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The Johns Hopkins Medicine IRBs
Production of widely used IV solutions disrupted - Potential research implications:
Due to the hurricane in Puerto Rico, production of widely used IV solutions has been disrupted. The products directly affected are smaller volume bags of sodium chloride (NS 50 mL and 100 mL minibags). Johns Hopkins Hospital and several hospitals across the country are now experiencing shortages of some products and are strategizing to find alternatives. The FDA has given Baxter International permission to import sodium chloride and other intravenous solutions from its manufacturing facilities in Australia and Ireland but this supply is not yet readily available.
A multidisciplinary team of health care providers here at Johns Hopkins Hospital have been analyzing Epic data and inventory to develop alternative plans if needed. This analysis includes data for clinical drug trials. The Investigational Drug Service pharmacists will be communicating with you if the shortage has or will potentially impact your clinical trial(s). The Office of Human Subjects Research is aware of this situation and is collaborating with pharmacy to review data and determine a process for further actions depending on the extent and duration of the shortage. As sodium chloride IV solution inventory is exhausted, information provided in the protocols and the investigator brochures will be utilized to identify available alternatives for IV solutions.
FWA Changes: By November 1, 2017 we will make changes to streamline the number of FWAs held by the institution and ensure that each legal entity has one FWA. This will require closing out some existing FWAs assigned to organizations that are components under either the Johns Hopkins School of Medicine FWA number or The Johns Hopkins Health System FWA number. For more information...
Training Sessions: Preparing for NIH's Single IRB Review Requirement: This training will review NIH's new policy for single IRB review and its implications; discuss how JHU will address the single IRB review requirement. For more information and to register...
NIH Announces New Changes Regarding Certificates of Confidentiality for NIH-funded Research: Effective October 1, 2017, all ongoing or new research funded wholly or in part by NIH as of December 13, 2016 that is collecting or using identifiable, sensitive information is automatically issued a Certificate of Confidentiality (Certificate) as a term and condition of NIH grant awards. For more information...
NIH's Single IRB Review Requirement: Effective January 25th 2018, the NIH requires that all grant applications for domestic, multi-site, non-exempt human subject research studies include a proposal for the use of a single IRB (“sIRB”) to review the research for all participating domestic sites. The JHSPH IRB, the SOM IRB, and the Homewood IRB are working together to address the new NIH requirement for sIRB. For more information...
Final Rule: Federal Policy on Protection of Human Subjects (Revisions to the Common Rule): The U.S. government has published its changes to the regulation known as “The Common Rule” governing Human Subjects Research. The IRB office is reviewing the new rule and will communicate information about the changes, including statements about what these changes mean for researchers at Johns Hopkins University in the next few months.
The rule goes into effect in 2018. A version of the final rule was made available on January 18, 2017, by the Office of the Federal Register and can be accessed at: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-protection-of-human-subjects. It is expected that the final rule will be published in the Federal Register on January 19, 2017.
The Institutional Official who has authority over the JHM Human Subjects Protection Program is the Vice Dean for Clinical Investigation. The current Vice Dean for Clinical Investigation is Dr. Daniel E. Ford.
The Johns Hopkins Medicine Institutional Review Boards (JHM IRBs) are responsible for protecting the rights and welfare of the human subjects of research conducted by faculty and staff at the Institutions. The JHM IRBs review all human subjects research projects conducted by Hopkins faculty and staff. To fulfill the agreement underlying the assurances, and to satisfy institutional policy, all faculty and staff at the Institutions must submit for JHM IRB review any human subject research project, regardless of funding source (or lack thereof) and/or location at which the research will be conducted.
Please Note: Part-time faculty are obliged to obtain JHM IRB approval of all human subjects activities conducted under the auspices of their Hopkins’ appointment ( which means “use of Hopkins’ personnel or space or the use of the faculty appointment in correspondence, agreements with sponsors, etc…”).
The Institutions operate under Federal-Wide Assurances associated with each of the organizations linked to the JHM IRBs. List of JHM FWAs
For more information on the federal guidelines that determine the kind of research the JHM IRB is required to approve please visit http://www.hhs.gov/
Guiding Principles of Institutional Review Boards (IRB)
Johns Hopkins experts discuss the critical role of Institutional Review Boards in research involving human subjects and the guiding principles they operate by:
- respect for persons
- risk and benefit analysis
- justice and fairness.
General IRB Questions