Skip to content. Skip to main navigation.

XV. Definitions

1) Adverse events- any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.

2) Conflict of Interest – an IRB member may not vote on a project, and is not counted towards a quorum, when s/he serves as a co-investigator or other member of the research team or when s/he or an immediate family member has a conflict of interest with a project being reviewed. Conflict of Interest (COI) is defined as a significant financial interest that could directly and significantly affect the design, conduct, or reporting of research.

3) Faculty Advisor / Supervising Investigator (SI) - This role is required when the Principal Investigator (PI) is a student.  The faculty advisor/supervising investigator (SI) is responsible for oversight of the ethical conduct of research and data collection, and for ensuring that the research is conducted in compliance with federal regulations and University policies and procedures, in accordance with an IRB-approved protocol.  The SI is responsible for ensuring appropriate qualifications of the student PI, and for vetting the protocol’s purpose, design, methodology, and procedures.  The SI is also responsible for record retention in compliance with federal regulations and University policies (for example, if the student leaves the University, the SI must take over recordkeeping duties to meet retention policies).  The SI is responsible for ensuring that reporting requirements are met, including continuing review reports, unanticipated problems involving risks to subjects or others, or non-compliance with federal regulations or determinations of the IRB.

4) FDA – The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services. The FDA is responsible for protecting and promoting health through the regulation and supervision of clinical trials, including new drugs and investigational new medical devices.

5) Human Subject – a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual, or b) identifiable private information.

6) Interaction - includes communication or interpersonal contact between investigator and subject.

7) 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.

8) Minimal Risk – 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.

9) Minor Modifications – modifications to a research project and/or consent documents that pose no additional risk to participants; or modifications that maintain similar or increased safeguards to protect the subject.

10) OHRP – The Office for Human Research Protections (OHRP) provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.

11) Principal Investigator (PI)

a) The Principal Investigator (PI) is the person who directs a research project or program and is responsible for the design, conduct, and reporting of research. The PI is responsible for the protection of human subjects and the ethical conduct of research in compliance with federal regulations and University policies and procedures.  The PI is responsible for obtaining IRB approval prior to initiation of any research involving human subjects, submitting continuing review reports in a timely manner, and obtaining approval for any protocol modifications prior to initiation.  The PI is responsible for obtaining informed consent and data from human subjects in a manner consistent with federal regulations and in accordance with an IRB-approved protocol.  The PI is responsible for submitting prompt reports of any unanticipated problems involving risks to subjects or others, or non-compliance with federal regulations or determinations of the IRB.  The PI is responsible for maintaining confidentiality of human subject data, and for maintaining records and documentation in accordance with federal regulations and University policies.

b) Students may act as the PI of an IRB Study. However, the student’s instructor or mentor on the project must be listed as the Faculty Advisor/Supervising Investigator on the IRB protocol. Oftentimes, the student’s thesis or dissertation advisor is listed as faculty advisor.  If the advisor changes over time through the course of the student’s academic career, the IRB protocol must be updated accordingly. Faculty Advisors share responsibility with a student PI and maintain certain authority over the student-led research; please see the defined role of Faculty Advisor/Supervising Investigator for details.

12) 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 subject 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 subjects.

13) Quorum – a majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.

14) Research - a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research even if they are a component of a larger non-research activity (e.g., instruction, demonstration).

15) Risk – the probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude may vary from minimal to significant.

16) Serious Adverse Experience (SAE) – Any adverse experience associated with the use of a medical product in a patientthat results in any of the following outcomes: death, a life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, a congenital anomaly/birth defect, required intervention to prevent permanent impairment or damage (devices), or other serious medical events.

17) Unanticipated problems - any incident, experience, or outcome that meets all of the following criteria:

(i) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;

(ii) related or possibly related to participation in the research (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and

(iii) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

18) Unexpected Adverse Experience (UAE) – Any adverse experience or suspected adverse reaction that is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, if an investigator brochure is not available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended.

back to index