Required Documents for Submission of Expedited Review Proposals

Accepted Criteria for Expedited Review

Protocols that meet expedited review criteria can be submitted at any time and are reviewed as received.

Applicable to research protocols that presents no more than minimal risk to human subjects and involves one or more of the following procedures*. These are the only acceptable criteria for expedited review:

  1. Clinical studies of drugs and medical devices when an investigational new drug (IND) application is not required, an investigational device exemption (IDE) application is not required, or the medical device is cleared/ approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy non-pregnant adults who weigh at least 110 lbs. and does not exceed 550 ml in an 8 week period and collection cannot occur more frequently than 2 times per week, or from other adults or children the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
  3. Prospective collection of biological specimens for research purposes by noninvasive means.
  4. Collection of data through noninvasive procedures (not involving anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
  5. Research involving materials (data documents, records, specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
  6. Collection of data from voice, video, digital, or image recordings made for research purposes.
  7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
  8. Continuing review of research previously approved by the convened IRB where research is permanently closed to enrollment of new subjects, all subjects have completed all research-related interventions, and the research remains active only for long-term follow-up of subjects or where no subjects have been enrolled and no additional risks have been identified or where the remaining research activities are limited to data analysis.
  9. continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

* See Expedited Review Form for complete criteria and references.

EACH EXPEDITED REVIEW PACKET SHOULD INCLUDE THE FOLLOWING:

  1. One (1) copy of complete protocol** and/or complete grant proposal including appendices. (Ex. NIH, NSF, AHA, etc). For grant proposals, a copy of the entire grant is required except for the budget.
  2. One (1) copy of the HS1A Form. (signatures required).
  3. One (1) copy of the Expedited Review Form (2 page form) (signature required).
  4. One (1) copy of the consent form, if applicable.
  5. One (1) copy of protocol abstract/synopsis (limited to 3 pages).
  6. One (1) copy of advertisement, questionnaires, or surveys, if applicable.
  7. One (1) copy of the Investigators Brochure, if applicable.
  8. 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.
  9. One (1) copy of the required HIPAA form. (see HIPAA web site for instructions.)

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 sent electronically. The HSIRB will make any necessary working change 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)