RESEARCH is any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
[In a recent document entitled NIH Primer: Research and Privacy NIH has clarified the meaning of the term "Generalizable Knowledge". In this publication NIH defines the term as follows: "Generalizable Knowledge is knowledge related to health that can be applied to populations outside the population served by the covered entity." That is, outside of MUOT.]
[NOTE: Even though medical practice may generate information potentially utilizable for research, medical practice IS NOT an activity designed to contribute to generalizable knowledge. On the other hand, use of those medical data for an investigational purpose IS an activity designed to contribute to generalizable knowledge]
HUMAN SUBJECTS refers to living individuals 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.
[NOTE: Special note should be made of the fact that, although not required by federal regulations, it is MUOT policy that IRB approval must be obtained for research use of all autopsy material, cadavers, and cadaveric material.]
INTERVENTION includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
INTERACTION includes communication or interpersonal contact between investigator and subject.
PRIVATE INFORMATION includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information which has been provided for specific purposes by an individual which the individual can reasonably expect will not be made public (e.g., a medical record). Private information must be individually identifiable, i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information, in order for obtaining [or using] the information to constitute research involving human subjects.
Are you collecting IDENTIFIABLE PRIVATE INFORMATION about study subjects? Ask yourself the question "If I realize that I omitted a data point when I was reviewing a medical record (or interviewing a subject) for my research data, can I go back to that record (or that subject) to "fill-in" the omitted data point?" If the answer to that question is "Yes", then the information you collected was IDENTIFIABLE.
[NOTE: IRB approval is required not only during the period when patients are being entered into the study, but for the entire time that PRIVATE INFORMATION about study subjects is being collected/analyzed for a investigational purposes.]
Use this decision-support chart to help you decide.
If you still have any questions concerning
whether a protocol you are contemplating requires IRB review please call the
MUOT IRB Office (extension 6796).
research@meduohio.edu