Guidelines, Templates and Sample Consent Forms
Update March 5, 2014: Please note that with the implementation of CATS and the HRPP Toolkit, the UP HRPP program has replaced the previous templates for informed consent with new versions. These forms look very different from the previous templates and include a lot more instruction on regulatory requirements for those developing informed consent forms for their research studies. When developing the informed consent for a new study, investigators are strongly encouraged to use these new templates. When a date for the release of CATS to the remainder of the University is set, investigators will be REQUIRED to use these templates. The IRB will grandfather in consent forms for studies that have already been approved as long as they continue to meet the appropriate approval criteria.
These templates are also available in the IRB Library in CATS.
Exemption Determination (Exempt) Studies
- Summary Explanation for Exempt Research (DOC)
Expedited & Full Review Studies
- Consent Form Template - Signed (DOC)
- Consent Form Template - Waiver of Written Documentation of Consent (DOC)
- For Studies Utilizing the Social, Life & Engineering Sciences Imaging Center (SLEIC) MRI
HIPAA Consent Information
- HIPAA Consent Form Wording (RTF)
- Authorization to Use & Disclose Protected Health Information for Research Purposes (RTF) | (DOC)
FERPA Consent Information
- The Family Educational Rights and Privacy Act (FERPA) (20 U.S.C. § 1232g; 34 CFR Part 99) is a Federal law that protects the privacy of student education records.
- For more information about FERPA, please visit the U.S. Department of Education website located at: www.ed.gov
- For information about how FERPA applies for studies conducted with Penn State students, please visit the Penn State’s registrar website at: www.registrar.psu.edu/
- Please read the following information provided by the Office of the University Registrar regarding the responsibilities of investigators using student educational records in their research: FERPA Guidelines for Researchers
- For information about how FERPA applies to students at another institution where the research will be conducted, please contact that institution.
Certifying Translation of Documents
- Certificate of Translation Form (RTF)