Research and Partnerships Announcements
Purdue Launches Online Annual Reporting
Module for FCOI Management
Disclosure and management of research-related financial interests are under
increased scrutiny by the federal government, the public, and scientific journals and societies. Failure to disclose financial interests in research projects and
clinical trials is often reported in national news outlets. These renewed interests
in ethical issues related to conflicts of interest in research have prompted federal
funding agencies — such as the National Institutes of Health and the National
Science Foundation — and the Office of Management and Budget to revise and
update financial conflict of interest regulations for awardee institutions and
contractors.
To help investigators at Purdue navigate requirements and fulfill their financial
interest disclosure and management responsibilities, the Executive Vice President
for Research and Partnerships (EVPRP) office has developed — and, in conjunction with Sponsored Program Services, implemented — a software suite/online
application that facilitates compliance with Financial Conflict Of Interest (FCOI)
regulations and the university policy on individual financial conflicts of interest.
The application, known as the Research-Related Financial Interest Disclosure
and Management System, facilitates investigator financial interest disclosure and
FCOI management throughout the life of a research project and tracks FCOI
training for investigators conducting research funded by the Department of
Health and Human Services.
To manage real or apparent research-related FCOI, EVPRP executes an FCOI
Management Plan (MP) for investigators with outside financial interests. The
MP requires continuous oversight and annual reporting of compliance to the
University Responsible Official from the designated Oversight Manager(s)
(usually the department head). Although the application has been online since
July 1, 2011, the annual reporting of compliance with the MP has remained a
paper-based process. Starting this year, the annual reporting will become part of
the FCOI Disclosure and Management application through the addition of an
Annual Reporting module. The new software will enable investigators and their
oversight manager(s) to collaborate in completing, submitting, reviewing, and
tracking the status of their annual report online, therefore reducing the administrative burden on both researchers and administrators. The module is
scheduled for launching at the beginning of January 2015.
With the implementation of the Annual Reporting module, Purdue is
now just one module away from eliminating all paper processes from
research-related FCOI disclosure and management. The design of the
final module of the system (which will allow for management plan
drafting, negotiations, updating and routing for signatures) is nearing
completion. Its projected launch is in early spring 2015.
Since its original implementation in 2012, the Research-Related FCOI
Disclosure and Management online application has processed more
than 15,000 proposals and collected over 30,000 proposal-based
Financial Interest Statements.
Purdue researchers can access the Research-Related FCOI Disclosure
and Management online application at https://webapps.ecn.purdue.
edu/VPR/PDD. Please contact Voichita Dadarlat at voichi@purdue.
edu if you have any questions or comments about this software.
Genomic Data Sharing
Policy from NIH
The National Institutes of Health (NIH) recently
released the Genomic Data Sharing (GDS)
Policy to promote broad distribution of
genomic data within the scientific community.
The policy gives examples of large-scale data
such as “… genome-wide association studies
(GWAS), single nucleotide polymorphisms
(SNP) arrays, and genome sequence, transcrip-tomic, epigenomic and gene expression data.”
In general, the sharing requirement will only
apply to genomic data acquired from large
regions of a genome (i.e greater than 100
genes), collected from greater than 100 human
or non-human samples. The policy is expected
to be a part of NIH award terms and conditions
beginning in January 2015.
The need to prepare for the new expectation is
integral to any qualifying proposal or activity.
Staff members within the Office of Research
and Partnerships are coordinating relevant
procedures across departments. Investigators
may be asked for additional information and
find new requirements associated with NIH
proposals or regulatory committee applications. The processes will be integrated into
existing regulatory compliance measures.
In this interim time, investigators can
find helpful information at http://1.usa.
gov/1thLsqr or direct questions to the
Research Regulatory Compliance staff within
the Office for Research and Partnerships at
evprpregulatory@purdue.edu.
