In This Issue
- CRTP Virtual Poster Presentation
- Clinical Research Center Available for your Research
- Research Community News and Updates
- New Drug or Device Regulatory Presentations
- AAHRPP Accreditation Site Visit April 27-29
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CRTP Virtual Poster Presentation Now Available |
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The Einstein Clinical Research Training Program (CRTP) ( funded by the NIH under the CTSA) is currently hosting its annual poster presentation through a virtual platform! Click here to view the CRTP poster presentations from some of the members of our CRTP classes of 2020 and 2019 without having to walk along Main Street.
The CRTP and is also currently accepting applications due March 1st.
This 2-year program consists of a rigorous curriculum, emphasizing epidemiology, biostatistics, data analysis, grant writing, and research ethics; and a faculty mentored experience in clinical research, leading to the preparation of a thesis. Scholars successfully completing this program will earn a Master of Science (MS) in Clinical Research Methods degree granted by the Albert Einstein College of Medicine.
New this year are expanded course offerings for research methodologies across the translational spectrum in:
· Population & Clinical Sciences
· Patient Centered Outcomes Research
· Bench to Bedside Translational Research
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Clinical Research Center Welcomes Your Research |
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The Clinical Research Centers at Einstein and Montefiore campuses support protocols in epidemiology, genetics, general medicine, neurology, women’s health, pediatrics, psychiatry/behavioral sciences, infectious diseases and surgery. The units see ~4000 out-participant visits annually, intensive procedures, and first-in-human research and have resources available for your clinical research needs. The units are located at the Van Etten Building on the Einstein campus and Moses Research Tower on the Montefiore campus.
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Research Community News and Updates |
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AAHRPP Accreditation Site Visit April 27-29 |
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The Association for the Accreditation of Human Research Protection Programs (AAHRPP) has scheduled a remote site visit for April 27-29, the final step in the AAHRPP accreditation process for Einstein-Montefiore. AAHRPP is a worldwide independent accrediting organization that promotes the highest standards for protection of subjects, as well as the ethical conduct of research with human participants.
Anyone who is engaged in human research may be selected for an interview, which will be conducted remotely using Zoom. In anticipation of the site visit, OHRA may reach out to you to prepare you and provide you with required materials. The OHRA has prepared a dedicated AAHRPP Site Visit webpage that includes resources to prepare for the interviews. Current policies and procedures related to human subject protections can be found on OHRA’s website’s Policies and Procedures page. Christopher Eichstedt, IRB QA/QI Manager, has been leading the AAHRPP accreditation process. Please reach out to him at christopher.eichstedt@einsteinmed.org if you have any questions.
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New IND and IDE Series: Drug or Device Regulatory Processes |
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The ICTR and the Office of Human Research Affairs (OHRA) have collaborated to prepare a series of presentations on investigational drug and device studies. If you are interested in attending any of the presentations, please contact Kaori Germano (kaori.germano@einsteinmed.org) for more information.
March 4, 2:00-3:00 PM: IND Overview
We will provide an overview of Investigational New Drug applications, including FDA’s requirements, categories/types, tips for preparing an initial submission, ongoing reporting requirements, and the role of the IRB throughout the process.
March 11, 2:00-3:00PM: IDE Overview Part 1: Foundational Basics
We will provide an overview of Investigational Drug Exception applications, including FDA requirements, the IRB’s role, and post-approval requirements for non-significant risk device studies.
March 18, 2:00-3:00PM: IDE Overview Part 2: Expanded Access
We will provide an overview of types of expanded access and qualifying criteria for device determinations. We will also review IRB processes regarding Humanitarian Use Devices and physician responsibilities.
March 25, 2:00-3:00PM: IDE Overview Part 3: Specialty Cases
We will provide a review of software, combination products and general wellness in the IDE space. Definitions, factors for characterization and tips for getting started will be shared.
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Single IRB Policy Reminder |
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On January 20, 2020 the Revised Common Rule’s Cooperative Research Provision went into effect, bringing changes to cooperative research conducted by Einstein researchers. The provision requires all new federally funded human subjects research involving more than one institution to be reviewed and approved by a single IRB. Please research out to singleirb@einsteinmed.org with questions or go to the Einstein OHRA website for more details.
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Montefiore-Einstein Health Tech Innovation Seminar |
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The Health Tech Seminar will take place on Thursday, February 25th at 5:15pm over Zoom. The topic will be "Therapeutics" and will feature speakers:
Steven Almo, PhD Chair, Department of Biochemistry, Albert Einstein College of Medicine. Professor of Biochemistry and of Physiology & Biophysics, Wollowick Family Foundation Chair in Immunology, Director, Einstein Macromolecular Therapeutics Developmental Facility, Co-Founder of Cue Biopharma.
Shivali Gulab, PhD Chief Executive Officer, Avalia Immunotherapies.
Jose Quiroz, MD, PhD Candidate Albert Einstein College of Medicine, Co-Founder of Bow Therapeutics, Medical Entrepreneur Fellow, Celdara Medical.
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Rare Disease Research Day on March 1st |
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Rare Disease Day at NIH will be held virtually on March 1st with an all-day Zoom filled with panel discussions, rare disease stories through TED-style talks and more. This event is free and open to the public. To view an agenda and register, click here.
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Einstein-Montefiore investigators continue to succeed in obtaining funding. Some of these investigators with new grant awards are (from left to right):
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Publication by Einstein OHRA Staff and Faculty |
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Einstein is proud to announce that three members of its Office of Human Research Affairs, Melissa Epstein, PhD, Stefanie Juell, MA, and Gabriella Weston, MS, along with Epidemiology Professor and IRB Member Charles Hall, PhD, have co-authored a chapter in the forthcoming third edition of Institutional Review Board: Management and Function. The book, considered the standard text for IRB professionals, will be available on February 22, 2021. Congratulations, Melissa, Stefanie, Gabriella, and Charlie!
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Research in the Headlines |
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Harold and Muriel Block Institute for Clinical and Translational Research
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