A. Introduction
B. CORIHS Review
C. Required Procedures
D. What determines a potential subject's capacity to consent to research?
E. Characteristics of research subjects which may suggest a diminished capacity to provide consent
F. If a study proposes to include a subject population where all or some of the individuals will lack the capacity to consent
G. Who can provide consent for a patient to participate in a research study if the patient is incapable of doing so?

A. Introduction

An essential part of the consent process is assessing whether the potential subject has the capacity to make a decision about participating in a given research study. The proposed subject population and the inherent risks and benefits of a particular study will determine who should be responsible for assessing the capacity of potential subjects. These factors will also determine the procedures that should be followed if the subject is deemed incapable of providing consent.

An ethical balance must exist between the need to conduct research that asks questions about certain diseases or disorders, and the need to protect the affected, sometimes vulnerable, subject populations whose inclusion in the study can help answer those questions. However, the rights of the potential subject are always preeminent.

This section addresses consent issues in adult subjects only. Consonant with legal requirements on research involving minors, it is generally accepted that minors are not capable of consenting to research activities. This is due to an immaturity in decision-making skills (rather than an impairment). Parental permission and assent issues governing research involving minors are specifically addressed in Section 10 and Section 15 in this handbook.

B. CORIHS Review

1) During the review of a project, CORIHS makes an assessment of the risk and therapeutic benefit associated with the study procedures. Risk can be considered minimal, i.e., the level of risk encountered in the subject's daily life, or more than minimal risk. The study may contain no benefit, direct benefit, or indirect benefit (benefit to society, e.g., provides information about the disease in general).

2) Based on this assessment, CORIHS will determine what type of review the study can undergo (exempt, expedited, or full committee) and will determine if the proposed subject populations are acceptable for inclusion. Capacity to consent (described below) is one factor that is considered in this determination:

A. Subjects who lack the capacity to consent for themselves can be included in studies only if CORIHS confirms that one of the following criteria is met:

1. Risk is minimal (defined in the federal regulations as "the probability and magnitude of harm anticipated in the research are not greater in and of themselves than those encountered in daily life, or during the performance of routine physical or psychological examinations or tests")

OR

2. Risk is more than minimal, but there is a possibility of direct benefit to the subject

B. Individuals who lack the capacity to consent for themselves cannot be enrolled in research studies that include more than minimal risk and no direct benefit. These types of studies can enroll individuals who are able to consent for themselves only with added procedural requirements, to be addressed by CORIHS.

3) As a result of review, any additional safeguards (e.g., type of capacity assessment) required by CORIHS will depend on the nature of the study as well as on the time course (temporary, permanent, progressive or fluctuating) and extent of the alteration in capacity. With increasing risk and decreasing benefit, the safeguards imposed on the study will be necessarily more stringent.

C. Required Procedures to be followed by the Person Obtaining Consent for All Studies, All Subjects

The individual who signs the consent form as the 'Person obtaining consent' is responsible for leading the potential subject through the entire consent process. This means:

1. All aspects of the study, as described in the consent form, are first discussed with the potential subject.
2. The consent form is thoroughly reviewed with the potential subject and answers to the potential subject's questions are provided.
3. While reviewing the consent form, the person obtaining consent asks questions designed to assess the potential subject's understanding of the material. The person will specifically state this intent to the potential subject (i.e., the person is making sure the potential subject appreciates what s/he is being asked to do, and why ).
4. The potential subject is given ample opportunity to decide, without coercion or undue influence, whether or not to be in the study.
5. The consent process does not end with the formal signing of the consent document. Rather, it is an ongoing process that continues throughout the subject's participation in the study. The person obtaining consent remains responsible for continued assessments of the subject's understanding of what is happening to him/her, his/her willingness to participate and for providing the subject with any new information that may affect their willingness to participate.

It is the Principal Investigator's responsibility to train and supervise the study personnel who are obtaining consent.

D. What determines a potential subject's capacity to consent to research?

For the purpose of this section, a subject has the capacity to consent to his or her own participation in a research activity if s/he demonstrates an appreciation:

1. that the activity is research, not standard treatment
2. of the risks and benefits of a study
3. of the alternatives that are available if s/he does not participate
4. that, if s/he chooses not to participate, this decision will be accepted without penalty, i.e., without jeopardizing clinical care

In reaching a decision about participation, it is essential for the potential subject to demonstrate an ability to use this information in a rational manner. Thus, in considering risks, benefits, and available alternatives, subjects must show they understand the aspects of these factors that are unique to them as individuals. To highlight this distinction, a person who is suffering with severe depression may be able to demonstrate an appreciation of a, b, c and d above, but may not care, or may actually want to take risks. Such individuals should not be considered able to provide consent for themselves.

E. Characteristics of research subjects which may suggest a diminished capacity to provide consent

1. Certain individuals, such as those with severe dementia, or severe mental retardation, will have a diminished capacity to provide consent. For these individuals, see the section on 'Surrogate Consent,' below.



2. For other individuals, it will not always be easy to predict whether capacity will be diminished given the following:
• Many individuals with psychiatric illnesses have the capacity to provide consent.
• Medical illnesses (e.g., cerebral insult) may be accompanied by an impaired capacity to consent.
• Upon learning of a serious diagnosis (e.g. cancer), psychological "shock" may temporarily impair a person's capacity to provide consent, although the illness does not affect decisional capacity in and of itself.
• Individuals who are intoxicated with alcohol or with drugs may be unable to consent to research until the intoxication resolves.
3. In assessing capacity, it is important to note that capacity is neither a constant nor an absolute. For example:
• Stroke victims may not have the capacity to consent to research immediately after the onset of stroke, but may develop capacity as recovery progresses.
• Patients in the early stages of Alzheimer's disease may initially have the capacity to consent to research, but as the disease progresses, may lose the ability to decide to continue or withdraw from that research.
• Patients with schizophrenia often experience acute psychotic episodes followed by periods of lucidity.
• Patients who learn they are terminally ill, often experience an initial short-lived period of emotional shock and denial which impairs their capacity to provide consent.
4. The requisite level of capacity will necessarily vary from study to study and will depend on:
• the complexity of the information being presented, and
• the relative risks and benefits of the study (deciding to participate in a blood drawing protocol is 'easier' than deciding to participate in an experimental drug trial).

Therefore, when developing a research proposal, the investigator must determine whether the study will include any subjects who may not have the capacity to consent to the research, either initially, or at some point during the course of the study. If some or all subjects may have a diminished capacity to consent, the investigator must further determine if the potential impairment is temporary (e.g., 'shock' at the discovery of a medical diagnosis, intoxication), permanent (e.g., severe mental retardation), progressive (e.g., Alzheimer's dementia) or fluctuating (e.g., bipolar disorder).

F. If a study proposes to include a subject population where all or some of the individuals will lack the capacity to consent…

…CORIHS will first make a determination of the risk/benefit category. As addressed above, in order to be considered for inclusion of this population, the study must involve either minimal risk, or more than minimal risk with the possibility of direct benefit.

If the study can include this subject population, the committee will next make the determination of whether or not a formal attestation/documentation of capacity assessment by an MD or a mental health professional is required for each subject.

An independent assessment of capacity (i.e., by an MD or mental health professional not associated with the study who has familiarity with capacity to consent issues in human subjects research) may be required in instances where, e.g., the research involves more than minimal risk, or the research team does not include a physician or mental health professional who could be called upon to make the formal assessment. The above determinations will take into account the psychiatric, medical, and emotional status of the subject population, as well as the inherent risk/benefit ratio of the study design.

If CORIHS requires such formal documentation of a subject's capacity, the following statement is added to the end of the consent form:

"My signature below attests to the fact that I am a physician or mental health professional and I have interviewed (name of patient) on _______(date). I have determined that s/he does_____ does not_____ have the capacity to consent to participation in this research activity, in that s/he is____ is not____ capable of appreciating a) that the activity described in this consent document constitutes research, not standard treatment, b) the risks and benefits of this study c) the alternatives that are available if s/he chooses not to participate, and d) that the decision to not participate will be accepted without penalty, i.e., without jeopardizing his/her clinical care."

G. Who can provide consent for a patient to participate in a research study if the patient is incapable of doing so?

Reminder: such patients can only be enrolled in minimal risk research, or more than minimal risk research where direct benefit is possible.

1. Individuals who may consent on behalf of the patient include:
• a legally authorized/legally empowered representative

or

• an individual who is designated as a representative/agent through a health care proxy signed by both the subject and the appointed representative/agent. For a health care proxy to be effective, it must have been signed at a time when the subject had decision making capacity, and it must not specifically prohibit research.


2. For studies in which the patient is able to provide initial consent, but may lose the capacity to decide whether to continue or withdraw consent during the study as a result of disease progression (e.g., Alzheimer's disease), CORIHS recommends that the formal designation of a surrogate (via execution of the document presented in #1 above) be discussed with the subject early on in the research activity.



3. Individuals who consent on behalf of a patient should be informed that they must make the decision for or against participation based on 'substituted judgment', reflecting views that the potential subject expressed while capable of making their own decision. If the views are not known, the decision should be based on what is believed to be in the best interests of the subject.



4. Individuals who consent on behalf of a patient should receive education about the importance of their role, the study, the health status of the patient, the rights to refuse to participate or to withdraw consent at any time without penalty. This person should be taken through the entire consent process, as described earlier in this section.



5. Assent from the patient should be obtained whenever possible. No subject should ever be enrolled or continued in a research activity against their will.



6. Further, if an individual consents on the subject's behalf, the subject's capacity should be routinely assessed throughout the study (as reasonable with respect to the subject's disease state or disorder). If the subject regains the capacity to consent, s/he should be presented with the information about the study, as in the initial consent process, and be given the opportunity to decide to continue or withdraw from the study.

H. Conclusion

Obtaining ethically valid consent from all subjects in clinical studies is essential to the research program at SBU. CORIHS hopes that this section will be of assistance to investigators in developing new protocols, and in assuring that current research activities provide maximal protection of human subjects.

Return to Human Subjects Research at SBU

Last Updated: 2007-11-06