The Office of the Vice President for Research (OVPR) Research Compliance Services group would like to share some important updates with the research community at UConn Health.
Institutional Animal Care and Use Committee (IACUC):
A new IACUC policy (effective 2/23/17) requires documentation of veterinary consultation prior to submission of animal care and use protocols if painful/distressful procedures (pain categories D and or E) will be used. The IACUC also recently updated its policy on expiration dates for drug mixtures used in laboratory animals. Click here to view the updated policy.
Institutional Biosafety Committee (IBC):
The IBC is in the process of implementing new IBC training for researchers through the CITI training program. Researchers will be notified by the IBC in the next few months to take this online training. Please stay tuned.
Institutional Review Board (IRB):
The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule). The Final Rule was published in the Federal Register on January 19, 2017. Some of the changes encompassed within the revised Rule include 1) an expansion of categories of research that may be exempt, 2) elimination of the need for continuing review for research that qualifies for expedited review and for research that has reached the stage of long-term follow-up or data analysis, 3) a broad-consent provision relating to the storage and use of data and specimens in secondary research and 4) additional requirements regarding the consent form. The compliance date for most of the revisions within the Rule is January 18, 2018. The compliance date for use of a single IRB for cooperative research is January 18, 2020. Staff within the Human Research Protections Programs (HSPP) at UConn Health will be revising policies and procedures and offering educational sessions related to these changes. The research community should continue to follow current policies and procedures until the HSPP publishes revised documents.
The new NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information covers all applications for funding (including grants, contracts, and other transactions) submitted on or after January 18, 2017 that request support for the conduct of any clinical trial. Studies that are wholly or in part funded by NIH grants submitted on or after this date must be registered and results must be reported on ClinicalTrials.gov.
NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Health-related biomedical or behavioral outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.
Click here for assistance with ClinicalTrials.gov registration.
Financial Conflict of Interest in Research Committee (FCOI):
The 2017 Individual Financial Disclosure in Research reporting period started February 8, 2017. In order to remain in compliance with university policy and federal regulations, UConn Health employees who are involved in research are required to complete an annual questionnaire in the UConn Health COI-SMART electronic disclosure system. The deadline to complete is April 30, 2017. We recommend, however, that you submit your disclosure well before the deadline because this process must be completed prior to the institution submitting any grant applications to DHHS agencies on your behalf. The setup of new and continuation awards will also be delayed until you are in compliance.
If you did not receive an automated e-mail invitation to complete the questionnaire and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Dr. Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or email@example.com.