IRB New Study Submission

Research & Education > TriHealth Hatton Research Institute

IRB New Study Submission

  • IRB meetings are held on the first and third Tuesday of every month at 12:30 p.m.
  • Completed IRB New Study Submission packets should be submitted via email to irb_hrpp@trihealth.com by the predetermined deadline for which you would like your study to be reviewed.
  • Please note: If your submission is incomplete, processing will be delayed.

If you have any questions about the IRB New Study Submission Process please contact Alexandra Robinson-Gantt, IRB Coordinator at:

Please use the forms below to submit a new study to the IRB:

  • IRB New Study Application/Checklist
  • New Study App. – Attachment 1
  • New Study App. – Attachment 2
  • New Study App. – Attachment 3
  • New Study App. – Attachment 4
  • IRB Informed Consent Template
  • Conflict of Interest Questionnaire – Must be completed for the PI, Sub-I’s and Lead Coordinator/Research Specialist, unless the PI attests on behalf of study staff
  • Approved Administrative Review Application
  • Waiver or Alteration of Informed Consent (if applicable)  The IRB may approve a consent procedure that does not include, or which alters, some or all of the elements of informed consent or waive the requirements to obtain informed consent if the IRB finds that the research meets specific criteria.  Note:  This waiver provision is not applicable to FDA regulation research.
    • Waiver of Documentation of Informed Consent (if applicable) – For federally funded research, the IRB may waive the requirement for an Investigator to obtain a signed consent form for some or all subjects provided the IRB has not waived the requirement for seeking prospective informed consent and it finds: That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; or
    • That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., drawing a blood sample, or asking shoppers in a mall about the ambient lighting or temperature).
     
  • Waiver of Authorization (if applicable)   The board will review requests for alteration, waiver or partial waiver of authorization. Under the HIPAA Privacy Rule, a "Covered Entity" may use or disclose Protected Health Information (PHI) for research purposes without authorization from the research participant if the "Covered Entity" obtains proper documentation that an IRB has determined that the alteration or waiver, in whole or in part, satisfies privacy rule requirements. A "Covered Entity" may request a Partial Waiver of Authorization to use and/or disclose PHI for recruitment purposes. Such recruitment activities may include, but are not limited to, conducting telephone or internet screenings and accessing or creating a recruitment database.

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