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 updated its information about human subjects research conducted in collaboration with the Baltimore City Health Department (BCHD) and the Maryland State Department of Health and Mental Hygiene (DHMH). Please review it if you work with the DHMH or City or County Health Departments in the State of Maryland.
- Please note there will NOT be a meeting for IRBX on July 3 2014.
- The Pan American Health Organization has published a research ethics casebook in Spanish for use in ethics training. We are posting the link on our page called “IRBs/RECs involved in international research.” Please share it with your colleagues.
- As internet research opportunities expand, investigators and the IRB will continue to address the related ethical issues. We have posted on our website the DHHS “Secretary’s Advisory Committee on Human Research Protections” (SACHRP) guidance “Considerations and Recommendations Concerning Internet Research”, and the slides from a webinar on “Conducting Internet Research” provided by the federal Office of Human Subjects Protections (OHRP), and will refer to these resources when reviewing internet studies.
- The U.S. Office of Research Integrity (ORI) and the Office for Human Research Protections (OHRP) have joined forces and created an interactive training video for clinical and behavioral researchers on protecting human subjects and research integrity. It might be useful. Here’s the link to the tool, called “The Research Clinic”: http://ori.hhs.gov/TheResearchClinic.
- 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 email@example.com (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.