The performance of original research is one of the most challenging and rewarding accomplishments for any provider at any level. It is also a requirement for academic promotion at most universities and scholarly activity is required by the Accreditation Council of Graduate Medical Education (ACGME) for programs to remain accredited. Although most residents and faculty do not choose original research as their scholarly activity projects, many do and some residencies such as General Surgery even include a research year.
For novice investigators, it is frequently unclear what is or isn’t research. What requires a full Institutional Review Board (IRB) review and what can be exempt or expedited? What about QA/QI projects–especially since the ACGME is now requiring those as well for most residencies–are those research? What does the FDA say about the use of medical apps in research? In the past year, I have been involved in research projects that dealt with each one of those scenarios. Most of the time, your local IRB is your best source of information for such questions. But wouldn’t it be nice to have an app to help explain some of these seemingly cryptic decisions?
The “Is It Research” IRB app was developed by Dr Joseph Breault, MD, MPH, the current IRB Chair of Ochsner Health Clinics in New Orleans, LA and CEO of Apps+Wow, LLC. The app attempts to guide you through the Federal Common Rule that all government funded research must follow. It is also the same set of guidelines the most IRBs follow across the country. The app allows you to answer several “yes/no” questions to help to determine if your idea is actually research. It also provides a nice algorithm that you can just look at and follow on your own. The app allows you to save each analysis and share them. Finally, the app contains numerous references from the Common Rule report to the Belmont Report that launched the concepts behind proper human subjects research, to information about the FDA and QA/QI projects and potential research dilemmas.
One of your family medicine residents is interested in your program’s outcomes performing vasectomy. He wants to look at past outcomes by chart audit of semen analyses and enroll new patients into a patient portal to increase patient compliance with completing their post-op semen analysis at 8 weeks. Is this just a QA/QI project or is it research? Let’s try out IRB app to see what it concludes.
Evidence based medicine:
The app uses accepted federal regulations and cites them throughout the app. Furthermore, the app includes PDF’s of key documents such as the Common Rule and the Belmont Report.
What providers would benefit from this App?
Students, residents, faculty, mid-levels, nurses and any other provider who performs research.
Disclaimer: The views expressed are those of the author(s) and do not reflect the official policy of the Department of the Army, the Department of Defense or the U.S. Government.
- Algorithmic layout that follows Federal Common Rule.
- Numerous “extras” such as full PDF’s of the Belmont Report, information from the FDA on medical devices, etc.
- Ability to save each analysis and share the results via email, print, text.
- Information about the developer’s expertise not listed in app, but easily found on website.
- Some PDF’s are not easy to read on the iPhone’s small screen.
- Information about medical devices and QA/QI projects not technically part of the main algorithm the app uses.
- Not available for Android.
An outstanding IRB “assistant” to help novice (and even experienced) researchers navigate the challenges of IRB approved research while learning more about the history and rules and regulations that govern such research. The app isn’t available for Google Play at this time as researchers using Android could benefit from it.
- Overall Score
- User Interface
Quick, easy to complete IRB questionnaire and includes ability to print the eval from the app.
- Multimedia Usage
Includes numerous PDF extras that cover rules and regulations in more detail and ability to share IRB analyses with others right from the app.
Reasonably priced, but one could simply call and question their IRB for less.
- Real World Applicability
Perfect tool for novice researchers and even experienced ones who want to learn more about the IRB process.
- Device Used For Review
iPhone 6 running iOS 8.4.1.
- Available for DownloadiPhoneiPad