Required Documents for Submission of Full Review Proposals

Each Packet Should Include the Following:

  1. FOUR (4) copies of complete protocol** and/or complete grant proposal including appendices. (ie. NIH, NSF, AHA, etc). For grant proposals, a copy of the entire grant is required except for the budget.
  2. Twenty-four (24) copies of the HS1A Form. (signatures required).
  3. Twenty-four (24) copies of protocol abstract/synopsis (limited to 3 pages).
  4. Twenty-four (24) copies of consent form.
  5. Four (4) copies of advertisement, questionnaires, or surveys, if applicable.
  6. Four (4) copy of the Investigators Brochure, if applicable.
  7. One (1) copy of the Fee for Commercially Sponsored Authorization Fee Form, if applicable. This form MUST accompany any NEW commercially sponsored research project submitted to the IRB.
  8. One (1) copy of the required HIPAA form. (see HIPAA web site for instructions.)

PLEASE NOTE: All 24 copies must be COLLATED (Assemble in proper order, ie. each packet consisting of HS1A form, synopsis, consent, etc.) when submitted or they will be returned.

FOR ELECTRONIC SUBMISSION OF HSIRB DOCUMENTS / FORMS

In order to expedite the review and approval process of all new projects involving human subjects, the HSIRB has requested that a copy of the informed consent(s) be send electronically. The HSIRB will make any necessary working changed and send a highlighted copy back to you for verification. The electronic copy of the informed consent would be submitted in addition to the usual documents submitted for review, i.e. protocol, HS1A form, informed consent.

Please send the electronic copy of your informed consent to the HSIRB mail box hs-irb@research.buffalo.edu when submitting new or renewal applications.

**The complete protocol must provide:

  • Specific aims.
  • Experimental design.
  • Methods.
  • Background and details of the proposed involvement of humans in the research, including:
    • the characteristics of the subject population
    • anticipated numbers and rate of accrual
    • age ranges
    • health status
    • and anticipated time to complete the study
  • The proposed research should specify the gender and racial/ethnic composition of the subject population, as well as criteria for inclusion and exclusion of any subject population.
  • If ethnic, racial, or gender estimates and continuing review numbers are not included in the background data for a protocol, the investigator must provide a clear rationale for exclusion of this information
  • Confidentiality - Describe procedures for protecting the confidentiality of the subjects' responses.
  • Risks - Discuss any physical, psychological, legal, or social risks for participants, and discuss how you will protect the subjects.
  • Data Safety Monitoring Plan. For more information on DSM see the Recent HSIRB Memo: Guidelines for Data and Safety Monitoring (July 2004)

DEADLINES FOR SUBMISSION OF FULL REVIEW PROPOSALS

Proposals that require review by the convened HSIRB must be submitted by the close of business by the last day of each month for the following months review. Proposals received after the due date will be held for the following month's review session. No exceptions will be allowed.

  • Friday, November 30, 2007 for December 2007 review.
  • Monday, December 31, 2007 for January 2008 review.
  • Thursday, Januqry 31, 2008 for February 2008 review.
  • Friday, February 29, 2008 for March 2008 review.
  • Monday, March 31, 2008 for April 2008 review.
  • Wednesday, April 30, 2008 for May 2008 review.
  • Friday, May 30, 2008 for June 2008 review.
  • Monday, June 30, 2008 for July 2008 review.
  • Thursday, July 31, 2008 for August 2008 review.
  • Friday, August 29, 2008 for September 2008 review.
  • Tuesday, September 30, 2008 for October 2008 review.
  • Friday, October 31, 2008 for November 2008 review.
  • Friday, November 28, 2008 for December 2008 review.
  • Wednesday, December 31, 2008 for January 2009 review