
“Consent” is an individual right of a competent adult. According to federal regulations, an adult does not “give consent” on behalf of a minor. “Consent” is not the correct term to use in studies involving minors.
“Permission” is the term used for what a minor’s parent(s) or guardian(s) must provide for the minor to participate in a study. Whether the permission of one or both parents or guardians is required will depend on the level of risk and benefit to the child and will be determined by the IRB and communicated to the principal investigator.
“Assent” is the term used for what a minor aged 7 years or older gives to confirm participation, provided that the child has been deemed capable of assenting by the IRB. Taking into account age, maturity, and the psychological state of a minor, age 7 is widely accepted as the age at which one is capable of understanding consequences and therefore capable of providing assent. Researchers should not interpret failure to object as assent. Studies involving minors under the age of 7 years do not require the minor’s assent.
Waiver of Permission or Assent
Federal regulations allow the IRB to waive the requirement for permission or assent under certain circumstances. In determining waiver of permission or assent, the IRB considers the nature of the research, risks and benefits, and the minor’s age, maturity, and psychological state.
- Permission of a minor’s parent(s) or guardian(s) may be waived if the IRB determines the requirement for permission is not reasonable in order to protect the minor (for example, an abused child). If permission is waived, the IRB must ensure that an appropriate mechanism for protection of the minor is substituted.
In very specific circumstances in which a study holds a prospect for direct benefit to the health or well-being of a minor and the study intervention is available only through the study, a minor’s assent is not necessary, provided that the minor’s parent(s) or guardian(s) provide permission. If the study does not meet this strict requirement, the minor’s wishes not to participate prevail over the parent’s or guardian’s permission.
For more information about the enrollment of minors in research, please go to the Health Sciences IRB or to the Social, Behavioral & Educational Research IRB (Medford/Somerville campus).