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THOMAS JEFFERSON UNIVERSITY

SURROGATE CONSENT FOR A RESEARCH PROTOCOL – OHR-8B

Version Date – FOR OHR USE: 9/1/16

IRB Control #:

Medical Title:

Name of Subject: ______

COMPLETE SECTIONS “A,” “B” AND “C” BELOW. WHEN APPROVED, THIS FORM WILL REPLACE THE SIGNATURE PAGE OF THE IRB APPROVED CONSENT FORM.

  1. REASON FOR SURROGATE CONSENT:

Reason for Subject’s Inability to Give Informed Consent:[1] ______

______

B.SURROGATE INFORMATION (In Order of Priority):

______COURT ORDER AUTHORIZING GUARDIAN CONSENT

Date of Order: ______Name of Guardian: ______

______POWER OF ATTORNEY Name: ______

(A copy of the power of attorney documentation should be retained in the study file.)

______SPOUSE Name: ______

______PARENT Name: ______

______ADULT CHILD Name: ______

______ADULT BROTHER/SISTER Name: ______

______OTHER ADULT RELATIVE Name:______Relationship:______

  1. PATIENT’S ASSENT TO PARTICIPATE (If possible, the assent of the patient should also be sought):

______The subject’s assent to inclusion in the study was sought and obtained.

______The subject is unable to assent for the reason provided in section A.

______The subject is unable to assent for the following reason:

Non-Waiver of Legal Rights Statement

By your agreement to allow the above-mentioned patient to participate in this study, and by signing this surrogate consent form, you are not waiving any of your or the patient’s legal rights.

In order for the patient to participate in this research study, you must sign and date this form.

You affirm that you have read all pages of the consent form. You have been told that you will receive a copy.

Signatures:

______

Subject’s Name Subject’s Signature Date

(Required if the subject was able to assent to participate. Surrogate signature also required.)

______

Surrogate’s Name Surrogate’s Signature Date

______

Name of Person Conducting Signature of Person Conducting Date Consent Interview Consent Interview

______

Name of Investigator Signature of Investigator Date

or Co-Investigator or Co-Investigator

Copy of Signed and Dated Consent Form Given to the Subject/Parent/LAR

***

______

Name of Witness Signature of Witness Date

(Witness required if the only language the subject/surrogate speaks and understands is English, but the subject/surrogate cannot read English, or if the subject/surrogate is blind or cannot physically sign the consent form.)

Instructions:

For complete information, please refer to OHR Policy IC 707: Policy and Procedure on Surrogate Consent

  1. When this form is used to obtain surrogate consent, use the approved consent form to conduct the consent discussion. Replace the signature page of the consent form with the surrogate consent form.
  1. To document the consent of the surrogate, the surrogate consent form will be completed.
  1. In addition, when the patient is capable of assenting to participate at the time of surrogate consent, inform the patient about the study according to the patient’s level of understanding. In this case, please check the option in section C indicating that ‘The subject’s assent to inclusion in the study was sought and obtained’ and ask the patient to sign the signature page of the surrogate consent form.
  1. When consent is initially provided by a surrogate, if the patient later becomes able to assent, you must obtain assent using the method described in this form. If the patient later becomes able to consent, consent should be obtained using the approved method of obtaining consent for the study. If the patient later becomes able to assent/consent but decides not to, the study data obtained up to that point cannot be used unless the subject signs a written agreement (such as the HIPAA section of the consent form).
  1. In a study involving surrogate consent, when a patient is initially able to consent, encourage the subject to appoint a surrogate or surrogates in order of priority at the beginning of the study. Note the surrogate(s) in the patient files.
  1. In section A, the ‘Reason for Subject’s Inability to Give Informed Consent’ must be completed.
  1. In section B, when selecting a surrogate, approach surrogate’s in order of priority, from highest to lowest. Start at the top of the list and work your way down.
  1. The intent of section C is to document whether or not assent was sought and obtained from the patient at the time of surrogate consent. Please complete this section accordingly.
  1. In section C, ‘Reason for Subject’s Inability to Assent’ should only be completed if the last option is checked.

[1] Examples of evidence to consider include indications in the medical record concerning whether the subject was oriented times three, whether the subject was alert and communicating with others, whether the subject was able to write messages on paper, and whether the subject was able to adequately respond to questioning regarding his or her participation in the research. Other considerations include the subject’s baseline cognitive status and the administration of medications that might impair mental capacity.