Request for Research and Data
C8 Health Project data are now available for release to researchers. Relevant institutional review board (IRB) approval is required prior to release of any data for research purposes. As directed by the amended court order, all projects must benefit science, medicine, human health, the Class, or society in general.
Researchers may request Brookmar C8 Health Project Survey responses, data from studies conducted by the C8 Science Panel (Drs. Fletcher, Savitz, and Steenland), and/or C8 Health Project serum.
Dr. Fletcher Data Dictionary 1
Please click on the following links to view the nature and format of available data:
To request C8 data for research, please print out, complete, scan, and e-mail the C8 Health Project Data Request Form, the C8 Health Project Data Use Agreement, along with the additional documents listed (as applicable) in section 22.214.171.124 of the C8 Health Project Standard Operating Procedures to the C8 Health Project Coordinator at C8HealthProject@hsc.wvu.edu
Each request will be reviewed for scientific merit by one member of the C8 Data Oversight Committee who will make a recommendation to the C8 Data Oversight Committee. The requestor will be notified of the committee’s decision.
Release of Electronic Data for Research
For approved research requests for electronic data, a limited electronic datafile will be placed on a secure, internal WVU Health Sciences Center server as specified in section 3.5 of the C8 Health Project Standard Operating Procedures.
Release of Serum Samples for Research Notice on the Methods for the Collection, Processing, Handling, and Storage of the Stored Serum Samples: Samples available for research are the residual serum samples remaining after PFC analysis for the C8 Health Project was completed. All samples were collected in 2005-2006, and there is variation in the amount of sample remaining for each participant which may limit capacity to repeat experiments and therefore, reproducibility. It should be noted that, when collected, the samples were not specifically intended for inclusion in additional research projects. As such, for each sample the time from collection to initial freeze, and number of freeze-thaw cycles cannot be determined. The general collection and processing procedures, therefore, may not meet the most rigorous laboratory standards for specific types of analyses and individual researchers must consider how sample age, processing, and freeze-thaw cycles affect the biological targets being measured in these samples. [Prospective researchers will be required to acknowledge in writing this sample disclaimer and include the statement below in any forum (e.g., manuscript, grant, proposal, or presentation, etc.) that proposes the use of or reports the results from analysis of these samples.]
Disclaimer Statement: For inclusion in manuscripts, grants, proposals, presentations, etc.:
“It is acknowledged and disclosed here that the residual samples from the C8 Health Project, collected during 2005-2006, have heterogeneity with regard to processing, including the number of freeze-thaw cycles subsequent to original analysis. All results reported here/analyses proposed here must be interpreted within the context of these limitations, which are more fully described elsewhere [reference to the full web disclaimer?]”.
To prevent freeze-thaw damage and thus preserve the integrity of the serums, approved research requests for serums shall be fulfilled no greater than four times in a calendar year.
Pursuant to the amended court order, researchers not affiliated with West Virginia University are not permitted to receive individual level data, whether identified or de-identified. However, requestors can propose a research project, and submit code that allows the research question to be answered. Submitted code for a project that is accepted by the C8 Data Oversight Committee will be run on behalf of the submitting scientist by data holders identified in a West Virginia University IRB protocol.
Appropriate fees will be charged to recover reasonable and legitimate costs associated with fulfillment of research requests. Please make checks/money orders payable to: West Virginia University.
For any questions related to the process of requesting C8 data for research, please contact:
Director, Clinical Research/Adjunct Professor
WVU Department of Emergency Medicine
1 Medical Center Drive, HSS Rm. 2223
Morgantown, WV, 26506