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Guidelines, Templates and Sample Consent Forms

Please note that with the implementation of CATS and the IRB Library, the University Park HRPP program has replaced the previous templates for informed consent with new versions.  These forms look very different from 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 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.

The consent form templates are located in the IRB Library (within the "Templates" tab) in CATS-IRB.  Additionally, please refer to the Investigator Manual (HRP-103) located within the IRB Library (within the "General" tab) for information regarding development of consent documents and documenting participant consent.

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To Access the IRB Library:

  1. Go to CATS-IRB
  2. Log in with your Penn State Access Account Username and Password
  3. Click on "IRB" (below the CATS logo in the upper left-hand side of page)
  4. Click on "IRB Library" (left margin)
  5. Click the appropriate tab (Standard Operating Procedures, General, Worksheets, Checklists, Templates)

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Exemption Determination (Exempt) Studies

  • ORP Summary Explanation Research (Exempt Research) (HRP-590)

Expedited & Full Review Studies

  • ORP Consent Form Signed (HRP-588)
  • ORP Consent Form (Waiver of Written Documentation of Consent) (HRP-589)

HIPAA Consent Information

  • 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.

 

 


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The Human Research Protection Program in the Office for Research Protections ensures compliance with Federal, state, and local regulations as well as institutional policies and procedures regarding the use of humans as participants in research.