Informed consent provides the individual with the pertinent information regarding the research in which s/he is being asked to participate, and the opportunity to make an informed decision regarding whether or not to participate in the research. The primary purpose of informed consent is to protect the prospective human subject.
No. A waiver of documented informed consent may be granted by the Institutional Review Board in certain circumstances. However, in such cases, the subject must give verbal informed consent and an information sheet similar to the informed consent form is often required.
Minors (nonemancipated individuals younger than 18) may not give legal informed consent. In research involving minors, informed consent must be obtained from the minor’s parent or guardian. This does not mean that the minor has no say in whether they participate in the research, however. In cases where the minor is able to understand what his/her participation would entail, informed assent must be obtained from the minor.
- About the HRPP: The Basics
- Student Researchers
- Working With Special Populations
- Special Topics
- Forms and Instructions
- Guidelines, Policies and Regulations
- Data Management and Protection
- Required Training
- Glossary of Terms
- Frequently Asked Questions
- Contact Us
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Human Research Protection Program
Bernstein-Marcus 2nd floor, MS 116
415 South Street
Waltham, MA 02453