Glossary
Certification
Certification means the official notification by the institution to the supporting Federal department or agency component, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.
Conflict of Interest
A “Conflict of Interest” means a Significant Financial Interest that could directly and significantly affect the design, conduct, or reporting of Research or a Sponsored Program.
Department or Agency Head
Department or agency head means the head of any Federal department or agency and any other officer or employee of any Federal department or agency to whom authority has been delegated.
Dependent
Dependent is defined as any person who receives more than one-half of his or her annual support from an Investigator, whether or not related to that Investigator.
Financial Interest
“Financial Interest” is defined as anything of monetary value, whether or not the value is readily ascertainable, including, but not limited to, salary, commissions, consulting fees, honoraria, equity interests, interests in real or personal property, dividends, royalties, rent, capital gains, intellectual property rights, and forgiveness of debt, other than:
1. compensation from BYU;
2. income from seminars, lectures, or other educational activities sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education;
3. income from service on advisory committees, or review panels for a public federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C. 1001(a), an academic teaching hospital, a medical center, or a research institute that is affiliated with an Institution of higher education; or
4. an interest arising solely by means of investment in a mutual, pension, or other institutional investment fund where the Investigator does not exercise control over the management and investments of such fund.
Human Subject
“Human subject” means a living individual about whom an investigator (whether professional or student) conducting research obtains:
(i) data through intervention or interaction with the individual; or
(ii) identifiable private information.
“Intervention” includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
“Interaction” includes communication or interpersonal contact between investigator and subject.
“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).
“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
Institution means any public or private entity or agency (including federal, state, and other agencies).
IRB
IRB means an institutional review board established in accord with and for the purposes expressed in this policy.
IRB Approval
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.
Legally Authorized Representative
Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Minimal Risk
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.
Research
Research means 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 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. For purposes of this part, the following activities are deemed not to be research:
Scholarly and journalistic activities (e.g., oral history, 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. 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 the course of an event or crisis that threatens public health (including natural or man-made disasters). 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. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Significant Financial Interest
Significant Financial Interest means one or more of the following Financial Interests of the Investigator (and those of the Investigator’s Family Members) that reasonably appear to be related to the Investigator’s University Responsibilities:
(1) With regard to any publicly traded entity, it is the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, the value of which exceeds $5,000 from one enterprise or entity;
(2) With regard to any non-publicly traded entity, it is the value of remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator holds any equity interest;
(3) Intellectual property rights and interests, upon receipt of income related to such rights and interests subject to the de minimis thresholds set forth by the federal regulations and guidance;
(4) Salary, remuneration, or similar payments which exceed, or are expected to exceed, $5,000 within any one-year period, when aggregated for the member and his or her Family Members; or,
(5) Any reimbursed or sponsored travel, related to an Investigator’s University Responsibilities subject to the de minimis thresholds set by the federal regulations and guidance; provided, however, that Investigators need not disclose travel that is reimbursed or sponsored by a federal, state, or local government agency, an Institution of higher education as defined at 20 U.S.C 1001(a), an academic teaching hospital, a medical center, or a research institution that is affiliated with an Institution of higher education.