UConn Health Logo Health

Research Compliance Services News

OVPR Research Compliance News

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.

 

 ClinicalTrials.gov:
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 gfernandez@uchc.edu.

 

 

Annual Individual Financial Disclosure in Research

The Office of the Vice President for Research would like to announce that the 2017 Individual Financial Disclosure in Research reporting period has started today. 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.

An automated e-mail inviting applicable employees to complete the questionnaire should be in your inbox. The sender name on the e-mail is UConn Health Financial Disclosure in Research.

If you did not receive an automated e-mail invitation and believe you need to complete the form, or if you have any questions regarding the form or the disclosure requirements, please contact Gus Fernandez-Wolff in the Office of the Vice President for Research, Research Compliance Services at x8125 or gfernandez@uchc.edu.

Thank you for your cooperation.

For more information, contact: Gus Fernandez-Wolff at x8125 or gfernandez@uchc.edu

IRIS Upgrade – System Down Time

The Human Subjects Protection Program (HSPP) within the Office of the Vice President for Research would like to inform the research community that the IRIS system is scheduled to be upgraded to version 10.03 during the second week of November. The upgrade is scheduled to begin the morning of Tuesday, November 8th and will require that the system be temporarily taken off-line. We anticipate the system will be available for use on Tuesday, November 15th. Please note these dates and plan accordingly. Another announcement will be sent to confirm when the system is back on-line.

Please note, when the system is brought on-line it will include a new version of the application form. The new application form was developed with input from a working group comprised of IRB staff and members, study coordinators and investigators. It is significantly different than the current application. If you were in the process of completing an application form when the system was shut down for the upgrade, we suggest that you do not convert to the new version when prompted.

Mayra Cagganello continues to offer training in the new version of IRIS, and we strongly encourage you to take advantage of that training. The training schedule is available from the HSPP web site at http://research.uchc.edu/rcs/hspp/ Training manuals will also be posted in the Help section of the IRIS system.

We appreciate your patience during this upgrade process.

If you have questions regarding the upgrade, you may contact Deborah Gibb.
For more information, contact: Mayra Cagganello at cagganello@uchc.edu

ResearchMatch now available to UConn researchers

Research MatchThe Office of the Vice President for Research (OVPR) is pleased to announce that UConn is now part of the ResearchMatch Network. ResearchMatch.org is a national online recruitment tool, funded by the National Institutes of Health and maintained at Vanderbilt University. ResearchMatch connects interested participants with research studies that might be a good “match” for them through its secure, online matching tool. There is no cost to UConn researchers who use ResearchMatch to conduct recruitment feasibility analysis or participant recruitment.

For more information, including the process for using ResearchMatch as a recruitment tool, please contact Ellen Ciesielski in the OVPR Research Compliance Services at 860-679-6004 or email researchmatch@uchc.edu.

New Export Control Policy

The Office of the Vice President for Research (OVPR) would like to announce a new policy related to Export Control compliance, effective 12/14/2015. Intended to protect national security and support foreign policy, export controls are federal laws that regulate how certain controlled information, technology, software, services and goods can be shipped, transferred or transmitted to individuals or organizations overseas.  They also regulate the release of certain information to foreign nationals who are in the U.S. and their ability to work with or have access to certain technologies and software while in the U.S.  This policy has been put in to place to ensure that the University and its employees remain in full compliance with federal regulations, has been approved for all UConn campuses, and can be found at the University’s Policies & Procedures page.

The OVPR has developed resources related to Export Controls to assist faculty and other members of the University community that are available on the Research Compliance Services page.

If you have any questions relating to Export Control and/or this policy, please contact:

Dr. Wesley Byerly
Associate Vice President for Research Integrity and Regulatory Affairs
Office of the Vice President for Research
(860) 679-2230
byerly@uchc.edu