Informed Consent

 

"Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness."

(Belmont Report, 1979)

Along with assessing the risk presented to human subjects, the IRB is especially concerned with ensuring that every research study implements an appropriate informed consent process. As outlined in the Belmont Report, the purpose of informed consent is to (a) provide potential participants with information about the study so they they can make an informed decision about whether or not to participate and (b) to provide enrolled research subjects with ongoing information so that they can decide to continue their participation. In order for an individual's decision to participate, or to continue their participation, in a research study to be meaningful, he/she must be able to (a) understand the information that is presented and (b) understand that his/her participation is completely voluntary and may be ended at any time.

It is important to understand that informed consent does not just refer to a piece of paper that a research subject signs. Rather, it refers to a process—which may be one time, or may be ongoing, depending on the research—through which the research subject affirms their informed and voluntary decision to participate in the research. When describing the informed consent process of your study, do not simply refer to the informed consent document—describe the setting in which consent will be obtained, who will be obtaining consent from the subjects, and whether there will be any ongoing reminders for subjects about the nature of their participation and ability to withdraw from the study at any time.

 

Required Elements of Informed Consent

The federal regulations (45 CFR 46.116) provide clear guidance on what information must be provided to human research subjects as part of the informed consent process:

 

  • a statement that the study involves research;
  • an explanation of the purposes of the research;
  • the expected duration of the subject's participation;
  • a description of the procedures to be followed;
  • 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 whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained;
  • 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; and
  • 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.

 

In addition, the following information also should be provided, if 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; and
  • the approximate number of subjects involved in the study.

 

If the study is a clinical investigation of a medical device or drug, the following statement must also be included on the informed consent document:

 

A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.

 

In addition, as part of ongoing compliance efforts, the Food and Drug Administration may inspect the records pertaining to this study.  FDA auditors maintain strict confidentiality of all records reviewed.

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Altering or Waiving Informed Consent Requirements

There are certain circumstances in which an investigator may deem it necessary to not provide one or more of the requirement elements of consent (above) to a research subject. However, the IRB may only approve a waiver of alteration of the informed consent requirements if the investigator demonstrates that all of the following are true:

 

  • the research involves no more than minimal risk to the subjects;
  • the waiver or alteration will not adversely affect the rights and welfare of the subjects;
  • the research could not practicably be carried out without the waiver or alteration; and
  • whenever appropriate, the subjects will be provided with additional pertinent information after participation (45 CFR 46.116(d)).

 

For clinical investigations involving drugs or medical devices, a waiver of alteration may only be approved in accordance with 21 CFR 50.23 (i.e., circumstances are life-threatening; informed consent cannot be obtained from the subject; time is not sufficient to obtain consent from the subject's legal representative; no alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the life of the subject) or 21 CFR 50.24 (i.e., emergency research).

If you believe that your research meets the requirements for waiving or altering the consent requirements, please submit the Request to Alter or Waive Informed Consent form with your research proposal.

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Documentation of Informed Consent

In general, investigators are required to document that research subjects gave their consent to participate by obtaining a signed copy of an informed consent document.

However, there are certain circumstances in which it is permissible for the investigator to not obtain documentation of the subject's decision to participate (45 CFR 46.117 or 21 CFR 56.109). If you believe that your research meets the requirements for waiving the requirement to document consent, please submit the Request to Alter or Waive Informed Consent form with your research proposal.

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.

A common situation in which the documentation requirement is waived is with online survey research. For this type of research, a "signed" consent document would likely be the only individually identifiable information that the subject would provide to the investigator. In these cases, a process in which the subject is provided with information about the study and must agree to the terms of participation in order to access the survey questions is most appropriate.

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Permission and Assent

Consent applies only to individuals deemed legally able to act independently in their own interests. Assent is similar in that researchers aim to ensure that the preferences of individuals are honored with regard to their participation in a research study. For non-autonomous participants, permission from a parent or guardian is required, but even if permission is obtained, it is common to not compel that person into participating as a subject unless s/he also agrees (assents).


So, for autonomous individuals, informed consent is obtained. For non-autonomous individuals, researchers first obtain informed permission from the parent or guardian and then informed assent from the potential participant.

Obtaining assent is not legally binding but should be done to demonstrate respect to the individual. The following is targeted at child participants but offers important guidance for any participant not legally capable of granting consent.

 

  • Take the time to explain to a child, at whatever age they can begin to understand, at an appropriate level of complexity, what is going on in the proposed study, why the study is being done, what will be done to them, and, that if they object, the activity will be terminated and that they will not be punished or scolded. As children develop, they gradually become the primary decision-makers for themselves. Obtaining assent can be viewed as a part of this development and should be an interactive process in which information and values are shared and joint decisions are made.
  • When participants are not legally able to grant consent, a guardian/parental permission form shall be developed and used (not a consent form). It will contain the same content as standard consent forms.
  • The child should be given an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. This explanation should include a discussion of any discomforts and inconveniences the child may experience if s/he agrees to participate.
  • Unless formally waived by the IRB, child assent and parent permission must be obtained for each participating minor.
  • For pre-reading children, a simple oral explanation of the study shall be offered to the child before any study-related procedures are conducted (provide the IRB with a script of this).
  • For elementary school-aged children able to read independently, informed voluntary assent should be obtained without pressure from parents or investigators. An appropriate assent form may be used; if so, include it in the IRB proposal.
  • For middle school-aged children and older, a separate assent form to read and sign should be utilized. The assent form should be written as simply as possible and cover the following points:
 
  • what the study is about;
 
  • why s/he qualifies for the study;
 
  • the procedures that will be done;
 
  • the potential benefits and the potential risks;
 
  • the voluntary nature of the study;
 
  • an assurance that s/he may withdraw from the study after discussing it (or not) with parents/guardians;
 
  • an assurance that s/he will be treated the same whether or not s/he agrees to join the study; and
 
  • an invitation to ask questions.

 

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Use of IRB Informed Consent Templates

In order to help investigators ensure that all required elements of consent are included in their consent documents, the IRB has developed informed consent, permission, and assent templates. Using these templates also aids the IRB in reviewing your consent documentation as it is easy for reviewers to determine if all required information is present.

However, you are not required to use the IRB templates. If you choose to create your own informed consent forms, please do not also submit the IRB template as part of your proposal. The IRB only needs to review the exact documentation that the subject will be provided.

If you do choose to create your own consent form, it must include all requirement elements of consent, unless you are requesting to alter or waive those requirements.

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