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the identifiers and the codes
b
.
b) In the case that human data cannot be linked in any way to individuals (for instance, analysis
published or publicly available datasets), the research activity is not considered to include
‘human subjects’ and would not require IRB review. When in doubt, a determination request
can be submitted to the OSU IRB at
IRB@oregonstate.edu or visit
https://research.oregonstate.edu/irb.
3. Collection of data through direct interaction (includes phone calls, etc.) with patients or through
intervention with the intention to disseminate the results is considered ‘human subjects research’
and requires IRB review
c
. A research study meets the criteria of a clinical trial if one or more
human subjects are prospectively assigned to one or more interventions (which may include
placebo or other control) to evaluate the effects of those interventions on health-related
biomedical or behavioral outcomes (see https://grants.nih.gov/policy/clinical-trials/definition.htm
).
OSU Students are not allowed to serve as Principal Investigators on such projects but they may
participate as co-investigators after completion of human ethics training available through the
OSU IRB office.
a) Student presentations, such as posters, simply to document the educational experience or to
fulfill programmatic requirements are not considered ‘dissemination of results’.
b) Student presentations, such as posters, at professional or scientific meetings outside OSU
that make the results of the data collection publicly available are considered ‘dissemination
of results’. Students wishing to make patient-related data publicly available must have IRB
approval.
Footnote comments:
a
Note that HIPAA authorization and consent or a waiver from the site will also be required.
b
If the Principal Investigator is an OSU person, that person would need to submit an IRB
application only if identifiable or coded data were being provided to other OSU persons. If instead,
a non-OSU person is de-identifying the data and then giving it to the student (so no one at OSU
ever has identifiable data) it may not need IRB review. De-identification must be done by
someone other than the student before the student accesses the data.
c
If conducted at the clinical site/covered entity, HIPAA authorization or waiver from the site may
also be required.
Glossary
Coded: Identifying information (such as name or social security number) that would enable the
investigator to readily ascertain the identity of the individual to whom the private information or
specimens pertain has been replaced with a study-specific number, letter, symbol, or combination
thereof (i.e., the coded identifier); and a key linking the coded identifier to personal/medical
identifiers exists, enabling linkage of the identifying information to the private information or
specimens.
De-identified: When collected, data contained identifiers or information that would permit
identification of the individual(s) about whom the data were collected, but the identifiers or indirect
links to identity have been removed and no longer exist anywhere in any form. Exception: When
coded data are shared between researchers and a data use agreement is in place between the
institutions that no identifiers will be shared, these data are considered de-identified. This exception
does not apply when the holder of the key is involved in the research. For example, a PI sharing
coded data with a student researcher is conducting research with identifiable data because it is their
responsibility to oversee all aspects of the study.
Individually identifiable: The identity of the subject is or may readily be ascertained by the
investigator or associated with the information. Individually identifiable information is not limited to
name, date of birth, or contact information.
For questions regarding this policy, please contact the OSU IRB Office at IRB@oregonstate.edu
.