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Johns Hopkins Medicine Clinical Research

Discover the latest news, resources and links to offices supporting clinical research at Johns Hopkins Medicine.


What's New?

  • On June 1, 2022, the new Johns Hopkins University policy, approved in January 2022, on investigator-held INDs/IDEs will take effect, requiring institutional approval to serve as sponsor-investigator and submit an application for a new IND or IDE to the FDA. 

    The policy does not apply to IND/IDEs submitted before the effective date or to IND/IDE exempt studies. Detailed guidance for the process to secure institutional approval from the Office of Clinical Trials (OCT) Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program is available. 

  • For those involved in clinical research hospital billing, please note that as of 4/1/22 hospital billing charges are decreasing slightly for both federal/non-profit and commercial sponsors.

    Details are in this letter. To access pricing and develop budgets or for questions, please contact the Clinical Research Support Services (CRSS) team at

  • A new university policy is now available that will help investigators who wish to serve in the role of sponsor-investigator and hold an IND or IDE to understand their responsibilities. The policy will help maintain our compliance with FDA regulations and ensure support for investigators who wish to serve in this important role.

    The policy will be effective June 1, 2022.

    The Office of Clinical Trials will be responsible for supporting investigators in adhering to this policy. Additional information including tools to prepare for policy implementation will be released in Spring, 2022.

  • Our experience over the past two years and your hard work have prepared us well to safely continue clinical research during the current surge, recognizing the need to navigate limited resources and staff.  We trust that you will be able to leverage flexibilities incorporated as part of the restart process. Please see this message for guidance and recommendations.

  • We have implemented improvements to the registration process for Human Subjects Research (HSR) Compliance Training. Investigators and Study Team Members will be able to enroll in required training courses (initial training, ICH GCP and recertification) by selecting one “bundle” in myLearning. Once enrolled in myLearning, you will be directed to the CITI site where courses will be added to your plan by selecting the “bundle” you wish to complete. Please review this guide on how to get started. For additional questions, please contact the IRB Help Desk at

  • The OHSR and IRB staff have two new ways to communicate with you:

    • Microsoft Teams. On the Contact page, you can find contact information for staff members, including new Microsoft Teams phone numbers, email addresses and newly added links to chat with a staff member.
    • Request a Consult. If you want a comprehensive discussion about, e.g., protocol planning assistance, please request a consult, and the OHSR staff will connect you with an appropriate team member.

  • We are pleased to announce the launch of the Johns Hopkins Office of Clinical Trials, led by Mark Sulkowski. The office’s mission is to help Johns Hopkins clinical investigators and research teams to push the boundaries of discovery with support to develop, initiate and conduct clinical trials within the framework of human research participant protection and regulatory compliance.

  • We are pleased to announce that the Johns Hopkins Medicine Human Research Protection Program (HRPP) was awarded full accreditation for another five years, effective June 15, 2021. Unique and strategically placed Johns Hopkins Medicine and HRPP services that support researchers earned it an area of distinction recognition from the Association for the Accreditation of Human Research Protection Programs council.

    The area of distinction is a special recognition for HRPPs that have an aspect of their program that is considered a model for other organizations. This important achievement reflects Johns Hopkins’ continuing commitment to protecting the rights and welfare of research participants.

  • Data protection attestation has been integrated into eIRB and public health institutional review system tracking (PHIRST) to enable sharing of limited data sets among Johns Hopkins University (JHU) researchers. This change eliminates the need for a data use agreement for most transfers of a limited data set to JHU collaborators. New guidance is now available to help JHU researchers?navigate the process?and requirements?for requesting use of Johns Hopkins Medicine (JHM) data.

  • If you are interested in or are working with artificial intelligence (AI), please register here to join a growing Johns Hopkins University community of AI scholars. Please contact Stuart Ray with questions or for more information.

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