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Belarus Background info for JJ McGowan, Head OSMO/NIAID

Lessons learned about working with Patient Data
by

Ross Henderson

on 13 December 2013

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Transcript of Belarus Background info for JJ McGowan, Head OSMO/NIAID

How to build a patient database?
Lessons learned from working with patient data

Bottom Line
Up Front

We can provide cyber-infrastructure and scientific support as well as build patient databases for biomedical research by using existing de-identifiable patient data
.

IRB TERMINOLOGY
Space
Galaxy
IRB Terminology
Research means a systematic investigation, including research development, testing

Dilemma
How can we effectively provide cyberinfrastructure support for biomedical researchers when we have to deal with patient information?
Short answer: Use existing de-identified,
publicly available patient data

Belarus TB Database BTBDB
International collaboration with National Science of Academy in Belarus to create a TB patient database and a portal website to make TB CT images and clinical information publicly available for biomedical researchers worldwide.

The Belarus TB Portal contains so far 150 deidentified TB patients’ information as follows:
Demographic and social information
Clinical information
Radiological findings
Lab results
CT images

QUESTIONS
Is it research?
No. Then no need to submit to IRB.

Not by me… but I’m working on
a database that has patient
information and I’m dealing with it.

Do I need IRB? . . . .

IRB Terminology (cont'd)
Coded: identifiers have been removed from the dataset under consideration but can readily be replaced through
the use of a master list that is accessible to the investigator
.

Identifiable or non-coded: the identity of the
subject is documented, linked or associated
with the data.

Then. . .
If you answer “yes”
to any of these, you might need IRB submission.
Double check on IRB decision chart
Lewis Kim
Andrei Gabrielian
Ross Henderson

BCBB Staff Meeting
August 5, 2013

If you are involved in collecting information instead of using existing data, you need to submit for IRB approval (even if you are not collecting identifiable information).
and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject means a living individual about
whom an investigator (whether professional
or student) conducting research obtains:

Data through intervention
or interaction with the individual,
or Identifiable private information.

In order to build a database,
we need to put data in it, which means we will end up with
receiving patient data and
analyzing that data in order
to construct schema
and build tools.
1. Will the database contain
identifiers
such as name, address, SSN, or medical record number?

Yes -> Submit to IRB

No -> next question

What do you mean by “
identifiers
”?
Anonymous: the identity of the respondent cannot be determined;
no links exist
between the data and the individual about whom the data are recorded.
De-identified: identifiers have been removed from the dataset under consideration;
links
between the data and the individual about whom the data are recorded exist but
are
not readily accessible to the researcher
.

Source:
Columbia University Medical Center: IRB Terminology Related to Tissue or Data Collection

2. How will information be obtained for the database?
Will the
source
be
existing
clinical or research information?



3. Will you create and use the “de-identified” database?
To de-identify data for inclusion in a research database that the PI/PM is
creating
and want to make it publicly available, double check with regulatory specialists to see if you are subjected to other regulation.

Just because you are free from IRB, that doesn’t mean you are completely safe yet.

No IRB submissions and no HIPAA forms are required to
use
a research database that has already been fully de-identified (contains no identifiers, as described above)

Several more things to consider…
http://www.cumc.columbia.edu/dept/irb/policies/TERMS_Re_Tissue_or_Data_Collection_030904.html

Will patients/subjects be interviewed, tested, or otherwise contacted for the purpose of obtaining research data?*
Yes --> Submit for IRB approval even if you are not collecting identifiable information
No --> IRB needed
*A researcher who will interact with subjects for the purpose of collecting identifiable
data for a database should ask for the subject's consent and HIPAA authorization.

Will you be conducting interviews, surveys or focus groups?
Do you intend to publish findings or disseminate information based upon your work?

Do you intend to collect information and then
present it to a public audience or at a conference?

Are you seeking grant funding?
Is there any way to link the data you plan to collect with identifying information?
Will you need access to sensitive data or records?
http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c5
Questions?
Full transcript