The Accelerating Excellence In Translational Science (AXIS)Charles Drew University of Medicine and Science

Institutional Review Board & Office for the Protection of Human Subjects

Department Summary:

The Office for the Protection of Human Subjects (OPHS) is the administrative office for the Institutional Review Board (IRB). Our office provides ethics and regulatory consultation and pre-review service to help CDU researchers with the development of their research protocols and IRB applications.

1.What kind of services do you provide for researchers?
Consultation with investigators on designing ethically sound human subject research protocols and preparing the documents for IRB review.
Pre-review of IRB documents prior to submission.
Education and training on applicable regulations and laws as well as CDU’s IRB policies and procedures.
Determine whether the study requires IRB review.
Pre-review of Human Subjects Protection section in grants.

2.Describe a typical interaction with a researcher.
A typical interaction starts off with an inquiry by the investigator as to whether they need to submit an IRB application. We ask the researcher to send us the research protocol, unless we can use the decision matrix to determine whether their activity is human subject research. The staff reviews the protocol and usually follows up with a phone call or e-mail with further questions to determine whether the study (1) is not human subject research (no IRB review needed), (2) falls under exemption category, (3) falls under expedite category, or (4) requires full-board review. The staff sends e-mail to the investigator with links to the IRB forms and CITI online training, as well as guidance on which IRB forms and supplemental documents to submit. The investigator submits the entire IRB application packet either via e-mail or as hardcopy to our office. The analyst then does the pre-review and sends comments back to the investigators. The revisions to the IRB application occur several times between the investigator and staff before the complete IRB application packet is sent to the IRB reviewers. Once the application has been either reviewed at the fully convened IRB meeting or by the expedited mechanism, the staff notifies the researchers to pick up the IRB correspondence with the review results.

3.Tell us one thing researchers might not know about your office.
Our front door says “IRB” for Institutional Review Board. I’ve been told that some people thought it was the “Internal Revenue Board”!

4.What are your plans to improve research services in the future?
Start a hands-on training session on how to effectively fill out an IRB application and problem solving workshops based on real and hypothetical research studies.
Collaboration with CTSI and RTRN institutions to reduce multiple IRB reviews in collaborative projects.

5.What’s the best way for researchers to reach you?

The Research Resource Spotlight series focuses on the offices and departments at CDU that are available to help researchers enhance their productivity and excel at translational research. It is produced by AXIS (Accelerating Excellence in Translational Science) which is funded by NIH Grant #U54 RR026138.

Institutional Review Board (IRB)/Office for the Protection of Human Subjects (OPHS)

Building F





Wednesday, February 01, 2012

      Junko Nishitani, Ph.D.
IRB Director
(323) 563-4966

      Margie Dike, Ph.D., M.P.H.
Senior IRB Analyst
(323) 357-3649

      Dawna Masterson, B.S., CCIP, CIM
Policy and Regulatory Analyst
(323) 357-3654

A typical interaction starts off with an inquiry by the investigator as to whether they need to submit an IRB application.

The OPHS/IRB team is here to help. Send us an email about your research protocol.