Unless waived by the COUHES, all research involving minors requires both the informed written consent of a parent/guardian, as well as the suitably documented assent of the child, if the child is over 7 years old.
What is commonly referred to as "Passive consent" or “opt-out consent” occurs when a parent or guardian’s consent is assumed unless they communicate otherwise. In limited cases, COUHES may allow passive consent if a study meets the conditions for a waiver or alteration of informed consent.
The passive parental consent procedure may be used in school settings where the following conditions are met:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration;
- If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format; and
- Whenever appropriate, the subjects and parents will be provided with additional pertinent information after participation.
The researcher must explain the reasons why the waiver is essential to the study. Inconvenience and expense are not acceptable factors in making a determination about "practicability."
Some school districts require active parental consent regardless of whether waiver or alteration of consent is appropriate. Researchers should check in with the participating school district(s) prior to the development of a passive consent process.
Additional considerations:
- Develop a sound plan for informing parents/guardians: The application should explain how the consent document will be distributed to parents/guardians in a way that ensures a high likelihood that they will receive the information.
- Provide sufficient time: Ensure parents/guardians have enough time after receiving the consent document to read it, ask questions, and opt-out prior to the start of research activities.
- Make it easy to opt-out: Provide clear instructions detailing how parents/guardians may inform the researchers that they do not want their child to participate in the research.
COUHES considers additional factors such as the size, population, data collected, and complexity of the research to determine if a waiver is appropriate. All requests will be reviewed on a case-by-case basis.