University at Buffalo - The State University of New York

A-1 Overview

All projects submitted to the HSIRB are evaluated for possible expedited review. Expedited review is a type of review that can be conducted by the IRB Chair or a designee of the Chair. The reviewer will determine whether the project is “not greater than minimal risk” and represents one or more categories for which expedited review may be conducted. When the project meets the requirements for expedited review, the regulations specify that the reviewer may approve or require modifications to the project in order to gain approval. When modifications are requested, the investigator should respond, in writing, indicating that the requested modifications will be made or provide a justification for not doing so. The Chair, or designee, will review the investigator’s response and may approve the project as submitted, request further modifications, or refer review of the project to the full board.

The regulations specifically prohibit disapproval of a project by the expedited review process. Projects that cannot be approved by the expedited process, including “recommended disapprovals” will be referred to the full board for review. The investigator will be notified, in writing, of any determinations

Research activities that present “no more than minimal risk” and meet expedited review criteria, as listed below, may be reviewed by the expedited review process. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or performances or routine physical or psychological exams or tests. Acceptable criteria for expedited review are:

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 HSIRB 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 HSIRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

A-2 “What” to Submit for Expedited Review

To be considered for expedited review, the following project documents, as applicable, should be submitted to the HSIRB:

1. A complete protocol (See Protocol Requirements) OR, for grant proposals (such as through NIH, NSF, or AHA, etc.), a copy of the entire grant proposal (except for the budget section) including appendices is required


2. Completed and signed HS-1A Application Form


3. Expedited review form


4. Protocol abstract/synopsis (limited to 3 pages)


5. All consenting document(s), as applicable to the research project (e.g., consent, parental permission, and child assent - (preferably in electronic format)


6. Advertising and recruitment materials (e.g., flyers, posters, newspaper ads, press releases, bulletins, TV or radio spots, websites, internet ads, electronic mailings, recruitment letters, scripts for telephone contacts)


7. Questionnaires, surveys, etc., when applicable


8. Authorization of Fee Collection for HSIRB Review of a Commercially Sponsored Research Protocol


9. HIPAA form(s) as required by the project

A-3 “How” to submit to the HSIRB: Electronically or by Mail

See: Submission Deadline Dates and How to Submit Materials for HSIRB Review

B-1 Overview

Full board review is required for human subject research projects that have not been classified as exempt or expedited. This includes projects involving the following:

• Greater than minimal risk to subjects
• Use of investigational drugs, devices, or biologics for which an IND/IDE is required
• FDA approved drugs and devices presenting more than minimal risk
• Risk to vulnerable populations
• Illegal activities such as drug use
• Private activities such as sexual behavior
• Deception

Applications requiring review by the full board must be received in the HSIRB office by 4:00 pm on the last business day of the month in order to be reviewed at the following month’s meeting. Click here for the list of specific deadline dates.

B-2 “What” to Submit for Full Board Review

The HSIRB requires that 24 packets of the submission documents be assembled according to the following instructions. Submissions that are not properly assembled will be returned to the investigator to be re-assembled:

• 4 packets should include ALL of the following:
• The remaining 20 packets should include items b-e

1. A complete protocol (See Protocol Requirements) OR, for grant proposals (such as through NIH, NSF, or AHA, etc.), a copy of the entire grant proposal (except for the budget section) including appendices is required
2. Completed and signed HS-1A Application Form
3. Protocol abstract/synopsis (limited to 3 pages)
4. All consenting document(s), as applicable to the research project (e.g., consent, parental permission, and child assent - (preferably in electronic format)
5. Advertising and recruitment materials (e.g., flyers, posters, newspaper ads, press releases, bulletins, TV or radio spots, websites, internet ads, electronic mailings, recruitment letters, scripts for telephone contacts), when applicable
6. Questionnaires, surveys, etc., when applicable
7. Investigator's Brochure, when applicable
8. Authorization of Fee Collection for HSIRB Review of a Commercially Sponsored Research Protocol, when applicable
9. HIPAA form(s) as required by the project (see: HIPAA Information)

B-3 “How” to submit to the HSIRB: Electronically or by Mail

See: Submission Deadline Dates and How to Submit Materials for HSIRB Review