IRB: Common Application Problems

  • Lack of Proofreading, Clarity, and Detail
    Researchers need to provide information in a way that is clear, detailed, thorough, and understandable to anyone who does not have prior knowledge of the research. Responses should be complete and contain grammatically correct sentences that fully answer the question. Responses should be focused on the question at hand. Providing extraneous information that does not answer a specific question does not enhance clarity.

  • Poorly Worded and Disorganized Consent Documents
    A consent document should contain easily understandable language (aim for a sixth grade reading level) that anyone can follow. Think about your audience and what they should know or would want to know when deciding if they want to participate in your study. For example, your consent document should not contain a literature review that was copied from your application. It should not contain acronyms, theoretical models, or technical jargon which most participants will not understand. The consent document should be concise and provide relevant information that is presented in a comprehensible way to participants. The format should be clutter-free and easy to read.

  • Copying and Pasting from Past Submissions
    Do not copy and paste answers you may have seen elsewhere into your application. Oftentimes, researchers copy and paste material because they believe it is what the IRB wants to hear. There are no magic phrases that will result in IRB approval. Focus on addressing the specific questions in the application in your own (grammatically correct and proofread) words. Make sure that any templates you follow are tailored to your research. The IRB office does not provide copies or samples of previously approved submissions. There is no need to review someone else’s work in order to get IRB approval.

  • Lack of Consistency across Documents
    Ensure there is consistency throughout your project documents. For example, you may not introduce new methods in the application or on consent forms that were not listed in your research summary at the beginning of the application. Submissions should be proofread to ensure there are no contradictory or conflicting statements. Any requested revisions must be addressed to all applicable documents.

  • Revisions That Do Not Address Concerns
    Most requests for revisions or clarifications by the IRB are not optional. If a comment or revision is only suggested and not required, this specific information will be noted in the email to you. Otherwise any requested revisions or clarifications for more information must be addressed to all relevant sections of the application and to all relevant documents. You are responsible for contacting the IRB Office if you do not understand IRB requests. Students who submit multiple iterations of their application that do not sufficiently address IRB comments will be referred back to their faculty supervisors. IRB staff will not act as a substitute for faculty guidance and supervision on student research, and faculty supervisors may be asked to resubmit revisions on behalf of their students. Faculty who fail to address requested revisions and/or do not provide the clarifications requested by the IRB will have their applications referred to a full committee review.

  • Retroactive Timelines and Inactive Submissions
    The IRB may not approve research retroactively. You may not begin any work with human participants (including recruitment and consent procedures) until you have IRB approval. The proposed timelines and start dates in a submission must allow enough time for review, revisions, and approval. You are responsible for ensuring that your stated start date and timelines are still appropriate when submitting revisions. Likewise, you are responsible for ensuring that all revisions are submitted before your start date passes. The IRB Office has the authority to administratively withdraw a submission if we do not hear from you by the proposed start date when revisions were requested by the IRB.

Overall, the more time you invest in checking and proofreading your submission, the faster the review and approval process. Please do not expect IRB staff and IRB members to assume this responsibility for you. Emails sent to the IRB analyst asking for a check of the materials prior to submission will not receive a response. The IRB analyst will screen your submission once it is submitted via email to irb@sjsu.edu