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New PCORI Policy Has Data Rules In Line with HIPAA Regulations

A new data sharing policy adopted by the Patient-Centered Outcomes Research Institute stipulates that all personally identifiable health information must be deidentified in accordance with HIPAA regulations.

data sharing

Source: Thinkstock

By Fred Donovan

- A new data sharing policy adopted by the Patient-Centered Outcomes Research Institute (PCORI) stipulates that all personally identifiable health information must be deidentified in accordance with HIPAA regulations.

On Sept. 7, the PCORI board approved the new policy, which requires researchers who receive PCORI funds to share their data sets and documentation for reanalysis and reuse. The Washington, D.C.-based non-profit was created by Congress in 2010.

Informed consent obtained from study participants must be sufficiently broad to permit future research by other researchers. Requests to access data and documents in the repository will be reviewed based on the scientific merit of the request and on the qualifications of the requestors, PCORI explained in a press release.

PCORI said the new policy advances its commitment to open science by encouraging use of data from the studies it funds to allow other researchers to verify and build on those findings. The hope is that this will generate new evidence for healthcare decision makers.

Data sharing can help accelerate the discovery of innovative healthcare approaches through analyses, reproduction of published findings, and development of avenues for new research, related PCORI.

Under the policy, certain research teams that receive PCORI funding — particularly those that receive larger PCORI awards — are expected to place the data generated during their studies, as well as the documentation for how the data was produced, into a repository designated by PCORI.

The data, including deidentified information collected from study participants, full protocols, metadata, and statistical analysis plans, will then be made available to other research teams for reanalysis and additional analyses. A feature of PCORI’s approach is that funding will be provided to research teams to prepare the data and other materials for sharing.

“Through this data sharing policy, we’re taking a major step in advancing open science,” said PCORI Executive Director Joe Selby. “By supporting how others may use information generated by the studies we’ve funded, we’re helping to enhance the quality and increase the quantity of evidence for healthcare decision making. We’re also reducing redundancy in collecting clinical data sets, which can speed research and the production of more useful evidence.”

The data sharing policy is the latest in a series of initiatives that PCORI has undertaken to support the transparency and broader availability of research results. The institute’s earlier policy on peer review and public release of research findings ensures that all results from PCORI-funded studies, whether positive or negative, undergo a review and are made publicly available on PCORI’s website in a final research report.

PCORI noted that it also develops brief summaries of all the studies and posts them as public and professional abstracts on the website. In addition, through its public access policy, PCORI covers the costs for journals to make papers presenting the final results of PCORI-funded studies freely available to the public.

PCORI has invested $2.4 billion to fund more than 440 patient-centered comparative clinical effectiveness research (CER) studies and other projects designed to enhance CER methods and the infrastructure to conduct CER rigorously and efficiently.

Last month, PCORI’s board approved $85 million to fund 16 new studies comparing two or more approaches to improve care and outcomes for conductions that impose high burdens on patients, caregivers and the healthcare system, such as unsafe opioid use, cancer, depression, and stroke.

The funding includes $5 million for a University of Washington study comparing two approaches to reduce unsafe opioid prescribing in the workers’ compensation system in two state systems, Ohio and Washington.

This is the latest project in PCORI’s portfolio of CER studies on substance use disorders and pain management, 15 of which focus on opioid use.

The board also approved the selection of 28 new members to serve on four of PCORI’s five advisory panels and reappointed five members for an additional term on the advisory panel on patient engagement. Panel members from across the healthcare community help to refine and prioritize research questions for potential funding and offer feedback on the design of clinical trials.


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