Application & Instructions

Prior to IRB review, research projects require prior approval by the Scientific Research Committee or by the Nursing Research Committee.

New investigators must complete training in the protection of human subjects prior to receiving IRB approval of a protocol. Training materials and information may be obtained by contacting the IRB office.

The IRB application and instructions are available for download in Microsoft Word format or by calling the IRB office at (860) 714-4068. An IRB application consists of:

• Typewritten application with all sections completed. Application must be signed by the Principal Investigator. SFHMC policy does not allow trainees and students to be Principal Investigators. For all categories of review, submit original plus 11 copies.

• Consent document that is appropriate to the proposed research and written in simple, non-technical language that can be easily understood by the prospective subjects. A consent form template is available on line or by calling the IRB office. For full review, submit 12 copies. For expedited review, submit 1 copy.

• If a waiver of consent is requested, the Principal Investigator must complete and submit a Waiver of Individual Authorization for Disclosure of Protected Health Information Questionnaire. For full review submit 12 copies. For expedited review submit 1 copy.

• A Protocol giving a complete description of the proposed research in technical language. In general, this applies to protocols requiring full review; submit 2 copies.

• Investigator’s Brochure (including data on previous animal and human experience associated with the investigational article) supplied by the manufacturer. In general, this applies to protocols requiring full review; submit 2 copies.

• As appropriate to the proposed research, copies of all questionnaires, interview protocols, assessment materials, experiment session outlines, and descriptions of materials that subjects will encounter. For full review, submit 12 copies. For expedited review, submit 1 copy

• Advertisement for subject recruitment, if applicable. Guidelines for advertisements are included in the IRB application instructions. Advertisements may be approved by expedited review; submit 12 copies.

• Curriculum vitae for each investigator listed on the application. 1 copy required for all categories of review.

• Documentation of training of off-site investigators. One (1) copy required for all categories of review.

• Application Fee. A fee of $1,250 is charged to studies supported commercially (pharmaceutical or device manufacturer).

Approval will be delayed for applications that do not carefully attend to the elements listed above, as well as the four IRB considerations—risks, benefits, knowledge, and consent process.

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