IRB and Human Subjects Research (adapted from compliance.rice.edu)
Rice University reviews all human subjects research conducted by students, faculty, and staff. The group tasked with conducting this review and approving research that includes human participants is called an Institutional Review Board (IRB) and consists of Rice faculty and staff. Their primary function is to determine if the research meets certain ethical standards and principles. SPARC-Rice Compliance administers all processes related to IRB approval. Below is a summary of IRB terms and review processes. For complete information and access to forms, go to https://compliance.rice.edu/irb or contact firstname.lastname@example.org.
What is "human subjects research"?
The Institutional Review Board (IRB) conducts review and approval of research that involves human participants. A project is considered Human Subject Research if it meets the below criteria, as defined by the Department of Health and Human Services:
- The project meets the definition of research: a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
- The project involves Human Participants: a living individual about whom a research investigator (whether a professional or a student) obtains data through intervention or interaction with the individual or from individually identifiable information.
Definition of Terms
- “Intervention”: both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
- “Interaction”: communication or interpersonal contact between investigator and subject.
- “Identifiable information”: information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).
- “Private information”: information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
IRB for Student Research
As a student, you are able to complete your study proposals in Cayuse IRB. You will need to list your Faculty advisor as investigator (PI) and yourself as Co-Investigator (Co-I). Students can be added to existing studies as Co-Investigators by modification. The PI is the individual on the study that is responsible for ethical conduction of the study. These responsibilities include proper documentation and reporting to the IRB, ensuring all researchers involved in the research are adequately and properly trained. The PI is ultimately responsible for the oversight of the consent process to ensure all participants are informed properly for adequate consent to participate. The PI assumes all responsibility for compliance of federal, state, local and institutional policies. The PI may not initiate any research involving the interaction with human participants prior to the IRB approval.
Each research scenario for student research has its own circumstances that will indicate the review, etc. See the chart below for common scenarios with likely processing requirement:
1. Does your RESEARCH involve direct interaction with individuals (e.g., in person, via mail, email, online survey, or telephone), or data from human subjects for which the researchers will have access to identifiers?
Then IRB is required. Submit the IRB with faculty advisor as Principal Investigator and student as Co-Investigator
2. Is your RESEARCH limited to secondary analysis of data, records or specimens that are either publicly available, de-identified or otherwise impossible to be linked to personal identities.
Then submit application for IRB Exempt Determination.
You are required to complete the Collaborative Institutional Training Initiative (CITI) Human Subjects Research training modules:
Training is needed prior to approval of your study or the addition of study personnel.
Documentation of this training can be uploaded as a pdf in the training section in the IRB protocol in Cayuse IRB, or verified by the Compliance Administrator at the time of the review of the study. When you complete all of the required modules successfully, you may print your completion report through the "Print" link on the learner’s menu. The PI on the study should keep a copy of the study researchers’ training for their records.
A faculty advisor must be identified by any student who wishes to conduct human subjects research. This advisor should be someone who is able to review your proposed research and offer guidance about your study design, subject population, planned interventions, and more. In addition to assisting with your research design and implementation, the advisor must have completed CITI human subjects research training.