PRIM&R invited members of our Emerging Professionals Working Group (EPWG) to write about topics of relevance to their work and to the research ethics community. We hope these posts open conversations among research ethics oversight professionals at all points in their careers.
My first encounter with the IRB was as a principal investigator (PI). I was a sociology master’s student at the time, and I was conducting my thesis on presentation of self on Facebook. My cohort and I had learned of the IRB in the course of our studies, but we were only really aware of it in the same way that one is aware of historical events encountered in a text book: bad things happened in research, IRBs were created, bad things no longer happen in research.
My experience submitting to the IRB didn’t do much to alter my understanding of the IRB process, either. From what I could tell, here was the course of events:
- My committee signed off on my research methodology
- I filled out a very extensive form describing my research methodology and submitted it to the IRB
- I waited a number of weeks while my project went through a mysterious process, finally emerging with the label ‘exempt’
- I fretted internally: It doesn’t say approved, does this mean I can start? Exempt from the IRB? Did I even need to submit in the first place? Did I just waste a number of weeks waiting for nothing?
- I realized that my survey measure needed some revisions and filled out an amendment form and submitted it to the IRB
- I waited a number of weeks and my project emerged from the black box, again labeled ‘exempt’
- I fretted internally: Again!? Was this amendment even necessary? It still doesn’t say approved, does this mean I can start?
- My advisor said I could start my project
- I conducted my survey
- I wrote the rest of my thesis
- I defended my thesis
- I graduated a semester later than I intended
Now, a few years later, I am an IRB Administrator, doling out "exempt" labels of my own. The process makes much more sense from this side of the desk, because I have the context I was missing as a student, including what the regulations actually say, why the IRB review takes as long it takes, and how the exempt sausage is made. Most importantly, I now understand why IRB review continues to be important (it turns out, bad things do still happen in research).
I can’t go back in time to demystify the IRB process for my former self, but I can share some of the things I have learned that may be helpful to other researchers in working with the IRB.
Use the IRB as a Resource
Before submitting a new research study, or an amendment or continuing review for an ongoing research study, call the IRB. Let them know about your project, and confirm you are submitting under the correct level of review. Inquire about the wait time and the turnaround time policy. Find out if there are any study-specific requirements (such as site permissions or IRB approval for outside collaborators) that you will need to address in order for the study to be approved.
The IRB staff review studies every day, so they know what information is needed to approve a study, and what kind of gaps would result in a contingency or question. And because they are versed in federal regulations and institutional policy, they can let you know whether a study qualifies for exemption, or whether a potential protocol change necessitates an amendment. In short, the IRB can be your best resource for how to effectively submit to the IRB—don’t be afraid to use them!
Inconsistencies Slow the Review Process
Prior to hitting the submit button on your IRB application, make sure that your application and consent documents are internally consistent. The IRB review process can be inherently long, and the time it takes can depend on a number of factors, including how many studies are in the review queue at any given time, and how complex these studies are. But applications that are clear and consistent can be reviewed much more quickly than those where the IRB has to reach out to the PI with questions in order to make sense of the proposed procedures.
Day to day, the majority of inconsistencies I see fall within the methodology or the data confidentiality sections of the application. For instance, an application might say the study consists of a single survey, while the consent references a follow up interview procedure; or, an application might state that data are anonymous even though identifiers are being collected to link survey data over time.
Researchers can shorten the amount of time it takes the IRB to review their study by checking their consent document against their IRB application prior to submitting and ensuring that their procedures are consistent and clear. If you have any questions about how to complete a section of the application, call the IRB; it will be much quicker to have that phone conversation up front than to have to respond to contingencies or requests for clarification later, when your study has already sat in line for the initial review and will now have to sit in line again so your clarification can be reviewed.
Let the Regulations Work for You
In some respects, the regulations guiding human subjects research are stringent, but they also offer a lot of room for flexibility. Depending on your institution’s policies, you may be able to take advantage of some of this flexibility when submitting to the IRB and when conducting your research.
For instance, if your IRB has determined that your study is exempt from the regulations, you may not need to submit amendments to the IRB for changes you make to the protocol after approval, as long as the changes do not increase risk to the participants. (Had I known this when I was a researcher, I may have even been able to graduate on time!)
Even with higher-risk studies, the IRB may be able to grant waivers, such as a waiver of documentation of informed consent, which can make the research process smoother while maintaining protections to the participants.
So, when you're designing your methodology, consider giving the IRB a call. The IRB works with the federal regulations every day, so they can alert you what regulatory wiggle room you might have available to you.
The IRB review process is a necessary part of conducting research, but it doesn’t have to be scary or confusing— it can actually be helpful. I didn’t take advantage of my IRB as a resource when I was a researcher, but I hope others can learn from my experience and reach out to their IRBs to see what they have to offer.
Sarah Luery is an IRB Administrator at the University of Southern California.