Investigators are responsible to discuss the research with subjects, and to document the subjects’ consent to participate. The consent process must be adapted to the decision-making needs of the subject. Different studies--depending on degree of therapeutic benefit and risk--require different emphasis during the consent discussion. The consent form is an important part of this process and is intended to guide the investigator and subject in the consent process.
• Federal regulations describe the required elements of consent.
- A statement that the study involves research, an explanation of the purposes and the expected duration of the subject’s participation, and a description of the procedures, noting any procedures which are experimental;
- A description of reasonably foreseeable risks or discomforts;
- A description of benefits to the subject or others that may reasonably be expected;
- Disclosure of appropriate alternative procedures or courses of treatment;
- A statement of the degree to which confidentiality of records identifying the subject will be maintained;
- For studies involving more than minimal risk, a description of any compensation that will be provided, and of medical treatments that are available in case of injury;
- Who to contact for answers to questions about the research, about research subjects’ rights, and about research-related injury;
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject would otherwise be entitled
• There are additional elements that must be included if appropriate.
- A statement that there may be unforeseeable risks to the subject (or the embryo or fetus) if the subject is or may be pregnant;
- Anticipated circumstances under which the subject’s participation may be terminated without the subject’s consent;
- Additional costs that may accrue to the subject as a result of participation;
- Consequences of early withdrawal from the research, and procedures for orderly termination of participation in such an event;
- A statement that any significant new findings that may relate to the subject’s willingness to continue will be provided;
- The approximate number of subjects involved in the study.
• The requirement to obtain informed consent can be altered or waived if all of the following conditions pertain:
- The research involves no more than minimal risk to subjects;
- The waiver or alteration will not adversely affect the rights and welfare of subjects;
- The research could not practicably be carried out without the waiver or alteration; and
- When appropriate, subjects will be provided with additional pertinent information after participation.
Categories of Surrogates Who May Provide Consent for Adults Who Lack Capacity to Consent
1.Family Member: Parent, spouse or adult child.
2.Health Care Proxy: The Health Care Proxy form must designate the category of research (level of risk, category of benefit) for which proxy consent is authorized. **
3.Article 81 Guardian: The court order appointing the guardian must specify that the guardian has the authority to authorize consent for the particular category of research.
4.Court Approval. * Under certain circumstances a court approval may authorize participation in non-therapeutic research.
5.Patient Chosen Surrogate: The form designating the surrogate must designate the category of research (level of risk, category of benefit) for which surrogate consent is authorized.
- Surrogate Consent on Behalf of Incapable Patients (OMH Facilities)
When a non-objecting patient has been found to lack sufficient capacity to consent, he/she must be so informed. Consent to his/her participation in research involving more than minimal risk may be provided by the surrogates listed below. Surrogate consent must always be on the basis of the known wishes of the person when capable or, if unknown, the person’s best interests. The assent of the patient is also required to the extent that the patient is capable of providing assent.
Patient Chosen Research Surrogate
- Health Care Proxy **
A person appointed guardian under Mental Hygiene Law Article 81 may provide consent to therapeutic research if the court order appointing the guardian specifies that the guardian has the authority to consent to therapeutic research
- Court Approval
After providing written notice to the patient, a court proceeding may be initiated seeking approval for the person's participation. The court must find by clear and convincing evidence: a) the person lacks the capacity to provide informed consent to the therapeutic research; b) the research holds out the prospect of a direct benefit to the person that is important to the health or well being of the person; c) the research is consistent with what is known of the person's personal wishes, preferences and desires; d) the research is in the person's best interest; and e) the proposed experimental treatment is narrowly tailored to give substantive effect to the person's liberty interest, taking into consideration all relevant circumstances, including, the benefits to be gained from the treatment, the adverse side effects associated with the treatment, the risks of the treatment, and any less intrusive alternative treatments.
** Use of Health Care Proxy is currently under review. Please consult with the IRB Director (Phone #: 646-774-7155).
The PCS Model permits the subject to appoint any trusted individual to serve as his or her surrogate decision-maker. However, the Surrogate may not be an administrator or employee of the facility at which the research is conducted unless this person is related to the subject by blood, marriage or adoption. Note: The selection of a patient’s spouse as a surrogate is revoked upon the legal separation or divorce of the patient and spouse unless the patient specifies otherwise. The Surrogate is informed that his or her decisions are to be based on a “substituted judgment” standard, to the extent that the subject’s wishes are known. Substituted judgment means that the Surrogate’s decisions are based on what he or she believes the subject would have decided if the subject were competent to make decisions.
- Capacity to Consent
The method(s) used to evaluate capacity to consent must be specified by the investigator in the IRB approved protocol and will be noted in the IRB’s approval notice. If no method is specified, then a clinical assessment of the patient’s ability to consent is required (this is based on accepted standards: ability to evidence a choice, understand the information provided, rationally manipulate the information to make the choice, and appreciate the decision and its significance).
The witnesses to the subject’s choice of a Surrogate may not be named on the IRB protocol or otherwise serve as a member of the research team. While the Independent Evaluator may serve as one of these two Witnesses, the Surrogate may not.
- Independent Evaluator
For the PCS policy, an Independent Evaluator is defined as an appropriately qualified and licensed physician (Board Eligible in “Psychiatry and Neurology”) or a licensed clinical psychologist who makes the capacity determinations (to consent and to choose a surrogate) in the PCS model. He or she must be trained in the patient chosen surrogate procedure. The Independent Evaluator may not be a member of the study team (e.g., may not be a Researcher) and if a member of the research division may not report directly to the study PI.
- Consent Procedure Note
A Consent Procedure Note provides a narrative description for the clinical record describing elements of the assessment of capacity that merit additional documentation including but not limited to the basis for the determination, methods or instruments used, consent enhancements employed, and relevant information from history or from the record which bear on the determination of capacity. A Consent Procedure Note must be written both with respect to a subject’s capacity to consent to research and a subject’s capacity to choose a surrogate (if applicable).
This policy describes the requirements of the NYSPI-IRB for the patient chosen surrogate (PCS) model for surrogate-based research. These requirements conform to procedures authorized by the NYS Department of Health for the NYS Office of Mental Health following the NYS Supreme Court Appellate Division’s decision of T.D. vs. Office of Mental Health.
PCS permits surrogate-based enrollment of a subject who lacks capacity for more than minimal risk therapeutic research and may also be used in minimal risk research. It may only be used when the IRB approval notice specifically endorses the item “surrogate based research using the patient chosen surrogate model”. It may not be used when it conflicts with the terms of an existing advanced directive that provides or prohibits authorization of an individual to make research decisions on behalf of that subject.
This approach is unique in recognizing that some subjects with impaired decision-making ability are unable to provide informed consent for a particular research study, but retain the decision-making skills necessary to choose a surrogate to make this decision on their behalf. PCS requires additional safeguards to protect the rights of individuals who are unable to fully protect their own interests through the consent process.
- The Principal Investigator, all Researchers and Independent Evaluators read this policy and procedure statement and sign a copy as evidence of training in the requirements. This signed document is retained by the Principal Investigator and made available for inspection upon request.
- The Researcher discusses participation with the research subject and makes an initial determination as to whether the subject has the capacity to consent to the study or lacks this capacity. When the researcher judges that the subject does not have capacity, but may have capacity to appoint a surrogate, steps 4-16 are followed.
- If the initial determination by the Researcher indicates that the subject has the capacity to consent to the study:
a. The Independent Evaluator assesses the subject’s capacity to consent to the study.
b. When the Independent Evaluator determines that the capacity determination cannot be made at the time of the evaluation, this fact should be documented as indicated on Form I, Item 1. No further consent procedures should be conducted with respect to that subject unless and until this Independent Evaluator is able to make such a determination.
c. If the Independent Evaluator determines that the subject has the capacity to consent, s/he documents his or her determination on PCS Form I, Item 1 (see Appendix for all forms) and writes a Consent Procedure Note.
d. The subject is asked to consider participation, and document his or her consent on PCS Form II, Consent Form Signature Page, Item 1.
e. The Researcher documents the subject’s consent on PCS Form II, Item 2.
f. Subject enrollment may commence.
- The Independent Evaluator assesses the subject’s capacity to consent to the study. When the Independent Evaluator determines that the capacity determination cannot be made at the time of the evaluation, this fact should be documented as indicated on Form I, Item 1. No further consent procedures should be conducted with respect to that subject unless and until this Independent Evaluator is able to make such a determination.
- When the subject is determined to lack capacity to consent by the Independent Evaluator, the Independent Evaluator discusses his or her finding with the subject along with the subject’s right to have the determination reviewed.
- The Independent Evaluator evaluates the subject’s capacity to choose a surrogate and determines and documents whether the subject is interested in appointing a Surrogate and his or her capacity to do so (PCS Form I, Item 2).
- The Independent Evaluator writes a Consent Procedure Note in the clinical record.
- The Researcher provides information to the subject about the process of choosing a surrogate (Record of Choice of Surrogate, PCS Form III(a)). The subject’s decision to appoint a Surrogate is made and documented (PCS Form III(b), Item 1). This also serves as documentation of the subject’s assent.
- This process (described in 8 above) is observed by two Witnesses and documented in PCS Form III(c), Item 2. PCS Form III must also be signed by the person providing the information (reading the form) to the subject.
- The Researcher then discusses the subject’s participation with the Surrogate and reviews the consent form. The Surrogate is given an opportunity to ask questions.
- The Surrogate provides consent for the enrollment of the subject and documents this permission on the Surrogate Consent Signature page, PCS Form IV, , Item 1.
- The Researcher then documents consent by the Surrogate on PCS Form IV, Item 2.
- The Researcher completes and signs the Study Consent Enrollment Checklist.
- The required letter of notification is forwarded to the MHLS.
- Subject enrollment may commence.
- The Principal Investigator reviews and signs off on the Study Consent Checklist and forwards a copy along with a copy of the MHLS letter to the IRB.
Patient Chosen Surrogate (PCS) Forms