OHRA oversees the Kennedy Krieger pre-review process for all human subjects research studies where Kennedy Krieger is identified as a study site on an IRB application. OHRA is available to assist Principal Investigators in writing clear, organized, and well-designed research protocols.
The Hugo W. Moser Research Institute at Kennedy Krieger, Inc. has its own Federalwide Assurance Number (FWA00005719) for research involving human subjects, issued by the U.S. Department of Health & Human Services Office of Human Research Protections (OHRP). The Johns Hopkins Medicine Institutional Review Board (JHM IRB) serves as the IRB of record for Kennedy Krieger. Accordingly, Kennedy Krieger adheres to the JHM IRB institutional policies and guidelines insert link https://www.hopkinsmedicine.org/institutional_review_board/] for the conduct of research.
All Kennedy Krieger faculty and staff must submit for JHM IRB review any human subject research or quality improvement project application. In some multi-site non-exempt human research studies, Kennedy Krieger administration may approve reliance on an external IRB other than Johns Hopkins as the single IRB of record. However, a JHM IRB local context application submission with review and approval is still required for these single IRB studies with external reliance. For more information on single IRB, please contact Elaine Stashinko at email@example.com
All new applications requiring review by the JHM IRB are submitted electronically via the eIRB system and are subsequently pre-reviewed by the Office of Human Research Administration (OHRA) at Kennedy Krieger.
OHRA’s pre-review process consists of checking for application completion and inclusion of all required elements, as well as a risk and safety review assessment. When necessary, the Principal Investigator is asked by the pre-reviewer to provide additional information and make application revisions. OHRA ancillary committees may also be consulted during the pre-review process in special circumstances, such as conflict of interests in research, high risk research, or data security concerns.
For more information, please see Research Involving Human Subjects Policy.