Office of the Vice President for Research (OVPR)
COVID-19 Guidance for the UConn Health Research Community
The Office for the Vice President for Research (OVPR) website has posted a COVID-19 Guidance for the research community at UConn Health. Information about the impact and changes caused by the COVID-19 outbreak on research activities are described on this guidance. Information on this web site is updated frequently.
IRB Policies – Revisions
IRB Policy 2011-015.0. -Recruitment and Payment and policy 2011-011.0- Research Personnel have been revised to better outline the requirements and expectations for recruitment of UConn Health patients. The policies denote, among other items, that the person who first approaches a patient about research participation must be someone with an existing treatment relationship with the patient and that members of the study team (e.g., principal investigators, co-investigators, study coordinators, consenters, etc.) interacting with the patient-participant must be affiliated with UConn Health (e.g. faculty appointment, employee, student, intern, volunteer).
If the study submitted for review has a Principal Investigator who is not a paid UConn Health faculty member, there must be a paid faculty member from UConn Health as a co-investigator on that study who is responsible for patient involvement.
IRB Forms – Update
The following forms have been revised:
- Consent checklist – Addendum for Genetic Research – This form was revised to clarify wording and to re-order the elements of consent.
- Main Consent Checklist – This form was revised to add elements for inclusion of any requirements imposed by a specific funding Institute, Office or Center within NIH related to data sharing (added in the NIH section of the checklist)
- Main Consent template – This template was revised to add instruction for investigators to check whether the funding entity has any specific requirements regarding data sharing language and if so to include it. The NIAAA suggested language was provided as an example.
Connecticut Law Raises Legal Age to Buy Smoking Products to 21
As of October 1, 2019, the State of Connecticut change the legal age for smoking from 18 to 21. UConn Health investigators who are conducting studies with tobacco products should review their studies and as needed revise them to comply with this new law in Connecticut.
NIH Update: Guidance for NIH-Funded Clinical Trials and Human Subjects Studies Affected By Covid-19
The National Institute of Helath ( NIH) has published the following guidance NOT-OD-20-087 outlining the flexibilities available to recipients impacted by COVID-19 for delays to ongoing research, delays to research progress for NIH-funded clinical trials and human subject studies, and unanticipated costs.
Disclosure Form for Work Submitted to Medical Journals
As stated by Darren B. Taichman, MD, PhD; Joyce Backus, MSLS; and Christopher Baethge, MD; et al, in their published article titled “A Disclosure Form for Work Submitted to Medical Journals. : A Proposal from the International Committee of Medical Journal Editors” the International Committee of Medical Journal Editors (ICMJE) adopted the “ICMJE Form for the Disclosure of Potential Conflicts of Interest” as a mechanism for collecting and reporting authors’ relationships and activities that readers might consider relevant to a published work.
The ICMJE has proposed changes to this disclosure form to enhance transparency and accuracy in the information captured by this form. The ICMJE is requesting feedback about the proposed new form. Comments received by April 30, 2020 will be consider for the finalization of the revised version. The current ICMJE Form for the Disclosure of Potential Conflicts of Interest is available and downloadable in PDF at their website. To enter your comments on the proposed form, please click here.
Recent Articles Published by Central IRBs
ADVARRA IRB:
Key Biosafety Considerations for Coronavirus Research: This article provides an overview of the coronavirus and describe strategies for developing medical countermeasures to combat the recent outbreak. A description of the opportunities, risks, and risk mitigation strategies for coronavirus are also discussed in this article.
Beyond the Regulations: More Considerations for Emergency Research: this article describes what the researchers and research organization must know about “Emergency Research.” The authors explain emergency research is only feasible if a plan is in place. These plans include but are not limited to the establishment of a front-line staff communication plan, an evaluation of clinical operations, and a plan to respond to media inquiries.
Western IRB (WCG):
Your 5 Questions About Enrollment Assistants Answered: In this article WCG describes the services they provide through “Enrollment Assistants” (EAs) for recruitment, and enrollment in clinical studies. Mark Summers, president of patient engagement from WCG addresses the following questions: (1) how can a person from outside the study team legally work at a site? (2) How accepting are sites of EAs–especially sites that have never worked with one? (3) Are EAs trained onsite or by WCG Three Wire? (4) Would an Enrollment Assistant be more beneficial to, say, a large academic center than to a small standalone research site? (5) How do you keep track of your enrollment performance metrics?
COVID-19 Preparedness for Health Care Institutions: Insights Paul Biddinger, MD and Scott Gottlieb, MD: This article is a summary of takeaways and key points from the March 13, 2020 webinar sponsored by WCG.