Explanation of Procedures
The following information must be included in the Explanation of Procedures section of the consent form:
- A description of the study design and, where appropriate, method of subject assignment to groups (for example, randomization).
- A sequential description of each procedure to be applied to the subjects, and how often it will be performed. All procedures, both experimental and non-experimental, must be described. Procedures that are experimental and/or performed for the research purposes only should be identified as such. For example, the subject will undergo routine physical rehabilitation for a knee injury and a CT scan will be performed for research purposes. The physical rehabilitation must be described as normal prescribed therapy, and the CT scan must be identified as a procedure performed for research purposes. For some research projects, it may be appropriate to identify the individual(s) who will perform the procedures and/or interact with the subject.
- A statement where the research will be conducted, when the research will be conducted, and how much time (include per session and/or total time) will be required of the subject.
- A statement concerning any medications, foods, or other substances that are not allowed either before or during participation in the study.
- If the research study involves incomplete disclosure or deception, all subjects must be debriefed as soon as possible after participation. The consent form for non-disclosure/deception studies should contain a statement concerning when and where the debriefing session will be held.
- The Explanation of Procedures section should not contain detailed instructions to the subject that do not have an impact on the consent process. Detailed instructions, where necessary, should be placed in a separate handout.
Explanation of Procedures
