individual or involving identifiable private information regarding a living individual must be reviewed by the IRB. Intervention includes both physical procedures by which data are gathered (for example venipuncture) and manipulations of the subject or the environment that are subject’s performed for research purposes (for example, comparing test performance in a quiet vs noisy environment). Interaction includes communication or interpersonal contact between an investigator and a subject (examples: interviews and surveys). 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 and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (the identity of the subject is or may readily be ascertained by the Investigator or by association with the information) in order for obtaining the information to constitute research involving human subjects. This may include identifiable private information obtained from a primary subject regarding a third party. Definition of Research Only certain activities involving human subjects qualify as subject to the jurisdiction “research” of the IRB. The federal regulations define to (i.e. “research” mean “a systematic investigation the gathering and analysis of information) designed to develop or contribute to generalizable knowledge”. A major factor in determining whether an activity is research subject to IRB review depends upon the to to generalizable and Investigator’s intent “contribute knowledge”, whether there is a systematic design in advance, generally utilizing a scientific approach or protocol, for the defined purpose of contributing to generalizable knowledge. If the Investigator intends to publish or disseminate the results, the activity will be viewed as intending to contribute to generalizable knowledge, and therefore constitutes research subject to the Activities that may result or be included in a IRB’s jurisdiction. thesis, dissertation, journal article, poster session, public speech, or presentation must be reviewed by the IRB.
individual or involving identifiable private information regarding a living individual must be reviewed by the IRB. Intervention includes both physical procedures by which data are gathered (for example venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (for example, comparing test performance in a quiet vs noisy environment). Interaction includes communication or interpersonal contact between an investigator and a subject (examples: interviews and surveys). 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 and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (the identity of the subject is or may readily be ascertained by the Investigator or by association with the information) in order for obtaining the information to constitute research involving human subjects. This may include identifiable private information obtained from a primary subject regarding a third party. Definition of Research Only certain activities involving human subjects qualify as “research” subject to the jurisdiction of the IRB. The federal regulations define “research” to mean “a systematic investigation (i.e. the gathering and analysis of information) designed to develop or contribute to generalizable knowledge”. A major factor in determining whether an activity is research subject to IRB review depends upon the Investigator’s intent to “contribute to generalizable knowledge”, and whether there is a systematic design in advance, generally utilizing a scientific approach or protocol, for the defined purpose of contributing to generalizable knowledge. If the Investigator intends to publish or disseminate the results, the activity will be viewed as intending to contribute to generalizable knowledge, and therefore constitutes research subject to the IRB’s jurisdiction. Activities that may result or be included in a thesis, dissertation, journal article, poster session, public speech, or presentation must be reviewed by the IRB.
SUNYOrangeIRBPolicyandProceduresFinalDraftJuly2013.docx