The College’s IRB has assured federal regulatory agencies that the institution will review and approve all research that meets the federal definition of human subjects research.
Determining whether or not a project meets the federal Office of Human Research Protections (OHRP) definition of research involving human subjects is a two-step process. First, the investigator must determine if the project meets the federal definition of research. If this is met, the researcher must then determine if the project includes human subjects. The information below will help you assess whether IRB review is required.
Note: Projects that involve activities covered under Food and Drug Administration (FDA) regulations involving human subjects require submission to the IRB.
The Federal Policy for the Protection of Human Subjects (Common Rule) defines research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge...”
Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. It includes the collection of information and/or biospecimens and the quantitative or qualitative analysis of that information.
Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional research.
Developing or contributing to generalizable knowledge means that the intent or purpose of the systematic investigation is to draw conclusions or generalize outcomes beyond the specific population or entity studied.IRB review is not required if your project does not match the definition of research. You do not need to submit an application.
The Federal Policy for the Protection of Human Subjects (Common Rule) defines human subjects as “…a living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
About whom” is key: Consider if the project focuses on the person or if the focus is on policies, practices, or procedures about which the person is knowledgeable. Projects which collect information about policies, practices, or procedures – even if the person who provided that information is identified – do not constitute human subject research.
Intervention includes both physical procedures through which information or biospecimens are collected (e.g. venipuncture) and manipulations of the subject or the subject’s environment (e.g. exercise, noise levels).
Interaction includes communication or interpersonal contact between the investigator (or research team) and the living individual. Examples include interviews, questionnaires, surveys, or focus groups.
Identifiable means 1) the identity of the individual from whom the information or biospecimens was obtained may be readily ascertained by the investigator; or 2) the identity of the individual from whom the information or biospecimens was obtained may be readily associated with the data or specimen.
Private Information is information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical record, employee or student records).
Examples of identifiable, private information include the subject’s name, address, phone number, social security number, medical record number, student or employee identification number, or in some cases, the combination of data such that they can identify a single individual through deductive reasoning. For example, data about employer, job title, age and gender may not individually identify a subject, but when combined, could in certain cases, identify a specific individual.
What is NOT considered identifiable, private information: If the information cannot be linked to a living individual, or is considered public (e.g. census data)or is given with the expectation that it will be made public and that it will be linked to the individual (e.g. biography or news story), then it would not be considered private identifiable information. For example, use of a publicly available data set that does not contain identifiers or codes linked to individuals does not involve human subjects research. However, use of a publicly available data set that does contain identifiers or codes linked to individuals does involve human subject research.
If your activity is research but does not involve human subjects as defined in the regulations your activity does not fall under the purview of the IRB. You do not need to submit an application.
If you have determined that your research does meet the federal definition for human subjects research, you will need to apply for IRB review and approval before you begin (the IRB will not review projects retrospectively).
Read further OHRP guidance.
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