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Informed Consent



"Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. It is too often forgotten that informed consent is an ongoing process, not a piece of paper or a discrete moment in time. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate. This assurance protects all parties: both the subject, whose autonomy is respected, and the investigator, who otherwise faces legal hazards." [Source: http://ohrp.osophs.dhhs.gov/irb/irb_chapter3.htm]

You must explain your project to potential participants in simple, everyday language so they can understand what will happen to them plus the risks and benefits they might expect. Your explanation can be given either orally or in writing. In either case, you must supply, as part of your review materials, a copy of either the script of what you will say or the written explanation.

Circumstances in which a Written Consent Form May Not Be Required
There are some situations where a written consent form may not be required:

  1. If the principal risks are those associated with a breach of confidentiality concerning the subject’s participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior);

  2. If the consent document is the only record linking the subject with the research; or

  3. If the research presents no more than minimal risk and involves procedures that do not require written consent when they are performed outside of a research setting.

If there is no written consent form, an oral or written presentation of the research should be provided to the subjects by the investigator. A copy of the presentation must be provided to the IRB along with a description of how the participants will receive the presentation and how their consent will be recorded.Please note that most of these exceptions are designed to maintain confidentiality. The investigator must create and follow procedures that ensure confidentiality even when written consent is not required.