Consent and Assent Instructions

Consent and Assent Instructions: Consent: Is provided by the Legally Authorized Representative Assent: Is required to the extent possible for subjects 12 years and younger using this Page Is required for subjects ages 13 through 17 years using the Assent Box Page [Note: Delete the above directions, and use the remainder as an additional page of the informed consent if the child is 12 years old or younger.] Title:

Sub-Investigator(s):

IRB Number:

Assent Page for Subjects 12 Years of Age and Younger

As an investigator in this study or person delegated by the investigator to obtain consent / assent, I certify that:  I have discussed this study with the child and explained it to the degree possible given the child’s age and ability to understand and participate in the assent process. While no discussion or explanation is expected for infants, a meaningful conversation with as young a child as possible is expected.  When the study is for the potential benefit of the child (category 2 research as determined by the IRB), the child’s affirmative assent is not required if the parents (or legally authorized representative) give permission/consent. Given the child’s age and ability, every reasonable effort to have the child understand and participate in the decision to be part of the study must be made.  When the study has no potential benefit for the child and is greater than minimal risk (category 3 research as determined by the IRB), the child’s affirmative assent is expected to the extent possible given the child’s age and ability. Generally, a child who is greater than 6 years old can refuse to participate in these types of studies and this decision must be honored.

Name of child subject: ______(no signature from the child subject 12 years and younger is expected)

______Signature of Person Conducting Informed Consent Discussion / Printed Name Date