Human Research Protection Program Office (HRPPO)/Institutional Review Board (IRB)

*This is written by someone who finds clinical research vexing, and hopefully will be a good insight for those who want to partake an academic career but are not sure how to jump over this initial hurdle that is made of 90% hesitation and 10% actual difficulty. *

During your clinical training, while reviewing a new publication, upon interaction with an interesting patient or sometimes during conversation with a mentor, you may come across some great ideas that can be translated into clinical research.

We all know about that ‘big road bump’ between taking that idea, formulating into a research question, conducting the review and getting your answer: that hurdle is the submission and acceptance of an IRB.

IRB is required when research is being conducted involving ‘human subjects’ and we are all glad that these regulatory bodies exist to protect against violation of human rights to ensure research is conducted ethically and in compliance with federal regulations. However, sometimes, the fear of having to go through what appears to be an arduous process hinders materialization of some great research.

My advice is to not consider the IRB as an obstacle in your publication goal; rather use it as a tool to help you refine your research question. The review board is interested in only one thing; protection of the human subjects in the study. If you, the investigator, are trying to do the same for your study subjects, and can reflect that in your IRB application, getting approved by an IRB should not be an issue.

For the most part, the experience of submitting an IRB and completing a project, regardless of how small or simple, is a great learning experience and talking point for future interviews. The aim is not to revolutionize medicine (you will get opportunities to do that as you grow in your career). For the new or inexperienced researcher, the aim should be to understand the process and be able to finish a project from start to finish.
Since lists make things simple, let me type out the process for you in simple words. To start off, you will need:

1. An IDEA that is  
   1. interesting for you (since you will like be spending a minimum of 12 months working on it)
   2. practically possible given your schedule
   3. a retrospective review that will most likely obtain an expedited renewal and waiver of consent (discussed later)
2. A MENTOR that is
   1. familiar with this process and is well published
   2. understands your clinical duties
   3. you can approach easily with any question and is responsive to emails or phone calls
   4. wants to help you learn: *You will have to meet frequently and correspond often so it is imperative that they have the same goals as you: to be able to effectively navigate the system to take your project to completion. *
3. A SENIOR (fellow or resident) who has been through this process and can guide you with regards to small things that you may not want to bother your mentor with.
4. A practical TIMELINE. Keep in mind that you will likely be applying for fellowship at the end of your second year (unless taking a gap year) and you may want to present your work at meetings or have a manuscript submitted prior to ERAS application opening. All of these will factor into how urgently your IRB needs to get completed and when you must get started on it.

Next you will try to define what you are trying to accomplish and how you plan to do it without adversely affecting the safety and privacy of your research subjects.Time for another list, this time about what needs to be done prior to submitting the IRB.

1. Complete the mandatory CITI program training. 
2. Visit the UTSW IRB page to familiarize with the institutional resources available at your disposal. IRB completion is done in two phases. First, you must create your study in Velos, the institution’s study management system. This phase is fairly easy, you will only need a few pieces of data such as name of PI, Title, Objectives, Funding, and Blinding. Once Velos is complete, change your study status to “IRB-Submission Initiated”. This will send the study to the next phase – the eIRB (Don’t worry, this does not mean that the study has been sent for review). The second phase of IRB is the eIRB – this is where you will create the details of your study including a brief introduction and, most importantly, the methods of your study. Further instructions to navigate through Velos and eIRB portals are available.
3. After you review these pages, having access to institute specific templates is essential. Some helpful forms are available here. In particular, this Protocol Template should help you guide your writing. Your mentor may also be able to help. These will help you gether your thoughts on how you plan on executing your study. You want to be clear and demonstrate that your study does not pose undue risks to your subjects, but this does not need to be a review of all the literature published on the subject.
4. Next you will start typing out the study proposal and protocol. This will be the crux of the IRB. It will include all aspect of the investigation from your aims, outcomes, design, data gathering, data storage, processing, analysis etc. This may be the hardest part of the process for a new investigator and is frequently where residents get hung up. I recommend several sessions of reviewing and re-reviewing by all investigators to make it fool proof. This process will also help you understand what you are trying to accomplish through the research and how to process and present your data effectively. It may be helpful to work on this outside of the eIRB/Velos environment (i.e. in Word) so that you can expedite submission when ready. A sample blank template is available here that should have all necessary info prior to submission to IRB. An IRB application that is sufficiently in-depth will make writing the “Introduction” and “Methods” section of the resulting manuscript very easy.
5. Your faculty sponsor will be your most valuable tool in getting the IRB approval. Since there are so many different types of permutations available for the study design you choose, having someone guide you through this really speeds up the process, at least on your end. When submitting your eIRB, the review type (exempt, expedited, or full board) will vary in each case. Same holds true for the type of consent required. You may also consider meeting with a biostatistician to ensure proper trial/study design for the factors/outcomes you are wanting to analyze.
6. There is a consensus amongst many of my colleagues who participated in different types of research studies: for the new clinical researcher, A SIMPLE RETROSPECTIVE STUDY is the best option for your first IRB submission. With this type of study, you will often be able to obtain an ‘Expedited Review’ and ‘Waiver of Consent’. That will save a lot of time and effort necessary to validate consent and risk management. Additionally, retrospective studies work well with resident timelines in that they can be generally completed within a few months to a year and in the resident’s downtime.