Informed Consent

Basic Elements for Informed Consent

CFR 45 46.116 General requirements for informed consent.

For Minimal Risk Activities

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Required for recruitment of subjects in verbal scripts/cover letters, and in consent letters (activities not exceeding minimal risk)

  • Who you are
  • What you are doing
  • Why you are doing it
  • Benefits/Risks for participation
  • What subjects will be asked to do and how long it will take
  • Participation is voluntary
  • No penalty for nonparticipation/withdrawal from study
  • How confidentiality/anonymity will be handled
  • Who to call if any questions regarding research design

For Activities Exceeding Minimum Risk

Additional elements are required, as appropriate, if activities exceed minimal risk.

Additional protections are required for the following populations:.

Pregnant Women, Human Fetuses and Neonates Involved in Research

Biomedical and Behavioral Research Involving Prisoners as Subjects

Children Involved as Subjects in Research