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Authority to develop, implement, and monitor all human subjects protection programs has been designated by the President of JHM and the President of KKI to one Institutional Official (IO), the Vice Dean for Clinical Investigation. The JHM IRBs are authorized by the IO to review human subjects research projects and clinical investigations conducted by Hopkins faculty and staff. All faculty and staff at the Organization must submit for JHM IRB review any human subjects research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted. JHM IRB approval or acknowledgement is required before a project may begin.
Except for research that is exempted or waived under 45 CFR 46.101(b) or 45 CFR 46.101(i), all human subjects research conducted at the Organization will be reviewed, prospectively approved, and subject to continuing oversight and review at least annually by the JHM IRB. The review will address all the criteria listed in 45 CFR 46.111 and 21 CFR 111: that risks to subjects are minimized through sound research design and are reasonable in relation to anticipated benefits and knowledge gained; that the selection of subjects is equitable such that no population or subpopulation bear an imbalance of the burden of research or enjoy an inequitable share of the benefits; that the informed consent process and documentation plan is appropriate; that the safety of the study is protected by an appropriate plan and monitored by an independent party, if needed; that the privacy of subjects and the confidentiality of study data is protected; and that adequate protections are in place for vulnerable populations. The IRB will evaluate whether resources are adequate to protect participants’ rights and welfare.
The JHM IRBs may approve, require modification to secure approval (“table”), or disapprove proposals. JHM IRB review and approval of research studies and exemption determinations are required BEFORE the research begins. JHM IRB disapproval may not be overruled by any other Organization authority. The JHM IRB may suspend, place restrictions upon, or terminate approval of research studies falling within its jurisdiction that are not being conducted in accordance with JHM IRB requirements or that have been associated with unanticipated problems or events. By verbal or written recommendation, the IRB Chairperson or another IO may prompt the Principal Investigator (PI) to voluntarily suspend the research. The JHM IRB may have the consent process or the research procedures of any study observed by a third party if the JHM IRB determines that such observation is indicated. The decisions of the JHM IRB shall be conveyed to the PI in writing. The PI will notify any sponsors or other interested parties, such as those involved in multi-center studies, as necessary, of IRB decisions (45 CFR 46.109(d)).
A JHM IRB decision to table or disapprove a study must be conveyed to the PI with an explanation of the reasons for the decision. The PI has the opportunity to respond to that explanation in writing.