Visit the Research Compliance Office's FAQs and Resources page to determine if your project needs IRB review. If the RCO determines that an IRB protocol is needed for your project, submit the request in eProtocol's MyDashboard.
To complete the Data Privacy Attestation form in eProtocol's MyDashboard, start a Modification and follow the link in section 11b or 15 (Waiver of Authorization or Waiver of Authorization for Recruitment) to specify the PHI and to roughly categorize the clinical data being requested. For a Chart Review protocol, follow the link in section 3a or 5 (Waiver of HIPAA Authorization).
Once you have created the Data Privacy Attestation, open the protocol in "Edit" mode and click the link in section 11b/15 or 3a/5 to import the attestation into the protocol. The tool will generate text in section 11b/3a. Be sure to click the "Save" icon.
When the IRB approves your protocol, you will receive an email notification. The IRB's panel meeting dates and deadlines are available here.
We will be electronically notified after you complete the attestation form. Stanford Health Care and Stanford Children's Health require that requests for clinical data for research be verified by a third party. This verification process involves checking that the language in the attestation is consistent with the language in the protocol and that that protocol is internally consistent (if the data requested is identifiable).
If any discrepancies are found you will be asked to revise either the wording of the attestation or the wording of the protocol so both are in compliance.
If you are doing research, you must involve the IRB. No exceptions. Even if you only need counts from the STARR Cohort Discovery Tool, you must get a determination of non-human-subjects review from the IRB prior to publication of results.
That being said, both the cohort tool and the chart review tool are available to researchers who have not yet launched their investigation. This is known formally as "support for preparatory to research activities," and we are delighted to be able to offer aggregate counts and descriptive statistics, either via the cohort tool or via custom queries to the clinical data warehouse, as well as anonymized data review cohorts, in support of this important early phase to research projects. However, this data can only be used to prepare for the formal launch of your research study (e.g., applying for funding).
There are two basic modes for obtaining clinical data for research, chart review and data extraction. In chart review, we provide you with the URL to an online portal to the data suitable for manual review. In data extraction, we supply you with a data set in the format of your choice. Typically, data is shared using the comma-separated values (.csv) file format suitable for use in a statistical analysis tool such as SAS or R.
The choice of which option to pursue will typically be dictated by how the information you seek is represented. Information in narrative form (e.g., clinical notes and reports) is not generally amenable to data extraction and must be reviewed manually. If, however, you are interested in structured data such as lab values, billing codes, or flow sheet data we can create a data extract for you.
The language in the confidentiality/privacy and HIPAA authorizations sections of your IRB must accord with the language generated by the Data Privacy and Security attestation forms. If there is a disconnect, you will be asked to revise either your request or your IRB in order to bring them into agreement.
Data for research obtained from RIC is subject to compliance agreements implemented by Stanford Health Care (SHC) or Stanford Children’s Health (SCH). Such agreements change over time and may result in the filtering of the patient and/or encounter records. This means that a data record obtained on one date may be filtered out at a later date, even for the same query.
If you need data in support of clinic operations or quality improvement, you should request assistance from the appropriate hospital reporting group. Our group only grants access to data in support of academic research.
First, check with your department to see if there is a biostatistician on staff available to assist you. If none are available, you should familiarize yourself with the services offered by the Stanford Center for Clinical and Translational Education and Research (SPECTRUM). Spectrum acts as a clearinghouse for research support at the Stanford School of Medicine and maintains a list of services available to researchers. You may also request a statistical consultation directly.