Definition of Research on Human Subjects Any systematic investigation designed to develop or contribute to general knowledge based on data obtained from human subjects. This includes both original studies and replications of existing studies performed by faculty, students, or others. The phrase 'considered to involve human subjects' as used in these Policies and Procedures is considered to involve a full range of activities described in this section, and include activities that make use of such things as:
- Bodily materials, such as cells, blood or urine, tissues, organs, hair or nail clippings, even if you did not collect these materials
- Residual diagnostic specimens, including specimens obtained for routine patient care that would have been discarded if not used for research
- Private information, such as 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 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.