The Office of Regulatory Support and Quality Assurance is pleased to offer the “Research Compliance Training Program” to help raise and maintain knowledge and awareness of research compliance by University employees who conduct human subjects research. The program is composed of 16 training courses (seven new, seven existing and two modified) that will be offered multiple times throughout 2012 on both the medical and Coral Gables campuses.
The University of Miami is fully committed to maintaining objectivity in research and upholding the highest scientific and ethical standards in a manner that assures the integrity of the scientific record.
In response to the new U.S. Department of Health and Human Services (DHHS) conflict of interest regulations for Public Health Service (PHS) funding, the University has formed an advisory committee to discuss the necessary changes to our policies and infrastructure. We have also established an IT working group to support the advisory committee, assess our current IT systems, and develop an IT implementation plan. In accordance with the new regulations, changes to UM’s policy and procedure for conflicts of interest in sponsored research will be fully implemented by August 24, 2012.
The National Health Council recently announced the availability of a database that will help link unfunded NIH applications with potential non-governmental funding sources. The database will serve as a clearinghouse for unfunded research proposals. Principal investigators can enter basic information about their scored but unfunded NIH grant applications directly into the HealthResearchFunding.org database. Researchers with proposals that have been peer-reviewed but not funded by a NHC member patient advocacy organization may also register. Potential funders also can search the database to find projects they might be interested in funding.
The University of Miami tracks all subjects involved in clinical research protocols that test a drug, device or biologic and/or involve procedures, lab tests, and/or interventions on a patient. According to the policy, a principal investigator (PI) or their designee must submit a research subject enrollment/disenrollment form within 24 hours of subject consent or disenrollment from a study (for any reason other than the end of the study). A principal investigator or their designee must submit a research subject enrollment/disenrollment form within 24 hours of subject consent or disenrollment from a study (for any reason other than the end of the study) by entering the subject’s enrollment status in Velos eResearch. For more information, visit the enrollment policy or browse the FAQs.
The UM Proposal Transmittal form has been updated and should be used effective immediately. Two new fields were added to the form at the bottom of page two. Instructions for completing the new fields are included under “Additional Information Required” on page one of the instructions section.
The Federal Funding Accountability and Transparency Act (FFATA) requires disclosure information of entities receiving federal funding through federal awards, such as federal contracts and sub-contracts and federal grants and sub-grants. The Office of Research and the Controller’s Office are working collaboratively to gather the information required for FFATA reporting.
The Office of Research listservs are the primary communication tool for the research community.