Which Projects or Studies Must Be Reviewed by the IRB?
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.
Step One: Is it Research?
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...”
What is systematic investigation?
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.
What is generalizable knowledge?
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.
Step Two: Does it involve human subjects?
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.”
Data about living individuals through intervention or interaction
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 private information about living individuals
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).
Examples That Are Not Human Subjects Research
- The 2018 revision to the Common Rule clarified that the following categories are not human subjects research:
- Public health surveillance activities, including 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 federal agency) in support of intelligence, homeland security, defense, or other national security missions.
- Scholarly and journalistic activities – such as such as biography, oral history, journalism, and historical scholarship - including the collection and use of information, that focuses directly on the specific individuals about whom the information is collected.
- Course-related activities including instruction in research methodologies and techniques for educational or teaching purposes but not intended for use outside the classroom do not require review. However, class assignments that are intended to collect information systematically with the intent to contribute to generalizable knowledge meet the federal regulatory definition of research. Student research projects such as theses and independent studies that collect data through interaction/intervention with living individuals or through access to private information do require IRB/HSPC review.
- Service surveys issued or completed by College personnel for the intent and purposes of improving College services/programs or for developing new services or programs for students, employees, or alumni, may not meet the definition of human subject research as long as the privacy of the subjects is protected, the confidentiality of individual responses are maintained, and survey participation is voluntary. If the survey is being conducted to produce generalizable knowledge or survey data is used in the future for a new study producing generalizable knowledge, IRB review may be required.
- Information-gathering interviews with questions that focus on things, products, or policies rather than people or their thoughts about themselves may not meet the definition of human subjects research. Example: interviewing students about campus cafeteria menus or managers about travel reimbursement policy.
- Research involving publicly available data such as census data or labor statistics
- Secondary use of coded private information or biological specimens that were not collected for the currently proposed project provided the investigator cannot link the coded data/specimens back to individual subjects
- Research involving cadavers, autopsy material or biospecimens from now deceased individuals
- Quality improvement/quality assurance projects designed to improve the performance of any practice in relation to an established standard or to determine if aspects of any practice are in line with established standards
- Case history or case studies which are published and/or presented at conferences are not considered research if the case is limited to a description of clinical features and/or outcomes of few subjects that do not contribute to generalizable knowledge
Read further OHRP guidance.
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