IRB & Human Subjects Research
Many undergraduate students engage in research that involves human subjects. These projects require Institutional Review Board (IRB) approval. Browse one of the following sections for IRB related help:
- What is human subjects research?
- Do I need IRB approval?
- What do I need to do to receive IRB approval?
- Who do I contact for help?
What is research?
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
A Systematic investigation means an activity that may include:
- Collection of observational 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; or
- Some demonstration and service activities.
Contributions to generalizable knowledge means public presentation of the study data through any of the following:
- Meetings, conferences, seminars, poster presentations, and similar venues;
- Publications distributed beyond Notre Dame including evaluation reports, journal articles, papers, dissertations; and,
- Senior Theses, Master’s Theses, Dissertations, and Projects
What is the definition of human subject?
A human subject is any living individual about whom an investigator obtains data:
- Through observation of the individual, or
- Through intervention or interaction with the individual, or
- Through the collection of private information
- Counting the frequency or otherwise recording specific behaviors of humans
- Audio or video tape recording of the subject’s behavior or interactions
- Manipulations of the subject’s environment; or
- Applications of procedures or treatments, such as drugs, devices, or biologics; or
- Administration of psychological therapies or counseling to change behavior or promote well-being
- Communication with the subject; or
- Interpersonal contact with the subject; or
- Physical procedures to collect data, such as taking blood samples
Private information must be individually identifiable and includes:
- Information about behavior that the subject expects will not be observed or recorded
- Specific information about the individual that the individual can reasonably expect will not be made public
If your research meets the above definition, you will need to submit an application for IRB approval before you can begin.
IRB review of classroom-related activities is not required when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods.
Data collected for a class project may not be used for publication or presentation, unless the project was reviewed and approved by the IRB prior to recruitment and data collection. Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.
All research with human subjects must be reviewed and approved by the University of Notre Dame’s Institutional Review Board (IRB).
- All students conducting research projects are required to have a faculty advisor. By signing the protocol form the faculty advisor both attests to the veracity, accuracy, and completeness of the application and identifies him/herself as the one held responsible for insuring that the research is conducted in compliance with research standards.
- Students must complete the appropriate training in research ethics and the protection of human subjects. All researchers listed on an IRB protocol must complete the standard Social and Behavioral Section. As a first time user, when prompted to select the training modules, click on Social and Behavioral Research under the Human Subjects heading. This is the only module you are required to complete for human subjects certification. The following link connects you to the Collaborative Institutional Training Initiative site: https://www.citiprogram.org/
- Students must submit a protocol using the University’s E-Protocol Submission gateway.
- Plan ahead and submit early. The IRB meets monthly to review full-board protocols so students are advised to submit their protocols no later than three months before they plan to begin their research.
All questions regarding human subjects research or how to navigate the IRB process can be directed to Nakesha Alexander at firstname.lastname@example.org.