FHCRC Consent Forms: Tools and Tips
On this page: requirements, model consent forms (templates), resources for writing better consents, and recruitment.
Model consent forms (templates)
- Consent for Clinical Research [download Word doc] updated March 27, 2015
- Consent for minimal/low risk studies [download Word doc] updated September 1, 2014
Note: This consent form is intended for studies that involve minimal risk or low risk to participant; the IRB's review will include a determination about level of risk. If you need advice before submission about whether this form is appropriate, please contact an IRB analyst.
- "Consent R": Consent to donate extra tissue samples for research during a planned clinical evaluation for blood or marrow stem cell transplantation [download Word doc] updated September 1, 2014
- Public Health Sciences (PHS) Consent for Research [download Word doc] updated September 1, 2014
- Public Health Sciences (PHS) Consent for minimal/low risk studies [download Word doc] updated September 1, 2014
- Assent (participants aged 7-13) [download Word doc] updated April 7, 2012
- If you require assistance with consent form development, please utilize the model consent documents found on the website. You may also contact your IRB Analyst for assistance if you have further questions regarding use of the model consent form or are seeking sample consent documents that were previously IRB approved and provide good models for specific types of research activities.
- Simplification of Informed Consent Documents (NCI page)
- Template Risk Language for Common Cancer Drug (NCI page)
- Tools for simpler vocabulary:
Pre-signed consent forms should not be used. A signature line for a principal investigator or researcher is required only for research needing to comply with International Conference on Harmonization (ICH) guidelines. If the research study requires a signature by the principal investigator or study staff, there are several options:
- Include a statement that the principal investigator acknowledges that a member of the study staff consented the research participant.
- Same as above, but with a line for the study staff member's signature.
- Use only check boxes.
- Use check boxes as well as a signature line .
Please contact James Riddle, IRO Assistant Director at (206) 667-6501 or Karen Hansen, IRO Director at (206) 667-4867 with your questions regarding pre-signed consent forms.
All study recruitment materials that will be used to recruit potential research participants and method of compensation must first receive IRB review and approval prior to use of the material. For more information, see the IRB policy/procedure on Recruitment and Compensation (Policy 2.0) [pdf] [all IRB policies/procedures]