Message from the Vice Dean
Gail Daumit, Vice Dean for Clinical Investigation, has released her plans for the future of the Clinical Research program. Learn about updates and expansions in her open letter.
This new Initiative seeks to transform healthcare such that every patient is known as a person and treated with respect, dignity and compassion. As a first step, they will fund up to 5 small grant proposals, and investigators will form a collaborative learning community. Details found here.
Please reach out to Mary Catherine Beach [email protected] with any questions.
Early-career faculty and new cross-divisional teams are encouraged to submit proposals for:
The Johns Hopkins University Catalyst Awards, for early-career faculty who are undertaking exceptional research or creative endeavors to help them launch their careers. The awards are up to $75,000 for faculty members appointed to a full-time tenure-track or tenure-track equivalent faculty position within no less than three years and no more than 10 years, as of July 1, 2023.
The Johns Hopkins University Discovery Awards focus on cross-university, faculty-led research and discovery. The awards are up to $100,000 for interactions among faculty from across the university.
There is a new platform available for payments and reimbursements for Johns Hopkins School of medicine study participants.
Greenphire ClinCard is a reloadable prepaid debit card available as an alternative to study teams to provide a simple, secure, and fast way to disburse study participant payments and reimbursements. The ClinCard portal helps automate, track, and report on incentive payments across all studies and stay compliant with tax law and HIPAA regulation. More information on this program here.
ClinCard is available now for new School of Medicine protocols needing to pay or reimburse study participants. Beginning February 15, 2023, the ClinCard option will be available for participants in existing School of Medicine studies.
To learn more and complete the online, recorded ClinCard training, please go to myLearning and search for “ClinCard” or the full course name “ClinCard Study Coordinator and Approver Training”.
Any questions about the new platform, please email [email protected].
The Johns Hopkins Doris Duke Early Clinician Investigator Award honors the academic achievements and potential of early career clinician scientists conducting original and rigorous clinical research projects. In order to be eligible for the award, applicants must have extraprofessional caregiving responsibilities. The grant provides each scholar up to $30,000 of supplemental research funds, in direct costs, over 12 months to support awardees’ current or developing research. Awardees are connected with helpful resources, have mentorship meetings with the program directors, and are welcomed into a community of program scholars. The application deadline is Friday, February 3, 2023.
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.
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.
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 [email protected].
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 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.
Johns Hopkins Office of Clinical Trials
The new Johns Hopkins Office of Clinical Trials (JH-OCT) will help Johns Hopkins clinical investigators and research teams to push the boundaries of discovery with unparalleled support to develop, initiate and conduct clinical trials within the framework of human research participant protection and regulatory compliance. The JH-OCT brings together three groups in the school of medicine Office of Research Administration that provide essential services to efficiently move clinical trials contracts and budgets forward: clinical research contracting, clinical research support services and clinical research billing compliance. JH-OCT is the gateway for clinical investigators to find the tools, resources and support required to advance discovery and clinical care in our community and beyond.
Mark Sulkowski, MD
Professor of Medicine
Senior Associate Dean for Clinical Trials