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Charles R. Drew University of Medicine and Science Office for the Protection of Human Subjects Institutional Review Board
Written Justification and Explanation for Requesting Proxy/Surrogate Consent
1. Please provide a scientific rationale for the use of proxy/surrogate consent for this project.
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2. Please explain why the proxy/surrogate consent is ethically justified for the proposed project.
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3. Please provide an analysis of the risk-benefit ratio for participation in this project that justifies the enrolling of subjects through proxy/surrogate informed consent.
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4. Please outline the process for implementation and documentation of the non- emergency proxy tree and emergency room options outlined in the State law.
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a. Please provide the procedures for contacting individuals outlined in the guidelines and requesting their informed consent.
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b. Please outline the procedures for determining whether the clinical condition of the subject may allow them to dissent or resist participation in the research.
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c. Please outline how you will ensure that conscious subjects take part in the discussion and have an opportunity to object to participation in the research. Please note: though conscious subjects may not have the cognitive ability to provide informed consent, they may retain the ability to dissent (say “no”) or resist participation in the research.
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Rev. 6/2015a Form 119 Page 2 of 3 5. Non-emergency room research
a. Please outline how you will assess whether the proxy has “reasonable knowledge of the subject” to serve as the surrogate decision maker regarding participation in the research. For example:
Have you ever had a discussion about health care issues with the subject? If so, has s/he indicated….
Do you have frequent contact with the subject? If so, what is the nature of your contact?
How well do you know the subject?
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b. Please describe how you will comply with the following requirement: When there are two or more available persons who according to the proxy tree may give surrogate informed consent and who are in the same order of priority, if any of those persons expresses dissent as to the participation of the person in the medical experiment, consent shall not be considered as having been given.
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c. The law requires that when there are two or more available persons who are in different orders of priority in the surrogate tree, refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate. Please outline the procedures for addressing disagreements among members of the proxy tree regarding participation of the subject in the research.
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Assurances
By requesting to use the proxy/surrogate decision tree, I provide the following assurances:
- The research relates to the cognitive impairment, lack of capacity, or serious or life threatening diseases and conditions of participants.
- Surrogate consent will only be obtained when the subject lacks the capacity to provide informed consent and does not express dissent or resistance to participation.
- Subjects who are not able to provide informed consent will be asked whether they wish to participate in the research.
Rev. 6/2015a Form 119 Page 3 of 3 - Subjects will be excluded if they express dissent or resistance to participation in the research.
- Subjects who regain the capacity to provide legal informed consent will be provided the opportunity at that time and their refusal will result in appropriate withdrawal from the research.
- For non-emergency room research, when there are two or more available persons who are in different orders of priority in the surrogate tree, refusal to consent by a person who is a higher priority surrogate shall not be superseded by the consent of a person who is a lower priority surrogate.
- I will not enroll by proxy/surrogate consent any subjects involuntarily committed pursuant to Part 1 (commencing with Section 5000) of Division 5 of the Welfare and Institutions Code, or who have been voluntarily admitted or have been admitted upon the request of a conservator pursuant to Chapter 1 (commencing with Section 6000) of Part 1 of Division 6 of the Welfare and Institutions Code.
- Surrogates will not be paid for providing informed consent.
______Signature of Principal Investigator Date
Rev. 6/2015a Form 119