The Johns Hopkins All Children's Institutional Review Board (IRB) oversees all research involving human subjects conducted by Johns Hopkins All Children's Hospital staff and employees, regardless of the location of the research or its source of financial support. The Johns Hopkins All Children’s IRB is one of seven Johns Hopkins Medicine IRBs, which it joined in 2013.
The Johns Hopkins All Children’s IRB reviews and approves all research activities involving human subjects to ensure that the rights, safety and welfare of the participants are protected. The board also reviews and approves all research uses of human tissue/specimens obtained from Johns Hopkins All Children's Hospital patients, and reviews the use of all hospital patient records for research purposes.
The board requires research personnel who are involved in human subject research to be appropriately trained before conducting research. Principal Investigators and research staff are required to complete training on human research subject protection and regulations.
Additionally, the hospital uses an electronic Johns Hopkins All Children's Hospital Institutional Review Board protocol submission system called eIRB to efficiently create and submit research protocols for review and approval. All new protocols must be submitted through eIRB, a process that became effective June 2014. The Johns Hopkins All Children’s IRB meets monthly.
Ellen Bedard, MSOB, CCRP
Johns Hopkins All Children’s Associate Institutional Review Board Manager
Johns Hopkins Medicine All Children's Hospital Institutional Review Board is guided by federal regulations which include, but are not limited to the following. Principal Investigators and research staff are strongly encouraged to review these regulations.
- The Belmont Report
- Title 45, Part 46 Code of Federal Regulations
- CFR - Code of Federal Regulations Title 21
- FDA: A Guide to Informed Consent
- HHS Office of Human Research Protections
- FDA Guidance for Institutional Review Boards, Clinical Investigators and Sponsors
- Guidance for Industry: Investigator Responsibilities - Protecting the Rights, Safety, and Welfare of Study Subjects
- Consolidated Guidance for Industry: E6 Good Clinical Practice
- Good Clinical Practice in FDA-Regulated Clinical Trials
- NIH HIPAA Privacy Rule Information for Researchers