A-1 Overview

All projects submitted to the CYIRB 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 CYIRB 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 CYIRB 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 CYIRB:

Expedited Review - minimal risk to the research subjects.

1. Protocol (see Protocol Requirements) OR, for grant proposals (such as through the NIH, NSF, or AHA, etc.), a copy of the entire grant proposal (except for the budget section) including appendices is required.
2. Expedited Review Form
3. Core Data Form completed online in IRBNet
4. Multi-Site Addendum (if applicable)
5. Form for Financial Approval of Research at WCHOB, if applicable
6. Research Involving Children: Protocol Specific Determinations Form
7. Other forms as applicable to the research being conducted (e.g., Waiver of Consent or Waiver of Documentation of Consent Form, etc.)
8. All Consent/Parental Permission documents and Assent documents (as applicable - >7 years age).
9. Advertising and recruitment materials (e.g., letters, postcards, flyers, posters, newspaper ads, press releases, bulletins, TV or radio spots, websites, Internet ads, electronic mailings, recruitment letters, and scripts for telephone contacts)
10. Questionnaires, surveys, etc., when applicable
11. Authorization of Fee Collection for IRB Review of a Commercially Sponsored Research Protocol, when applicable
12. HIPAA document(s) as required by the project

A-3 ?When? to Submit to the CYIRB

Projects for expedited review can be submitted at any time and are reviewed as received. [IMPORTANT NOTE: At the time of review, the CYIRB may determine that a ?full review? of the project submission is required. In such instances, additional requirements may apply.]

A-4 ?How? to submit to the CYIRB

Effective October 2, 2012, all submissions to the CYIRB must be made via IRBNet. For instructions, see the IRBNet information page.

See also: Submission Deadline Dates and How to Submit Materials for CYIRB 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 CYIRB office on or before the 15th of the month. Click here for the list of specific deadline dates.

B-2 ?What? to Submit for Full Board Review

1. Protocol (see Protocol Requirements) OR, for grant proposals (such as through the NIH, NSF, or AHA, etc.), a copy of the entire grant proposal (except for the budget section) including appendices is required.
2. Online Core Data Form found in IRBNet
3. Form for Financial Approval of Research at WCHOB, if applicable
4. Research Involving Children: Protocol Specific Determinations Form
5. Other forms as applicable to the research being conducted (e.g., Waiver of Consent or Waiver of Documentation of Consent Form, etc.)
6. All Consent/Parental Permission documents and Assent documents (as applicable - >7 years age). Submit paper copies and also submit electronic versions of these documents.
7. Advertising and recruitment materials (e.g., letters, postcards, flyers, posters, newspaper ads, press releases, bulletins, TV or radio spots, websites, Internet ads, electronic mailings, recruitment letters, and scripts for telephone contacts)
8. Questionnaires, surveys, etc., when applicable
9. Investigational Drug Data Sheet (if applicable)
   
   [IMPORTANT CHANGE IN REQUIREMENTS: CONTINUE to submit this form to the CYIRB as part of your application for full board review along with other applicable FDA documents. CHANGE: It is no longer necessary to submit a separate application to the WCHOB Investigational Drug Subcommittee (IDS)]
10. Investigator?s Brochure, if applicable
11. Authorization of Fee Collection for IRB Review of a Commercially Sponsored Research Protocol, when applicable
12. HIPAA document(s) as required by the project

B-3 When to submit to the CYIRB

The deadline for submission of NEW studies to the CYIRB for Full Board Review is the First Day of the Month.

If the first of the month falls on a weekend or holiday, studies will be due the first business day thereafter.

Please do not hesitate to contact us, if you have any questions:
Telephone: 878-7141
Email: cyirb@research.buffalo.edu

B-4 ?How? to submit to the CYIRB

Effective October 2, 2012, all submissions to the CYIRB must be made via IRBNet. For instructions, see the IRBNet information page.

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