Institutional Review Board

 

The Johns Hopkins University School of Medicine, The Johns Hopkins University School of Nursing, the Johns Hopkins Hospital, and the Kennedy Krieger Institute require that no research project involving human subjects be initiated until the project has been reviewed and approved, or declared exempt from review.

The Joint Committee on Clinical Investigation (JCCI) is the Institutional Review Board (IRB) charged with the responsibility for review and approval of human subjects research conducted by faculty members (full or part-time) of The Institutions, and all research involving patients and/or employees of The Johns Hopkins Hospital or The Kennedy Krieger Institute, and/or employees or students of the School of Medicine. Review is required regardless of source (or lack of source) of funding for a project and regardless of the site at which the research is performed. The JCCI operates in compliance with the U.S. Code of Federal Regulations, Department of Health and Human Services (DHHS) Title 45 Part 46, entitled "Protection of Human Subjects", as well as the Food and Drug Administration (FDA) regulations on human subjects research.

The JCCI has a useful and informative website:

http://infonet.welch.jhu.edu/research/jcci/

Here you can find direct links to most JCCI forms. It's also a great resource to familiarize yourself with guidelines and operating procedures.

Some forms you might need for your IRB submission would be:

Research Project RPN application
Consists of a form and questionnaire

Consent form
Should be on pastel blue colored paper

Radiation forms
The radiation committee is so helpful. Call them!

Drug data form
Is it an IND study? Remember to submit a copy of the protocol and Investigator's brochure for studies of investigational drugs or devices.

A new application is called an RPN (Research Project Notification). If your study is an industry-initiated project, you are typically required to fill out the application form, obtain the sponsor's IND#, protocol, investigator's brochure, investigational new drug form and the radiation forms. Tip: To save time, submit the consent form for review by the sponsor at the same time that you submit to the IRB. You can always make changes later. If your study is NIH-funded, be sure to submit the Human Subjects Section of the grant along with the application, as well as a full copy of the grant.


Meeting Schedule

The Full Committee meets the 2nd and 4th Tuesday of each month to approve new studies. The Sub Committee meets every Monday to review amendments to existing studies. Be sure to submit all correspondence by 5 pm the Friday preceding the meeting. Putting the letter off just one more day, that is until Monday, means that your study will be delayed another 2 weeks until the next Full Committee meeting. Be sure that in future correspondence to either IRB you reference the RPN # in your correspondences and correct title. The RPN # is assigned by the IRB and will appear on the first letter you receive concerning your study.

If you are an investigator whose research falls within the purview of JCCI, please address your correspondence to Dr. Thomas Hendrix; if you are a Bayview investigator, please contact Dr. Briefel.

Thomas R. Hendrix
Chairman, JCCI
Johns Hopkins University
129 S/M Administration
Baltimore, MD 21205
Phone 410 955-3008
Fax 410 955-4367
e-mail jcci@jhmi.edu

Gary Briefel, MD
Chairman
IRB Bayview Medical Center
Johns Hopkins Asthma & Allergy Center
Room 3B-79
5501 Hopkins Bayview Circle
Baltimore, MD 21224
Phone: 410 550-1853
Fax 410 550-0877
e-mail jhbmcirb@jhmi.edu

 

 

 

 

 

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