What is considered not to be under IRB's purview
1. Studies on "About what" (vs "About whom")
Some studies require interaction with humans but the focus of the study is not on these individuals. Such studies that focus on "About what", rather than "About whom", may not require IRB oversight.
|Focus of study is "About what"||Focus of study is "About whom"|
|If the focus of a study is only on products, methods, policies, procedures and organizations, and not a study on humans, it is not considered human subjects research.|
- Studying organisational structure by surveying employees.
- Studying the presence of naturally occuring microbes in the air (produced by humans).
|If the focus of a study is on a group of people or on their personal details, it is considered human subjects research. |
- Interviewing employees about their working experience and problems they are facing at work.
- Studying samples of microbes directly produced by each individual.
|=> IRB approval not required||=> IRB approval required|
2. Service Evaluations and Audits
Service evaluations and audits often involve a systematic collection of information about activities, or characteristics and outcomes of programs to make judgments about the programme (or processes, products, systems, organizations, personnel, or policies), improve effectiveness, and/or inform decisions about future program development. However, these evaluations are often specific to the service or programme that is being evaluated, and often does not lead to generalisable knowledge. Hence, such evaluations and audits does not require IRB approval.
3. Scholarly and journalistic activities
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, are not considered to come under IRB's purview. This is because the information collected from specific individuals are not extended to draw generalizations about other individuals or groups. For example, a journalist or a biographer might collect and present factual information to support their presentation of the character of an individual. Such fields of inquiry generally have their own codes of ethics. Other areas include oral history, journalism, biography, historical scholarship, literary criticism and legal case research.
In contrast, if the activity involves collecting and using information about individuals for the purpose of drawing generalizations about such individuals or a population of which they are members, then these would come under IRB's purview. This would include research areas in anthropology or sociology, where methods such as participant observation and ethnographic studies are used, in which investigators gather information from individuals in order to understand the beliefs, customs, and practices, not only of those individuals, but also of the community or group to which they belong to. The purpose and design of such studies or activities is to reveal something about the community or group – that is, to develop generalizable knowledge.
It is not always easy to determine if a study require IRB approval or not. If in doubt, please contact any of the IRB staff in your area to discuss, and to obtain a decision from IRB.