Institutional Review Board
The Johns Hopkins Bloomberg School of Public Health is committed to protecting the rights and welfare of all individuals who participate as subjects in research. The School has two on-site Institutional Review Boards (IRB X and IRB FC) and an external IRB (the Western IRB) that reviews certain studies on our behalf. It is the responsibility of faculty and students to ensure that formal IRB approval is obtained before initiating contact with human subjects in any research project.
The holiday season will soon be here, and because Thanksgiving, Christmas, and New Year’s all fall on IRB meeting days, we will have fewer meeting days to review your submissions. The IRB Office will hold a meeting the day before Thanksgiving (November 27, 2013), however, to avoid backups and delays which could adversely affect your research, please think ahead and submit your Progress Reports and Amendments well in advance. Thank you.
- The IRB is happy to post a new Khmer (Cambodian) of its Field Training Guide. Please let us know if you have other translations available to post
- The IRB revised the Unanticipated Problem Event Report Form by adding a section that asks about risks of harm that go beyond study operations and typical “SAE” items that might affect a single participant to include changing local social/political conditions and other potential harms that could have broader implications. We hope this addition will make it easier to fill out the form.
- To all investigators whose studies may be affected by the government shutdown: Please let us know if you need help with research stoppages, review deadline problems, or other IRB related complications to your work.
- The JHSPH IRB is launching a new web-based module series called “QUALITY IMPROVEMENT THROUGH SELF-ASSESSMENT.” This series is designed to help human subjects research investigators meet their commitment to comply with legal, regulatory, and institutional requirements by monitoring their own research studies. It’s public, and we are not collecting identifiers from the users. We’d appreciate feedback from you; please direct questions/comments/suggestions to our Quality Improvement Specialist at email@example.com.
- The JHSPH IRB has revised the Investigational Drug Data Sheet (IDDS) required for research applications that involve Investigational New Drug Applications. The instruction section is simpler and the form incorporates a more detailed protocol section to collect site specific information. Please feel free to contact the IRB office if you have any questions.
- We have updated our CITI FAQs to help you understand the new compliance training requirements.
- The JHSPH IRB has updated its requirements for human subjects research ethics training for JHSPH faculty, staff, and students engaged in human subjects research. Certification of completion of CITI training must be renewed every 5 years. Certain specialized research requirements have been added for investigators conducting clinical trials, working on Native American reservations, using Protected Health Information (PHI), and/or funded by the Department of the Navy. Training requirements for non-JHSPH collaborators have not changed. The IRB has updated its website to more fully explain its requirements and CITI course offerings under the CITI training link.