Diversity Program Consortium Data Sharing AgreementApproved: September 6, 2019
The National Institutes of Health (NIH) recognizes the need to diversify the scientific workforce by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences (collectively termed "biomedical") research workforce. With that in mind, in 2012, it convened the NIH Advisory Committee to the Director (ACD) Working Group on Diversity in the Biomedical Research Workforce to explore strategies to attract, prepare and sustain the interest of individuals in the scientific workforce, including those from underrepresented groups (NIH's Interest in Diversity). In response to the Working Group’s recommendations, which were endorsed by the ACD, the NIH established the Common Fund Program “Enhancing the Diversity of the NIH-funded Workforce,” also known as the Diversity Program Consortium (DPC). In Phase I, this program allowed for the formation of a national collaborative consisting of three integrated initiatives:
In Phase II, new awardees joined the consortium through the DPC Dissemination and Translation Awards (DPC DaTA).
In partnership with the NIH, DPC awardees employ approaches to strengthen institutional capacity to engage and prepare individuals, including those from underrepresented groups, for successful careers in biomedical research. The interventions focus on infrastructure, faculty development, student engagement, research training and mentorship across the career pathway. A primary goal of the DPC is to provide robust evidence on effective ways to enhance diversity by engaging and sustaining the interest of individuals in the biomedical research workforce and to encourage the dissemination of successful diversity enhancing interventions to a wide variety of institutions across the United States.
To facilitate the evaluation of the program, a core set of data across the DPC awardee sites is collected at intervals as outlined in the Consortium-Wide Evaluation Plan (CWEP). In addition, individual awardees collect and store site-level data for evaluation and research purposes to meet the goals of the program. This Data Sharing Agreement (DSA), developed in conjunction with DPC’s awardees and the Executive Steering Committee (ESC), describes the requirements for data collection, integrity, storage, security, confidentiality, use, sharing, ownership, rights, and responsibilities. The DSA may be modified to meet the evolving needs of the consortium. A revised DSA must be approved by the ESC, which includes representation from each awardee and the NIH.
The original DSA developed and implemented during Phase I of the DPC remained in effect from March 16, 2016 until this revised DSA was approved on 09/06/2019. To ensure compliance, the DSA is incorporated into the terms and conditions of each award. This DSA supersedes the original DSA and should be referenced to address topics related to DPC data going forward. This DSA will remain effective until June 30, 2029, 5 years after the end of the funding period.
The CEC is responsible for implementation of the consortium-wide evaluation activities in collaboration with the awardees, the ESC, and the NIH. The NIH will be responsible for oversight and adherence of the DPC awardees to this DSA. These terms apply to each DPC awardee in Phase I (RFA-RM-13-017, RFA-RM-13-016, RFA-RM-13-015) and Phase II (RFA-RM-18-004, RFA-RM-18-003, RFA-RM-18-002, RFA-RM-18-006, RFA-RM-18-005; RFA-RM-19-003). In addition to the DPC awardees, all non-consortium parties granted access to DPC data (see below for access conditions) will adhere to this DSA. Failure to abide by the terms and conditions of this DSA, including data security/disclosure provisions, may result in (i) denial of further access to the DPC data, (ii) denial of access to NIH-funded resources, and (iii) federal or state penalties. Liability will be aligned with data ownership and rights.
The NIH is committed to protecting the rights and privacy of those whose information is collected during the conduct of its funded research, and awardees will be responsible for compliance with this DSA. This DSA is made under the NIH’s authority to conduct and fund research; to provide training/training assistance; to collect information as to the practical application of such research and training activities; to assemble accurate data to evaluate research priorities and scientific opportunities; and to maintain records in connection with these or other agency functions (42 U.S.C. §§ 241 and 282, and 44 U.S.C. § 3101). This DSA incorporates by reference the NIH's data sharing policies for research and the Family Educational Rights and Privacy Act (FERPA) guidelines on use or disclosure of student educational records in the conduct of research, when applicable.
As delineated in the Notices of Grant Awards, each “awardee will retain custody of and have primary rights to site-level data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies. All evaluation-related consortium data will be shared with the NIH upon request and at the conclusion of the award.” During the funding period, the CEC has responsibility for management and oversight of the consortium-wide evaluation BUILD data and long-term NRMN follow-up data as delineated in this agreement, and the individual awardees retain ownership over the use of their site-level data.
The CWEP data collection instruments, processes, and schedules for data collection developed on behalf of the DPC adhere to those approved by the UCLA-CEC Institutional Review Board (IRB), or other relevant IRB governing the consortium-wide data collection. All non-CWEP site-level data collection instruments and procedures must adhere to the governance of the local site IRB.
Consortium-wide and site-level data are required to determine the effectiveness of DPC training, mentoring, and research-capacity building interventions on outcomes. The data categories include the following:
DPC awardees are expected to work collaboratively with the CEC to meet consortium-defined standards of data completeness and quality. The DPC process for submission of CWEP data includes the CEC providing a description of data to be submitted, the submission timeline, and access to the secure consortium data repository for the transfer of data. The process includes quality assurance activities to be completed by awardees, as well as quality review, risk assessment, and de-identification to be completed by the CEC. Quality review includes confirmation of identifiers for linking with other consortium-wide data, assessment of valid values, explanations for missing data, and completion of logic or skip patterns. Disclosure risk assessment includes review for sensitive and infrequent (rare) data points that could be used to identify individuals. For both quality reviews and disclosure risk assessments, the CEC works with each institution to resolve any outstanding issues with data quality.
To protect the rights and privacy of individuals whose information is collected, all parties under this DSA must agree to adhere to the highest standards for data transfer, storage, and access. The NIH and the DPC recognize that data security in multisite and collaborative research requires compliance with organizational policy, IRB guidelines, as well as local, state and federal laws and regulations to safeguard participant privacy and ensure data protection. To transfer data, awardees must use a secure file transfer service over an encrypted connection. Physical and/or electronic data are to be maintained securely and retained for up to 5 years following the end of the program funding period.
The long-term impact of the DPC will be in the broad dissemination of evidence-based effective DPC training, mentoring, and research-capacity building strategies. All DPC awardees are expected to disseminate outcomes to the wider community. Two types of dissemination products include evaluation outcomes and hypothesis-based research findings. Evaluation outcomes represent the results with respect to the Hallmarks of Success and will inform the community about the overall effectiveness of the training, mentoring, and research-capacity interventions. Hypothesis-based research is based in a theoretical framework, tests models or hypotheses, and delineates findings that will inform the biomedical community about what factors influence the outcomes.
During Phase II, the DPC is expected to develop and implement a Dissemination Strategic Plan for both Phase I and Phase II data describing (1) major consortium-wide evaluation themes and hypothesis-driven research areas, (2) the types of dissemination products (e.g., data briefs, presentations, publications), (3) the data required for the analyses, (4) the expertise needed to produce rigorous products, and (5) a realistic timeline for producing the dissemination products, taking into consideration the time required for outcomes. The Dissemination Strategic Plan will be developed by consortium members and approved by the ESC. Additionally, each awardee is responsible for implementing their site-level dissemination plans.
To promote synergies and reduce redundancies, the DPC developed an approval process for DPC awardees to access data for disseminating consortium products. The approval process is described in the Publications and Presentations (P&P) Policy and is managed by the Publications and Presentations sub-Committee (PPsC) of the Executive Steering Committee. The process requires either a notification or an application as described below.
During the funded period of the program, access to de-identified data for parties outside of the DPC requires submission of a Data Request Form describing the proposed use of the data and identifying an institutional sponsor who is a member of the DPC. Requests for access to de-identified site-level data from an outside party requires sponsorship by the Principal Investigator(s) of that site. Documentation of Human Subjects Ethics training and IRB approval or exemption must be provided with the data request. Outside parties must agree to use the requested data only for the approved use. All such requests will be reviewed by the ESC according to the P&P Policy. In addition, within 24 months of the termination of Phase II funding, de-identified CWEP data will be made available for public use, consistent with the NIH data sharing agreement for NIH funded research, through an open access portal on the CEC public website.
DPC awardees agree not to misuse or disclose DPC data except as permitted under this DSA and/or required by law. Unauthorized use or disclosure of data must be reported to an NIH Program Official within one day of discovery and include both corrective actions to prevent future unauthorized use/disclosure, as well as efforts to mitigate any adverse effect of the unauthorized use/disclosure. The NIH Program Official will implement review procedures within the NIH.
As per the Cooperative Agreement Terms and Conditions, “any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. The three members will be a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.”
