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Part 3 – Informed Consent

  1. How variable is your subject population’s ability to comprehend the study?
  2. Who will be allowed to explain the information? Is the duty delegated in writing?
  3. Is the consent document understandable to your postal worker, grocery clerk, and elementary school teacher?
  4. Is the agreement to continue re-confirmed at regular intervals?

 

Definition

A concise definition of informed consent is found in Principle One of the Nuremberg Code.

Informed consent is absolutely essential. "This means that the person involved

  • should have legal capacity to give consent;
  • should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and
  • should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision."

 

Compliance with the third part of the definition requires that the subject know:

  • The nature, duration, and purpose of the experiment;
  • The method and means by which it is to be conducted;
  • All inconveniences and hazards reasonably to be expected; and,
  • The effects upon his health or person which may possibly come from participation in the experiment.

An IRB must consider both the consent process and the consent document. By their nature, however, IRBs can evaluate only the capabilities of the representative person (or range of people) in the target population. It is the investigator or his or her designee who must evaluate the consent of the individual. Each individual who initiates, directs or engages in the research has the duty and responsibility for ascertaining the quality of the informed consent.

Questions that IRBs ask in general -- and that researchers must answer for each individual participant-- might occur to anyone seeking the informed agreement of another. Consider a person asking another for consent to a marriage or to a gene therapy study.

  • Is this potential subject autonomous? Is he or she capable of making decisions both legally and mentally?
  • Is the person in a position to exercise that autonomy? Although force or fraud are rare, pressures exist – both due and undue – that may not be immediately recognized by the study team.
  • Is a person dependent on a care-giver or an institution that would make refusal difficult or that would contribute to the "therapeutic misperception."
  • Are time, resources or people available to assist the person in making an enlightened decision? Is time available? Is the person encouraged to talk the question over with a spouse or important advisor?
Informed Consent Requirements
Informed consent is a process. When one person suggests participation in a study to another person, the first person generally has something specific in mind and the second is in their hands.
  • Capability and Capacity of person consenting
    People who lack the capacity to consent are considered to be a vulnerable population and provisions must be made to ensure level of understanding to make informed decisions and protect them from risk.

    Mental capability can develop independently of age and can diminish later. Capacity is much more difficult to measure than a person’s age. Each person should be evaluated by the investigator or his/her designee in accord with the nature and risks of the study.

    Emotional capacity can change instantly. A normally functioning adult can, with disastrous news, become emotionally disabled. The duration of that disability varies. Requesting a person’s consent immediately after a terminal diagnosis is inadvisable. If attempted, it should be followed with substantial assistance.
  • Autonomy of person consenting:
    The Nuremberg Code made it clear that the consenting person, "should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion. . ."

    A person without options has no choice. A person grasping for any available treatment – experimental or not – will take incredible risks. Many constraints are known only to the potential subjects. A choice between paying for an expensive drug or taking a chance on receipt of a placebo plus monitoring for free may be no choice at all.
  • The Information Element:
    The written word is required but may be the worst possible method to convey information for many people. Use of pictures, diagrams, videos or demonstrations is encouraged.

    The transmittal of information begins far before the consent form is introduced. Advertising, magazine articles, word-of-mouth, and the internet provide information either placed (and controlled) by the investigator or the sponsor, or from someone else (uncontrolled).

    ALL recruitment materials from the investigator, sponsor, research base or others targeting subjects for an NGHS IRB approved study must be reviewed by the IRB.
  • Basic Elements of Informed Consent :
    • information, oral or written, given to the subject or the representative MUST BE in language understandable to the subject or representative (45 CFR § 46.116)
    • purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental
    • a description of any reasonably foreseeable risks or discomforts to the subject
    • a description of any benefits to the subject or to others which may reasonably be expected from the research
    • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
    • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
    • for research involving more than minimal risk, an explanation as to the availability of medical treatment in the case of research-related injury, including who will pay for the treatment and whether other financial compensation is available
    • an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject
    • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
  • Additional elements of informed consent to be applied, as appropriate:
    • a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable
    • anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent
    • any additional costs to the subject that may result from participation in the research
    • the consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject
    • a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject
    • the approximate number of subjects involved in the study

 

Documentation of Informed Consent (45 CFR § 46.117) 

A. Except as noted in (C) below, informed consent shall be documented by the use of a WRITTEN CONSENT form approved by the IRB and signed and dated by the subject or the subject’s legally authorized representative at the time of consent. A copy of the consent form shall be given to the person signing the form.

B. Translations

  • "Informed consent information should be presented ‘in language understandable to the subject’ and, in most situations, be documented in writing".
  • An oral presentation of informed consent to non-English speaking participants is permitted as long as:
    • The witness/translator is fluent in both English and the language of the participant;
    • A written summary of what is presented orally is prepared (i.e., the IRB-approved English language informed consent document). At the time of consent, the person obtaining the consent and the witness/translator signs the summary.
    • The NGHS IRB approved short form written consent document (stating that the elements of consent have been presented orally) is in a language understandable to the participant. At the time of consent, the short form should be signed by the participant and the witness/translator.
    • A copy of the summary shall be given to the subject or representative, in addition to a copy of the short form.
  • The IRB must receive all foreign language versions of the short form document as a condition of approval. Expedited review of these versions is acceptable if the protocol, the full English language informed consent document, and the English version of the short form document have already been approved by the convened IRB.
  • The investigator should present plans to support continued consent in the participant’s primary language.

C. The IRB may waive the requirement for the investigator to obtain asigned consent form for some or all subjects if it finds either that the:

  • Only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality
    •  
    • in this instance, each subject should be asked whether they want documentation linking them with the research, and the subject’s wishes shall govern
  • Research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Waiver from the Entire Consent Process

The several kinds of consent waivers are often mixed together generating confusion. This is one area in which the DHHS and the FDA differ considerably.

The following are the rules of both DHHS and the FDA. They are structured differently making direct comparison difficult.

§46.116 General Requirements for Informed Consent

§ 50.23 Exception from general requirements

c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consentprovided the IRB finds and documents that:

1) The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine:

i) Public benefit of service programs;

ii) Procedures for obtaining benefits or services under those programs;

iii) Possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under these programs; and

iv) The research could not practicably be carried out without the waiver or alternative.

 

a) The obtaining of informed consent shall be deemed feasible unless, before use of the test article (except as provided in paragraph (b) of this section), both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following:

1) The human subject is confronted by a life-threatening situation necessitating the use of the test article.

2) Informed consent cannot be obtained from the subject because of an inability to communicate with or obtain legally effective consent from the subject.

3) Time is not sufficient to obtain consent from the subject’s legal representative

4) There is no available alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject.

 

d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

i) The research involves no more than minimal risk to the subjects.

ii) The waiver or alternative will not adversely affect the rights and welfare of the subjects;

iii) The research could not practicably be carried out without the waiver or alternation and

iv) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

 

b) If immediate use of the test article is, in the investigator’s opinion, required to preserve the life of the subject, and time is not sufficient to obtain the independent determination required in paragraph (a) of this section in advance of using the test article, the determinations of the clinical investigator shall be made and, within 5 working days after the use of the article, be reviewed and evaluated in writing by a physician who is not participating in the clinical investigation.

c) The documentation required in paragraph (a) or (b) of this section shall be submitted to the IRB within 5 working days after the use of the test article.
 



Waiver of Consent for Studies of Emergency Situations

Both sets of regulations allow for the IRB to approve a study involving a situation in which few, if any, of the subjects will be capable of giving consent and in which a legally authorized representative is not known. These regulations are complex and demanding. Any NGHS investigator considering such a study should contact the IRB office as early as possible

     Example: A study of a resuscitation device in conditions in which the subject is unconscious and no next of kin is available within a set window of time.

Please Note: Medical care may "require" use of an investigational drug, a drug that is not available on the market for any indication. The use of the investigational drug is not research (there is no systematic investigation or FDA submission). Data may not be used within any report of results for DHHS but is required within FDA safety reporting.

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