November 2005, Issue 5

Informed Consent: A Process Not Just a Piece of Paper

As with many laws, those governing informed consent were demanded after an appalling misuse of power and an affront to civilization. During World War II Nazi doctors performed unethical experiments on human subjects. The Nuremberg code that arose from the trials of these doctors was the first major international set of laws for human subjects research. In the United States during the 1950s and 1960s there were also research studies that raised scientific and ethical concerns because they exceeded the boundaries of human decency. The concerns raised were addressed in the Belmont Report. While the Nuremberg code embodies the spirit of the laws that are in effect today in the United States, they are implemented in the Belmont Report, which sets forth three principles for the ethical conduct of human subjects research:

1. Respect for persons: recognition of the autonomy and dignity of individuals and the need to protect those with diminished autonomy or impaired decision-making skills (for example, children, aged subjects, or disabled subjects);

2. Beneficence: an obligation to protect persons from harm by maximizing benefits and minimizing risks; and

3. Justice: fair distribution of the benefits and burdens of research.

The Belmont Report identified informed consent as the foundation of the principle of respect for persons. The process of informed consent includes the construction of the consent form and the circumstances surrounding the presentation of the request for consent to the prospective subject — the who, what, when, where, and why of the presentation. While due consideration must be given to the content of the written consent form, equally important is the process by which informed consent is obtained.

Informed Consent Form

The informed consent form must contain all the information necessary to enable a person to voluntarily decide whether or not to participate as a research subject. The Office of Human Research Protection (OHRP, a division of the US Department of Health and Human Services) provides the following guidelines on informed consent:

  • Language: The consent form must be written in lay language (i.e., understandable to the people being asked to participate). If the subject does not read English, a certified translation into the subject’s native language must be used.
  • Content: Describe the study's purpose, duration, experimental procedures, alternatives, risks, and benefits. Describe the overall experience that will be encountered and any alternatives to participating in the research project, such as receiving the study medication through a clinic without the need to volunteer for the research activity. For more on what to include in the form, please see Informed Consent. You only need to include those items that pertain to your research. Two pages is an appropriate length for most consent forms in social, behavioral and educational research.
  • Written or oral consent: While written informed consent is normally mandated, oral consent may be necessary when subjects are illiterate or frightened to put their name down on a piece of paper. See Request for Waiver of Consent. Oral consent consists of two parts:
    • A short-form written consent that states that the elements of informed consent have been presented orally to the subject or the subject's legally authorized representative. The short form must be signed by the subject or the representative and by a witness. If the subject is unable to sign, he or she can use a thumbprint or other recognized “signature.”
    • A summary, approved by the Tufts Institutional Review Board (IRB), of what is said to the subject, signed by the witness and by the research spokesperson obtaining consent. A copy of the summary is given to the subject or the representative, in addition to a copy of the short form.

When oral consent is used with subjects who do not speak English, (i) the oral presentation and the short-form written document should be in a language understandable by the subject; (ii) the IRB-approved English language informed consent document may be used as the summary with a certified translation from English to the other language; and (iii) the witness should be fluent in both English and the language of the subject.

The IRB may waive the informed consent requirement if 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; or if the 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.

Circumstances Surrounding the Request for Consent

The request for consent must be presented to the prospective subject in a manner that protects the subject from any form of coercion and gives the subject the information necessary to make an informed decision, as well as the time and resources needed to make the decision. There must be an appropriate separation between the request and the consent to insure that consent is informed and given freely. It is important for the PI to think through the ramifications of who may be present at the request. The presence of certain people, such as government representatives, may put pressure on the prospective subject to consent. Research spokespersons requesting consent should look for signs of confusion on the faces of prospective subjects, so they can explain anything that may not be understood. The prospective subject should understand what they are consenting to, when they will need to be available for follow-up, and why the research is being conducted. If privacy is an issue, where the request is carried out is also important.

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