Data presented in the ICDB Annual Data Report are for clinical and government reporting purposes only. This data report may be used to summarize the Immunology Center population (for presentations and grant applications) but cannot be published without obtaining appropriate IRB approval. If you intend to use these data or need more detailed data for any research purpose, please follow the procedure noted below:
1) All requests for data from ICDB must be done through the completion of a “CFAR Clinical Data Request Form (DRF)”. If the requestor is not a member of Infectious Diseases Division, then the applicant must select someone within the Division to act as the sponsor. Data will only be released to faculty members; we are not authorized to provide data to staff (i.e., research assistants, project directors).
2) If the data report requested is purely for research purposes, IRB approval information must be filled in and a copy of the IRB approval letter must be uploaded with the data request. Your IRB approval letter can be found within your IRBNet study documents. If the request is for clinical use at the Immunology Center or for government reporting, IRB approval is not needed.
The DRF will be forwarded to the Data Release Authorization Committee (A group of senior physicians from the Immunology Center at The Miriam Hospital). The committee will review the Data Request (approval from at least two committee members is required). If approval is granted, the data will then be sent to the requestor.
3) Data (after steps above are successfully completed) which includes individual identifiers can not be sent via e-mail. Requestor must contact Dr. Fizza Gillani (firstname.lastname@example.org) at the Immunology Center to obtain the data.
4) Names of patients for research purposes will be issued only if appropriate IRB approval is obtained and/or preparatory to research has been arranged with the Lifespan IRB office. See IRBNet Forms and Templates for accounting of disclosure information and instructions.
5) Each PI (requestor) is responsible for the confidentiality, privacy and proper use of data that is released to him/her (specifically when the data includes patient identification variables).
6) Everyone performing human subject research must have educational training in the protection of study volunteers. It is the Principal Investigator’s (PI’s) responsibilities to make sure any colleague who has access to the data or who uses the data have appropriate training. It is also the researcher’s responsibility to properly discard or file the data after project is completed. Please call the Lifespan Research Protection Office (RPO) for guidelines.