IRB Informed Consent Process and Consent Forms
The central concept in the protection of human subjects is to ensure that the individual can make an informed decision on whether or not to participate in research. Prospective participants must be given adequate information on both the possible risks and the potential benefits of their involvement to allow them to make informed decisions. As a researcher, it is your responsibility to educate potential participants about risks and benefits, obtain their consent before involving them in your research, and keep them informed.
Informed consent is not a single event or just a form to be signed – rather, it is an educational process that takes place between the investigator and the prospective subject. The informed consent process is usually documented with a consent form signed by the research participant. In certain cases, documentation of consent may be waived and an information sheet used instead. Samples of both types of forms are provided below.
- CSUSM Video Training on Informed Consent
- CSUSM Informed Consent Instructions
- Consent Form Requirements for Languages Other than English
- FAQ about informed consent and consent vs. child assent forms
- Letterhead/masthead for consent document
- Regulations pertaining to Waivers of Consent
Sample Consent Forms
- Kinesiology--off campus recreational activity
- Kinesiology--using exercise equipment
- Education--teacher participants
- Education--classroom bullying-parent consent and child assent
- Education--middle school-parent consent and child assent
- Oral History--interview consent template
- Psychology--assessment and survey questions
- Social Sciences--focus group
- Examples of Risk
- Consent Form Training Link (University of Minnesota) Thorough training on why Consent is important. Plus a tool for creating your own Consent document.
- Consent Process Presentation (based on PRIM&R presentation 12/2010)
- OHRP Educational Videos (HHS.gov, U.S. Department of Health & Human Services)