Minutes will be taken by the Vice Chair. In the absence of the Vice Chair the Chair will appoint a member of the IRB to take minutes. In the absence of the Chair, the Vice Chair will preside over the meeting and the minutes will be taken by a member of the IRB committee designated by the Vice Chair. Protocol for Full IRB Review Meeting The minimum of five IRB members must be present to convene a full IRB review. In order for the research to be approved, it shall receive the approval of a majority of those voting members present at the meeting. Principal Investigators, including those who are also IRB members, should attend the meetings to offer information and answer questions about their protocols at a convened meeting, but may not be present during voting. Although convened meetings of the IRB are open to the public, materials submitted for review, discussions of protocols, and individual votes are considered confidential and should not be discussed outside of the meeting context. If, during an IRB meeting, the Chair moves the meeting to executive session then any visitors will be asked to leave the room until the executive session has ended. Documentation The IRB, in collaboration with the Office of Institutional Research, must maintain files that include a complete history of all IRB actions related to review, approval, or denial of a protocol, including continuing reviews, amendments and adverse event reports. The IRB must retain all records regarding an application (including those which did not receive approval) for at least 3 years. For all applications that are approved and the research initiated, the IRB must retain all records regarding that research according to requirements of the funding agency, but at minimum for three (3) years after completion of the research. The IRB must make all records available for inspection and copying by authorized representatives of the sponsoring Department or Agency, the Department of Health and Human Services, the Food and Drug Administration, the Department of Veterans Affairs, and other federal regulatory agencies, at reasonable times and in a reasonable manner. The IRB must prepare and/or maintain the following documents: Copies of all documents including but not limited to; research applications reviewed, scientific evaluations, approved sample consent documents, data safety monitoring
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.