Responsible Conduct of Research Fast Track Fall Course
The Responsible Conduct of Research (RCR) is now a credited course available to any FAU undergraduate, graduate or post-doctoral researchers. This two-credit fast track course, open to all of FAU, will be offered through the College of Education on four Saturdays throughout the month of November from 9 a.m. to 3 p.m.
This course will encompass material previously included in the four-part workshop format and expands upon the areas of responsible research featuring new topics such as social responsibility in research, collaborative science within academic and industry, intellectual property and research misconduct.
Research Integrity is also currently developing an RCR Implementation Plan to better inform researchers at FAU on the necessary training requirements as applicable to different funding agencies.
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Welcome to the new Biological Safety Officer Dr. Frank Novembré
Frank Novembré, Ph.D., recently joined FAU as a biological safety officer. Novembré, who began Aug. 19, received his bachelor’s in physics from Tulane University, Louisiana, as well as a master’s and doctorate in microbiology from The University of Medicine and Dentistry of New Jersey/Rutgers University. Previously, Novembré studied poxvirus immunobiology at the Centers for Disease Control then went onto the National Institutes of Health, where he worked as a post doc on nonhuman primate models of AIDS.
Novembré went on to join the faculty of the Yerkes National Primate Research Center of Emory University in Atlanta, Ga., and continued his work on nonhuman primate models of AIDS, focusing on molecular and neuropathogenesis.
In 2011, Novembré shifted gears to biosafety, joining Baylor Scott & White Research Institute in Texas, as the biosafety officer, building the biosafety program from the ground up for eight years before joining FAU.
Novembré brings the experience of being both a principal investigator and biosafety officer, and will support the university community as we work on growing and advancing our safety and training programs at FAU.
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IRB News: New IBC Requirements for Human Subject Research
Attention researchers: There is a new procedure from EH&S requiring that principal investigators using human blood, blood products, body fluids or tissues, submit a registration form to the IBC, and complete an Exposure Control Plan.
The IBC Registration Form is available on the
DOR Website
.
The Exposure Control Plan, as well as EH&S requirements, are available on the
EH&S Website
.
For more information regarding these new requirements please contact Frank Novembr
é
, Ph.D., biological safety officer/public health officer, EHS, at 561-297-2936 or
fnovembre@fau.edu
.
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Resources for Researchers
1. Guidelines for International Researchers:
4. New IBC Form Version 3 available online at the DOR Website:
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Tips from the IRB Coordinator(s):
- The provisions of the New Common Rule do NOT apply to old protocols
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Where to Post Informed Consent Forms for NIH-Funded Clinical Trials
The revised Common Rule requires that an IRB-approved version of an informed consent form be posted on a public federal website for all National Institutes of Health (NIH)-funded clinical trials. This must be done after enrollment ends and within 60 days of the last study visit.
NIH recently released additional guidance regarding which federal websites allow for the posting of these informed consent forms. FAU recommends using ClinicalTrials.gov though other options are available.
Using ClinicalTrials.gov:
- You can upload an IRB-approved version of the form to the ClinicalTrials.gov study record. Note that ClinicalTrials.gov does not accept non-English documents.
For more information on this notice and for additional guidance visit the
NIH website
. If you have questions, please contact Ximena Levy, MD, MPH, at
xlevy@fau.edu
.
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In September, the Division of Research hosted George Gasparis, President of the
PEE
R Consulting Group, for a visit at FAU to assess and facilitate the growth of FAU’s clinical research enterprise and evaluate the Human Research Protections Program (HRPP) in preparation for accreditation from the Association for
the Accreditation of Human Research Protection Programs (AAHRPP).
Across two days, Gasparis met with research deans from the colleges of Nursing and Medicine, clinical research faculty from various disciplines, general counsel, t
he Provost
,
health sciences counsel, the chief compliance/privacy officer, the CRU
, the Office of the VPR; DOR executive staff, DOR HRPP team, and with members from the IRB committees.
Report highlights of the clinical research program at FAU as well as the HRPP program will be shared with university stakeholders when those reports are finalized.
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Training Center: Monthly Training Office Hours
Monthly training is available for researchers working with human or animal subjects. Check out the training calendars to register now. We invite you to set an appointment for IRB or IACUC related questions – even before submitting your protocol – by clicking these training calendars:
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24-hour Cancellation Rule
Please notify Helen Munchow if you are unable to attend an IACUC hands-on-training workshop for which you’ve already registered.
Contact Dana Mulvaney for ethics training workshops cancellations. Notifications must be submitted at least 24 hours before training.
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IRB Virtual Assistance on Canvas
We have launched an “IRB Education Course” on Canvas. This learning community serves as a virtual assistance and training platform, allowing you to get answers you need any time, from any device, and to connect with Human Research Protections Program staff or other researchers.
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Check Out the Beacon Online
The archived editions of
The Beacon
can be found online
here
.
Please share with colleagues or use as references to our tips and hints!
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