Research Informatics Quick Start Guide
What are the steps involved in obtaining clinical data for research?
Step 1: Contact the IRB
You will have to decide whether to apply for a determination of non human subjects review or an IRB research protocol; more information on that decision making process appears in our IRB process quick start guide. If you do decide to obtain an IRB protocol, use our online worksheet at https://med.stanford.edu/webtools/secure/forms/irbworksheet/ to generate language suitable for inclusion in both the confidentiality and HIPAA authorization sections of the protocol.
Step 2: Consult with us
In order to complete the approvals process you need a tracking number, which you can get by requesting a consultation.
Step 3: Complete the Data Privacy / Data Security attestation form
The next step in the process is to complete the Privacy Office research attestation form, also available online at https://med.stanford.edu/webtools/secure/forms/irbworksheet/. In this online form we ask you to explain what stage you are at in your study (i.e. do you have an IRB or not) and enumerate the type of data you wish to review, and sign an attestation to the effect that you will adhere to all applicable policies with regard to the privacy and security of the data. This form generates language describing the data access request in the same manner used to generate text for an IRB protocol used by the IRB worksheet mentioned in Step 1. If you have a determination of non-human subjects research you will be limited to completely de-identified data sets, which limits you to data extracts since the data review is only capable of partial de-identification.
Step 4: Obtain approval
When you complete the attestation form we are electronically notified. The hospitals require that requests for clinical data for research be verified by a third party; this verification process involves checking that either the data requested is fully de-identified (if covered by a determination) or the language used in the request is consistent with the language in the IRB, and also that that IRB is internally consistent (if covered by an IRB). If any discrepancies are found you will be asked to revise either the wording of the request or of the IRB in order to bring them into accordance with each other.
Step 5: obtaining data from Research Informatics Center
Once we have approval to proceed with releasing the data, we will work with you to verify that the data we supply you meets your research needs.
When does RIC require IRB involvement?
In broad, the answer is simple: if you are doing research, you must involve the IRB. No exceptions. Even if all you need for your research are counts from the cohort tool, you must go to the IRB and get a determination of non-human-subjects review 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 there are severe limitations placed on the use of this data: it can only be used to prepare for the formal launch of your research study (e.g. applying for funding).
If you are thinking of publishing and don't yet have an IRB, you need to get one. Here is a quick guide on how to get started.
What are my options for obtaining data?
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 comma separated value text file suitable for loading into a statistical analysis tool such as SAS or R. Your choice of which option to pursue will typically be dictated by how the information you seek is represented: information in narrative form, e.g. in clinic 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, flow sheet data and the like, we can readily create a data extract for you. More information about these two options for obtaining data are available at https://med.stanford.edu/researchit/services/data-extraction.html and https://med.stanford.edu/researchit/tools/chart-review-tool.html
N.B. 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.
What if I need data for non-research purposes?
If you need data in support of clinic operations or quality improvement, you should request assistance from the appropriate hospital reporting group. Our group can only give out data in support of research.
How do I get help analysing the data?
The process for obtaining the services of a biostatistician varies by department. Check first within your department to see whether there is an analyst on staff who can assist you. If not, you should make a point of familiarizing yourself with the services offered by the Stanford Center for Clinical and Translational Education and Research, or SPECTRUM. They act as a clearinghouse for research support at the Stanford School of Medicine. They will refer you back to Research IT for informatics services, but will be able to connect you to sister service organizations such as biostatistical services and study design.
I still have questions!
Contact us! We're here to help. Please fill out a consultation request to let us know how we can assist you.