Many activities fail to meet the definition of research and therefore, don not require IRB review and approval. Most case reports and much of the Quality Improvement activities that take place do not meet the definition of research. The IRB may review these to assure that they are not research and therefore, do not need to be reviewed.
How does the Common Rule define research?
45 CFR 46.102(d)
HHS regulations define research as 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 purpose of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.
*Systematic means that the activity follows a written plan and adheres to scientifically accepted principles for research design.
How does the FDA define research?
FDA Definition of Research
21 CFR 56.102(c) FDA regulations define the term clinical investigation or research to mean any experiment that involves a test article and one or more human subjects where the test article is regulated by the FDA. The FDA considers the term clinical investigation as being synonymous with the following: research, clinical research, study, and clinical study.
FDA regulations govern clinical investigations that support applications for research or marketing permits for products regulated by the FDA, including food and color additives, drugs for human use, medical devices for human use, biological products for human use, and electronic products. This includes any new or unapproved item regulated by the FDA and the application of approved items to new populations or indications.
Research from the FDA's perspective, hinges on whether or not an investigational test article, which could be a drug, a biologic or a device is used. This definition is totally different from the HHS definition.
What kinds of activities are included in these definitions of research?
Many different types of research activity are encompassed by these two definitions.
For example, research objectives may range from understanding normal and/or abnormal physiological or psychological functions or social phenomena, to evaluating diagnostic, therapeutic or preventive interventions and variations in services and practices.
The activities or procedures involved in research may be invasive or noninvasive, and include removal of body tissues or fluids; administration or application of chemical substances or forms of energy; surgical interventions; modification of diet, daily routine or service delivery; alteration of environment; observation; administration of questionnaires or tests; randomization of subjects; review of records, and so forth.
Research activities may also be conducted or supported within a program or activity that otherwise may not be considered research, such as some demonstration and service programs. As such, the research aspect of the program falls under the jurisdiction of the CHOP IRB.
For IRB review and project implementation, a research project must be described in a protocol or, for an exempt submission, in the eIRB application.
Examples of activities that do not meet the definition of research
- Activities not designed to produce generalizable knowledge;
- Innovative clinical care;
- Off-label use of drugs or biologics as part of usual clinical care;
- Work Preparatory to Research;
- Case reports and small case series;
- Scholarly and journalistic activities, including the collection and use of information, that focus directly on the specific individuals about whom the information is collected;
- Educational presentations;
- Quality Improvement activities that implement known interventions and that do not use research methodologies;
- Public health surveillance activities (e.g. the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority);
- 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.