VA ECHCS (Attachment L1)

Checklist for Research Involving

Decisionally-Challenged Subjects

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

Under appropriate conditions, VA Investigators may obtain consent from the legally authorized representative of a subject (surrogate consent) at the VA.

In order to protect human subjects from exploitation and harm and, at the same time, make it possible to conduct essential research on problems that are unique to persons who are incompetent, or who have an impaired decision-making capacity, the VA Investigator must follow the guidelines described below if such surrogate/proxy consent will be requested:

Yes / No / Comments
Will the practitioner in consultation with the VA Chief of Service provide an appropriate medical examination to determine that the prospective research subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time?
Note: Consultation with a psychiatrist or licensed psychologist must be obtained when the determination that the prospective research subject lacks decision-making capacity is based on a diagnosis of mental illness.
Will the patient’s decision-making ability be assessed through the use of an objective tool, and will it be documented that the patient does not have sufficient judgment to understand the design, risks and benefits of participation in the study, if it is so assessed?
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 include 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 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/surrogate and the patient’s right to object?
Yes / No / Comments
Per VA Regulations (VA Handbook 1200.5), will proxy/surrogate consent
Be obtained from a health care agent appointed by the person in a Durable
Power of Attorney for Health Care (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)
Note: The preceding list contains the only proxy/surrogate entities who are allowed to provide consent for research purposes per VHA regulations. Any disclosures that are required to be made to a subject by the investigator must be made to the subject’ surrogate. VA’s General Counsel has determined that the VA would not look to Colorado state law in determining the appropriate surrogate for consent to research.
If feasible, will the practitioner explain the proposed research to the
prospective research to the prospective research subject even when the
surrogate gives consent?
Note: Under no circumstances may a subject be forced or coerced to participate in a research study.
Note: If any interested person, or guardian, or attending physician believes that the patient has regained
decisional capacity, the attending MD must re-examine and determine whether or not the patient has
regained capacity and must enter the decision and the basis, therefore, into the medical record and must
notify the patient, the surrogate, and the person who initiated the re-determination of the determination.
Include a description of the psychological or medical screening criteria you will use to determine the participant’s decision-making capacity or attach a copy of the objective tool you will use:
Is it feasible to do the study without including this population? Yes No
If yes, the researcher cannot use proxy/surrogate decision makers.
Why should this population be included in the research study?
Does the study provide medical treatment? Yes No
Is there a placebo-arm to the study? Yes No
If yes, does the placebo-arm receive services that will maintain, diagnose, treat, or provide for a person’s physical or mental health or personal care?

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

VA Investigator: ______

Print Name Signature

Date: ______

If you have any questions regarding research involving decisionally-challenged participant

requirements at the VA, please contact

Lynne Brandes at or Connie Steinbrunn at .

Attachment L1: VA Surrogate Consent

F-101, Revision 001, Revised 2/08 Page 1 of 3