Institutional Review Board
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:
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
Should be on pastel blue colored paper
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.
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
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
Johns Hopkins University
129 S/M Administration
Baltimore, MD 21205
Phone 410 955-3008
Fax 410 955-4367
Gary Briefel, MD
IRB Bayview Medical Center
Johns Hopkins Asthma & Allergy Center
5501 Hopkins Bayview Circle
Baltimore, MD 21224
Phone: 410 550-1853
Fax 410 550-0877