Research
Research is defined by the Department of Health and Human Services as “a systematic investigation, including research development testing and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46.102(d)). Systematic investigations range from observing behavior to asking questions to testing drugs to performing surgery. If you plan to publish or present the results of your investigation, it is almost certainly “designed to develop or contribute to generalizable knowledge,” which would mean it qualifies as “research.” If you are not sure whether your project is research under this definition, check with OHRPP staff.
Human Subject
A human subject is defined as “a living individual
about whom an investigator (whether professional or student)
conducting research obtains (1) data through intervention
or interaction with the individual, or (2) identifiable
private information”(45
CFR 46.102(f)). If your research project involves
gathering data from or about one or more
living individuals through intervention
or interaction (including observing or talking to them),
your research requires OHRPP / IRBreview. If your
research involves using identifiable private information
about one or more living individuals, even if you never have
direct contact with them, your research requires OHRPP / IRB review. If you are studying one or more deceased
individuals, your research probably requires review
at the exempt level. If you are studying data about
living people, but the data are not identifiable (that
is, if the data cannot be connected to specific individuals),
your research probably requires review at the exempt level.
If you are studying tissue samples, your research
requires review, even if you have no direct contact with
the tissue donor(s). The level of review depends on whether
(a) the tissue donor is alive or dead and (b) it is possible to
find out from whom the samples came, as seen in the following
table. Level of Review for Research on Human Tissue
Samples
|
donors alive? |
samples identifiable? |
review |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Again, when in doubt, ask OHRPP staff whether the project you are planning must be submitted for review. If your project qualifies as human subjects research, the next step is to estimate the level of review it requires.
Minimal Risk
“Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” (45 CFR 46.102(i)).
Vulnerable Populations
“Vulnerable populations” include children (under age 18), fetuses, pregnant women, persons with mental disabilities, prisoners, persons with physical disabilities, and economically or educationally disadvantaged persons.
