IRB: Research that Involves Human Participants

Rice University considers the protection of human participants in research activities to be a fundamental requirement for the ethical research conduct. For this reason, Rice has adopted a Human Research Protection Policy (Rice Policy 326). This policy outlines the requirement that all research projects involving human subjects be reviewed by Rice's Institutional Review Board (IRB). The IRB ensures proper oversight of research projects that involve human subjects and verifies compliance with the complex system of federal regulations provided by the Office of Human Research Protection (OHRP) and the Food and Drug Administration (FDA), each of which must be followed in the practice of research with human participants.

Non-Research Activities that Involve Human Participants

Not all activities that involve human participants require IRB oversight. In particular, activities that take place in classes and have education or teaching as their goal, rather than research or the development of new information, are likely to fall outside of the IRB's purview. Additional guidance that will allow instructors to make a determination about whether their activities are likely to require IRB oversight, and a form to help them make this decision, can be found here.

Other activities, particularly those that involve conducting surveys and interviews, may also not require IRB oversight. In particular, if the intention of the activity is internal program improvement, it is likely that no oversight is required. IRB Administrators are available for consultation via email for helping with the determination of whether an IRB protocol should be submitted.

IRB Protocols - A Key Requirement for Conducting Ethical Research

The first step to obtaining IRB approval for research activities is to obtain appropriate training to conduct human participants research. Guidance for which courses are appropriate for research activity can be found here. The next step is to file an IRB Protocol and obtain approval. Detailed guidance about this process can be found here. An IRB Protocol should include a complete description of all research activities, the population that will be studied, and the projected risks and benefits of this research activity. Certain research projects, such as those involving special projects (e.g., research involving investigative devices or drugs, course- or community-based research, or research involving minors, pregnant women, or prisoners), are more complex. In these cases, we have developed additional guidance to assist with research design and protocol write-up to assist faculty.

IRB protocols should also include documents that describe how subjects will be recruited and information about the informed consent process. Helpful guidance and template forms for the recruitment and informed consent processes can be found here. The informed consent process is a key tenet of The Belmont Report, which enshrines the fundamental precepts for ethical research on human subjects, and informed consent is a key matter considered by the IRB during their review.

Once an IRB Protocol is submitted, it is reviewed for completeness, accuracy, and regulatory compliance by an IRB Administrator prior to being reviewed by the IRB or an IRB member. Further description of the institutional roles and responsibilities of the IRB and its components can be found here. A calendar of the meeting times of the IRB, and deadlines for submission of materials for review, can be found here. Upon completion of review, the investigator will be provided with a Determination Letter that documents approval, provides an expiration date (if one is determined), and may provide additional guidance about how the research may be conducted.

Importantly, Rice's Human Research Protection Policy clarifies that only the IRB, or designated IRB personnel, can determine whether a specific research activity requires IRB oversight. As a consequence, the Office of Research Integrity strongly encourages researchers who feel that their activities may involve intervention¹ or interaction² with human subjects³ or private⁴, identifiable private information⁵ from a human subject, or identifiable biospecimens⁶ from a human subject to contact an IRB Administrator to ensure that all appropriate oversight occurs.

Request a Classroom or Lab Presentation

The Human Research Protection Program provides educational resources and training opportunities for those involved in research with human participants. Faculty can arrange for class or lab presentations to discuss ethics, the history of research with human participants research, and/or the application process. To schedule a presentation, please contact an IRB Compliance Administrator.

Questions about IRB?

Answers to many of the most frequently asked questions can be found here. Additionally, IRB Administrators are happy to answer any further questions that you have either by email or over the phone - 713-348-4820.

For your convenience, the following definitions are provided

¹: An intervention is defined as either a physical procedure by which information or biospecimens are gathered (e.g., venipuncture, etc.) or manipulations of either the subject or the subject's environment that are performed for research purposes (e.g., changing the environment in which a subject performs a simple task, etc.) 45 CFR 46.102(e)(2)

²: An interaction is defined as any communication or interpersonal contact between investigator and subject. 45 CFR 46.102(e)(3)

³: A human subject is defined as a living individual whom, through intervention or interaction, an investigator (whether professional or student) conducting research obtains, uses, studies, or analyzes private information or biospecimens. 45 CFR 46.102(e)(1)

⁴: Private information is defined as information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. This information has been provided for specific purposes by an individual and the individual can reasonably expect this information will not be made public (e.g., a medical record). 45 CFR 46.102(e)(4)

⁵: Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or other persons with access to the private information. 45 CFR 46.102(e)(5)

⁶: An identifiable biospecimen is a biospecimen for which the identity of the providing subject is or may readily be ascertained by the investigator or other persons with access to the biospecimen or information associated with the biospecimen. 45 CFR 46.102(e)(6)