Definitions
The Federal regulations governing human subjects research contain several definitions that may vary from common-sense or academic usage of similar terms. This page contains the official regulatory definitions of several terms you may encounter on the IRB and HRPP website, in alphabetical order.
Adverse Event are research-related events that cause direct harm to human subjects. Any research-related physical, psychological, or social harm to subjects’ occurring during the course of the research.
Common Rule means the Federal Policy for the Protection of Human Subjects as adopted by (and codified in the regulations of) multiple federal agencies. For the purposes of this Policy and related policy guidance or procedure documents, the Common Rule refers to Subpart A of Department of Health and Human Services (HHS) regulations at Title 45, Part 46 of the Code of Federal Regulations (45 CFR 46, Subpart A).
Human Research Protection Program (HRPP) is a systematic and comprehensive approach, taken by an organization, to ensure human subject protection in all human research conducted under the auspices of the institution.
Human subject research means an activity that meets the definition of Research and involves human subjects as defined by HHS regulations.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Identifiable biospecimens are biospecimens for which the identity of the subject or subjects may readily be ascertained by the investigator or associated with the biospecimen.
Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Institution means any public or private entity, department, or agency (including federal, state, and other agencies). [In most uses on this website, “Institution” can be taken to refer to Bates College, unless you are conducting research off-campus under the supervision of another entity’s IRB.]
Institutional Review Board (IRB) is the generic name for any board, committee, or other group formally designated by an institution to review the conduct of Research involving Human Subjects. An Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, including obligating the institution to the terms of the Federalwide Assurance filed with the Department of Health and Human Services Office of Human Research Protection (OHRP) for the protection of Human Subjects.
Interaction includes communication or interpersonal contact between the investigator and the subject.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
IRB means Institutional Review Board.
IRB Approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
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.
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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Protocol is an application for approval of proposed research, submitted to the institution’s IRB.
Public health authority means an agency or authority of the United States, a state, a territory, a political subdivision of a state or territory, an Indian tribe, or a foreign government, or a person or entity acting under a grant of authority from or contract with such public agency, including the employees or agents of such public agency or its contractors or persons or entities to whom it has granted authority, that is responsible for public health matters as part of its official mandate.
Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge, consistent with the HHS definition of research (45 CFR 46.102(l)). Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. The following activities are deemed not to be research:
(1) Scholarly and journalistic activities (e.g., journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
(2) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during an event or crisis that threatens public health (including natural or man-made disasters).
(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(4) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Documentary films, podcasts, and oral histories that do not pose a specific question or hypothesis aimed at contributing to generalizable knowledge are outside the IRB’s purview. While these projects may still involve ethical considerations, they do not require IRB review. However, the IRB co-chairs are available to discuss any ethical issues you may encounter and can meet with you if you find it valuable. If you have any questions, please reach out to one of the IRB co-chairs directly.
Unanticipated Problem Involving Risks to Participants or Others (Unanticipated Problem) means any event or information that (1) was unforeseen and (2) indicates that the research procedures caused harm to participants or others, or that participants or others are at increased risk of harm.
Unexpected means when its specificity and severity are not accurately reflected in the informed
consent document.
Vulnerable Populations is a subgroup of the population who because of their status are at greater risk to be coerced or influenced to participate in human subjects research. This subgroup includes individuals with acquired immune deficiency syndrome (AIDS), fetuses, minorities, children (minors), prisoners, decisionally impaired persons, elderly and aged persons, international research subjects’, terminally ill patients, traumatized and comatose patients, students, and employees. Researcher should consider the fact that vulnerability can also be context-specific. It is important for researchers to consider the context as well as what is being asked of whom, and under what conditions. The same factors that make subjects available for research make them vulnerable to overuse.