The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) has the authority and responsibility to establish policies and practices for National Children’s Study data access and confidentiality in alignment with applicable law, regulation, and policy. To achieve Study objectives, these policies and practices must maximize the availability of quality data for the intended scientific purposes. At the same time, the Study must responsibly carry out its mandate by protecting participants and their communities against risk of intentional or inadvertent disclosures, whether directly or through inference, of private, confidential, or sensitive personal information. The Study must meet both objectives while also protecting the reliability, integrity, and validity of the data.
To these ends, in 2009, the National Children’s Study established a set of governing principles around data access and confidentiality that continue to be refined and incorporated into policy and practice. These principles and the overall approach to data access and confidentiality are described in the National Children’s Study Data Access and Confidentiality Concept of Operations (PDF 429 KB).
Data Access and Confidentiality Guiding Principles
Provide Quality Data
The National Children’s Study will prepare and make available quality datasets to authorized researchers on an ongoing basis throughout the course of the Study. The schedule of data release will reflect multiple factors including completeness, quality, risk, weighting, operational, and user needs. Some datasets will require a greater level of detail in terms of personally or socially identifiable data for scientific analysis (such as geographic information). Some data, by nature, are particularly sensitive (for example, biospecimens, environmental samples, or tribal affiliations); or are disclosive (facial images). Therefore, the purpose and nature of the dataset determines the disclosure-limitation methods applied, as well as the designation of the data as restricted- or public-use. Any disclosure risk-limitation techniques used will aim to preserve the quality of data to the extent possible for the purposes of a given dataset.
Task-Driven and Timely Access
Access to National Children’s Study data will be guided by project needs and staff roles throughout the data lifecycle, and thus, data access for all users will be guided by the requirements of the data user to complete his or her task. For those under contract (affiliated) with the Study, the specific roles and data access needs will be captured in the description of the work contracted to perform. Given the responsibility many of these contracted entities have in regards to daily operations, including field monitoring and protocol development, the sensitivity level and timeliness of access may be greater than those researchers not under contract (non-affiliated) with the Study.
Respective of any disclosure risks to participants, their families, or communities, the National Children’s Study data including, but not limited to, interview data, images, biospecimens, environmental samples, and supporting documentation will be made available to the research community for intended scientific purposes in a timely manner.
All people in contact with personally or socially identifiable data used by or collected by the National Children’s Study will be required to adhere to Study data-security guidelines. Study disclosure limitation policies and practices mandate a shared responsibility to limit disclosure risk, whether inadvertent or intentional, direct or indirect, of participant identities and their communities in a manner consistent with federal regulations.
Transparency of Process
The National Children’s Study Program Office will ensure that the research community is kept informed of plans for data dissemination and any updates to data access and confidentiality policies or practices. Disclosure-limitation decisions will be mindful of the integrity of the Study and the quality of its data files and will be communicated to all data users. When appropriate, the National Children’s Study Program Office will consult with respondents, potential data users, and relevant experts and other consultants to establish an improved understanding of both respondents’ privacy concerns and investigators’ scientific needs. This consultation will inform the balance between disclosure limitation and data utility. Further, disclosure-limitation strategies will be documented and represent a verifiable process.
National Children’s Study data access and confidentiality policies will conform to federal laws and regulations, national and agency policies, and be consistent with general federal guidelines regarding data confidentiality and disclosure limitation. Policies will also adhere to the commitment to confidentiality espoused in Study informed consent.