Elements of Informed Consent
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.
Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.