The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46.
The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study.
The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject. Thus, the information must be conveyed in language understandable to those being asked to participate as subjects in the research (45 CFR 46.116).
Please utilize the consent form templates below. The templates are required for use in research in which you are consenting participants. We will not accept consent forms that do not utilize these templates. If you are seeking to utilize the Information Sheet please attach the Documentation of Consent form below. Please also utilize the guideline for how to use the information sheet to help you to determine if your study qualifies for use. Additionally, if you are collecting any health related information you must submit a subject’s PHI authorization form or request a waiver by submitting the Waiver of PHI authorization form.
For an FAQ on Informed Consent from OHRP, visit this site: http://answers.hhs.gov/ohrp/categories/1566