Consent for Research
Templates
- Consent Template
- Parental Permission Template
- Assent Template
- Consent Addendum Template
- Short Form Consent Template for Non-English Speaking Participants
- OSU/WIRB Consent Template
- Waiver of Informed Consent/Waiver of Consent Documentation
Consent Template
Information pertaining to your research proposal should be added to the template using complete sentences in non-technical language, preferably at 8th grade reading level. The final version of the consent form presented to subjects should have the line numbers removed and the IRB protocol number and approval date added to the header of the document.
| Biomedical & Cancer Research | Behavioral & Social Science Research |
|---|---|
 Consent Template (12/15/05) |
Consent Template (12/15/05) |
| Instructions for Consent Templates (12/15/05) |
Instructions for Consent Templates (12/15/05) |
Parental Permission Template
Parental permission forms are recommended for inclusion of subjects less than 18 years old. Written assent forms are also recommended for subjects between the ages of 14 and 17 years old (see Assent Template).
| Biomedical & Cancer Research | Behavioral & Social Science Research |
|---|---|
| Parental Permission Template (12/15/05) |
Parental Permission Template (12/15/05) |
Assent Template
Written assent forms are recommended for subjects between the ages of 14 and 17 years old. Use complete sentences at approximately a 2nd grade reading level. Verbal or written assent may be necessary for those under the age of 14 years. If verbal assent will be obtained, a script for the assent process should be provided to the IRB for review.
| Biomedical & Cancer Research | Behavioral & Social Science Research |
|---|---|
| Assent Template (12/15/05) |
Assent Template (12/15/05) |
Consent Addendum Template
A consent addendum may be used for optional sub-studies presented at the start of subject participation or when new information becomes available during the study. This addendum template must be used in conjunction with the consent template.
| Biomedical & Cancer Research |
|---|
| Consent Addendum Template (8/05/05) |
OSU/WIRB Consent Template
Consent template to be used for all research protocols reviewed by WIRB. For more information, see the WIRB research page.
| Biomedical & Cancer Research |
|---|
| OSU/WIRB Consent Template (3/25/08) |
Waiver of Informed Consent (Appendix M1) and Waiver of Consent Documentation (Appendix M2)
Complete these forms to request a waiver or alteration of the consent process, or a waiver of consent documentation for the proposed research. DHHS regulations permit waivers (or alterations) of the consent process if the research meets certain conditions; however, FDA has no provision for waiver or alteration of consent. Additional guidance can be found in the following regulations: 45 CFR 46.116, 45 CFR 46.117 and 21 CFR 56.109.
All research |
|---|
| Waiver or Alteration of Consent Process (Appendix M1) |
| Waiver of Consent Documentation (Appendix M2) |
Glossaries
- Glossary of Medical Terms (OSU Medical Center)
- Glossary of Lay Terms for use in Preparing Consent Forms (Stanford University)
OSU Policies
- The Informed Consent Process and Elements of Informed Consent
- Documentation of the Informed Consent Process
- Assent and Parental Permission
