IRB Review and Application Process
IRB Protocol Review Process
The IRB review process is initiated by the submission of an IRB application along with all necessary supporting materials (see Forms). The IRB assesses the application materials to ensure, among other things, that subject participation is voluntary and fully informed, confidentiality of human subjects is maintained, and that no undue risks are posed to research subjects in the process of research.
At CSU Maritime Academy (CSUM), the review process may include requested changes in the research application in order to clarify procedures or to bring them into line with best human subjects' research practices. Submission of a complete application and prompt revisions of the application will facilitate a timely approval process.
Occasionally, when research is proposed that focuses on potentially vulnerable populations or poses possible risks to human subjects, the IRB exercises a particularly rigorous review that includes asking if the proposed research design minimizes potential risks and if the risks are justified by the potential benefits of the research. The IRB may also consult experts in the discipline being investigated. Such full board reviews take considerably longer, so researchers should plan accordingly.
IRB Review Categories
A project involving human subject research will receive one of three IRB review designations: Exempt, Expedited, and Full Review. How the project is categorized by the board is determined by project characteristics such as the nature of proposed research, the status of research subjects, and the level of potential risk associated with participation.
The exempt designation means that the research is exempt from federal human subjects regulations; however, that designation can only be made by the IRB, and therefore still requires submission of application materials. To qualify as exempt, the research must involve human subjects in one or more of six federally-defined categories, which present minimal risk to human subjects.
The expedited designation means that the project involves no more than minimal risk to human subjects and only involves procedures listed in one of nine federally defined categories. If research designation is determined to qualify for expedited review, the IRB chairperson and one additional reviewer may evaluate and approve the proposed research.
Full Board Review
Projects that do not fall into either the exempt or expedited review categories must undergo a full review by the IRB, which represents the most rigorous level of review. Such research typically involves vulnerable populations, projects that may involve coercion or undue influence, those that include sensitive data, those that involve some sort of deception in recruitment, and those which include more than minimal risk to subjects.
Student Research Projects
When students conduct research involving human subjects the project must be reviewed and approved by the IRB. The review process for student research follows the same guidelines as non-student research – with the important exception that a faculty member be identified as a supervisor for the project and therefore be expected to review the student proposal prior to submission to the IRB.
A classroom-based project/exercise is one that is assigned within a class solely for evaluating, teaching and learning research tools or for pedagogical purposes, and which will not be reported outside of the classroom or published in any form. When such projects require students to interact with and gather data from human subjects, the project does not require review or approval by the IRB.
How to Prepare Your Application for IRB Approval
The application process requires the submission of the completed application form, along with supplementary materials which vary with the type of research being conducted as described below. You may find it helpful to review the section on Frequently Asked Questions prior to completing the application form.
Principal Investigator Certification
All researchers interacting with human subjects in any way must provide evidence of certification in the ethics of human subject research. No IRB Application will be reviewed without proof of certification. See the Training & Compliance page for information about acceptable online training courses.
The basic application form asks for identifying information about the investigator(s), a summary of the research, detailed description of procedures relevant to human subjects' involvement, description of data collection and storage methods, human subject recruitment protocol, involvement of other institutions, and information on how the project will obtain consent from its subjects.
All IRB applications must be submitted using the IRB Application Template.
For survey- and interview-based research, a copy of the research instruments (e.g., the questionnaire or interview guide/questions) must be submitted with the application.
For most forms of research, forms indicating voluntary and informed consent are required to be presented to and signed by each human subject. For such research, a consent form for the project must be submitted along with other application materials to the IRB for review. You may review sample consent forms on the forms page.
Letter of Institutional Cooperation
When research is being conducted at another institution or organization of any kind, or when the investigator is otherwise relying on cooperation with another institution, a letter from that institution acknowledging and supporting that relationship is required.
IRB Application Submission & Processing
IRB applications and all supplementary materials should be submitted electronically via email as PDF attachments to email@example.com. Applicants should be prepared to provide, on request, a hard copy of all application documents.
All appropriate application support documents must be provided prior to IRB review.
Timelines for Review & Approval
The IRB review of projects that are eligible for Exempt or Expedited Review designations can be completed within approximately two to three weeks during the academic year. If your research requires Full Board Review, then review can take up to 3 months.
Often, the IRB will request revisions to application materials to ensure that the research is consistent with ethical and best practices in human subject research. If all suggested changes are made promptly, the review process is able to proceed more swiftly after resubmission.