Institutional Review Board

print

Institutional Review Board

BioDevelopment


An Institutional Review Board (IRB) is a committee established to review and approve research involving human subjects. The purpose of the IRB is to ensure that all human subject research be conducted in accordance with all federal, institutional, and ethical guidelines.


0


Overview

Our facility has an FDA-approved IRB. This board operates independent of OBI management and is able to perform expedited reviews for research protocols and informed consents. The IRB reviews, approves and monitors research to ensure that all ethical considerations of a project are evaluated and that the benefit of the research outweighs potential risks. A key goal of the IRBs is to protect human subjects from physical or psychological harm, which they attempt to do by reviewing research protocols and related materials. The protocol review assesses the ethics of the research and its methods, promotes fully informed and voluntary participation by prospective subjects capable of making such choices (or, if that is not possible, informed permission given by a suitable proxy), and seeks to maximize the safety of subjects. This board is diverse and is composed of a mix of medical and lay members which allows for objectivity in ensuring protection of the rights of human subjects.

Customize

Study Approval Time
N/A 2-3 Weeks 1 Month 2 Months 3 Months

Worksheet for Clinical Investigation
N/A Currently 0% Currently 50% Need Review of Current Draft

Subject Consent Form
N/A Currently 0% Currently 50% Need Review of Current Draft

Study Budget Development
N/A Currently 0% Currently 50% Need Review of Current Draft

Protocol Submission
N/A FDA Submission

COLLECT:

Custom collections from a pool of thousands of healthy donors.

CHARACTERIZE:

Flowcytometry characterization of immune cells.

ISOLATE:

Research or GMP grade positive or negative cell selection procedures.

EXPAND:

Flask or automated expansion services.

FREEZE:

Controlled rate freezing using custom cryo-preservatives.

STORE:

Monitored LN2 vapor phase storage of products and samples.