NICHD Data and Specimen Hub – Data Archive Policy Statement


Available for download as a PDF here: NICHD DASH Policy [190 kB]


1. GOAL OF THE POLICY

NICHD has established the NICHD Data and Specimen Hub (DASH) as a mechanism for NICHD funded extramural and intramural investigators to comply with NIH data sharing policies, including the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy. NICHD DASH will enable investigators to organize, store, and mine data from NICHD funded research studies for purposes of secondary research use.

The purpose of this NICHD DASH Data Archive Policy Statement is to provide an overview of the data archive component (not the specimen archive component) of DASH that is available to house research data from NICHD funded research studies when such data are ready for sharing as per NIH policies. This Policy Statement also serves to inform investigators about how to submit data to, and request data from, NICHD DASH.

NICHD recognizes that databases and repositories will be established by other entities to achieve different scientific aims or to integrate different analytic capabilities. The NICHD DASH Policy Statement is not intended to constrain the development of such databases and repositories nor curtail depositing data to them (as may be appropriate or required for some research programs).

2. PRINCIPLES OF THE POLICY

Consistent with its mission to improve public health through research, NICHD believes that the full value of research can be realized if data from NICHD funded research studies are made available as rapidly as possible to a wide range of scientific research investigators. Rapid and broad data access is particularly important because of the extraordinary opportunities for making comparisons across multiple studies.

Consistent with the NIH Data Sharing Policy and the NIH Genomic Data Sharing Policy, NICHD strongly advocates the sharing of human research study data. NICHD supports the sharing of data derived from NICHD funded research studies that are:

3. APPLICABILITY OF THE POLICY

The NICHD DASH Policy Statement applies to NICHD funded extramural and intramural research data that investigators seek to share:

NICHD encourages research investigators funded by the Institute to use NICHD DASH to share data with other investigators. NICHD funded investigators who do not submit their data to NICHD DASH should provide the name of the alternate data archive used to the appropriate NICHD Program Officer responsible for the study and are encouraged to justify why submission to the alternate archive is more suitable. This would allow NICHD DASH to catalog and provide a link to data storage locations of all NICHD funded research studies.

4. SCOPE OF THE POLICY

The NICHD DASH Policy Statement reflects and builds on existing NIH polices and specifically addresses the following for the data stored in NICHD DASH:

  • Protection of research participants,
  • Scientific publications,
  • Intellectual property,
  • Governance, and
  • Data submission and access requirements.

5. NICHD DASH POLICY CONSIDERATIONS

5.1 Protection of Research Participants

Protection of research participants is a fundamental principle underlying biomedical research. NICHD is committed to responsible stewardship of data throughout the research process; such stewardship is essential to protecting the interests of study participants and to maintaining public trust in biomedical research.

To ensure that the identities of research subjects cannot be readily ascertained with the data, NICHD DASH will store only data that are without identifiers and coded. Specifically, before submitting the data to NICHD DASH, investigators must:

  1. Strip the data of individually identifying information according to:
  2. Assign to the de-identified data random, unique codes.

NICHD will not hold direct identifiers to individuals whose data are stored within NICHD DASH, nor will NICHD have access to the link between the data code and identifiers that may reside with the primary investigators and institutions for particular studies (Refer to Section 7.1.1 for additional information on data de-identification and coding guidance).

5.1.1 Non-research Use of Data

As an agency of the Federal Government, NICHD is required to release government records in response to a request under the Freedom of Information Act (FOIA), unless those records are specifically exempted from release. With cases pertaining to NICHD DASH, NICHD believes that release of material would constitute an unreasonable invasion of personal privacy under FOIA Exemption 6, 5 U.S.C. § 552 (b)(6). NICHD also acknowledges that legitimate requests for access to data made by law enforcement offices may be fulfilled.

5.1.2 Stigmatization

Some data to be included in NICHD DASH may be highly sensitive because they may suggest the existence of either individually identifiable or socially stigmatized traits. Analytical tools increasingly are able to make inferences about individual traits (e.g., height; weight; and skin, hair, and eye color) and to suggest predilections for characteristics (e.g., risk of developing some diseases) and behaviors with social stigma.

In recognition of these concerns, the NICHD DASH Policy Statement includes steps to protect the interests and privacy concerns of individuals, families, and identifiable groups who participate in research. Specifically, institutions submitting clinical research datasets to NICHD DASH must certify that an Institutional Review Board (IRB) and/or Privacy Board (as applicable) has considered such risks, and all identifiers have been removed from the data (Refer to Sections 5.1 and 7.1). In addition, the NICHD DASH Committee (Refer to Section 6) will approve access only for research uses that are consistent with the limitations to data use as defined by the submitting institution. In the event that data access requests raise questions or concerns related to privacy, confidentiality, risks to populations or groups, or other relevant topics, the DASH Committee will consult with other experts as appropriate before making a final decision on release of data to requesters.

5.1.3 Informed Consent

Research participants may not be aware of the potential privacy risks associated with the placement of their data in NICHD DASH. Adequate consent for data sharing requires participants to understand both the risks and potential benefits of the proposed sharing. Key stakeholders in these considerations are: research participants who have participated in prior studies; investigators developing informed consent processes; institutions approving the submission of datasets to NICHD DASH; and IRBs asked to review studies proposing broad data sharing.

NICHD recognizes that the ethical considerations relevant to data sharing are complex and dynamic. Participant interests relevant to sharing data from clinical research extend beyond individual participants to families, communities, and cultural sensitivities. Furthermore, especially complex issues exist where participant consent has been provided by proxy (e.g., pediatric research or studies involving mental health disorders). NICHD recommends that these broad interests be considered before submitting data to DASH.

In general, data submitted to NICHD DASH will be from studies where data collection has ended and the study is ready to be shared. For such studies, NICHD anticipates considerable variation in the extent to which data sharing has been addressed within the informed consent documents. As described under Data Submission Requirements (Refer to Section 7.1), the submitting institution must determine whether a study-specific data set is appropriate for submission to NICHD DASH.

In the event that a participant withdraws consent for sharing of their individual-level data stored in NICHD DASH, the submitting institution will be responsible for informing NICHD DASH. In such cases, NICHD will remove the dataset in question, terminate the data use agreement(s) established with any data recipient(s), and instruct them to destroy the dataset in question that was provided by DASH. NICHD will request the data submitter to furnish a redacted data set de-identified of HIPAA identifiers, as replacement and inform previous recipient(s) if and when such dataset is available.

5.1.4 Return of Results

NICHD will not provide study participants with results of secondary analyses from data submitted to NICHD DASH. NICHD DASH and secondary data users will not have access to identifying information; consequently, neither party will be able to return individual results directly to the subjects.

5.2 Scientific Publication

The nature of NICHD DASH dictates that the data deposited from research studies are available for meaningful secondary analysis to investigators who request the data, and that all results emanating from such use are under the purview of the requesting investigators without restrictions for publication. NICHD expects all investigators who access data from NICHD DASH to acknowledge the contributing investigator(s) who conducted the original study, the funding organization(s) that supported the work, and NICHD DASH in all resulting oral or written presentations, disclosures, or publications of the analyses. Guidance for acknowledgement text will be provided in the NICHD DASH Data Use Agreement to be signed by the requesting investigators and their authorized institutional business official.

5.3 Intellectual Property

NICHD encourages development of new diagnostics, therapeutics, or other interventions building on basic discoveries enabled through data obtained from NICHD DASH. Data recipients are free to pursue patent protection on any inventions or discoveries developed through their analysis and use of NICHD DASH data.

NICHD expects that findings identified through NICHD funded research studies and their obvious implications will remain available to all investigators, unencumbered by intellectual property claims. NICHD discourages premature claims on potential pre-competitive information that may impede research, although it encourages patenting of technology suitable for subsequent private investment that may lead to the development of products that address public needs.

NICHD expects that results and conclusions derived from the use of data obtained from NICHD DASH and citations of resulting publications will be deposited back and made available to other investigators. Approved users and their institutions, through the execution of the NICHD DASH Data Use Agreement, will acknowledge the goal of ensuring the greatest possible public benefit from NICHD funded research studies.

6. GOVERNANCE AND OVERSIGHT OF NICHD DASH

NICHD recognizes that scientific, ethical, and societal issues relevant to the NICHD DASH Policy Statement are evolving and has established a governance structure that will:

  • Ensure ongoing institutional oversight for NICHD DASH including adequate quality controland security measures for data and data use practices;
  • Obtain regular input from public representatives, including those with expertise inbioethics, privacy, data security, and appropriate scientific and clinical disciplines; and
  • Revisit and revise the Policy Statement as appropriate in accordance with any newfederal or NIH policies and guidance that impact data sharing.

The NICHD Director and/or designee will oversee the NICHD DASH Policy Statement and its implementation. In carrying out this responsibility, the NICHD Director will consult the NICHD DASH Committee composed of NICHD staff with the appropriate policy knowledge. The Committee will provide oversight over the management and performance of NICHD DASH. Specialized sub-committees related to data submission, data access (such as the Data Access Committee), and quality control will report to the DASH Committee. In order to maintain policies consistent with evolving technological and ethical considerations, the NICHD Director will solicit, on an as needed basis, recommendations on the NICHD DASH Policy Statement from external experts representing public and scientific stakeholders through the NICHD Council.

The NICHD DASH Committee will establish and maintain operating policies and procedures for NICHD DASH to address issues including, but not limited to:

  • Privacy and confidentiality of research participants,
  • Interests of individuals and groups,
  • Data submission procedures,
  • Data access and use procedures, and
  • Data security mechanisms based on the content and level of risk.

7. DATA SUBMISSION AND ACCESS REQUIREMENTS FOR NICHD DASH

7.1 Data Submission Requirements

Extramural and intramural investigators who are submitting study data to NICHD DASH must comply with the specific requirements listed below:

7.1.1 De-identified Data

In order to minimize risks to study participants, data submitted to NICHD DASH must be stripped of identifiers and coded (Refer to Section 5.1.1). Keys to the codes will be retained by the submitting institutions. Data must be de-identified according to the following criteria:

  • The identities of research subjects cannot be readily ascertained or otherwise associatedby NICHD DASH staff or secondary data users (45 C.F.R. 46.102(f));
  • The 18 identifiersi enumerated at section 45 C.F.R. 164.514(b)(2) (the HIPAA Privacy Rule) are removed; and
  • The submitting institution has no knowledge that the remaining information could beused alone or in combination with other information to identify subjects.

NICHD has developed a Guidance for Data De-Identification and Coding for investigators to utilize when preparing data for submission to NICHD DASH.

7.1.2 Institutional Certification

All submissions to NICHD DASH must be accompanied by an Institutional Certification from responsible Institutional Official(s) of the submitting institution stating that they approve submission to NICHD DASH and that the identities of research participants will not be disclosed to NICHD.

At a minimum, the Institutional Certification must assure that:

  • The data submission is consistent with all applicable national, tribal, and state laws andregulations,2 as well as relevant institutional and study policies;
  • The appropriate research uses of the data and its limitations that are consistent with theinformed consent documents are delineated during the process of data submission toNICHD DASH;
  • The identities of research participants will not be disclosed to NICHD DASH;
  • The investigator will be responsible to inform the NICHD DASH if data needs to beremoved from the Archive for any reason, such as change in informed consent; and
  • An IRB and/or Privacy Board, as applicable, reviewed and verified that:
    • The submission to the NICHD DASH and subsequent sharing for research purposes areconsistent with the informed consent of study participants from whom the data were obtained,3
    • The investigator has de-identified the study data in compliance with the standards outlined in the NICHD DASH Policy,
    • It has considered the risks to individuals, their families, and groups or populations associated with data submitted to NICHD DASH, and
    • The data to be submitted were collected in a manner consistent with 45 C.F.R. Part 46.
7.1.3 Data Quality and Documentation

Data submitted to NICHD DASH must be individual level data that is cleaned, de-identified, and usable for secondary analysis. All data submitted to NICHD DASH must be accompanied by proper documentation to ensure meaningful use of the data and to prevent misuse, misinterpretation, and confusion. Documentation provides information about the methodology and procedures used to collect the data, details about data variable codes, definitions of variables, variable field locations, frequencies, etc. The precise content of documentation will vary by scientific area, study design, type of data collected, and characteristics of the dataset. Examples of documentation files include protocols, codebooks, data dictionaries, data collection instruments, methods for data cleaning, data analyses plans, summary statistics, project summaries, and bibliographies of publications pertaining to the data.

7.1.4 Data Withdrawal and Resubmission

In the event that a dataset submitted to NICHD DASH must be modified or corrected, such action is the sole responsibility of the submitting investigator and their institution. For any dataset previously submitted to the NICHD DASH, where such dataset requires modification or correction, the submitting investigator and their institution may request deletion of a specifically identified dataset in its entirety from NICHD DASH. Upon receipt of such request from the submitting investigator and their institution, the NICHD DASH shall delete, in its entirety, the specifically identified dataset. The submitting investigator and their institution are encouraged to resubmit the modified or corrected dataset into NICHD DASH.

Please refer to Section 5.1.3 for further guidance on data withdrawal and resubmission.

7.2 Data Access Requirements

Access to individual level data in NICHD DASH will require the investigator to submit a Data Request Form and a Data Use Agreement, which is co-signed by the Principal Investigator and the designated Institutional Official(s).

Data access requests should include a brief description of the proposed research use of the dataset(s). Requesting investigators will be required to sign a NICHD DASH Data Use Agreement, whereby they agree to:

  • Use the data only for the approved research,
  • Not share data with individuals other than those listed in the request,
  • Protect data confidentiality,
  • Not attempt to identify individual participants from whom data were obtained,
  • Follow appropriate data security protections,
  • Follow all applicable laws, regulations, and local institutional policies and procedures forhandling data,
  • Not sell any of the data,
  • Agree to report violations of the Data Use Agreement to NICHD DASH,
  • Acknowledge the contribution of the data submitter(s) and NICHD DASH with regardto publication and intellectual property, and
  • Provide annual progress reports on research using the data.

The NICHD DASH Data Access Committee will review requests for data to determine whether the proposed research use is scientifically and ethically appropriate and does not conflict with constraints or data use limitations identified by the institutions that submitted the data. In the event that requests raise concerns related to privacy, confidentiality, risks to populations or groups, or other concerns, the NICHD DASH Data Access Committee will consult with other experts as appropriate.

Investigators and institutions seeking data from NICHD DASH will be expected to meet data security measures (e.g., physical security, information technology security, user training).

8. INQUIRIES

For inquiries on the NICHD DASH Policy Statement, please send an Email to supportdash@mail.nih.gov.

9. REFERENCES

1 The identities of research subjects cannot be readily ascertained or otherwise associated with the data by the repository staff or secondary data users (Common Rule); and the following data elements have been removed (HIPAA Privacy Rule).

  1. Names.
  2. All geographic subdivisions smaller than a state, including street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial three digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census: a. The geographic unit formed by combining all ZIP Codes with the same three initial digits contains more than 20,000 people. b. The initial three digits of a ZIP Code for all such geographic units containing 20,000 or fewer people are changed to 000.
  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.
  4. Telephone numbers.
  5. Facsimile numbers.
  6. Electronic mail addresses.
  7. Social security numbers.
  8. Medical record numbers.
  9. Health plan beneficiary numbers.
  10. Account numbers.
  11. Certificate/license numbers.
  12. Vehicle identifiers and serial numbers, including license plate numbers.
  13. Device identifiers and serial numbers.
  14. Web universal resource locators (URLs).
  15. Internet protocol (IP) addresses numbers.
  16. Biometric identifiers, including fingerprints and voiceprints.
  17. Full-face photographic images and any comparable images.
  18. Any other unique identifying number, characteristic, or code, unless otherwise permitted by the Privacy Rule for re-identification

In addition, the submitting institution should have no actual knowledge that the remaining information could be used alone or in combination with other information to identify the individual who is the subject of the information.

2 Applicable Federal regulations may include HHS human subjects regulations (45 CFR Part 46), FDA human subjects regulations (21 CFR Parts 50 and 56), and the Health Insurance Portability and Accountability Act Privacy Rule (45 CFR Part 160 and Part 164, Subparts A and E).

3 For retrospective (older) studies where the participant consent form does not explicitly state broad data sharing, the IRB will determine whether the data can be submitted to NICHD DASH.