Application Forms

Forms: Getting Started

• Non-Exempt Consent Form Template for Participants — The sections and certain language in this template must be followed for non-exempt research.
• Supplemental Consent Language
• Informed Consent Checklist
• Exempt Research Study Information Sheet for Participants — for use with exempt studies only.

Additional Forms for Special Populations or Sensitive Data

Documents are in MS Word format (.doc/x). Make sure that you save your completed version in either MS Word (.doc/x) or as an Adobe PDF (.pdf) file and submit these as an attachment in the PERA IRB Go-Live website.

Assent for Children in Research

• Assent Form (for research involving children) — informs children in simple language about the study procedures and voluntary nature of participation.

Protected Health Information (PHI)

For additional guidance on PHI in research applications, click here.

• Authorization for Release or Use of PHI — Required content for researchers to give participants prior to requesting release of Personal Health Information (PHI) from a physician or other covered entity under HIPAA. Note: many hospitals and clinics will have their own version of this form to use.
• Authorization Instruction Sheet — Guidance to complete the Authorization for Release or Use of PHI Template.

External Collaborators

For guidance on which agreement(s) you may need to add non-Purdue researchers to your project, click here.

• Coded Information Acknowledgement — affirms that you will be receiving fully coded/deidentified human subjects research data from another investigator’s study.
• Letters of Collaboration — if your research proposes to conduct research at an external site such as a workplace or school the site will need to document their agreement to grant access for research.
• Exempt and Non-Federally Funded Independent Investigator Acknowledgement Agreement — for exempt human subjects research or non-exempt research that is not part of a federally sponsored project with another individual who does not have an IRB overseeing research.
• Federally Sponsored Non-Exempt Independent Investigator Agreement — for non-exempt human subjects research on a federally sponsored project with another individual who does not have an IRB overseeing research.
• Confidentiality Agreement Transcription and/or Translation Services — Required if IRB protocol data or documents must be translated or transcribed by an outside party or consultant.

Studies Involving Deception

• Deception Debriefing Consent Template — guidance if your study proposes to use deception or incomplete disclosure. All studies proposing deception or incomplete disclosure must meet criteria described by the IRB in Purdue HRPP Standard Operating Procedure(s) (SOP) 301 and/or 321.