If you are on the medical campus please visit the BUMC IRB website.
Before submitting an Institutional Review Board (IRB) application, first determine if IRB review is actually required for your project. IRB review and approval is required for projects that:
- Meet the definition of research
- Involve human subjects and
- Include any interaction or intervention with human subjects or involve access to identifiable private information
IRB approval is required before you start your research.
Federal regulations require that research projects involving human subjects be reviewed by an IRB. The IRB must approve or determine the project to be exempt prior to the start of any research activities. The IRB cannot provide approval or determinations for research that has already been concluded.
Does your project meet this definition of research?
Research is defined as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A systematic investigation follows a predetermined plan for looking at a particular issue, testing a hypothesis or research question, or developing a new theory that may include:
- Collection of quantitative or qualitative data
- Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
- Collection of data using experimental designs such as clinical trials
- Observation of individual or group behavior
Contribute to generalizable knowledge means that the purpose or intent of the project is to test or to develop scientific theories or hypotheses, or to draw conclusions that are intended to be applicable and/or shared beyond the populations or situations being studied. This may include one or more of the following:
- Presentation of the data at meetings, conferences, seminars, poster presentations, etc.
- The knowledge contributes to an already established body of knowledge
- Other investigators, scholars, and practitioners may benefit from this knowledge
- Publications including journals, papers, dissertations, and master’s theses
If the project does not meet the definition of research (i.e. is not a systematic investigation or does not contribute to generalizable knowledge), as described above, then the project does not require IRB review and an IRB application is not required.
No, my project is not considered research.
If you are uncertain about if your project is research, please contact the CRC IRB office.
Yes, my project is considered research.
If the project meets the definitions of research (i.e. is a systematic investigation or does contribute to generalizable knowledge), as described above, the next set of questions apply.
Are human subjects involved?
A Human Subject is a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
If the project does not meet the definition of research or the project does not include human subjects, as described above, then the project does not require IRB review.
No, my project does not involve human subjects.
No further action is needed. You do not need IRB approval for research that doesn’t involve humans. If you have research that involves animals you are subject to Institutional Animal Care and Use Committee IACUC oversee... regulations.
Yes, my project includes human subjects.
If the project does include a human subjects aspect, you need to determine if there is any interaction or intervention with subjects or if there is any access to identifiable information.
Interaction: Any communication or interpersonal contact between the investigator(s) and the subjects. This includes in-person, mail, telephone, etc. Online surveys (even if anonymous) involve interaction.
Intervention: Physical procedures or manipulations of the subject or his/her environment (e.g. taking blood samples, exercise studies, use of devices, cognitive tasks, etc.)
Access to Identifiable Private Information
Private Information: Information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place (e.g. person’s home, exam room, public restroom, etc.) OR has been provided for specific purposes with a reasonable expectation that it will not be made public (e.g. medical records, student records, employee file, etc.)
Identifiable Information: The identity of the individual is or may be readily ascertained by the investigator or others either directly or indirectly through the use of codes or a combination of data points.
If the project does not include any interaction or intervention with human subjects or include any access to identifiable private information, then the project does not require IRB review. If even one of the above categories are met (interaction, intervention, access to identifiable private information), an IRB application is required.
No research activities can be conducted without IRB approval. When in doubt, contact the IRB.
Frequently Asked Questions
What happens if I start my research without obtaining IRB approval?
Implications for Students
- Credit may be withheld
- Dissertation or thesis work will not be accepted
- Articles may not be published
- Funding may be withheld
Implications for Faculty/Staff
- Funding may be withheld
- Articles may not be published
- Suspension of research
What are some examples of studies that do require IRB review?
- Pilot studies that involve human subjects
- Master’s theses
- Use of identifiable information from medical records, student records, employment records, or other private sources, Research studies that collect data about human subjects through interaction or intervention with subjects, such as surveys (paper, online, telephone, etc.), interviews, focus groups, cognitive testing, etc.
- Research studies that include subjects to examine devices, products, food, drugs, supplements, etc.
What are some examples of studies that don't require IRB review?
- Data collected for internal departmental or administrative purposes, such as teaching evaluations, student performance data, etc.
- Activities designed solely for quality improvement or evaluation of a particular program, course, etc.
- Oral histories or biographies (unless data will also be used to contribute to generalizable knowledge)
- Training activities unless the training activity is conducted for research purposes
- Single case studies
Can I obtain documentation that my project does not require IRB approval?
Back to Human Subjects