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:
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.
For more information, go to http://www.tufts.edu/central/research/IRB/main.htm.