Who Must Apply for Human Subjects Review?
What projects require IRB review?
If the project you propose meets all three of the following conditions (45 CFR 46.102(d)), then you must complete a human subjects review application and receive approval from Evergreen's IRB before you begin recruiting participants for your project.
1. The project is a systematic investigation
A systematic investigation applies consistent protocols and procedures. As described in the Belmont Report, the term research "designates an activity designed to test a hypothesis [and] permit conclusions to be drawn...Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective." Examples of systematic research frequently involve conducting the same types of activities consistently with a number of people—such as written surveys and questionnaires, scripted interviews, interventions to take common measures across a research population, or manipulations designed to record individual responses to particular events or stimuli.
2. The project is designed to lead to generalizable knowledge
Generalizable knowledge means research findings that apply to individuals and circumstances beyond those being studied. Results of a study are considered generalizable if they have relevant characteristics of and implications for more individuals than those in the sample studied. "Generalizable" also frequently implies that research findings will be published, presented, or shared publicly in some other manner at any point after the completion of the study.
3. The project involves collecting data or private identifiable information about human subjects
- Human subjects of research are alive. Studies about people who are no longer alive do not require review.
- Human subjects research is about human beings. Human beings are the topic of human subjects research—not, for example, policies, organizational procedures, products, or things.
- Intervention includes both physical procedures by which data are gathered (for example, drawing blood) and manipulations of the subject or the subject's environment that are performed for research purposes.
- Interaction includes communication or interpersonal contact between investigator and subject, such as interviews or surveys.
- Identifiable private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, medical history and conditions, personal habits, criminal activity, feelings or opinions that if made public could present social or economic risk, and others.) Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects. Information is identifiable, for example, when the investigator knows the identity of one or more participants, or when identifying data are recorded with the information, or where the participant's identity may be ascertained from the combination of the information collected.
Investigators have ethical responsibilities in conducting any kind of research, whether or not a project requires IRB oversight
Any type of research has ethical considerations. Projects that do not require human subjects review and oversight by the IRB still require ethical practices. Researchers and faculty advisers have primary responsibility for ensuring that their investigations are handled ethically. The principles articulated in the Belmont Report should guide any investigation relying on human participants, whether or not the project requires review by the IRB: first, minimize the risk to participants and ensure the potential benefits outweigh the risk (beneficence); second, ensure all participants are fully informed about the purpose, procedures, and risks of the research and give voluntary consent to participate (respect for persons); third, promote equity in research (justice). Many professions and academic disciplines (e.g., journalism, education, oral history) also have their own guides for the ethical conduct of research that are worth consulting.