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Forms & Applications

ATTENTION University Park Faculty, Staff & Students: Effective October 1, 2009, University Park faculty, staff, and students must submit applications for NEW studies using the IRB eSubmission process (PRAMS) located at http://www.prams.psu.edu. Paper applications for NEW studies WILL NOT be accepted beginning October 1, 2009. Instructions for accessing PRAMS from outside of the Penn State computer network are available at: http://www.research.psu.edu/orp/areas/humans/applications/accessingprams.asp.

Other Campus Locations: Use of the IRB eSubmission process (PRAMS) to submit applications for NEW studies will be required as of January 1, 2010. However, you may begin using the system now - http://www.prams.psu.edu. Instructions for accessing PRAMS from outside of the Penn State computer network are available at: http://www.research.psu.edu/orp/areas/humans/applications/accessingprams.asp.

New Studies
Modifications
Continuing Reviews
HIPAA Forms
Unanticipated Problem Forms (formerly Adverse Events)
Other IRB Forms
What is the IRB looking for? IRB Reviewer Checklists

  • NOTICE: All applications are now being scanned for electronic storage. Please do not use colored ink or staples. If highlighting is needed, please use light pastel colors such as yellow.
  • Approximate time required for the review process:
    • Exempt Studies: 7 business days*
    • Expedited Studies: 3 weeks*
    • Full Review Studies: See IRB Meeting Schedule for deadline - approximately 45 days*
      * NOTE: The review process may take longer if revisions and/or additional information are required. Approval is NOT guaranteed within a definitive timeframe. Submit information well in advance of the anticipated involvement of human participants.
  • To determine which application form to submit, please see Types of Review.
  • The forms are available in RTF and DOC. It is recommended that MAC Users utilize the DOC file.

New Studies

ATTENTION University Park Faculty, Staff & Students: Effective October 1, 2009, University Park faculty, staff, and students must submit applications for NEW studies using the IRB eSubmission process (PRAMS) located at http://www.prams.psu.edu. Paper applications for NEW studies WILL NOT be accepted beginning October 1, 2009.

Other Campus Locations: Use of the IRB eSubmission process (PRAMS) to submit applications for NEW studies will be required as of January 1, 2010. However, you may begin using the system now - http://www.prams.psu.edu

  • EXPEDITED & FULL REVIEW STUDIES
    • Application for Use of Human Participants - Expedited & Full Reviews (RTF) | (DOC)
      • Appendix 1: Conflict of Interest (COI) (RTF) | (DOC)
      • Appendix 2: Involvement of Children in Research (RTF) | (DOC)
      • Appendix 3: International Research (RTF) | (DOC)
      • Appendix 4: Involvement of Prisoners in Research (RTF) | (DOC)
      • Appendix 5: Involvement of Patients in Research (RTF) | (DOC)
      • Appendix 6: Involvement of Individuals with a Decisional Impairment in Research (RTF) | (DOC)
      • Appendix 7: Involvement of Neonates in Research (RTF) | (DOC)
      • Appendix 8: Screening Questions containing Identifiable Information (RTF) | (DOC)
      • Appendix 9: Waivers of Informed Consent (RTF) | (DOC)
      • Appendix 10: Recordings - Audio, Video, Digital, Photographs (RTF) | (DOC)
      • Appendix 11: Use of Computer and/or Internet in Research (RTF) | (DOC)
      • Appendix 12: Use of Deception in Research (RTF) | (DOC)
      • Appendix 13: Health Insurance Portability & Accountability Act (HIPAA) (RTF) | (DOC)
      • Appendix 14: Use of Drugs, Biologics and Other Substances in Research (RTF) | (DOC)
      • Appendix 15: Use of Biological Specimens in Research (RTF) | (DOC)
      • Appendix 16: Other Biomedical Procedures - Diagnostic Radiation Procedures (RTF) | (DOC)
      • Appendix 17: Data Safety Monitoring (RTF) | (DOC)
      • Appendix 18: Multi-Site Studies (RTF) | (DOC)
      • Appendix 19: Involvement of Pregnant Women or Fetuses in Research (RTF) | (DOC)
      • Appendix 20: Use of Medical Devices in Research (RTF) | (DOC)
    • See Consent Form Guidelines, Samples & Templates
  • Non-Human/Non-Research Determination Form (RTF) | (DOC)

Modifications

Continuing Reviews
  • Continuing Progress Report (CPR) forms are NOT placed on-line. The CPR Form is sent as an e-mail attachment to the principal investigator 75 days and 45 days prior to the study's approval expiration date.
  • Co-investigators, Project Coordinators and Advisors, if the principal investigator is a student, are copied on the e-mail notification; however, ONLY the principal investigator will receive the attachment.

HIPAA Forms
  • Authorization to Use & Disclose Protected Health Information for Research Purposes (RTF) | (DOC)
  • Waiver of Individual Authorization for Disclosure of Protected Health Information (RTF) | (DOC)
  • Letter to Revoke Authorization (RTF) | (DOC)
  • Data Use Agreement for Research 45 CFR 164.514(e) (RTF) | (DOC)
  • Data Collection for Reviews Preparatory to Research 45 CFR 164.512 (RTF) | (DOC)
  • HIPAA De-Identification Certification (RTF) | (DOC)
  • HIPAA Disclosure Tracking Form (RTF) | (DOC)
  • Research on Decedent's Information (RTF) | (DOC)
  • HIPAA Consent Form Wording (RTF) | (DOC)

Unanticipated Problem Forms (formerly Adverse Events)
  • SOP on Reporting of Unanticipated Problems Involving Risks to Participants or Others (RTF)
  • Problem Report Form (RTF) | (DOC)
  • Problem Accumulative Tracking Log (RTF) | (DOC)
  • Non Reportable External Event Report Form (RTF) | (DOC)
  • Other Event/Problem Accumulative Tracking Log (RTF) | (DOC)

Other IRB Forms
  • Project Close Out Report for Research Involving Human Participants (RTF) | (DOC)

What is the IRB looking for? IRB Reviewer Checklists
  • Full Review
    • New Full Review Study (RTF) | (DOC)
    • Full & Expedited Informed Consent Form (RTF) | (DOC)
    • Full & Expedited Recruitment (RTF) | (DOC)
  • Expedited Review
    • New Expedited Review Study (RTF) | (DOC)
    • Full & Expedited Informed Consent Form (RTF) | (DOC)
    • Full & Expedited Recruitment (RTF) | (DOC)
  • Exempt Determination
    • New Exempt Determination (RTF) | (DOC)
    • Exempt Determination Informed Consent Form (RTF) | (DOC)
    • Exempt Determination Recruitment (RTF) | (DOC)
  • Special Circumstances
    • Research Involving Children (RTF) | (DOC)
    • Research Involving Prisoners (RTF) | (DOC)
    • Research Involving Adults Unable to Consent (RTF) | (DOC)
    • Research Involving Pregnant Women and Fetuses (RTF) | (DOC)
    • Research Involving Neonates (RTF) | (DOC)
    • Research Involving Other Vulnerable Populations (RTF) | (DOC)
    • Human Participant Research – DHHS & FDA Regulations (RTF) | (DOC)
    • Investigational New Drug (IND) (RTF) | (DOC)
    • Waiver of Consent (RTF) | (DOC)