Definition of Research on Human Subjects: Any systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge based on data obtained from human subjects. This includes both original studies and replications of existing studies performed by faculty, students, or others. Research involving human subjects can consist of a full range of activities described in this section and include activities that make use of such things as:
Private information, such as personal, educational, or medical information, which can be readily identified with individuals, even if the information was not specifically collected for the study in question. Psychological or social research, or research on cell lines or DNA samples that can be associated with individuals fall into this category.
Private information that 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. The IRB has the sole authority to determine whether or not a research project constitutes the involvement of human subjects.
- Biospecimen (human): samples of any cellular constituents or liquid secretions of the human body. The molecular makeup of biospecimens reflects the physiologic or pathologic condition of the person from whom they derive; and provide sensitive and specific insight into the biologic state of the donor. This includes residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research
- Private information, such as personal, educational, or medical information, which can be readily identified with individuals, even if the information was not specifically collected for the study in question. Psychological or social research, or research on cell lines or DNA samples that can be associated with individuals fall into this category.
It is important to note that specifically excluded from this definition are activities whose primary focus is on benefiting the individual(s) involved in the procedure. (See item e., below.)
Activities Included as Research
- Physical, chemical, electrical or psychological stimulation of responses with the human body as well as interview, observation of behavior, administration of tests or other techniques of measurement, examination, or evaluation of individual humans.
- Observation of the performance of activities; or of physical or psychological reactions of individual humans or groups of human beings to stimuli which are either controlled by the investigator or are present in a normal non-manipulated environment.
- Observation or evaluation of the products of individual performance of tasks or reactions to stimuli in which human beings are directly involved through their active conduct or through giving consent to have procedures performed upon them.
Activities Specifically Excluded: These activities are distinguished from research as understood under the auspices of the IRB and include activities that may be classified as beneficial services. Activities under "Excluded" do not need IRB approval. These activities include:
- Teaching/training of individuals.
- Performance of diagnostic evaluation of individuals which will directly benefit the individual, or the relation of an individual to whom the human participant has agreed to assist, or the mass screening of disease.
- Performance of therapeutic procedures for the direct benefit of the individual participating or for the relation of an individual participating as in the interviewing relative to counseling services.
Clinical Training and Research: Clinical training covers those procedures and activities that are used to teach students to engage in professional activities with human beings other than the teacher or student involved in the procedure. Clinical training is excluded from the scope of this policy. Research training is intended to train the student in the methodology and the procedures for conducting research involving human subjects and is involved in the scope of this policy.
- There may be cases where the original procedure is performed as Clinical training or as Diagnosis or as Therapy and at some later date the case record, or product of such service, would be the subject of study. In this case, it is the subsequent use of records or products that will constitute research involving human subjects and is subject to this policy.
- If Research training utilizes research designs, methodology, procedures, and/or techniques that are frequently used and does not violate minimal risk or confidentiality, then the original design must be approved by the IRB with periodic review every five years.
Categories of Human Research: It is expected that any research involving human subjects will be reported to the IRB Chair. Even if it is determined that a research activity is exempted from review, the researcher pursuing this activity must obtain permission from the IRB approving the work under the exempt classification.
- Research funded by external agencies requiring review, e.g., DDHS. Such research will be reviewed by the IRB in accord with the appropriate agency guidelines.
- Research not funded by agencies requiring review but employing human subjects in a manner not explicitly exempted. Such research shall be subject to either an expedited or a full review by the IRB and must conform to the principles outlined in this document.
Explicitly exempted research are projects of no or low risk. These guidelines are principally based upon those established by the U.S. Department of Health and Human Services (HHS). Specifically exempt from full IRB review are:
Research on normal educational practices that are conducted in schools. (Examples of normal educational practices include research or comparison of instructional strategies and techniques, curricula, and classroom management methods.)
- Research which involves the use of educational tests (cognitive, diagnostic, aptitude, achievement) if the investigator will record the information so obtained in a manner that makes identification of the subjects impossible.
- Research involving survey or interview procedures where the subjects are legally competent, and where the investigator identifies himself/herself, and states that he/she is conducting a research survey interview.
Research involving the observation (including observation by participants) of public behavior in places where there is a recognized expectation of privacy, except where both of the following conditions exist:
Observations are recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects, and
- the observations recorded about the subjects, if they became known outside of the research, could reasonably place the subjects at risk of criminal or civil liability, be damaging to their social standing, or be damaging to the subjects' financial standing, employability or reputation.
- Observations are recorded in such a manner that the human subjects can be identified directly or through identifiers linked to the subjects, and
- Research on normal educational practices that are conducted in schools. (Examples of normal educational practices include research or comparison of instructional strategies and techniques, curricula, and classroom management methods.)
Participant Information Statement, Informed Consent Form, and Informed Consent: In many research activities an informed consent must be obtained by the investigator from each of the participants; or, in the case of those not able to give consent (e.g., children, mentally handicapped), consent must be obtained from their guardians or legal representatives.