About The Gazette Search Back Issues Contact Us    
The newspaper of The Johns Hopkins University March 29, 2004 | Vol. 33 No. 28
Policies and Procedures for Human Subjects Review Board

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 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 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

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":

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": or "Expedited Review Checklist":

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


The Gazette | The Johns Hopkins University | Suite 540 | 901 S. Bond St. | Baltimore, MD 21231 | 443-287-9900 |