By Mary A. Banks, BS, BSN
“Let us watch well our beginnings, and results will manage themselves.” ~ Alexander Clark
You are an investigator or study coordinator. You have been procrastinating for weeks, but now you know that the time has come…you need to sit down and write your INSPIR application! But, you are hesitating because you are really not quite sure where to begin, either because this is your first IRB protocol, or you have submitted protocols previously which needed multiple corrections and modifications before they were approved by the IRB. You are really anxious for this submission to go smoothly. You know there are multiple resources available to assist you, but, the volume of information available makes sorting through it all very challenging.You are in luck! The purpose of this article is to provide investigators with an overview of some of the numerous resources available to investigators who are writing their INSPIR protocols. Secondly, this article specifically advises investigators on how to select the most appropriate IRB review pathway for their protocols, thus increasing the chance that the IRB review process of their protocols will go smoothly.
One of the first questions you will need to tackle as you prepare to write your IRB (INSPIR) protocol is, “What type of IRB application should I be submitting?” Technically, there is only ONE INSPIR application. However, since INSPIR is a “smart form”, the questions in the application are populated based on the answers you provide early in the application. The selection options under Question 10.3 of the INSPIR application are the ones that most significantly determine the review pathway of the study and heavily determine which additional questions are placed on the INSPIR application. If you answer Question 10.3 incorrectly, you could end up doing a much longer application than necessary. Or, you could end up not providing the IRB with enough information to complete the review; and, therefore, the application would have to be returned to you for a complete “do-over”.
Over the past few years, there have been a significant number of CR TIMES Feature Articles that have been written to assist investigators in determining the appropriate review pathway for their research. Some of the most common types of research seen at BUMC are noted in the table below with a link to these CR TIMES articles.
If you take the time to reference the articles which correspond with your research and follow the guidelines within the articles, you will go a long way towards ensuring that you are providing the information necessary for the IRB to review your protocol. If, after reading the articles, you still have questions about what type of review your research will qualify for, it will be well worth the time and effort to contact the CRRO (Clinical Research Resources Office at 617-638-8876 or www.bumc.bu.edu/crro) for assistance with this determination prior to completing your INSPIR application.
Here are some of the most common research scenarios, some possible review options, and where to find more information.
All IRB protocols at BUMC must be submitted via INSPIR (Integrated Network of Subject Protection In Research). The IRB does not accept human subjects research protocols submitted via other methods. For investigators who are unfamiliar with INSPIR, there is a lot of information on the IRB website with specific details about INSPIR.
Investigators are encouraged to consult the detailed INSPIR instructions on the IRB website about how to complete initial INSPIR protocols, how to create consent forms, how to attach recruitment materials, etc.
Questions 1-10 of INSPIR: The following questions must be completed for all INSPIR applications for all studies, no matter the review path. Next to the specific INSPIR questions are some links to CR TIMES articles or information on institutional websites which provide additional guidance as to how to answer the questions.
After completing Sections 1 to 10 in INSPIR, the rest of the application is populated with questions based on the answers to the questions above. Therefore, the numbering of the sections in the applications will vary. Question 12 on an Exempt application will not necessarily be the same question as Question 12 on an Expedited application.
The following table represents some key points in the IRB applications, and references links from previous CR TIMES issues regarding these topics.
Developing an IRB application is challenging. The information that needs to be provided to the IRB varies greatly depending on the research study. There are many resources available to BUMC investigators to assist them in writing their IRB protocols. This article provides a summary of many of those resources from previous Feature Articles in the Clinical Research Times. Investigators are also encouraged to consult with the BUMC Clinical Research Resources Office if they have questions when preparing their INSPIR applications, especially for questions related to IRB review pathways.
This Quiz applies to the current recertification period from July 1, 2013 to June 30, 2015. We recommend that you take this quiz now so you can stay up-to-date.