Implementation of Funder Data Sharing Policies

HRA Members Meeting Spring 2018

At the March 2018 Members Meeting, HRA members and clinicians shared their processes, considerations, and implementation of data sharing policies.

Encourage and facilitate reagent and data sharing

The St. Baldrick’s Foundation, a not-for-profit organization with the aim of raising funds to help find cures for children with cancer, is committed to improve transparency and openness of research. Liz Jackson, Director of Grants Administration at the St. Baldrick’s Foundation, explained that applicants must write a “data sharing proposal on how they plan to publish and share their results.” Using Proposal Central to implement their application forms enabled an efficient way of collection information on data sharing plans and platforms. “Knowing where people are sharing their data enables us to guide other researchers towards specific databases,” said Jackson.
St. Baldrick’s Foundation does not mandate how and where to share data, but raises the awareness of transparency and openness, and will soon start the process of creating policies, follow up, and monitoring procedures to ensure that data and reagents are appropriately shared after the completion of projects. Their application guidelines are similar to those from the National Institutes of Health and Simons foundation, which provide detailed statements of the expectations for the use of funds.

Lessons from Implementing Data Sharing Policies

Jason Gearson, Senior Program Officer at the Patient-Centered Outcomes Research Institute (PCORI), emphasized their commitment to open science and shared lessons they learned from implementing initiatives that enable public access to the findings from PCORI-funded studies. Their data sharing policy was developed by PCORI staff with input from expert advisory group and the Research Transformation Committee (RTC) as well as other funders and regulators like the Gates Foundation, European Medicines Agency and NIH. The policy was then “drafted in a manner that enabled PCORI to incorporate additional operational details and procedures over time,” said Gearson.

During the public comment period four key implementation issues were raised:

1. Restrictions on data use
2. Requestor qualifications and required documentation
3. Informed consent
4. Applicability to other health systems data

After discussions and implementation of these raised points, the data sharing pilot project was started, which led to additional insightful considerations for data governance and submission. One issue that rose to the top was the “variability in understanding data sharing terms,” which requires explicit and detailed communication of the expectations to the investigators. It also takes a considerable amount of time to prepare data for submission, which involves the curation and review of the submitted data as a key part of the process to ensure a valuable resource for others. Additionally, Gearson stated the importance of discussing ownership of the data up front, since tension to publish and being recognized can complicate the sharing process.

Clarity throughout

The Open Data Policy of the American Heart Association requires certain applicants to include a data sharing plan with the application. Any factual data that is needed for independent verification of research results must be made freely and publicly available in an AHA-approved repository within 12 months of the end of the funding period.

Belinda Orland, Sr. Manager of Research Operations at the AHA, explained that these policies were drafted by a committee over the course of three meetings, but refining it to gain approval took about 18 months. Orland listed some key points that will help other funders implement an open science policy.

• First, developing a FAQ document early on reduces confusion and resistance, while more clarifications can be added throughout the process.
• Providing a sample data plan makes it easier for applicants to follow along.
• Monitoring what other organizations are doing, establishing a permanent committee to monitor open science issues, and recommending changes to the policy as needed will be very helpful.