IRB INFORMED CONSENT FORM

For Seeking Consent for Human Subjects to Participate in Research

Instructions: The PI signature(s) and date(s) must be included on the Informed Consent Form that is submitted to the IRB. It is suggested that you also include the signatures of any Co-PI(s) or student investigators listed on this project but only the PI signature is required on the consent document. After IRB approval of your research application, a signed copy of the Informed Consent Form will be returned to you to make copies for use with your prospective participants. A copy of this form must be provided to the study participant after signing it and the original is retained by the PI.

Date Prepared/Revised:

Project Title:

Principal Investigator:

Co-PI(s):

This form has been approved for use by the UMass Lowell IRB and is valid for a period not to exceed one year from the approval date.

Authorized IRB Approval Signature Approval Date:

Essential Sections of the Informed Consent Form (see IRB Manual of Policy and Procedures)

Study Purpose:

Procedure and Duration:

Potential Risks and Discomfort:

Incentives/Compensation (if any):

Anticipated Benefits to the Subject or to Non-subjects:

Right to Refusal or Withdrawal of Participation:

Assurances of Privacy and Confidentiality:

Additional Information:

PI ASSURANCE AND SIGNATURE

(Refer to definition of PI for who is authorized to sign here.)

1. Printed Name: Signature: Date:

2. Printed Name: Signature: Date:

3. Printed Name: Signature: Date:

4. Printed Name: Signature: Date:

PARTICIPANT SIGNATURE

I understand the foreseeable risks and/or discomfort that have been described in this document. I have read the statements contained herein, have had the opportunity to fully discuss my concerns and questions, and fully understand the nature and character of my involvement in this research program as a participant and the attendant risks and consequences.

Research Participant: Date:

Printed Name: and Signature

Parent, Guardian, or Legal Representative (if applicable): Date:

Printed Name and Signature

Agency Official (if applicable): Date:

Printed Name and Signature