The Krieger School of Arts and Sciences, Whiting
School of Engineering, School of Professional Studies in
Business and Education, SAIS and the Applied Physics Lab
require that all research projects involving human subjects
be reviewed and approved, or declared exempt, by the
Homewood internal review board before a project may be
initiated.
The Homewood IRB, known as the Homewood Human Subjects
Review Board, or HSRB, is charged with the responsibility
for review and approval of human subjects research
conducted by faculty members (full or part time), students
and staff of the JHU divisions listed above. The
requirement for review applies regardless of the source (or
lack of source) of funding for a project and regardless of
the site at which the research is performed.
The HSRB operates in compliance with the U.S. Code of
Federal Regulations, Department of Health and Human
Services Title 45 Part 46, titled Protection of Human
Subjects. A copy of the DHHS and FDA regulations may be
obtained online at the respective agency Web site and also
at the JHU Research and HSRB Web sites.
The primary concerns of the HSRB are to determine
that:
1. the rights and welfare of the subjects are
protected adequately,
2. the risks to subjects are outweighed by the
potential benefits of the research,
3. the selection of subjects is equitable and
4. informed consent will be obtained and, when
appropriate, documented.
To apply for review, go to the HSRB Web site at
www.cog.jhu.edu/hsrb to find "Application for IRB
Review." Submit the application with all required materials
to the Homewood HSRB office located at 151 Krieger Hall (or
237 Krieger, if sent by campus mail). Or you may submit the
material electronically (preferred method) to
hsrb@jhu.edu.
If you e-mail the application, you must send a hard copy of
the signature page or fax the page to 410-516-0150.
Required materials include the consent form to be used
with your subjects. To see approved consent form templates,
go to
www.cog.jhu.edu/hsrb/Forms.html#consentforms.
If applicable to your protocol (e.g., if children are
involved), there may be additional forms to submit. The
application form provides information as to what additional
forms may be required.
All applications submitted to the IRB must designate a
faculty member, or senior staff member in the case of APL,
as the principal investigator or supervisor. The
institution requires that responsibility for compliance
with institutional guidelines and policies rests with a
faculty member of the department in which the project will
be conducted. Therefore, postdoctoral fellows, staff or
students may actively conduct human subjects research
activities, but either the principal investigator of record
or supervisor on a research project submitted to the HSRB
must be a Johns Hopkins University faculty member, or a
senior staff member at APL.
The IRB home page contains the link "Deciding Whether
and How to Apply":
www.cog.jhu.edu/hsrb/Deciding.html.
The information available here guides you through the
process of determining whether you must submit an IRB
application and, if so, what type of application to
submit.
If you believe that your research qualifies for
exemption or expedited review, begin your application
process with "Exemption Checklist":
www.cog.jhu.edu/hsrb/Exemption.html or "Expedited
Review Checklist":
www.cog.jhu.edu/hsrb/Expedited.html.
You must submit the checklist with your application, and
only the HSRB can decide whether the research qualifies for
exemption or expedited review.
Projects eligible for exemption or expedited review
take two to three weeks to process, whereas three to six
weeks may be needed for projects requiring full-board
review. If you have any further questions or concerns,
contact the HSRB at 410-516-6580 or hsrb@jhu.edu.
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