Basics and Background

What is the Policy for Data Management and Data Sharing?

Fundamentally, the Policy articulates PCORI’s expectation that Awardees make data and data documentation (Full Data Package) from their PCORI-funded research projects available to third-party requestors. Importantly, it provides funding to our Awardees for their time and effort in preparing the Full Data Package to be shared. The Policy includes details about what data certain Awardees will be expected to deposit into a designated data repository and when that data would be available for third-party requests. It describes the data request process, the criteria used to assess the scientific merit of the requests, and the independent committee that will review data requests.

When was the Policy approved?

The Policy was approved by PCORI’s Board of Governors on September 7, 2018.

Why did PCORI develop the Policy?

The Policy is an expression of PCORI’s commitment to open science. We already have policies in place to support the transparency and availability of the results of our funded studies (PCORI's Process for Peer Review of Primary Research and Public Release of Research Findings and PCORI’s policy on Public Access to Journal Articles Presenting Findings from PCORI-Funded Research). This data sharing policy now makes the underlying data and data documentation, referred to as the “Full Data Package” (e.g., study protocol, metadata, and analytic code) available for further scientific inquiry. By sharing the data generated from PCORI-funded research studies, we hope to foster scientific advances that will ultimately improve clinical care and patient outcomes.

How was the Policy for Data Management and Data Sharing developed?

The sharing of clinical research data is a complex issue, and we arrived at this policy through careful deliberation, listening to stakeholders and a commitment to learning by doing. This included obtaining public comment on the Policy; consulting an Expert Advisory Group convened by PCORI for their experience with data sharing issues; conducting a Pilot Project that brought together data repository organizations with PCORI Awardees to assess technical and operational challenges related to implementing this Policy; and speaking with other funders and regulatory agencies about their experiences in developing data sharing guidance and policies.

Implications for PCORI Research Awardees

What does the Policy mean for Research Awardees funded BEFORE January 1, 2019?

Since 2015, PCORI has established in its funding announcements and in its research contracts that Awardees must develop a data management and data sharing plan and be prepared to share research project data. In addition to pre-specified data management and data sharing plans already in place, awardees funded through a Pragmatic Clinical Studies (PCS) or Targeted funding announcement before January 1, 2019 will be invited to participate in the Policy on a voluntary basis.

What does the Policy mean for Research Awardees funded AFTER January 1, 2019?

Awardees funded after January 1, 2019, through a Broad or Broad Pragmatic Studies (category 1 through Cycle 3 2023 only) PFA may participate in data sharing on a voluntary basis. These Awardees are encouraged to speak with their Program Officer and submit questions related to data sharing participation to [email protected].

Awardees funded after January 1, 2019, through a Pragmatic Clinical Studies, Targeted, Broad Pragmatic Studies, PCORnet®, or Phased Large Awards for Comparative Effective Research (PLACER) PFA are required to adhere to Policy requirements as outlined in the table below.

Table 1: Awardee Data Sharing: Awardee Requirements by PFA
PCORI Funding Announcement (PFA)Funding CyclePolicy ExpectationsRequired Elements
Pragmatic Clinical Studies (PCS)Cycle 1 2019 – Cycle 3 2021Required (all funded studies)Full Data Package
TargetedCycle 1 2019 and afterRequired (all funded studies)Full Data Package
Broad1Cycle 1 2019 – Cycle 3 2021Not RequiredMaintenance of Full Data Package for 7 years following the Final Research Report (FRR) acceptance
Broad Pragmatic Studies (BPS)2Cycle 1 2022 -Cycle 3 2023

Category 1: Not required

Category 2: Required

Category 3: Required

Category 1: None

Category 2: Full Data Package

Category 3: Full Data Package

Cycle 1 2024 and afterRequired (all funded studies)

Category 1: Full Data Package

Category 2: Full Data Package

Category 3: Full Data Package

Phased Large Awards for Comparative Effective Research (PLACER)Cycle 1 2019 and afterRequired (all funded studies proceeding to full scale study conduct)Full Data Package
  1. Broad (Cycle 1 2019 – Cycle 3 2021 [Addressing Disparities; Assessment of Prevention, Diagnosis, and Treatment Options; Communication and Dissemination Research; and Improving Healthcare Systems]): The Policy calls for maintenance of the Full Data Package for seven (7) years following acceptance by PCORI of the Final Research Report. In that time, PCORI may provide funds for the deposition of the Full Data Package to the PCORI-designated repository in circumstances where PCORI requests such deposition (e.g., due to PCORI estimate of high importance of research project findings or external research request).

  2. Broad Pragmatic Studies (BPS) (Cycle 1 2022 and after):

  • Category 1 – Research projects with direct costs up to and including $5 million.

  • Category 2 – Research projects with direct costs greater than $5 million and up to a maximum of $10 million.

  • Category 3 – Research projects with direct costs up to $10 million that utilize PCORnet® to conduct observational studies and/or pragmatic trials that are national in scale.

Table 2: Awardee Data Sharing Requirements: Research Projects conducted using PCORnet®
Research ProjectCyclePolicy ExpectationsRequired Elements
Research Projects conducted using PCORnet®Cycle 1 2019 and afterRequired (all funded research studies conducted using PCORnet®)PCORnet® Data Package3
  1. PCORnet® Data Package Components: Full Protocol for specific research project; description of the PCORnet® Common Data Model tables, including ancillary or ad hoc tables (if applicable); all code used to query PCORnet® data; aggregate level dataset(s); aggregate results of any new or research-project-specific data quality investigations; and results from research-project-specific analytical queries.

A full data management and data sharing plan for the proposed research project will not be evaluated at the application stage; however, such a plan will be required and must be submitted to PCORI as part of the Full Protocol if an award is made. As described in the Policy, the plan must adhere to the PCORI Methodology Standards for Data Integrity and Rigorous Analyses, specifically Standard IR-7.

When will PCORI include the data sharing milestones and budget into the awardee contract?

For required awardees Cycle 1 2019 – Cycle 3 2021, PCORI will contact awardees directly to include data sharing milestones into the contract via a contract modification and address the related data sharing budget materials post contract execution. Starting with Cycle 1 2022 required awardees, data sharing milestone will be included in the contract prior to contract execution while the data sharing budget will be addressed closer to the DFRR due date. 

  • Note: PLACER Studies funded in or after Cycle 1 2019 are required to participate in the data sharing in accordance with the Policy. However, data sharing milestones will NOT be included in the PLACER feasibility milestone schedule at the time of initial contract execution. Upon approval for a PLACER study to proceed to the full-scale study phase, the data sharing milestones will be included in the amended award contract.

Why does PCORI require that only some of its Awardees share their data?

PCORI made an organizational decision at the outset of the Policy’s development that the requirement to share data should focus initially on its larger research investments and would not strictly require participation for awardees prior to the Policy’s official approval in September 2018 (awardees prior to the Cycle 1 2019 funding cycle).

That said, the Policy specifies that in certain circumstances PCORI may request that other Awardees share their data (e.g., based on its estimation of high importance of research project findings and/or requests from external researchers). The Policy also states that Awardees may request funding from PCORI for allowable data sharing costs if they are interested in making their data available in the PCORI-designated repository. PCORI will consider such requests on a case-by-case basis and provide funding for approved requests.

What are the IRB/consent language requirements regarding PCORI’s data sharing Policy?

As noted in the Policy, IRB-approved participant informed consent forms must permit data collected as part of the PCORI-funded research project to be de-identified and shared with researchers not affiliated with the original project for appropriate secondary research purposes. PCORI does not require specific consent language and encourages Participating Awardees to consult their IRB and consider guidance from sources such as ICPSR, PCORI’s designated repository partner, or the Multi-Regional Clinical Trial group, among other sources.:

Please be attentive so that language in the informed consent documents does not improperly preclude data sharing that is required as set forth in the Policy.

Additionally, if the intended data deposit includes data collected through other sources than the PCORI-funded study, Awardees should seek data sources with appropriate informed consent. If such sources are not available, please consult with PCORI.

Please note that for Participating Awardees funded through a PLACER PFA, informed consent should comply with the guidance provided above throughout the feasibility phase.

If participating in data sharing voluntarily, please consult with your local IRB regarding PCORI’s data sharing processes and any concerns related to study consent language.

Please direct any data sharing-related informed consent questions to [email protected].

PCORI Funding to Support Data Sharing

What is PCORI paying for?

PCORI is committed to providing funding to support Awardees’ reasonable costs to prepare data and data documentation for sharing. Reasonable, allowable costs include:

  1. Time and effort related to preparing the Full Data Package and working with the repository staff to curate the data and supporting documentation, de-identifying data (in accordance with the HIPAA Privacy Rule (45 C.F.R. § 164.514(b)); attaching metadata to foster discoverability, interpretation, and reuse; and formatting data for transmission and storage at PCODR for long-term preservation and access.
  2. Local data management considerations, such as unique and specialized information infrastructure necessary to provide local management, preservation, and access to data, (e.g., before deposit into the PCORI-designated repository) or another established repository. Budget estimates should not include costs associated with the routine conduct of research. Costs associated with collecting or otherwise gaining access to research data (e.g., data access fees) are considered costs of doing research and should not be included in data sharing budget materials. Indirect costs associated with the prime institution and any subcontractors are allowable.

If there are any questions on allowable costs or proposed budget limits, please contact your PCORI Project Team and cc [email protected].

How much funding will PCORI provide?

PCORI will cover reasonable costs associated with PCORI will reimburse Awardees with eligible research awards for reasonable costs associated with preparing, depositing, and working with the repository staff to curate the Full Data Package (or required data elements, as applicable) in the PCORI-designated repository. Awardees should provide a proposed budget for data sharing costs (which may vary depending on the size and complexity of the research project) to PCORI, however, funding should not exceed $75,000 total costs, inclusive of prime and any subcontractor direct and indirect costs (see section below for considerations for budget requests exceeding $75,000). Data sharing funding is primarily for personnel costs, which can include consultants and subcontractor personnel costs. The PCORI base salary cap for personnel is $200,000 annualized per individual, per year, excluding fringe benefits. See the PCORI Cost Principles.

Data Deposition and Availability of Data

What data and data documentation will I deposit?

The deposition is centered around the Full Data Package, which is comprised of the Analyzable Data Set, Full Protocol, metadata, data dictionary, full statistical analysis plan (including all amendments and all documentation for additional work processes), and analytic code from a PCORI-funded research project.

The concept of a Full Data Package is drawn from the 2015 Institute of Medicine Report, Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Our rationale for requiring the Full Data Package is to support the transparency and usability of the data and increase the likelihood that third-party requestors can analyze the data without additional assistance from the original investigators.

What if I am not able to deposit the Full Data Package due to applicable legal or contractual restrictions (e.g., the informed consent obtained from research project participants is not sufficiently broad, my research project data includes health system or other types of proprietary data)?

PCORI recognizes that there may be applicable restrictions that preclude the deposition of certain research project data due to contractual and legal obligations that may attach to them. In such cases where deposition of the Full Data Package is not feasible, PCORI will determine if a complete or partial exemption from the requirements of this Policy should apply. For further guidance on the exemption request process, refer to the below FAQ “Will exemptions and waivers from the Policy be considered?

Where do I deposit the data and data documentation?

Data will be deposited in the Patient-Centered Outcomes Data Repository (PCODR) at the Inter-university Consortium for Political and Social Research (ICPSR). ICPSR provides a highly secure data hosting environment and data access platform, as well as the capacity to serve as an experienced partner to our Awardees in curating the data and metadata from their PCORI-funded studies.

Awardees will work directly with ICPSR staff to curate and deposit their full data package. ICPSR will then maintain the full data package in the repository and handle data use requests (see below).

Awardees must not send their research project data directly to PCORI or PCORI staff. PCORI does not receive or maintain any research data collected from the research projects it funds.

What is the data deposition process, and when will it begin and end?

All awardees participating in the Policy must enter into a Data Contributor Agreement (DCA) prior to submitting a DFRR to PCORI. The DCA is a contractual agreement between the Awardee institution (the Data Contributor) and the repository (ICPSR) and outlines rights and responsibilities for the parties involved. Please find a template DCA here.

DCA Submission Instructions: The DCA should be processed through the Participating Awardee institution’s appropriate channel (such as the office of general counsel) and a signed version should be sent to [email protected] with the acronym PCODR in the subject of the message. If any edits are requested by the institution, please submit a tracked changes version of the DCA to [email protected] with the acronym PCODR in the subject of the message.

Once the DCA is executed, the Awardee will begin working with the PCORI-designated repository to curate the data and the metadata shortly after submission of the Draft Final Research Report. PCORI expects this data sharing activity to take approximately 2-4 months, concurrent with Peer Review period (which may take up to 13 months).

When will the data from a research project be made available for third-party requests?

The PCORI-designated repository will make the data available for third-party requests when PCORI makes the Final Research Report available on the PCORI website pursuant to PCORI’s Process for Peer Review of Primary Research and Public Release of Research Findings, or at the time of publication of the research project’s primary results in a peer-reviewed journal, whichever comes first.

Data Request Process and Review of Requests

How do third-party researchers submit a request for data?

Individual investigators or teams of investigators seeking access to data from PCORI-funded studies must complete and submit a data request form to the PCORI-designated repository.

Who can submit a request for data?

There are no categorical restrictions on what types of individuals or entities may request to access the PCORI Awardee research data. Data requestors will be evaluated for their overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request.

Are there restrictions on the kinds of data requests that are acceptable?

Yes. Data requests for non-scientific uses, such as in support of litigation, quality improvement projects, and for promotional/marketing purposes will not be accepted.

What criteria are used to evaluate data requests?

PCORI believes that requests for data must demonstrate scientific merit.  As such, the Policy articulates criteria by which proposals are to be evaluated by the review committee. These criteria include but are not limited to: a scientific purpose that is clearly described; the data requested will be used to develop or contribute to generalizable knowledge to inform science, medicine and/or public health; the proposed research can be reasonably addressed using the requested data; the data requestor team has the appropriate expertise to conduct the proposed research; and the proposed research includes question(s) and outcomes that are relevant to patients.

Who reviews the data requests?

An independent review committee comprised of five voting members will review and adjudicate third-party data requests. Details about the committee composition can be found in the Policy. A member of the Awardee research team that generated the requested data will be invited to attend the review as a non-voting participant. The committee and the review will be managed by the PCORI-designated repository.

What happens when a data request is approved?

If the data request is approved, the data requestor(s)’s institution must enter into a Data Use Agreement (DUA) with the designated repository. The DUA will specify the terms and conditions of data use, as well as the responsibilities and obligations of data requestors. A copy of the DUA is available in the appendix of the template DCA.

Human Subjects Protections

What has PCORI done to address data privacy concerns and human subject protections in this Policy?

In developing this Policy, PCORI has been attentive to data privacy and human subject protections concerns. More specifically, the data subject to the requirements of the Policy must be de-identified in accordance with HIPAA regulations. Additionally, only data from participants whose informed consent permits de-identified data to be archived at a data repository and used for secondary research will be made available for third-party requests. The Policy also requires that third-party data requestors enter into a data use agreement with clear prohibitions against using the data to re-identify individuals and redistributing the data to people who haven’t been approved to use the data.

Exemptions and Waivers

Will exemptions and waivers from the Policy be considered?

Yes. PCORI will consider amending or waiving some or all of the data submission requirements of the Policy if an Awardee’s research project data is subject to legal, contractual, or institutional policy requirements that preclude data sharing. Please refer the Policy for more details.

It is the responsibility of the Awardee to provide a written explanation to PCORI with supporting documentation to demonstrate why it would not be feasible to comply with part or all of the Policy. Please note that the Administrative Official should submit the Data Sharing Exemption Request Form and supporting documentation to the PCORI Project team and cc [email protected].  Once the request and supporting materials have been received, PCORI will convene the Exemption Request Review Committee and a decision will be communicated to the Awardee.

Please keep the following in mind when considering an exemption from PCORI’s Policy:

  • Per the terms of the Policy, only de-identified data will be deposited in the data repository.
  • Information about the Policy is included in the PFA as well as executed PCORI contracts – claiming lack of knowledge or failing to include specific language about data sharing into study consent forms is not an adequate justification.
  • Claiming business or operational competitive risks are not an adequate justification.

Any questions regarding PCORI’s Policy on Data Management and Data Sharing should be sent to [email protected].

Additional Assistance

Where can I find additional resources related to the Policy?

PCORI held a webinar about the Policy in November 2018 in order to provide additional information and answer questions from Awardees. The archived webinar and presentation slides can be found on the PCORI's New Data Sharing and Data Management Policy: What You Need to Know archived event page.

Additionally, PCORI and ICPSR jointly hosted a webinar to provide more information on the data sharing contract modification process and details on data deposition. Watch the archived webinar. We will continue to make other resources available on our website under Awardee Resources.

Please also refer to PCORI’s Data Sharing webpage for more information.

Where do I send additional questions I have about the Policy?

You can send your questions to: [email protected].

If you are a current Awardee, please include your assigned Program Officer and Program Associate as CC’s on the emails.

Posted August 31, 2023; Updated: February 9, 2024

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