NICHD DASH Institutional Certification Template

NICHD DATA AND SPECIMEN HUB (DASH) – DATA SUBMISSION

Institutional Certification Template

Introduction

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (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.

Guidelines for Data Submission

TheNICHD DASH Policyprovides detailed guidance to assist researchers when submitting data to the DASH. Briefly:

1. All data should be de-identifiedof the 18 HIPAA identifiers prior to submission to the NICHD DASH. The data should be de-identified and coded as per the Data De-identification and Coding Guidanceprovided by NICHD.
2. Data documentation submitted along with the dataset is critical to meaningful use of the data by other investigators. 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.
3. AllsubmissionstotheNICHD DASH shouldbeaccompaniedbyan Institutional Certification (see Template below) from responsibleInstitutionalOfficial(s)ofthesubmittinginstitution statingthatthey approvesubmissiontotheNICHD DASH and that theidentitiesofresearchparticipantswillnotbedisclosedtotheNICHDDASH.

NICHD DATA AND SPECIMEN HUB (DASH) – DATA SUBMISSION

INSTITUTIONAL CERTIFICATION

STUDY NAME:

DATA SUBMITTING INSTITUTION PRINCIPAL INVESTIGATOR: Name

DATA SUBMITTING INSTITUTION: Name and address

This Institutional Certificationassuresthat:

1. The named principal investigator(s) and any co-investigators conducted the study and cooperated with NICHD DASH submission policies
2. Thedatasubmissionisconsistentwithallapplicable national, tribal, and state laws and regulations[i],as well as relevant institutional and study policies
3. The appropriate research uses of the data and their limitations that are consistent with the informed consent documents are delineated during the process of data submission to NICHD DASH
4. TheidentitiesofresearchparticipantswillnotbedisclosedtoNICHDDASH
5. The investigator will be responsible to inform the NICHD DASH Administrator if data needs to be removed from NICHD DASH for any reason, such as change in informed consent.
6. AnIRBand/orPrivacyBoard,asapplicable,reviewedandverifiedthat:

1. Thesubmission totheNICHD DASHandsubsequentsharingforresearchpurposesare consistentwiththeinformedconsentofstudyparticipantsfromwhomthedatawereobtained[ii]
2. Theinvestigator hasde-identified the study data and is consistentwiththestandardsoutlined in the NICHD DASH Policy
3. Ithasconsideredtheriskstoindividuals,theirfamilies,andgroupsorpopulationsassociatedwithdata submitted toNICHD DASH, and
4. Thedata tobesubmittedwerecollectedinamannerconsistentwith45C.F.R. Part 46

1. I certify to the best of my knowledge that the information submitted here is accurate.

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[i] 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).

[ii] 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 the NICHD DASH.