Elements of Informed Consent
July 1, 2002 less than 1 minute read
Elements of Informed Consent
From the Code of Federal Regulations Title 21, Section 50.25
Basic Elements of Informed Consent
- Statement explaining the purpose of the research, the procedures to be followed, the duration of participation and any investigational treatments or procedures
- Description of foreseeable risks and discomforts to volunteers
- Description of benefits that the volunteer can reasonably expect
- Disclosure of any alternative treatments or procedures that might be advantageous to volunteers
- Statement about how volunteer confidentiality will be maintained
- Explanation of compensation and whether medical treatments are available if injury occurs
- List of contacts to answer study-related questions and to help with research-related injuries
- Statement that participation is voluntary and that there is no penalty or loss of benefits for refusing to participate
Additional Elements on Informed Consent Forms When Appropriate
- Statement of unforeseeable risks to the volunteer, embryo or fetus — if the volunteer is or may become pregnant
- List of anticipated circumstances under which the investigator may terminate a volunteer’s participation
- Description of additional costs to the volunteer
- Explanation of the consequences and procedures if a volunteer decides to withdraw
- Statement about informing volunteers of significant new findings that might affect their willingness to participate
- Description of the number of volunteers participating in the study
Source: CenterWatch. Informed Consent: The Consumer’s Guide to the Risks and Benefits of Volunteering for Clinical Trials. Boston; 2002. For more information, visit CenterWatch on the web at www.centerwatch.com. Reprinted with permission.
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