How to Prepare for IRB Application

An IRB application is a document that describes the purpose, methods, and ethical considerations of a research project involving human subjects. An IRB, or Institutional Review Board, is a committee that reviews and approves such research projects to ensure that they comply with the federal regulations and the ethical standards of the institution. An IRB application is required for any research that involves human subjects, such as surveys, interviews, experiments, observations, or record reviews. Preparing an IRB application can be a challenging and time-consuming process, but it is essential for conducting research ethically and responsibly. In this article, we will provide you with some tips and guidelines on how to prepare an IRB application, as well as some resources and examples of IRB applications.

Why Preparing an IRB Application Matters

Preparing an IRB application matters because it helps you to:

  • Protect the rights and welfare of the human subjects who participate in your research. An IRB application ensures that your research minimizes the potential risks and maximizes the potential benefits for the participants, and that you obtain their informed consent and respect their privacy and confidentiality.
  • Ensure the quality and validity of your research. An IRB application ensures that your research follows the scientific and ethical principles of your discipline, and that you address any potential biases, conflicts of interest, or limitations of your study.
  • Comply with the legal and institutional requirements of your research. An IRB application ensures that your research meets the federal regulations, such as the Common Rule, which governs the protection of human subjects in research, as well as the policies and procedures of your institution, such as the Human Research Protection Program (HRPP), which oversees the IRB process.
  • Avoid any delays or problems in your research. An IRB application ensures that you obtain the necessary approval and authorization before you start your research, and that you report any changes or issues that may arise during your research. Failing to do so may result in the suspension or termination of your research, or the rejection or retraction of your publications.

How to Prepare an IRB Application

Preparing an IRB application can be a complex and lengthy process, but it can be made easier and more effective by following some steps and guidelines. Here are some suggestions on how to prepare an IRB application:

  • Identify your research question and design. Before you start writing your IRB application, you should have a clear and specific research question and design, which will guide your IRB application. You should also determine the level of review that your research requires, which depends on the type and level of risk involved in your research. There are three levels of review: exempt, expedited, and full board. Exempt review applies to research that poses minimal or no risk to the participants, and does not require the IRB approval, but only the confirmation of the exemption status. Expedited review applies to research that poses no more than minimal risk to the participants, and requires the approval of one or more IRB members, but not the full board. Full board review applies to research that poses more than minimal risk to the participants, and requires the approval of the full IRB committee at a convened meeting.
  • Research the IRB requirements and expectations. Before you start writing your IRB application, you should also research the IRB requirements and expectations of your institution and your funding agency, if applicable. You should familiarize yourself with the IRB application form, the IRB submission process, the IRB review criteria, and the IRB feedback and approval process. You should also consult the IRB website, the IRB handbook, the IRB staff, and the IRB members for any questions or clarifications. You should also review some examples of IRB applications from your discipline or field, and learn from their strengths and weaknesses.
  • Write your IRB application. When you write your IRB application, you should follow the IRB application form and instructions, and provide all the necessary information and documents. You should also write in a clear, concise, and coherent manner, using lay language and avoiding jargon or technical terms. You should also write in a respectful and professional tone, acknowledging the IRB’s role and authority, and addressing any potential concerns or issues. You should also proofread and edit your IRB application, and check for any errors, inconsistencies, or gaps. You should also seek feedback and guidance from your advisor, mentor, or peers, and revise your IRB application accordingly.
  • Submit your IRB application. When you submit your IRB application, you should follow the IRB submission process and deadlines, and provide all the required documents and materials. You should also keep a copy of your IRB application and the confirmation of your submission, and track the status of your IRB application. You should also respond to any queries or requests from the IRB in a timely and courteous manner, and provide any additional information or clarification that the IRB may need.
  • Wait for the IRB decision. After you submit your IRB application, you should wait for the IRB decision, which may take from a few days to a few weeks, depending on the level of review and the IRB workload. The IRB decision may be one of the following: approval, conditional approval, deferral, or disapproval. Approval means that your IRB application meets all the criteria for approval and that you can start your research as planned. Conditional approval means that your IRB application meets most of the criteria for approval, but that you need to make some minor changes or modifications before you can start your research. Deferral means that your IRB application does not meet the criteria for approval and that you need to make some major changes or revisions before you can resubmit your IRB application for another review. Disapproval means that your IRB application does not meet the criteria for approval and that you cannot conduct your research as proposed.

Conclusion

Preparing an IRB application is an important and necessary step for conducting research involving human subjects. An IRB application describes the purpose, methods, and ethical considerations of your research project, and seeks the approval of the IRB, which is a committee that reviews and approves such research projects. Preparing an IRB application can be a challenging and time-consuming process, but it can be made easier and more effective by following some tips and guidelines, such as identifying your research question and design, researching the IRB requirements and expectations, writing your IRB application, submitting your IRB application, and waiting for the IRB decision. By doing so, you can ensure that your research meets the ethical and legal standards of your institution and your discipline, and that you protect the rights and welfare of your human subjects.