Do you need a review by Solutions IRB? Research is defined as, “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 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” (Code of Federal Regulations, 45 CFR 46.102d). A Human Subject is defined as, “a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information” (Code of Federal Regulations, 45 CFR 46.102f). The purpose of most research involves some type of dissemination or presentation of the results to your field. The intention to contribute to the body of knowledge in your field is key to the definition, whether or not the completed research makes such a contribution or is accepted for publication. A majority of peer-reviewed journals and conferences now require documentation of IRB review prior to publication. In addition, most federal and state grants require similar documentation of IRB approval in some cases, prior to the release of grant funding. If you are not affiliated with an university or hospital IRB, you will need to use an independent institutional review board.
Are you an evaluator and want to know more about IRB review? Our brief article, Why should evaluators care about IRB review?, provides additional information. Look for additional articles soon. All of the following activities may be considered research:
- Pilot studies or preliminary data collection/analysis efforts
- Interview procedures
- Case studies
- Oral histories
- Analysis of existing data (secondary data analysis)
- Intervention studies
What type of research does not require approval? There are a few categories of research that may involve human subjects but do not require IRB applications and/or approval. These include the types of research listed below:
- Teacher and student evaluations if they are part of the normal education process and there are no plans for publication.
- Program evaluation research to benefit an organization for the purpose of quality improvement and no plans for publication;
- Projects designed to enhance or improve curricula offerings and no plans for publication;
- Marketing research.
If you are unsure whether or not your project meets the criteria listed above, contact us and arrange a phone conference or email the details of your proposed study.