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Good morning, good afternoon, and good evening, Compliance Rockstars, Clinical Research Professionals, Ethics Enthusiasts, and Investigators from around the globe! 230+ subscribers and counting!
I hope everyone has been doing well! It feels good to be writing to you all again. I absolutely love knowledge sharing and learning from others. As Iโve also mentioned in a previous post, writing has always been beneficial towards my mental health. Whatโs even better is knowing that blog posts can help folks in the research and compliance space to think differently. Or perhaps, enhance their current thinking on a particular subject.
In essence, I love to help people and explain complex topics in an easy format.
I would like to share top strategies to sharpen how to review your institution’s protocols. As a general reminder, these are my own interpretations. Any legal information discussed within this post should be discussed with your institution.
Sharpen your pencils folks and let’s begin:
Research the research
Have you ever been confused by an investigator’s proposed research protocol?
Perhaps the investigator is using jargon only well known in their field. The same can go for undefined acronyms. Just because the investigator knows their proposed research so well, doesn’t mean the reviewer has that same level of knowledge. The easy route would be to send back as one of your revisions the following:
“Avoid using technical jargon and define acronyms. This should be written in a way that anyone can understand.”
Of course, this can be one of your revisions…but what I’m proposing here is to dig deeper. See what you can learn about the proposed research yourself.
With everyone extremely busy, it can feel like you’re trying to just pump out reviews as fast as you can. Let me provide an example:
Maybe your first go-to resource is seeing how other IRBs have reviewed similar research proposals.
Sure, you can do this. This is a great way to see how other reviewers at other institutions review similar projects. Consider the following hypothetical example:
- The researcher would like to see how well their device can measure the average calories participants burn in a day.
- Their device is a wearable (i.e., a wristband).
- They want to compare this device with a device currently on the market (e.g., Fitbit).
- Their device is also linked to an app they created that will be downloaded to a participant’s phone.
- From the app, the researcher would like to obtain physiological and geospatial data.
At first glance, you may think…wow there are a lot of moving parts here. You may automatically wonder if FDA regulations apply in addition to the Common Rule. Or maybe, your head is spinning because you have no clue where to start. I urge you to think about the study design itself:
- You know the study team plans to compare their device to a Fitbit.
- You may already know that Fitbit has an app that is downloaded to a user’s phone.
By researching the research, I propose to take the following action…
- Read through the Fitbit instruction manual,
- Review the instructions provided:
- How to install the Fitbit app on your phone,
- How to care for the Fitbit,
- How to troubleshoot for an error, etc.
- Any potential risks listed by using the Fitbit,
- Any permissions required to ensure the Fitbit app accurately tracks your data
By understanding the mechanism behind the proposed research, you will start to notice your questions coming together:
- Did the study team provide instructions on how to use the device?
- Did the study team consider all potential risks and how to mitigate these risks?
- Did the study team indicate the specific data measures that’ll be collected from the device’s app?
- Did the study team list what permissions are required from the participant’s phone to successfully use the app?
- Did the study team consider if their app must be integrated with other apps on the participant’s phone (e.g., the Health app)?
By researching the research, you will find yourself asking the more critical questions. You should always consider what others are doing and regulations but try to put yourself in the researcher’s shoes. Help the researcher make their proposal that much more thought-out! By working together, we can help the researcher improve their protocol design. As a reviewer, you will start to think about the more in-depth questions to ensure adequate participant protections.
The split-screen hack
As a reviewer, we know we can have countless documents to review. This can be a daunting task in itself.
On top of that, it can take a lot of time to ensure consistencies within various sections of the protocol.
I would argue that the protocol is the most important document in a researcher’s proposal. The protocol how many important sections ranging from objectives to data collection methods, and so forth. I propose to use the “split-screen” function in Microsoft Word when reviewing the protocol document.
What is the “split” function in Microsoft Word?
By enabling this function, it essentially “splits” the document in half horizontally:
- You will notice two scroll bars on the upper and lower half of the screen.
- On the upper half of the screen, you can look at a certain section of the document.
- On the lower part of the screen, you can look at a completely different section within the same document!
Why would this be helpful, you may ask?
This is particularly useful with long protocol documents. Let’s take the example of reviewing a study’s objective against the data collection methods. In a perfect world, these two sections within the protocol would be consistent with one another. Sometimes, they aren’t. Also, depending on the protocol, the objectives could be the first section of the protocol. Then, the data collection methods could be somewhere in the middle of the protocol.
In lieu of scrolling back and forth in hopes you catch the inconsistencies; this ensures you absolutely catch any inconsistencies!
This hack is a time saver.
You can access this function in Microsoft Word using the steps below:
- Under the “Review” ribbon, within the “Window” section select “Split”.
- When you no longer need to use this, simply select “Remove Split” following the same steps listed in Step 1.
Streamline documenting common errors you see on protocols
What type of research does your institution typically review? Perhaps SBER?
Let’s roll with this example. Say within SBER, you notice many of the submission you review conduct surveys and interviews. Maybe these submissions include observations or focus groups as data collection methods. Now, I want you to take a moment and reflect. Are there common errors you see within protocols that you always need the researcher to address?
If you said “Yes”, then I recommend streamlining common errors you see into a template.
By this, I mean creating a document with standard reviewer comments. The document should contain standard verbiage that can be easily copied, pasted, and fine-tuned depending on the study you’re reviewing. It’s difficult to have standardized verbiage for proposed research, so I recommend starting with what you see the most. You can slowly build your list of common errors as you see different types of proposed research.
This efficiency tip isn’t just for you. This is something that should be shared!
I encourage you all to share these standard errors you commonly see within protocols with your team members. Help the team be efficient in the review process. You can even make it a living document where team members can comment on what they see in their reviews. It’s always important to have multiple sets of eyes for something like this. Someone else can think of something you didn’t even consider. It’s important to not only develop yourself, but also help your team thrive! Dive into success together.
Promote transparency in your communication with investigators
Has anyone ever told you to do something, and you ask why this action is necessary?
I know I have! I personally love to understand how things work. So, if someone says, “Hey, go do this”, I need to know why I have to. I need to understand why this particular step is important in the process. The same goes for researchers. They are inquisitive in nature. Therefore, if you’re asking a researcher to make a specific change in their protocol, tell them why this change matters.
Say you’re reviewing a consent form within the researcher’s application, and you notice there isn’t a statement about participant risk.
The researcher comes back and says, “Well, there isn’t any major risk to my study. I don’t see a point in saying this.”
This is where the “why” to your “ask” comes into play. Sure, you state that addressing risk is a regulatory requirement (i.e., basic element of consent). You should also state that the participant should be aware if risks are present. The participant should have all the details necessary for them to make an informed decision to participate. If there are no foreseeable risks or discomforts, then the participant should be aware of this. This can impact the participant’s decision-making process. By explaining these concepts to the researcher, they will be more inclined to incorporate this statement into the consent form. They will also be mindful of this in future submissions.
Reflect on oddball situations
Have you ever had a submission that was outside of the norm? Did the review process require additional steps that typically wouldn’t be required?
Now – I want you to imagine you came across another submission of this nature. Do you remember everything you did when you came across this oddball review the first time? Did you do your due diligence and document the process? Maybe you intended to but were caught up in another task and oops…you forgot. Here, I’d like to promote the IRB Precedent Tool. This is a structured way of documenting these oddball situations.
You can incorporate key details of:
- The situation itself,
- Steps you took during the review process,
- Any regulatory information that assisted you in making a determination, etc.
Unsure what I’m talking about? You can read more about this brilliant approach here: Steps toward a System of IRB Precedent: Piloting Approaches to Summarizing IRB Decisions for Future Use
Stay current with regulations and developments in the field
This…I must admit is a tough tip to implement.
With all the regulatory updates and publications coming out like clockwork, this can feel overwhelming. You can attempt this via:
- Signing up for various agency newsletters (e.g., FDA if you have mainly biomedical research). Another great one is the Office of Human Research Protections (OHRP).
- Rely on newsletters from various organizations such as PRIM&R for these types of updates.
- Check the Federal Register daily for any new rules or notices.
- Check agency websites daily for any regulatory updates.
- Review journals on a daily basis for developments in the field (e.g., Ethics and Human Research).
You can split the proposed tips above if you have multiple team members. One person (or multiple) can focus on regulatory updates while others focus on recent publications.
But what about those with small HRPP offices where there could be only 1-2 people?
Time for a little self-promotion. An excellent starting point would be to follow along this blog’s monthly posts (even if you aren’t in a small HRPP):
- Research Compliance Chronicle (see the first edition here): a comprehensive review of regulatory updates from the previous month including:
- Agency-specific news, policy updates, and new rules
- Presidential actions (i.e., executive orders)
- Proposed bills that can potentially impact research and compliance
- RAC Digest (see the first edition here): a comprehensive review of recent developments in the research administration and compliance fields from the previous month including updates from journals such as:
- Accountability in Research,
- AJOB Empirical Bioethics,
- JAMA, and many more!
Leverage experiences from senior personnel
Knowledge sharing is a hallmark in an optimal institution’s review committee.
You might remember what it was like when you first started your career as a research reviewer. Remember being overwhelmed – thinking – how could I possibly learn all this? Well, this is where knowledge sharing comes into play. Senior personnel are the hidden gems within a review committee. Why? They’ve likely seen many types of proposed research throughout their career. Not only common types of research projects, but also oddball scenarios. Leverage their expertise and learn from them. Explain your thought process on a particular scenario. Senior personnel will likely provide insights that you didn’t initially think about.
Consult with subject-matter experts
Having a diverse network of subject-matter experts to consult can aid the review process.
Engage with subject-matter experts when the particular topic within the proposed research is out of your purview. Similar to the tip above, these folks can provide the specific knowledge needed to ensure a comprehensive review. An example of this could include security concerns about an app the research proposes to use in their project. Building this diverse network of these folks can give you a shoulder to lean on to ensure adequate participant protection.
I hope you found this post useful!