Enrolling subjects ages 15-17 in a research study?

The Institutional Review Board (IRB) now has template consent form signature pages for studies involving 15-17 year old subjects. These may be used in your consent forms in place of the standard signature page. Use the guidelines below to help determine which page to use.

Studies involving research-related treatment and/or the provision of clinical care

Generally, per OHSU policy and Oregon law, subjects age 15 or older may provide legally effective informed consent for their own participation. However, obtaining consent from a parent or guardian is still the best practice in most cases. If you intend to seek consent from a parent or guardian for the minor’s participation, use signature page option #1. Note that 15-17 year old subjects are also asked to document their own consent on this page. Consult the Children as Research Subjects policy for similar circumstances involving pregnant youth or youth receiving mental health treatment.

If you believe that obtaining parent/guardian consent is not the best practice for your study, you may use signature page option #2. You should submit a memo to the IRB that (1) explains your rationale and (2) describes your plan to involve parents/guardians in the subjects’ study participation where appropriate. You will note the presence of a parent/guardian acknowledgment signature line on this page. Whether you should have the parent/guardian sign the consent form depends on the nature of the study and the individual subject’s circumstances. Generally, the IRB will defer to researcher discretion regarding when parent involvement in a study is appropriate.

Studies NOT involving treatment or clinical care

Subjects under age 18 may NOT consent to their own participation in these studies.  If this applies to your study, use signature page option #1 and add a second parent/guardian signature line. The 15-17 year old minor subject should still sign the bottom line of this page as documentation of assent.

Assent for subjects ages 7-14 (or older, if appropriate in light of the specific study circumstances or the nature of the subject population) should still be documented using the OHSU standard assent form or an assent form drafted specifically for your study.

These guidelines are meant to be flexible. The IRB understands that different types of studies may warrant different consent/assent procedures. Please contact your IRB analyst if you have questions about the best way to obtain and document consent and assent for your study.

Note: You are not required to incorporate these new templates into consent forms that have already been approved by the IRB.

If you have any questions about this policy, please contact the IRB.