Informed Consent Information

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 participant and an investigator, beginning with the initial approach of an investigator to the potential participant (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. A participant’s consent must be given freely, without coercion, and based on a clear understanding of participation, including risks and benefits. Therefore, the information must be conveyed in language understandable to those being asked to participate as subjects in the research (45 CFR 46.116).

The informed consent process must be approved by the IRB, should provide a clear definition of where the standard of care ends and research begins, and must allow for re-education provided to participants in a timely manner.

Every study personnel member who will be conducting the informed consent process should be included in the IRB application and trained appropriately.

Consenting instrument templates may ONLY be used for approved IRB studies.

The consent document or script must contain the following elements:

  • a statement that the study involves research
  • an explanation of the purpose of the research
  • an explanation of the expected duration of the subjects’ participation
  • a description of the procedures to be followed and if any are experimental
  • a description of potential risks and benefits
  • a description of treatment available if physical injury or psychological stress is experienced
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • an explanation of how to contact the research team
  • an explanation of how to contact someone outside the research team (the IRB)
  • a statement of participation is voluntary
  • a statement that refusal to participate will involve no penalty
  • a statement that the subject may discontinue participation at any time

 

Consent templates are available as a starting point for drafting the informed consent form to be submitted to the IRB for review. The templates include all required elements of informed consent. If you are requesting to utilize the Information Sheet, use the Waiver of Documentation of Consent. Guidelines are available for how to use the information sheet to help determine if the study qualifies for use.

If any health related information will be collected, a PHI authorization form or a Waiver of PHI authorization will be required.

 

Consenting instrument templates, including information about studies involving children, are available at the above links. The templates may not be used unless the study is approved by the IRB.  Template language requires modification appropriate to the study.  Additional elements may be needed depending on the study.

For an FAQ on Informed Consent from OHRP, visit this site: http://answers.hhs.gov/ohrp/categories/1566