IRB Manual
      4.5 Consent Procedures and Assessment of Capacity
   

Participation as a subject in any research project or activity shall not deprive any patient of any of the rights, privileges and protections provided to all patients. Included in these rights is the right to consent or withhold consent for proposed research, or to have a surrogate consent or withhold consent for a research involving an incapacitated person.

   
Capacity: To participate in research, a person must have sufficient capacity to make an informed decision. When there is reason to believe that some or all of the proposed subjects may lack capacity, the investigator must fully explain the capacity assessment process to the IRB. Investigators must be confident that any person, including a "normal volunteer," giving consent to participation in a research project has sufficient capacity to give that consent.

   

A person admitted to a facility, whether on a voluntary or involuntary basis, should not be assumed to lack the capacity to consent to research participation. Moreover, a person found incompetent by a court (e.g. incompetent to stand trial, had a guardian appointed), should not be assumed to lack the capacity to consent to participation unless the court ruling addressed such abilities. (If a person with a guardian is found to have sufficient capacity to consent to research participation, and does so, the guardian or committee should be notified.)


Capacity must be assessed in relation to a specific situation. Different research studies will require different levels of capacity. A person may have the capacity to consent to some protocols but not to others and capacity may also change over time.


A person's capacity may be increased by adapting the manner in which information about the study is provided. This may mean extending the consent process to allow the essential elements to be broken down into simpler components. Alternatively, it may be necessary to use different methods to inform some participants. For example, potential subjects could be shown equipment that will be used in addition to oral and written descriptions. Respect for the autonomy of individuals requires that investigators expend the time and effort to provide research participants with adequate information in a manner that maximizes understanding.


No patient, regardless of capacity or lack of capacity shall participate in research over his/her objection.


After reviewing the nature of the research, the qualifications and experience of the members of the research team, and the prospective subject population, the IRB may decide that assessments of capacity should also be made by a person or persons in addition to the person who will be obtaining the patient's consent. The IRB may require that the assessment of capacity be made by a specific person, or set minimum qualifications and other characteristics. For example, any combination of the following may be required by the IRB (this is not a complete list):

    - Not affiliated with the research
- Not affiliated with the institution*
- A specific professional qualification, eg. Licensed clinical psychologist or psychiatrist.
- A member of the treatment team.
- Specific member(s) of the research team.

   
*Outside consultants who are brought in to evaluate a patient's capacity to consent to participation are covered by the provisions of Section 7.35 of the Mental Hygiene Law (Actions against persons rendering professional services at the request of the office: defense and indemnification) and are covered by the provisions of the Public Officers Law (See Section 2.2 ).

   
The person authorized to assess the patient's capacity by the IRB must document his/her decision. The documentation may consist of a separate note in the patient's medical record or a section of the consent form which is then filed in the medical record. The documentation should contain the following elements:

   

"I examined __(name)________ on __(date)_______ for the purpose of determining whether he/she is capable of understanding the purpose, nature, risks, benefits and alternatives (including non-participation) of the research, making a decision about participation, and understanding that the decision about participation in the research will involve no penalty or loss of benefits to which the patient is otherwise entitled, for Dr. __(name)______'s research project __(title of project)__. On the basis of this examination I have arrived at the conclusion that:

(a) this patient has this capacity at this time [ ]
or (b) there is a doubt about this patient's capacity at this time [ ]
or (c) this patient clearly lacks this capacity at this time." [ ]

_________________________          _________________________          __________

Signature                                        Name Printed                                  Date

   


If the person(s) making the initial assessment of capacity is unable to make a determination of capacity or lack of capacity he/they shall report this to the IRB which shall designate another appropriate person to examine the patient. Based on the report of both assessments, the Clinical Director shall make a determination of the patient's capacity to consent to participation and shall document this decision in the patient's medical record.

   
Treatment team approval (OMH Facilities): Patients may only participate in research which does not come into substantial conflict with their individual service plans. Except for persons who are admitted to a facility for the specific purpose of participating in a research protocol, participation in research which involves more than minimal risk (as determined by the IRB) must be reviewed by the patient's treatment team. The team must determine whether the research comes into substantial conflict with the patient's individual service plan. This decision shall be made using the processes and procedures established by the facility for treatment team decisions. The decision of the treatment team must be documented in the patient's chart by a psychiatrist, clinical psychologist, nurse or social worker who is a member of that treatment team. It is acceptable to document this decision in an attachment to the consent form, which is then filed in the patient's chart.

4.5.1 OMH Inclusion of Subjects Who Lack the Capacity to Consent
   
Conditions for Approving the Inclusion of Patients Who Lack the Capacity to Consent (OMH Facilities)
   

The IRB must specifically review the inclusion of incapable subjects in any research protocol. As part of the justification provided by the investigator he/she must demonstrate the necessity of involving incapable subjects.


Surrogate Consent (Legally Authorized Representative) 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 Surrogates
 
(1)   
A psychiatrist or licensed clinical psychologist who is independent of the research must assess the patient's capacity to designate a surrogate.

 
(2)   
The document designating the research surrogate must be witnessed by two persons who are independent of the research. The psychiatrist or licensed clinical psychologist who assesses the patient's capacity to choose a surrogate may also be a witness to the choice of a surrogate.

 
(3)   
If the patient chooses a surrogate but is unable to sign the document another person may sign for the patient and the two witnesses shall, in writing, confirm the patient's choice of a surrogate and witness the signature of the person signing for the patient.

 
(4)   
The surrogate can not function as a witness to the choice of surrogate. A family member or friend of the patient who is not the surrogate may function as a witness.

 
(5)   
The surrogate can not be an administrator or employee of the facility at which the research is conducted or the facility conducting the research. This restriction does not apply if the person is related to the patient by blood, marriage or adoption. 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.

 
(6)   
Notice of the appointment of a surrogate must be provided to Mental Hygiene Legal Services (MHLS)  before the patient's participation commences.

 
(7)   

Documentation must include:
Documentation of Lack of Capacity
Record of Choice of Surrogate
Assessment of Capacity to Choose a Surrogate
Witness Documentation Choice of Surrogate
Letter to MHLS


   

Health Care Proxy

A person appointed under a health care proxy which specifies that the proxy has the authority to consent to therapeutic research may provide consent to therapeutic research. In order for the patient to participate in non-therapeutic research the health care proxy must specifically authorize the surrogate to consent to more than minimal risk non-therapeutic research.

Documentation must include:
Health Care Proxy Form
Documentation of Lack of Capacity (for more than minimal risk research, determination must be made by  an independent licensed MD or PhD)


   

MHL Article 81 Guardian

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.

Documentation must include:
Proof of guardianship
Documentation  Lack of Capacity (for more than minimal risk research, determination must be made by  an independent licensed MD or PhD)


   

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.

Documentation must include:
Determination of Lack of Capacity (for more than minimal risk research, determination must be made by  an independent licensed MD or PhD)
Court Order

     
4.5.2 OMH Facilities - Consent, Assent and Objection: Minors*
   
*A patient, under the age of 18, who is on voluntary status on his own application, or who is married or the parent of a child shall be considered an adult.

    Consent (OMH Facilities)
   
Consent to participation of a minor in research shall be obtained from a parent or legal guardian. If no parent or legal guardian is available consent may be obtained from an adult family member who is involved in making treatment decisions for the minor, or from a court of competent jurisdiction. (See Section 7.3 for additional federal requirements for research involving minors).

If the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the patients (for example, neglected or abused children), it may waive the requirement for the consent of the parent(s) or guardian provided that an appropriate mechanism for protecting the minors who will participate as subjects in the research is substituted. Waivers and the specific protective mechanisms must be specifically approved by the Commissioner. In most instances, this protective mechanism will involve an adult who is familiar to the subject, but is not associated with the research, agreeing to act in an advisory and advocacy role for the minor. A letter of agreement to serve this function should be obtained.

    Assent (OMH Facilities)
   
The assent of minors must be obtained in a manner approved by the IRB. When practicable the assent should be in writing. IRBs should review written assent documents and ensure that minors are provided with as much information as they are capable of understanding, in language appropriate to their age and abilities. The requirement to obtain the assent of a minor may be waived by the IRB if the capacity of the child is so limited that he/she cannot be reasonably be consulted. This decision may be made on an individual basis or, if appropriate, it may be made for a category of subjects if their age or other characteristics indicate that, as a group, they uniformly lack sufficient capacity.

    Objection (OMH Facilities)
   
A minor's objection to participation in research must be honored except when a child psychiatrist who is neither employed by the facility nor associated with the research, finds and documents that the intervention or procedure holds out a prospect of direct benefit that is important to the health or well being of the minor and is available only in the context of the research.

If a decision is made to treat a minor patient (with the consent of the person authorized to provide permission on behalf of the minor), in the context of a research project, over the objection of the patient, and the treatment is not emergency treatment, the Mental Hygiene Legal Service shall be notified and the treatment will be delayed for 4 calendar days. If, within that period MHLS files a legal action on behalf of the patient challenging the determination of the independent child psychiatrist, the treatment may be administered 3 calendar days thereafter, unless a court orders otherwise.

    Advocates (OMH Facilities)
   
IRBs should carefully review protocols involving minors to determine whether the potential subjects are capable of clearly expressing their objection to participation or continuing participation. When appropriate, the IRB should require that an advocate (eg. a member of the treatment team) be appointed to observe the research and interpret the behavior of the minor. If the minor's behavior is expressive of objection the advocate should have the responsibility to object to participation on the minor's behalf. The advocate should also encourage the minor to ask questions about the research and support him/her in expressing reservations or declining participation.


4.5.3 OPWDD Facilities - Capacity, Surrogate Consent, Objection and Conditions for Involving Adult Persons as Subjects
   
Participation as a subject in any research project or activity shall not deprive any participant of any of the rights, privileges and protections provided to all other persons in OPWDD facilities. Included in these rights is the right to consent or withhold consent for proposed research, or to have a surrogate consent or withhold consent for a research involving an incapacitated person (except when the specific conditions for a waiver of consent have been met).

No patient, regardless of capacity or lack of capacity shall participate in research over his/her objection unless it is authorized by a court, (because it is necessary treatment), under the conditions described below.

Participants may only participate in research which does not come into substantial conflict with their individual plan of services. Participation in research which involves more than minimal risk (as determined by the IRB) must be reviewed by the participant's program planning team. The team must determine whether the research comes into substantial conflict with the patient's individual plan of services. The determination shall be documented in the plan of services.

Research involving more than minimal risk which takes place in or involves participant(s) from an OPWDD residential or day services facility shall only include participants who have been duly admitted to that facility.

During initial and "continuing reviews" of protocols an IRB must review the consent procedures and documentation and satisfy itself that all of the required elements of consent are incorporated under circumstances that will promote voluntary informed consent.

    Assessment of Capacity (OPWDD Facilities) (Note: all capacity assessments are to be made for specific research projects. A person is likely to have sufficient capacity to consent to some projects but not to others.)

   
For research that involves no more than minimal risk, and with the approval of the chief executive officer, the IRB may permit the researcher to assess the potential subject's capacity to consent. The IRB and/or the CEO may require parties other than the researcher to assess a participant's capacity to consent. If there is a doubt about the participant's capacity (raised during the initial assessment of capacity), an assessment shall be made by the CEO or his or her designee.

For research that involves more than minimal risk, the assessment of a person's capacity to consent shall be made by the program planning team, in consultation with the researcher. If, following this assessment, a doubt exists about the person's capacity the following provisions apply:

 
(1)   
The CEO shall obtain, from a consultant, an independent written opinion and analysis of a person's capacity to give or withhold informed consent. The consultant must be a N.Y. State licensed psychologist or physician, or a psychiatrist holding appropriate licenser in N.Y. State; have experience in treating persons with developmental disabilities; and shall not be an employee of the facility.

 
(2)   
After considering the opinions of the consultant, the program planning team, and the researcher, the CEO shall then determine whether the participant lacks the capacity to consent.

 
(3)   
The opinions of the consultant, the program planning team, and the researcher, together with the CEO's decision shall be documented in the person's clinical record. The CEO's decision shall be communicated to the person and his/her parent, other nearest relative, guardian or correspondent.

    Conditions for Approving the Inclusion of Persons Who Lack the Capacity to Consent (OPWDD Facilities)
   
The IRB must specifically review the inclusion of incapable subjects in any research protocol. As part of the justification provided by the investigator he/she must demonstrate the necessity of involving incapable subjects. If the research involves more than minimal risk and/or invasive procedures the IRB may not approve the inclusion of incapable subjects unless it determines and documents that the project is likely to produce knowledge which has overriding therapeutic importance for the understanding or treatment of a condition presented by the person who will be participating. Concurrence of the CEO is required.

    Surrogate Consent (OPWDD Facilities)
    Note: If a participant has sufficient capacity to consent the decision of the participant shall be honored and consent or objection by a surrogate shall not be considered.

If an adult lacks the capacity to consent to participation consent may be sought from:

 
(1)   
For research that involves more than minimal risk, if a person lacks the capacity to consent to participation, consent may be obtained from a person's court appointed guardian who is legally empowered to consent to research; or an actively involved spouse, parent, adult child or other actively involved family member. Consent shall be sought from the parties on this list in the order stated. If the first available party on this list objects or if no party from the list is available or willing to give consent, application may be made to a court of competent jurisdiction.

 
(2)   
For research that involves no more than minimal risk, if a person lacks the capacity to consent to participation, consent may be obtained from a party listed in the previous section (i.e.,. persons authorized to consent to research involving more than minimal risk). In the absence of a party from this list consent may be obtained from a court of competent jurisdiction or from a party recommended by the IRB and appointed by the facility's governing body for the purpose of acting as a surrogate in the consent process. This party shall have no interest that conflicts with the interest of the person being represented and shall have knowledge and skills that insure adequate representation of the person. The party shall not be associated in any way, (except in this role or as an unaffiliated member of the IRB) with the research, the researcher(s) or the facility.

    No person may provide or withhold consent on behalf of a patient who lacks capacity if it is affirmatively shown that such person (the surrogate) lacks the capacity to make these decisions. The facility shall document a proposed surrogate's lack of such capacity in the participant's medical record.

    Objection (OPWDD Facilities)
   
No capable participant shall become or remain a research subject over the objection of the participant. If a participant objects to participation he/she shall be withdrawn from participation in a manner consistent with good clinical practice. If participation cannot, on clinical grounds, be abruptly discontinued, eg. if drug tapering is necessary to prevent serious withdrawal effects, the participant must be fully informed of the proposed withdrawal procedures.

No incapable participant shall become or remain a research subject over the objection of the participant or of any of the parties authorized to consent on behalf of the participant, except as specified below. Such patient shall be withdrawn from participation in a manner consistent with good clinical practice. If participation cannot, on clinical grounds, be abruptly discontinued, eg. if drug tapering is necessary to prevent serious withdrawal effects, the participant and any objecting surrogate must be fully informed of the proposed withdrawal procedures.

The objection of an incapable participant, or a party authorized to consent on his/her behalf, may be only be overridden if it is specifically authorized by a court of competent jurisdiction. If application is made to a court subsequent to the objection of the participant or one of the authorized surrogates, notice of such application shall be given to the objecting party and to the Mental Hygiene Legal Service. Application to a court shall only be made if it is considered to be in the best interest of the participant.

The intent of this provision is to permit incapable participants to be treated with investigational drugs or devices over their objection when standard therapies are unavailable or a participant has failed to respond to, or cannot tolerate, standard therapy, after meeting the conditions for treatment over objections.

If a party other than the participant or an authorized surrogate objects to the participant's involvement in the research, the procedures contained in 14 NYCRR 633.12 shall apply (procedures for resolving objections to decisions relating to care and treatment).

4.5.4 OPWDD Facilities - Consent, Assent and Objection: Minors*

    (See Section 7.3 for additional federal requirements for research involving minors).
*A patient, under the age of 18, who is on voluntary status on his own application, or who is married or the parent of a child shall be considered an adult.

    Consent (OPWDD Facilities)
    Consent to participation of a minor in research shall be obtained from a parent, legal guardian or actively involved family member. If no parent, legal guardian or actively involved family member is available, consent may be obtained from:

 
(1)   
A party appointed by the facility's governing body for the purpose of acting as a surrogate in the consent process by giving or withholding consent on behalf of a minor. This party shall have no interest that conflicts with the interest of the minor being represented, and shall have knowledge and skills to ensure adequate representation of the minor. The party appointed by the governing body shall not be associated in any way (except in this role or as a non-affiliated member of the IRB) with the research, the researcher(s) or the facility or entity.

or

 
(2)   
A court of competent jurisdiction.

    Assent (OPWDD Facilities)
   
The assent of minors must be obtained in a manner approved by the IRB. When practicable the assent should be in writing. IRBs should review written assent documents and ensure that minors are provided with as much information as they are capable of understanding, in language appropriate to their age and abilities. The requirement to obtain the assent of a minor may be waived by the IRB if the capacity of the child is so limited that he/she cannot be reasonably be consulted. This decision may be made on an individual basis or, if appropriate, it may be made for a category of subjects if their age or other characteristics indicate that, as a group, they uniformly lack sufficient capacity.

    Objection (OPWDD Facilities)
    A minor's objection to participation in research must be honored except when an authorized surrogate consents, and the child's program planning team finds and documents that:

 
(1)   
The intervention or procedure involved in the research is necessary treatment; and

 
(2)   
the intervention or procedure involved in the research is available only in the context of the research; and

 
(3)   
the intervention or procedure holds out a prospect of direct benefit that is important to the health or well-being of the minor.

    Advocates (OPWDD Facilities)
    IRBs should carefully review protocols involving minors to determine whether the potential subjects are capable of clearly expressing their objection to participation or continuing participation. When appropriate, the IRB should require that an advocate (eg. a member of the treatment team) be appointed to observe the research and interpret the behavior of the minor. If the minor's behavior is expressive of objection the advocate should have the responsibility to object to participation on the minor's behalf. The advocate should also encourage the minor to ask questions about the research and support him/her in expressing reservations or declining participation.

   
   
   

     


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