VA Proxy ChecklistApproval Stamp here:

Attachment L1

VA Surrogate Consent

Date: / PI:
VA PI (if applicable): / COMIRB #:
Version #:

If the patient is unable to give consent due to impaired decision-making capacity or incompetence, the VA Investigator must follow the guidelines described below:

Yes / No / Comments
Will the practitioner in consultation with the Chief of Service provide an appropriate medical examination to determine that prospective research subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time?
Will the patient’s impaired decision-making capacity be documented in the person’s medical record in a signed and dated progress note in CPRS? This note must including the following:
  • cause of the lack of the decisional capacity
  • nature of lack of decisional capacity, and
  • projected duration of the patient’s lack of decisional capacity

Will the patient’s decision making ability be assessed through the use of an objective tool, and will it been documented that the patient has sufficient judgment to understand the design, risks and benefits of participation in the study?
Will the attending, or his or her designee, make reasonable efforts to notify
the patient of the patient’s lack of decisional capacity and make reasonable efforts to advise the patient of the identity of the proxy and the patient’s
right to object?
If feasible, the practitioner must explain the proposed research to the prospective research subject even when the surrogate gives consent.
Per VA Regulations (VA Handbook 1200.5), will surrogate consent be
obtained from a health care agent appointed by the person in a DPAHC or similar document; court-appointed guardians of the person, or from
next-of-kin in the following order of priority
  • spouse
  • adult child (18 years of age or older)
  • parent
  • adult sibling (18 years of age or older)
  • grandparent
  • adult grandchild (18 years of age or older)

If any interested person, or guardian, or attending believes that the patient has regained decisional capacity, the attending shall reexamine and determine whether or not thepatient has regained capacity and shall
enter the decision and the basis therefore into the medical record and shall notify the patient, the surrogate,
and the person who initiated the redetermination of the determination.
Include a description of the psychological or medical screening criteria you will use to determine the participant’s decision making capacity:
Describe the specific diagnostic, symptomatic and demographic criteria for subject recruitment:

I understand and agree to follow the guidelines described above in accordance with VA Regulations for Surrogate Consent as defined in VHA Handbook 1200.5.

VA Investigator:______

Print Name Signature

Date: ______

Attachment L1: VA Surrogate Consent

CF-101, Effective 8/30/07 Page 1 of 2