Division of Research and Economic Development

Expanding the University's research enterprise.

Human Subjects Research: Forms and Submission Process


Submission Process and Forms

The Initial Review of Human Subject Research (Initial IRB Application) is required for all research that requires a human subject component (exempt, expedited, and full convened IRB review). What you will notice immediately is the there are many appendices to the Initial IRB Application. Most Principal Investigators (PIs), will seldom use beyond a handful of these. These forms have designed to streamline the review process so all information required for review is submitted at time of application. Our hope is to decrease the review time for researchers.

Protocol Review Process

The length of the approval process is influenced by several varying factors, such as the complexity of a protocol, the risk of the project to the research subjects, and the completeness of documentation. In all circumstances, early submission combined with accurate documentation will result in an expedited approval.

The IRB application process starts with your submission of the application form, consent forms and other required appendices/materials. The ORI staff pre-reviews your application to make sure all of the necessary materials are there for IRB review. The ORI staff will contact you by email if your application or forms are not sufficient and will let you know what needs to be done to get your application ready for review by the IRB. For information on what to submit, see what to include in my IRB submission package.

Applicants must submit application materials to the IRB at least three weeks prior to the date of the scheduled IRB meeting for all protocols that must be reviewed by the fully convened IRB. Please allow at least 6-8 weeks for protocol review, depending on the complexity of the project, the risk of the project to the research subjects, and the extent of revisions required.

IRB Committee Information and Meeting Schedule

All information must be submitted through IRBNet. For more information regarding IRBNet, see IRBNet Access and Guidance

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)

Appendices
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. 11-2015)
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, whited out so that all personal information so that it 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 that requires modifying the consent documents, you must 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.

 

IRB Consent Template Instructions (2/2017)

Consent Template (2/2017)

Low Risk Survey Consent Template (2/2017)

Parental Permission Template (2/2017)

Child Assent Template (2/2017)

 

HIPAA Forms

HIPAA Authorization

 

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