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Human Subjects Protection: Forms and Sample Documents

All forms must be submitted online via IRBNet.


IRB Forms

Initial IRB Application Form

Amendment Form/Changes to Research (rev. 03-2015)

Continuing Review Form (rev. 03-2015)

Secondary Data Analysis Worksheet (rev. 03-2015)

Institutional Authorization Agreement – Rely to URI Review (rev. 7-2015)

Institutional Authorization Agreement – URI Defers (rev. 7-2015)


Appendix A – Exempt Review (rev. 03-2015)
Appendix B – Expedited Review (rev. 03-2015)
Appendix C – Data Repositories (rev. 03-2015)
Appendix D – Deception (rev. 03-2015)
Appendix E – Devices (rev. 03-2015)
Appendix F – Drugs or Biologics (rev. 03-2015)
Appendix G – Genetic Testing (rev. 03-2015)
Appendix H – Storage of Biological Materials (rev. 06-2015)
Appendix I – Minors (rev. 03-2015)
Appendix J – Non-English Speaking Participants (rev. 03-2015)
Appendix K – Pregnant Women, Fetuses, Neonates (rev. 03-2015)
Appendix L – Prisoners (rev. 03-2015)
Appendix M1 – Waiver or Alteration of Consent Process (rev. 03-2015)
Appendix M2 – Waiver of Signed Consent (rev. 03-2015)
Appendix N – Waiver or Alteration of HIPAA Research Authorization (rev. 03-2015)
Appendix O – Research in International Settings (rev. 03-2015)
Appendix P – Radiation (rev. 03-2015)
Appendix Q – Adults with Decisional Impairments (rev. 03-2015)
Appendix R – Additional Personnel (rev. 03-2015)
Appendix S – Event Reporting (rev. 03-2015)
Appendix T – Change in the Number of Participants (rev. 03-2015)
Appendix U – Final Study Report (rev. 03-2015)
Appendix V – Unaffiliated Investigator (rev. 03-2015)
Appendix W – Faculty Student Assurance (rev. 03-2015)
Appendix X – Conflict of Interest in Human Subjects Research (rev. 03-2015)


Informed Consent Templates

Informed Consent Guidelines

Per the IRB 2014 Policy, the IRB is responsible for stamping all approved informed consent documents with the URI logo, project reference number, and approval/expiration information. When submitting an informed consent document, be sure to leave the bottom right corner of the document BLANK as this is the location where we upload our stamp.

When submitting a continuing review for your project, it is required that you submit:
— The most recently used consent document that has been signed and whited out so that all personal information is no longer visible.
— A new, clean copy of the consent document with the bottom right corner BLANK.

When submitting an amendment/modification for your project, it is required that you submit:
— The most recently used consent document where all new revisions have been highlighted.
— A new, clean copy of the revised consent document with the bottom right corner BLANK.

Standard Informed Consent Template

Informed Consent Template — Anonymous Research

Assent Template (older Children)

Assent Template (young children)

Parental Permission Template



HIPAA Authorization


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