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 IRB has modified its research plan and is posting TWO new documents: one is a new Research Plan for Secondary Data Analysis of Existing Data/Specimens, and the second one is a revised Research Plan for New Data Collection. We have tried to improve the logical flow of the documents, and to separate out the sections that are specific to certain types of studies. We have also tried to improve the descriptions of the information we need to complete our reviews to reduce the amount of back-and-forth with investigators. We welcome feedback, so please send your comments to firstname.lastname@example.org (our new IRB office email address). PLEASE DELETE ALL EARLIER RESEARCH PLAN TEMPLATES FROM YOUR COMPUTERS AND USE THE NEW VERSIONS. Thank you.
- The IRB is posting guidance on internet research written by the DHHS Secretary’s Advisory Committee on Human Research Protections (SACHRP). Investigators proposing such research should review its recommendations. It is also posting the President’s Bioethics Commission report on Ethical Management of Secondary and Incidental Findings.
The IRB is posting a new Data Security Guide created by Darren Lacey, Chief Information Security Officer and Director of IT Compliance for JHU and JHM. The guide is for investigators using clinical data, especially those using 500 or more medical records. All investigators who will use Protected Health Information (PHI) should review and follow.