Below are consent forms for Human Subjects Research. Most of these forms are to be signed by the subject of the research.
The forms must first be modified with information about the specific project. Keep in mind that the form will be read and agreed to by the subject; thus, the pronoun “I” refers to the subject, not the researcher. A copy of the modified form must be included with the Approval Request. Note that during research, all forms must be completed in duplicate; the subject retains one copy and the other is retained by the researcher.
Note: In order to meet the requirements of 21 CFR 50.20, the consent document must be in language understandable to the subject. When the prospective subject is fluent in English, and the consent interview is conducted in English, the consent document should be in English.
However, when the majority of anticipated study subjects are non-English-speaking people, and it is anticipated that the consent interviews are likely to be conducted in a language other than English, the PI should submit a translated consent form for IRB review.
For more information on consent and disclosure requirements, see the Code of Federal Regulations: Title 45, Part 46—Protection of Human Subjects.
(All links below link to Word documents.)
|If...||Required Form||To be Signed by:|
|subjects are over 18||Informed Consent Form for Adult Subject||the subject|
|subjects are under 18||the parent or legal guardian|
|you are filming or recording|
the subject or the parent/legal guardian
|planning on archiving data to be analyzed at a future date||Data Archival Consent Form||the subject or the parent/legal guardian|
|need to collect data off-campus||Site Approval Form||appropriate location administrator|
|you need a form in another language|
Adult Subjects Informed Consent Forms
- Human Subjects: firstname.lastname@example.org
- Non-Human Subjects: email@example.com
- Biosafety: firstname.lastname@example.org or email@example.com