Activities within the scope of the Institutional Review Board's (IRB) or Exempt Review Committee's (ERC) responsibilities include research, development, and related activities, which would normally be construed as biomedical or behavioral investigations involving human participants. Included are studies involving not only adults and children, but also investigations of prenatal life. Studies or procedures utilizing organs, tissues, or bodily fluids of a human being are also included, as are the use of graphic, written, or recorded information about individuals even when other institutions or investigators have collected this information.
For the purposes of IRB or ERC review, Marywood University stipulates the following definitions:
Research is a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute "research" for the IRB, whether or not they are considered research in other contexts.
Examples of systematic investigations include:
Research activity would normally include the following:
A human subject is a living individual about whom an investigator conducting research obtains:
(1) data through intervention or interaction with the individual; or
(2) identifiable private information.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the participant or the participant's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and participant.
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 (i.e., the identity of the participant is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human participants.
The probability of 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. Investigators have the obligation to request a clarification by the IRB regarding activities or procedures that are seen by the investigator as questionable in terms of their inclusion in this description.
Minimal risk for prisoner participants is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.
Approval means that either the Institutional Review Board (IRB) or Exempt Review Committee (ERC) has reviewed the research and that the research will be conducted within the policies and procedures outlined here and within the constraints of other institutional and federal, state and local requirements. Institutional Review Board (IRB) or Exempt Review Committee (ERC) approval does not necessarily include approbation of the research itself.
An "investigator" refers to an individual performing various tasks related to the conduct of human participants research activities, such as obtaining informed consent from participants, interacting with participants, and communicating with the Institutional Review Board or Exempt Review Committee. For the purposes of the HHS regulations, the Office of Human Research Protections interprets an "investigator" to be an individual who is involved in conducting research with human participants. Such involvement includes, but is not limited to:
Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. Some research studies are conducted by more than one investigator, and usually one investigator is designated as the "principal investigator" (PI) with overall responsiblities for the study.
In every study involving humans, investigators have certain responsibilities regarding ethical treatment of human participants.
Not research is a type of determination that is made by an administrator of the Office of Research and Sponsored Programs about a given project. When such a determination is made, it means that: