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.