Anyone affiliated with Tennessee Tech (faculty, staff, or students) who is conducting research involving human subjects must submit an application and receive approval from the IRB before beginning recruitment of subjects or data collection. To determine if your project is research involving human subjects, the DHHS (Title 45 §46.102) provides the following definitions, which are followed by the Tennessee Tech IRB:
Research: 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.
The following activities are deemed not to be research: (1) 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. (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 the course of 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.
Human Subject: 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.
Intervention includes both physical procedures by which information or biospecimens are gathered (for example, 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 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.
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.
An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
A systematic study occurs when a researcher implements or uses commonly accepted scientific methods
of data collection and analysis. This collection and analysis allow for the researcher
to methodically and objectively interpret the results to explore answers to predetermined
questions or testing predetermined hypotheses. The approach to a study alone does
not determine the need for IRB review. In many cases, people conduct interviews or
draw blood for reasons that have nothing to do with research.
The statement “designed to develop or contribute” is interpreted as a study that produces results that are intended for dissemination outside of the University via poster presentations, professional or student conferences, any form of publication, or in any online media.
Generalizable knowledge is results intended to (1) have predictive value, (2) provide scientific clarity, and (3) be applied to a larger population in order to further scientific knowledge or inform policy. Generalizable knowledge would be applicable to a scientific community beyond the classroom and beyond the participants in the study.
Additional useful definitions:
Risk is the probability of harm or injury (economic, legal, physical, psychological, social) occurring as a result of participation in a research study.
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.
Existing or secondary data are information in the form of data, documents, records, pathological specimens, or diagnostic specimens collected by someone else for research (e.g., survey data, interview transcriptions) or non-research purposes (e.g., results of blood work, mental health diagnoses, students' academic progress). Common examples of secondary data are medical records, student records, data collected for a previous study, or audio/video recordings collected for other purposes. For information to be considered "existing," it must have been collected at an earlier date for purposes other than the currently intended use.
Public data: Data collected by an organization with the intention of being, or otherwise authorized approval to be, released to the general public (e.g., U.S. Census data, General Social Survey datasets, PEW Research Center datasets). Such data do not include identifying information about the participants/subjects.
Restricted or private data: Data collected by a person or organization that is not available to the general public.
De-identified data: An existing dataset that has been stripped of all identifying information, by the owner of the dataset, in a manner that would guarantee that the data cannot be linked back to the subjects from whom it was originally collected.
Identifiers: Information within an existing dataset that links to specific individual subjects either directly or indirectly. Examples of direct identifiers are names, addresses, student T#s, phone numbers, social security numbers, patient ID numbers. Indirect identifiers are (a) information that, by using a single indicator or a combination of indicators, a reasonably knowledgeable person could ascertain the identities of the subjects by individual indicators (e.g., place of employment, job title, gender, age, ethnicity) or (b) information coded within the dataset linked that is linked to a key with identifying information about the subjects.
Vulnerable populations are particular classes of research participants who are likely to be vulnerable (or susceptible) to coercion or undue influence or who full agency in their decision-making capacities.
Examples of “vulnerable populations” are, but are not limited to, children (people under the age of 18), prisoners (i.e., individuals involuntarily confined or detained in a penal institution), pregnant women, human fetuses, neonates, people with cognitive, mental, or physical disabilities, people who are economically or educationally disadvantaged, or people with terminal illnesses.