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The Johns Hopkins Medicine IRBs
New Guidance Regarding Documents that Require an IRB Approval Stamp:
Starting on June 18th 2018 the IRB will enforce new guidance regarding documents that require an IRB approval stamp. IRB approval stamps will be placed in the top left corner of the document only, no exceptions. Additionally, documents requiring an IRB approval stamp will be accepted in MS Word and PDF formats only. For additional information please see the guidance regarding recruitment documents. Click here for more information...
New Course Announcement: Good Clinical Practice (GCP) Fundamentals
The JHM Office of Human Subjects Research is offering a GCP course entitled, “Good Clinical Practice (GCP) Fundamentals: Understanding and Applying GCP to Human Subject Research.” This 90 minute seminar occurs on the fourth Friday of every month, and satisfies the JHM “in-person” training requirement for investigator and study-team member re-certification. Click here for more information
Single IRB, Central IRB, Reliance Agreements...What do these names mean to you?
Effective 1/25/2018, NIH's SIRB policy applies to ALL NIH Funded multi-site studies to use a Single IRB of record". Click here for more information
UPDATE: Delay in Changes to the Federal Policy on Protection of Human Subjects (the Common Rule):
A revised version of the federal rule governing Human Subjects Research (i.e. the Common Rule) was scheduled to go into effect on January 19, 2018. On January 17, 2018 an Interim Final Rule was released delaying the effective date of the rule changes until at least July 19, 2018. The Interim Final Rule can be accessed at the following link: https://www.federalregister.gov/documents/2018/01/22/2018-00997/federal-policy-for-the-protection-of-human-subjects-delay-of-the-revisions-to-the-federal-policy-for.
Until the Final Rule becomes effective, all human subjects research must continue to comply with the existing Common Rule. The OHSR will keep study teams apprised of any changes to the federal requirements for human subjects protections. Please check the OHSR website frequently for any updates. For more information about the changes generated by the new rule, including information about forthcoming training sessions...
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...
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