Applying Ethics and Integrity to Human Research.
IntegReview reviews the following types of research: Phase I-IV drug/biomedical, medical device, social and behavioral, Investigator-sponsored, single and multiple investigator as well as research conducted in academic and hospital settings, expedited review for research that qualifies, expedited review of additional Investigators, research determined to be exempt, International research and Canadian investigators.
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IntegReview Ethical Review Board
3001 S. Lamar Blvd., Suite 210
Austin, TX 78704
Phone: 512-326-3001
Fax: 512-697-0085
Email:

Expedited Review Process

Certain kinds of research involving no more than minimal risk, as indicated in Title 21, CFR, Part 56.110 or Title 45, CFR, Part 46.110 may be reviewed utilizing the expedited review process.

GUIDELINES / ELIGIBILITY:

The FDA has established, and published in the Federal Register a list of categories of research that may be reviewed by the IRB through an expedited review procedure.  An IRB may use the expedited review procedure to review the following:

  • Some or all of the research appearing on the list and found by the IRB reviewer(s) to involve no more than minimal risk (new studies, new principal investigator submissions, continuing review)

Minor changes in previously approved research during the period for which approval is authorized.  IntegReview may utilize expedited review for the following:

  • Addition of a sub-investigator when the sub-investigator will not be performing study-related procedures that the Principal Investigator is not qualified to perform
  • Relocation of a previously approved study site or the addition/deletion of a study site
  • Change in Principal Investigator
  • Protocol Amendment
  • Investigator Brochure revision
  • Informed Consent revision
  • Advertising materials

PROCEDURE:

Expedited review is review of proposed research by the IRB Chairperson or a designated voting member or group of voting members rather than by the entire IRB.  The reviewer may exercise all of the authorities of the IRB except that the reviewer may not disapprove the research. A research activity may be disapproved only after a review by the full board.

TIMELINES:

Items that qualify for expedited review will be processed upon receipt and distributed to PI within two (2) business days following IRB review. Below is a breakdown of the total turn-around time for each type of submission:

  1. New study submissions: total processing time from completed submission to distribution to PI = within 6 working days
  2. New Principal Investigator submissions: total processing time from completed submission to distribution to PI = within 2 working days
  3. New/revised documents submitted following initial IRB approval (i.e. protocol amendments, IC revisions, etc.): total processing time from completed submission to distribution to PI = within 2 working days

Should you have other questions or concerns regarding the IntegReview Expedited Review Process, please call us at 512-326-3001 or send us an email at integreview@integreview.com.