- Case Studies
In-depth explorations of a particular project, policy, institution, program or system in a 'real life' context. Case studies are sometimes developed for classroom instruction using the 'case method'.
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under th applicable law of jurisdiction in which the research will be conducted.
- Cognitive Impairment
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseased affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interest
- Data and Safety Monitoring Board
A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trail to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of subjects about new information that might affect their willingness to continue in the trial.
- Engagement in Research
An institution becomes "engaged" in human subjects research when its employees or agents1 (i) intervene or interact with living individuals for research purposes; or (ii) obtain individually identifiable private information for research purposes [45 CFR 46.102(d),(f)].
An institution is automatically considered to be "engaged" in human subjects research whenever it receives a direct HHS award to support such research. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.
For more details, including examples of situations where an institution may or may not be considered engaged, please refer to the guidance
provided by OHRP on this topic.
- Generalizable Knowledge
Has not been explicitly defined in federal regulations, but can be: a) applied to individuals outside the research sample; b) predictive of future events; or c) widely applied as theories or principles that enhance scientific or academic understanding; or d) create general explanations about all that has happened in the past.
- Human Subjects or Human Participants
'Living individuals about whom an investigator (whether professional or student) conducting research obtains:
- Data through intervention or interaction with the individual or
- Identifiable private information.'
- Human Subjects Research
'Research' (as defined below) involving 'human subjects' (as defined above).
- Informed Consent
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
- Institutional Review Board (IRB)
A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
- IRB Approval
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.
Includes communication or interpersonal contact between investigator and subject.
Includes both physical procedures by which data are gathered and manipulations of the participant or the participant's environment that are performed for research purposes. Intervention includes communication or interpersonal contact between investigator and participant.
The individual(s) designated to have the appropriate level of authority and responsibility to direct the research project and/or activity.
Includes activities focused on the collection, verification, and reporting of information or facts on current events, trends, newsworthy issues or stories about people or events, with no intent to develop or test a hypothesis.
- Key Personnel
Individuals who contribute to the scientific development or execution of the project in a substantive, measurable way, whether or not salaries are requested on the corresponding grant application/contract proposal.
- Life Histories (or Life Stories)
Include 'any retrospective account by the individual of his [or her] life in whole or part, in written or oral form, that has been elicited or prompted by another person.' Life stories intend 'to show something about the kind of person a speaker is.'
- Minimal Risk
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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.
- Multiple Relationships (Financial Conflicts of Interest)
a. income: including receiving past, current, or expecting future income in the form of salary, stock or stock option/warranties, equity, dividends, royalties, profit sharing capital gain, forbearance of forgiveness of a loan, interest in real or personal property, or involvement in a legal partnership with the sponsor.
b. consultant: receiving past, current, or expecting future income in the form of consulting fees, honoraria, gifts, gifts to the University, or payments resulting from seminars, lectures, or teaching engagements, or service on a non-federal advisory committee or review panel.
c. service: serving in a corporate or for-profit leadership position, such as executive officer, board member, fundraiser officer, agent, member of a scientific advisory board, member of a scientific review committee, or member of a data safety monitoring committee, regardless of compensation.
d. intellectual property: inventor on a patent or copyright involving technology/processes and/or products licensed or expected to be licensed to the sponsor.
- Office for Human Research Protections (OHRP)
The Health and Human Services (HHS) office that oversees the regulation of research involving human research participants.
- Oral History
The National Oral History Association (OHA) defines oral history as 'a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life'. Oral history is a recorded conversation about the past with named individuals in which knowledge about specific events and individual lives is narrated in story form and made available to the public through deposit in archives. Biographical in nature and historical in scope, the scholarly oral history interview is rooted in particular recollections about history based on the individual perspective of the narrator.
- Principal Investigator (Protocol)
The scientist or scholar with primary responsibility for the design and conduct of a research project.
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statute; (2) detained pending arraignment, trail, or sentencing; and (3) detained in other facilities (e.g. for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.
- 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. 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.
- Protected Health Information (PHI or Identifiable Private Information)
Name; Address, including city and zip code; Telephone number; Fax number; Email address; Social Security Number; Date of birth; Medical record number; Health plan ID number; Dates of treatment; Account number; Certificate/license number; Device identifiers and serial number; Vehicle identifiers and serial number; URL; IP address; Biometric identifiers, including fingerprints; Full face photo and other comparable image
A quorum will be a majority (greater than 50 per cent) of the voting members of the IBC. For reasons other than conflict of interest, abstentions do not alter the quorum, or change the number of votes required.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities and they would be included in this definition of Research.
- Restricted Use or Limited Data Set
Files that have restrictions imposed regarding their use in research and contain data fields such as social security numbers, names, protected health information or other life history markers that might enable an unauthorized user to identify a participant.
- Secondary Data Set
Data that can be used in research and comes from public or private documents, including medical records, police reports, vital statistic records, student record.
A sample, as of human tissue, blood or urine, used for diagnostic or pathological analyses.
- Unanticipated Problem
An unanticipated problem involving risk to human participants or others, is one that (1) was unforeseen at the time of its occurrence, and (2) indicates that participants or others are at an increased risk of harm.