Informed Consent

Potential participants in research must be provided with complete information about what the experiment entails, including risks, benefits and alternatives to participation. They must understand this information; and they must be free to decide whether or not to voluntarily participate.

Obtaining the permission of an individual to participate in research is a carefully applied process and not simply the securing of a signature on the informed consent document.

Research participants generally should:

• Be told the study involves research.
• Be told the purposes of the research.
• Be told they can voluntarily participate in the research study, can decline to participate, and can withdraw at any time for any reason after the study has started without penalty.
• Be told about all the risks, side effects or discomforts that might be reasonably expected.
• Be told of any benefits to themselves and others that can be reasonably expected.
• Be told the study's duration, what would happen in the study and whether any procedures, drugs or devices will be used that are different from thoses that are used as standard medical treatment.
• Be told about appropriate alternative treatments that might be advantageous to the subject.
• Be allowed to ask any questions about the study before giving consent and at any time during the course of the study.
• Be allowed ample time, without pressure, to decide whether to consent or not to consent to participate.
• Receive a signed and dated copy of the informed consent form
• Be told how to contact the IRB with any concerns.
• Be told of any treatments or compensation available if complications occur during the study.
• Be told what patient health information will be used in the research, the risk to the participant’s privacy and confidentiality, an expiration date for the participant’s authorization to use this information, and how to revoke authorization.

(Adapted from Informed Consent: The Consumer’s Guide To The Risks And Benefits Of Volunteering For Clinical Trials, Kenneth Getz and Deborah Borfitz)