Research Consent for Adolescents

RESEARCH CONSENT FOR ADOLESCENTS

Researcher/Institution:    Study Title:

Protocol/Reference No.:    Principal Investigator:

Participant (Adolescent) Name:    Date of Birth:

Parent/Legal Guardian Name:    Relationship to Participant:

RECITALS

WHEREAS, the Institution and Principal Investigator seek to conduct the research described in this form for the purpose of advancing knowledge and improving health outcomes; and

WHEREAS, the Subject is an adolescent under the age of majority, and the law requires parental or legal guardian consent in addition to the adolescent's assent for participation in most research activities; and

WHEREAS, the Parent/Legal Guardian has authority to provide consent for the Participant's involvement in the research subject to the terms set forth below;

NOW THEREFORE

In consideration of the mutual promises and representations contained in this Research Consent for Adolescents, the parties agree as follows:

1. DEFINITIONS

For purposes of this Agreement, the following definitions apply: "Participant" means the adolescent named above; "Parent/Guardian" means the person signing as the participant's legal guardian; "PI" means the Principal Investigator named above; "Assent" means the participant's affirmative agreement to participate.

2. PURPOSE AND PROCEDURES

The purpose of the research and the procedures to be followed are described below. You should read this information carefully and ask questions about anything you do not understand.

Estimated duration of participation:    Number of visits/procedures:

3. RISKS, DISCOMFORTS, AND FORESEEABLE ALTERNATIVES

The Participant may experience certain risks or discomforts as a result of participation. The PI has provided an explanation of known and reasonably foreseeable risks, and alternatives to participation, if any, are described below.

4. POTENTIAL BENEFITS

Participation may or may not result in direct benefit to the Participant. Any potential benefits to the Participant or to others are described below.

5. CONFIDENTIALITY AND DATA USE

The Investigator will make reasonable efforts to maintain the confidentiality of research records. However, confidentiality cannot be absolutely guaranteed. Information may be disclosed as required by law or as necessary to protect the safety of the Participant.

Consent to audio or video recording of study activities

Consent to use de-identified data for future research

Consent to genetic analysis of biological samples

Data retention period and security measures:

6. VOLUNTARY PARTICIPATION AND WITHDRAWAL

Participation is voluntary. The Parent/Guardian and Participant have the right to withdraw from the study at any time without penalty or loss of benefits to which the Participant is otherwise entitled. The decision to withdraw will not affect standard medical care.

7. COMPENSATION AND COSTS

Compensation, if any, and costs to the Participant for participation are described below.

Compensation amount or reimbursement:

8. EMERGENCY TREATMENT AND LIABILITY

In the event of an emergency related to study procedures, reasonable efforts will be made to provide prompt medical care. The Parent/Guardian consents to emergency treatment if deemed necessary by the Investigator. The Institution's policies regarding liability and compensation for research-related injury are described below.

9. CONTACTS FOR QUESTIONS AND CONCERNS

10. NOTICES

All formal notices under this Consent shall be in writing and delivered to the contact information provided above for the Investigator or to the Parent/Guardian contact information provided on page 1.

11. GOVERNING LAW

This Consent shall be governed by and construed in accordance with the laws of the state or jurisdiction in which the Institution is located, without regard to conflict of law principles.

12. ENTIRE AGREEMENT; SEVERABILITY; AMENDMENTS; WAIVER; COUNTERPARTS

This Consent constitutes the entire agreement between the parties regarding the Participant's involvement in the research. If any provision is held invalid or unenforceable, the remaining provisions shall remain in full force and effect. This Consent may be amended only by a written instrument signed by the Parent/Guardian and the Investigator. No waiver by either party of any breach of this Consent shall constitute a waiver of subsequent breaches. This Consent may be executed in counterparts, each of which shall be deemed an original.

13. PARENT/GUARDIAN CONSENT AND ADOLESCENT ASSENT

By signing below, the Parent/Guardian affirms that they have read and understood the information provided, have had an opportunity to ask questions, and voluntarily consent to the Participant's involvement in the research as described.

I, the Participant named above, have read or have had explained to me the purpose and procedures of the research. I assent to participate: Signature:    Date:

Parent/Guardian: By signing below I consent to the Participant's participation in this research study and affirm that I am legally authorized to provide consent on the Participant's behalf.

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