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Governance and Regulation Guidelines

Researchers
#1

Hello,
I am new to the OHDSI community. I am a project manager working at an institution that is hoping to convert our EHR data into OMOP. In conjunction with the technical aspects of this process, we are also considering how to regulate and govern use of the OMOP database after it is created. We would like it to be open to trained researchers. Our IRB has indicated that studies using these limited data sets may not require submission of separate IRB protocols (although an initial protocol to create the database will be required). In the absence of IRB review, we are considering other methods of monitoring and regulating use of the data. Some specific questions we have are:

  • How do you ensure that researchers use the data for what they say they’re going to use it for? (ie., DUAs, submission of study proposals to a governance committee, review of papers before publication?)

  • Are there institutions who are already doing this? If yes, would you be willing to share guidelines and/or resources? (ie., examples of DUAs, structure of a governance/review committee, user access guidelines, etc.)

Any guidance on this process would be greatly appreciated!

Thank you,
Bonnie

#2

Hi @bowatson! Welcome to OHDSI!

Some things that might be relevant to your questions:

As a general rule, data sites in OHDSI only share summary statistics (e.g. person counts and hazard ratios), not patient-level information. That already limits what the data can be used for.

OHDSI studies are required to have a full protocol before asking other sites to participate. An example study can be found here. In the past, those sites requiring per-study IRB approval have done so based on the protocol provided by the study leader.

So far we have not made use of DUAs (to my knowledge), but we have discussed them in the past.

#3

Thanks for the reply. I work with @bowatson and would like to add a bit of additional info. Our goal as a CTSI is to provide much broader access to our underlying OHDSI data for our internal research community. We understand that as a Limited Dataset we can offer access without additional IRB protocols legally but from a governance point of view we would like our research users to clearly describe what they plan to do and commit to using the data only in the way they describe. We are wondering if anyone else offers this type of access for health services research and if they do could they share agreements that govern this use?

Thanks in advance,

Bill Adams

William G. Adams, MD
Professor of Pediatrics
BU-CTSI Director of Clinical Research Informatics
Boston University School of Medicine/Boston Medical Center
Community Health Informatics Director, Boston HealthNet
Phone: (617) 414-7707 Email: badams@bu.edu
http://profiles.bu.edu/William.Adams

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