The IRB is made up of administrators and faculty members that read through research proposals involving humans. They do this to ensure that the planned research activities are ethical in practice and compliant with the federal regulations governing research with human subjects.
A researcher submits an application to the IRB office that includes details about all study activities that they would like to implement. The application entails information about what the research is, why it is important, and how the researcher plans on carrying out the research project. The application provides information regarding who the participants in the study will be, what information the researcher will share with participants, what the processes for recruiting participants are, how the researcher plans on gaining informed consent from participants, what procedures are used in order to attain information from participants to use for research purposes, and finally – how all of that information will be analyzed and handled.
During the review process, the IRB looks over these protocols for issues like risks to participants, benefits to participants, and clearly articulated plans to carry out the research. The IRB reviews each individual study by thinking about the participants experience, what information participants will need in order to decide to be in the study, and if the study design poses risks and benefits to participants.
Once the IRB receives the application, the IRB office staff helps prepare the application for final review by making sure all materials are included, the application is consistent, and it meets all regulatory requirements. Once this is completed, the IRB office staff send the application for final review. The final review for a study is determined by the study design (including participant type, risks to participants, methods used in the study, etc) and the regulatory requirements for that design. The final review (dependent on level of review required) is either completed by IRB office staff, an individual IRB Full Board Member, or the convened IRB Full Board.
The IRB Full Board is made up of faculty members, staff members, students, community members, scientists, and non-scientists. Each IRB Full Board member has a diverse background ranging from diversity in sex, gender expression, race, religion, culture, age, areas of expertise, and life experiences (among many other things). These diverse perspectives allow for the Full Board to thoroughly review studies engaging all people. If a study requires expertise that is not represented by the Full Board, the IRB office will identify someone appropriate to advocate for that participant group.
Throughout the research process, the IRB serves as an advocate for all people in research, while also serving as the regulatory body that holds researchers accountable to ethical and complaint standards when completing research with human subjects.