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CHS Data & Specimen Distribution Policy
PROCEDURES FOR ACCESSING CHS DATA & SPECIMENS:
Access to individual level CHS data and specimens requires an association with the study, and agreement to abide by study policies and procedures. It is understood that data contain no personal identifiers; i.e. are de-identified, unless otherwise noted.
Visit the Forms & Agreements page to access and download the forms mentioned below.
Association with study and access
We define 3 levels of association with the study:
1) CHS Investigators who are or have been supported by the contract for their role in study management, data collection, or operations;
2) Collaborators who have no formal role in the study, but who wish to utilize CHS data in their scientific research; and
3) Ancillary Study Investigators who utilize CHS participants or resources to collect additional data or reanalyze specimens or scans.
Until December 2009, CHS Investigators were provided full access to study data. As of December 2009, CHS Investigators must follow study procedures as outlined below for obtaining data. Collaborators must obtain a CHS Investigator willing to sponsor their research, and access is given only to the data required for a particular research project after study approval of the project and completion of a Data and Materials Distribution Agreement (DMDA), which requires IRB review from their institution. Ancillary Studies require approval by the Steering Committee, and once new data are collected, they must be sent to the Coordinating Center for merging with other CHS data. In order to obtain biospecimens or scans, an Ancillary Study investigator needs to complete a Data and Materials Distribution Agreement (DMDA), which requires IRB review at their institution.
Study Policies and Procedures for data access
Data access is provided to CHS Investigators, Collaborators or Ancillary Study Investigators for scientific research upon completion of the following procedures.
1. Paper proposal
A paper proposal must be submitted for each paper. It is reviewed by the Publications and Presentations (P&P) Committee and the Steering Committee for consistency with the goals of CHS, lack of overlap with other work, scientific integrity, and evidence of collaborative authorship, including junior investigators. All persons who will have access to study data need to be named on the proposal. If there is a change of analyst (someone new who will access the data), the name of the new analyst needs to be communicated to the P&P coordinator for study records.
2. Data and Materials Distribution Agreement (DMDA)
A Data and Materials Distribution Agreement (see above) must be completed to obtain study data. This requires IRB review from the recipient investigator’s institution. University of Washington Investigators and Collaborators will have UW IRB approval via the internal gatekeeping process approved as part of the data repository IRB application.
3. Data Request
Data may be obtained from the Coordinating Center by submitting a Data Request Form to our Data Manager.
Human Subjects Gatekeeping Determination: personal identifiers or departures from protocol
Upon submission of a Paper or Ancillary Study Proposal, the CHS Coordinating Center will review the proposal to determine if its data sharing activities require additional review by the UW Human Subjects Division. If the proposal involves any of the activities listed below, then we may be required to seek review from HSD at UW before participating in the proposed project or releasing CHS data.
1. The project will transfer to the CHS Coordinating Center data derived from new contact with individual participants (e.g., through interviews, blood draws, urine samples, image scans, ultrasound studies, tissue samples, DNA samples, or other samples/procedures).
2. This new project represents a significant departure from CHS aims and the current, established uses of CHS data or methods of data collection, storage, and security.
3. Individual-level data will be made available in the future to researchers not currently affiliated with the proposed project (e.g., data posted to dbGaP or shared with a research consortium).
4. Data accessed for this project include any of the identifying items in the list below.
- Name
- Location: all geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes. A truncated version of the zipcode limited to the first three digits is not considered an identifying item if, according to the current publicly available data from the Bureau of the Census, the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people. The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people would need to be changed to 000 to be considered as non-identifying.
- Dates: 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.
- Telephone numbers
- Fax numbers
- Electronic mail addresses
- Social security numbers
- Medical record numbers
- Health plan beneficiary numbers
- Account numbers
- Certificate / license numbers
- Vehicle identifiers and serial numbers, including license plate numbers
- Device identifiers and serial numbers
- Web Universal Resource Locators (URLs)
- Internet Protocol (IP) address numbers
- Biometric identifiers, including finger and voice prints
- Full face photographic images and any comparable images
- Genetic data in a volume of 75 or more SNPs (single nucleotide polymorphisms) per individual
5. Items in the list above will be shared with researcher(s) outside the CHS Coordinating Center.
Coordinating Center procedures for protecting data
Data are stored on database servers located in a locked room in the entry-secured CHSCC building in Seattle, Washington. All personal computers connected to the server are password protected. With the exception of CHS database programmers and IT staff, access to CHS data by Coordinating Center personnel is limited to data sets with all personal identifiers removed, replaced by a study id number. Identifiable data and keys linking identifiable data to the study id number are kept in a separate password-protected database table.
Access to de-identified data by researchers outside the Coordinating Center is limited to data sets tailored to the research project for CHS Collaborators with IRB approval at their institution to access study data. All study and hospitalization dates are removed from the data before distributing and replaced with variables for “time on study”. In the rare instances when identifiable data have been approved for distribution, the data are encrypted prior to sending. The data manager keeps a record of data sets sent.