HIPC Data Sharing Plan

Introduction and Principles

The Human Immunology Project Consortium (HIPC) was established with the specific goal to share data as widely and freely as possible in order to promote new research and generate new hypotheses. In addition to individual Center projects, the HIPC program includes an Infrastructure and Opportunities Fund (IOF) supporting 1) pilot projects and 2) shared research infrastructure for ongoing development of the immunology project network which may include, for example, the development of shared databases, sample repositories, bioinformatics tools, sample sparing assays, centralized laboratory resources, and other collaborative activities. It is essential that data be made available to HIPC investigators, as well as those outside of the HIPC Centers, for the purposes of data mining. The method of data storage must enable easy comparison of standardized results and meta-data. The ease with which data can be shared and compared is critical to the success and mission of the HIPC Centers.

The HIPC Data Sharing Plan is designed to enable the widest dissemination of data, while also protecting the privacy of the participants and the utility of the data, by de-identifying and masking potentially sensitive data elements. This approach is fully compliant with the NIH public data sharing policy (http://grants.nih.gov/grants/policy/data_sharing).

In addition, this plan aims to benefit HIPC by providing active web links to relevant data in all of its publications and HIPC investigators should prepare all their manuscripts with this objective in mind. In order for this to be accomplished, HIPC centers will work with the NIAID Division of Allergy, Immunology and Transplantation-funded data repository known as the Immunology Database and Analysis Portal (ImmPort, ( www.immport.org ) and HIPC’s ImmuneSpace ( https://immunespace.org ) to ensure that all data are submitted to ImmPort early enough so that they are cleaned, appropriately curated and ready for public release by ImmPort and ImmuneSpace at the time of publication.

The HIPC Data Sharing Policy applies to all HIPC investigators (see definition below). HIPC Principal Investigators (PIs) are responsible for providing copies of this plan to their center investigators as well as to any other collaborators who receive HIPC funds, including IOF support.

Central Database(s)

HIPC investigators agree to deposit their data into ImmPort ( www.immport.org ) according to a timeline determined together with the NIAID HIPC center Program Officer, as outlined in the Data Deposition Plan. HIPC investigators further agree that ImmPort will clean and curate the deposited data and that these data will also be transferred to ImmuneSpace ( https://immunespace.org ), the HIPC’s data management and analysis engine. HIPC investigators agree that all publications supported by their HIPC award will include links to ImmuneSpace for access to the publication’s source data or links to the data sets in ImmPort.

To fulfill the HIPC data sharing objectives, HIPC investigators will enter all study data and meta-data into ImmPort as soon as they are available. This practice will save time and effort for the HIPC investigators, as it allows relevant staff to upload and curate/validate the data while they are still in the lab and helps the HIPC PIs remain current with their data deposition requirements.

Quality Control: To ensure quality and biological soundness, HIPC investigators will collaborate with the ImmPort/ImmuneSpace staff in validating, curating, and verifying data submitted.

Standards for Complex Data Sets: To support the proper use and interpretation of data and meta-data, standards for minimum information will be applied. These standards are developed by the HIPC Biostatistics and Bioinformatics Subcommittee using existing standards, including data standards developed by earlier HIPC investigators. Current HIPC data standards are available at http://ec2-52-7-115-95.compute-1.amazonaws.com/ribeiro/templates.jsf

Definitions:

  • A " HIPC investigator " is any Project Leader, Core Leader or other investigator funded under one or more of the HIPC U19 grants, as well as other investigators supported by the IOF.
  • A " HIPC Principal Investigator (PI)" is the PI of a HIPC U19 grant.
  • " HIPC Project Data" refers to all data associated with a HIPC-funded research project or clinical study (HIPC parent award and IOF projects), including the meta-data needed to interpret and mine the results.
  • A "data set, " is a subset of the HIPC project data associated with a manuscript in preparation for publication.
  • A " Complete Data Set " is a Data Set that has been submitted to ImmPort and has been curated by the ImmPort team.
  • A " Public Data Set, ": a Complete Data Set hat has been released to the public via ImmPort and ImmuneSpace.

Reports:

  • Data Deposition Plan: this report will be provided by the HIPC PI to NIAID at the initiation of the HIPC award and will be updated every year thereafter, for the duration of the HIPC award, before the award’s anniversary. This document describes all the HIPC Project Data that the center intends to collect (or has collected) during the duration of the award, including data generated in parent award projects, IOF projects and administrative supplements.
  • End-of -Year Data Deposition Report: Prior to each HIPC center’s grant anniversary date, ImmPort will provide a report to the center’s PI and to NIAID staff on all HIPC Project Data submitted to ImmPort. This report will also indicate which HIPC Project Data have been associated with a manuscript (Data Sets and Complete Data Sets), those that have been publicly released (Public Data Sets) and those that have not been associated with any manuscript.

Timeline for Data Deposition and Data Sharing

  • At the initiation of a HIPC award, the Data Deposition Plan template will be provided by the NIAID Program Officer. Each HIPC center will provide the Data Deposition Plan, which is a description of the HIPC Project Data that will be collected during the duration of the award.
  • The Data Deposition Plan will be updated at each HIPC award’s anniversary, and shared with NIAID Program Officer and ImmPort staff.
  • Each HIPC center will be uploading HIPC Project Data to ImmPort on an ongoing (and preferably “real-time”) basis in accordance to the Data Deposition Plan that the center has provided to NIAID.
  • When a manuscript is in preparation from a HIPC center/IOF project/administrative supplement, the PI and other relevant staff will work with ImmPort to identify the Data Set associated with that manuscript among the submitted HIPC Project Data. ImmPort will conduct/complete data curation and will make the Complete Data Set available to ImmuneSpace for further production.
  • At the time of the online publication, the Complete Data Set will be made public via ImmPort and ImmuneSpace (www.ImmunSpace.org), for access by outside investigators (Public Data Set).
  • If there are delays in publication, ImmPort and ImmuneSpace will make Complete Data Sets publicly available 9 months post submission of the manuscript. This can be postponed due to delay of the publication resulting from: a) rejection by one or more journals; or b) discovery of errors that require changes in the Data Set.
  • HIPC Project Data submitted to ImmPort, which remain without manuscript association, will be subject to public release 12 months after submission to ImmPort or at the end of the current HIPC/IOF award, whichever comes first. After each year’s End-of Year Data Deposition Report is released by ImmPort, the NIAID PO will review the relevant information with the HIPC center PI and will determine whether any of the HIPC Project Data that are not associated with a manuscript should be released to the public and when. If the HIPC PI wants to request a delay in the public release of these data, she/he will submit this request in writing and with justification to NIAID for review and final decision.

NOTE: Abstracts and oral presentations are not considered to be publications for the purposes of this HIPC Data Sharing Policy.

Access to Private Data:

  • HIPC investigator determines the right of data access to his/her private data (HIPC Project Data, Data Sets or Complete Data Sets, but not Public Data Sets). However, NIAID program staff and ImmPort/ImmuneSpace staff will have access to all data submitted into ImmPort. NIAID staff will access the data for administrative purposes only. ImmPort/ImmuneSpace staff will have access to the data for quality control/curation and oversight purposes only. To ensure data confidentiality at ImmPort and ImmuneSpace, data access is limited to curation staff prior to public release.
  • In some cases, NIAID staff may need to use private HIPC data for presentations to other Federal Agencies, or in response to Congressional inquiries. Such use of data is intended to promote NIAID initiatives, the HIPC program, and HIPC research goals. In these cases, NIAID will notify in advance those HIPC investigators responsible for generating the data, and provide an explanation of why access to the private data is needed. NIAID staff will make every effort to maintain the confidentiality of private data except for situations where public reporting (e.g. transcripts or slide presentations) is required by Federal policy or law.
  • Voluntary Data Sharing: Individual HIPC investigators may choose to share their private data with other HIPC investigators and non-HIPC investigators (including potential industry partners) if they obtain permission to do so in advance from all the parties who generated the data. Prior HIPC Steering Committee approval is not required, but NIAID strongly recommends that a confidentiality disclosure agreement (CDA) be in place prior to such data sharing. The terms of these CDAs should also cover the confidentiality and distribution of any post-meeting documents (e.g. transcripts, meeting notes, or slide presentations). HIPC investigators are strongly encouraged to create CDAs to share private data for the purpose of building HIPC collaborations and creating data standards. Sharing private data under this type of agreement is independent and does not affect the timeline for public data sharing, as described above.

Protecting Human Subject Data

It is the responsibility of HIPC investigators to protect the rights of human subjects, the privacy of human subject information, and the confidentiality of such data at all times. Prior to sharing, data shall be stripped of all identifiers to eliminate risks of unauthorized disclosure of personal identifiers. Accordingly, NIH policy will be adhered to, as outlined in the following:

"NIH Data Sharing Policy and Implementation Guidance: Human Subjects and Privacy Issues":
http://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm#hs

"Policy for Sharing of Data Obtained in NIH Supported or Conducted Genome-Wide Association Studies (GWAS)": http://grants.nih.gov/grants/guide/notice-files/NOT-OD-07-088.html

Non-Shareable Data

In cases where some data are not amenable to sharing (participant confidentiality concerns, third-party licensing or use agreements, etc.), the issue must be raised immediately with NIAID program staff in order to identify non-shareable data. NIAID staff may approve a limited exemption from data sharing in some circumstances.