IRB Protocol Review & 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 (the required supporting materials, along with all forms, are identified below.) The IRB assesses the application materials to ensure that proper procedures will be followed – most specifically, that 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 Channel Islands (CI), most research is of a type which presents little inherent risk of harm to human subjects, so review processes are generally quick. Often, minor changes in the research application will be requested 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, upon initial review of the application can facilitate the approval process to be completed within approximately 10 business days.
Occasionally, when research is proposed that focuses on potentially vulnerable populations or poses possible risks to human subjects, the IRB exercises particularly rigorous review and will make recommendations to ensure that procedures guarantee voluntary participation under fully informed consent (or assent), that the rights of research participants will be fully respected, that the research design minimizes any potential risks and is outweighed by the potential benefits generated by the research. In such cases, review might take longer, since such cases require the convening of the full IRB to review the proposed research and possibly substantial revisions.
IRB Review Categories
The proposed research can fall into one of three IRB review categories, primarily based on characteristics such as the nature of proposed research, the status of research subjects and the level of potential risk associated with participation. The three review categories are: Exempt, Expedited, and Full Review. Each of those categories is described below.
The exempt designation means that the research is exempt from federal regulations; however, that designation can only be made by the IRB, and therefore still requires submission of application materials. To qualify as exempt, research must fall into one of six federally-defined categories which present the lowest degree of risk to potential subjects. For example, research is designated as exempt if it is based on the collection of anonymous or publicly-available data, or the observation of public behavior, or collects information, and if subjects cannot be identified through the data, or present little risk if identified, and it does not involve vulnerable populations.
To qualify for expedited review, research must fall into one of nine federally-defined expedited categories. These categories involve collection of samples and data in a manner that is not anonymous and that involves no more than minimal risk to subjects. 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 review by the full IRB, which represents the most rigorous level of review. Such research typically involves vulnerable populations (such as children, pregnant women or fetuses, prisoners, ethnic minority and people with mental impairment); projects that may involve coercion or undue influence; those that include sensitive data; involves 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 – such as masters theses, capstone projects, or any research that may be presented orally or published for public access beyond the boundaries of the classroom – the project must be reviewed and approved by the IRB. The review process for student research is no different from the regular review process – with the minor exception that a faculty member must sign on as a supervisor for the project, which includes reviewing the student proposal prior to submission to the IRB.
Classroom Based Projects
Class based research projects, however, are approved in a different manner. A class-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. When such projects require students to interact with and gather data from human subjects, the project must be reviewed and approved by the IRB. However, in such instances, the project as a whole may be approved through an expedited process (rather than each individual student project). The supervising instructor can submit the Classroom based research project on two, single-page checklist forms, along with support documents. The documentation will offer evidence that the project entails routine interactions, and that students have been educated about appropriate human subjects protection practices and the results will not be presented outside the classroom or published in any form. The forms to be submitted for a class-based project are included below with a description of the approval process and requirements and the appropriate documentation necessary. Upon submission of the completed forms, following the guidelines, the instructor may advise students to commence the project.
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.
The basic application form asks for basic identifying information about the investigator(s), a summary of the research, and more 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 their consent etc. and additional support documents as identified on the first page of the application in the form of a check list. You may access the application form under Forms and "Faculty/Staff/Student Application Form".
If you plan to video tape any part of your research or capture it photographically, you must submit a completed and signed release form with your IRB application. You may access appropriate forms under Forms.
For survey and interview based research, a copy of the research instruments (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 the "Sample Consent Forms" in appropriate category under "Sample Forms." on the forms page. The following are examples of sample consent forms of several different types:
- Sample Adult Consent Form (MS Word, 30KB)
- Sample Student Consent Forms (MS Word, 31KB)
- Sample Parental Consent Form (MS Word, 30KB)
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 the cooperation of another institution, a letter from that institution acknowledging and supporting that relationship is required. You may review a sample letter of institutional support under "Samples Forms." You may adopt these forms for your particular needs:
- Sample Institutional Letter (MS Word, 23.5 KB)
- Sample Permission Letter from Institutional Management (MS Word, 23.5 KB)
Principal Investigator Certification
All researchers interacting with human subjects in any way must provide evidence of Principal Investigator Certification training before IRB approval can be granted. For information on PI Certification training, go to the page titled Training & Compliance, or link directly to online training.
IRB Application Submission & Processing
IRB applications and all supplementary materials should be submitted both electronically
and via hard copy. Electronic files should be submitted via email (as attachments)
to email@example.com. Two hard copies (one original copy with appropriate signatures) should be submitted
directly to: RSP, Madera Hall #1300 by 8:00 a.m. the Thursday prior to the weekly Monday IRB Review
All appropriate application support documents must be included in order for the IRB to proceed with the review.
Timelines for Review & Approval
In most cases, the initial IRB review can be concluded within approximately 10 business days. If your research requires full board review, then several additional weeks should be added to the processing timeline. Often, the IRB will request some revisions in the application or other forms to ensure that the research is consistent with ethical and best human subject research practices. If all suggested changes are made promptly, the IRB would be able to approve the research shortly after resubmission. If the proposed research requires full board review, then the process may take from 1-3 months. Applicants are strongly encouraged to carefully review the requirements for a complete application package, and submit all necessary support documents as part of the application by 8:00 a.m. Thursday. This would greatly facilitate the timely review and approval of the application.