Informed Consent in Exempt Level Research

Voluntary informed consent must be obtained from participants prior to data collection for any exempt research where the investigator will be collecting data through interaction with the participant.

Minimum Consent Information

  1. The identity and affiliation of the researcher.
  2. A clear description of the study procedures and how data will be used.
  3. A statement that this is a research study and that participation is voluntary.
  4. Contact information for questions about the research.
  5. The CPHS protocol ID number.

In some cases, researchers may find it necessary or appropriate to provide more information. For guidance on additional informed consent elements and template language, refer to our Informed Consent webpage, which includes information on the use of a Media Release form, if applicable.

**Note that the Office for Protection of Human Subjects does not review consent materials for exempt research determinations.

Additional Considerations

Investigators should seek consent under circumstances that minimize the possibility of coercion or undue influence and the information that is given should be in language that is understandable to the subject or representative. Additionally, the prospective subject should be given adequate opportunity to consider the information presented and ask any questions or express any concerns.

It is important to note that informed consent is a process that continues throughout the course of a study. The initial part of this process begins with recruitment, when the initial contact is made with a prospective subject. While OPHS also does not review recruitment materials for exempt research, investigators should still consider the following when recruiting and subsequently consenting subjects. (See the CPHS Guidelines on Recruitment.)

  1. Respect for Privacy
  2. Vulnerable Subjects
  3. Cultural considerations
  4. Conflicting roles

Where to address informed consent in eProtocol

The Study Procedures section, Part 4a of the exempt application, must briefly describe the recruitment and informed consent process.

Related information