IRB Support – Ethical, Thorough, and Approval-Ready

Hi! In other instructional videos, we talked about development of your topic, research, alignment among your foundational elements, methodology construction, and dissertation editing. All of this is great — the foundation is actually the most important part of your study.

However, it’s not the only necessary part of the dissertation process, and in this video, we’ll talk about the IRB process. It’s easy to forget this, since it’s not part of your dissertation manuscript — if it’s overlooked, though, or even if you start planning before you have your IRB process in mind, then you might hit a brick wall here. Because of the challenges of obtaining IRB approval, we often provide help with dissertation or thesis research at this stage — hopefully this video will help to clarify how to navigate the IRB application process.

Actually, you might be watching this video after your chair or another committee member remarked about the IRB-related difficulties that might follow if you pursue this or that plan in terms of sample or protocol. It doesn’t come up in the process until after the proposal — the first three chapters — at the vast majority of universities.

Some major online universities deviate from this pattern, and I should mention that we have a great deal of experience with those schools and how they operate differently! In either case, though, the IRB process appears only after a great deal of planning and development on your part. Thankfully, then, committees are often thinking about this even when you’re not!

It’s a significant step, as it determines whether you’ll be able to conduct your study in the first place. Without it, you won’t be able to even start recruiting for participants. You’ll be stuck in the dissertation, and without the ability to do more than set up assistance from an organizational partner or plan for recruitment.

And the purpose is to ensure that you’re acting within all ethical bounds as you conduct your research as you take on all those other steps, from recruitment and collection to analysis and data protection, even long after your study has been conducted. This is especially important for your university, as you’ll be acting as a representative of the school in carrying out your research.

Let’s say that you’ve worked with the topic that we first discussed in the problem statement module. Here’s the research gap:

And here it is! To catch you up to speed, you’re doing a phenomenological study! If you need a refresher on what a phenomenological study entails, be sure to check out our Qualitative Methods video. We’ll engage with the important IRB elements for this study, in particular, as it’s a fraught one and allows us to think through many of the issues you might encounter in your study.

First, an IRB overview: In some ways, your IRB application is an extension of your methodology chapter. It relies on your having clear procedures for recruitment, collection, and analysis, for one thing, and it also borrows information from the methodology in your dissertation about ethical protections that you’ll afford to participants, helping to safeguard their anonymity and confidentiality.

I should stop a moment and clarify about how the process looks different for primary and secondary research studies. Primary studies are ones where you interact directly with participants, interviewing them, conducting a focus group, observing them, or administering a survey.

Some of you might have decided to use an outside service, such as SurveyMonkey or Qualtrics, to recruit and collect data. In this case, you’re not having direct contact with participants, but since the data are being generated for your study, it’s still primary.

It’s a secondary study when you’re examining a data set that already exists, even as you plan your research. Most often, this is a quantitative study, as numerical data are much more likely to be found “in the wild.” For a review on what quantitative methods entail, be sure to have a look at our Quant Methods video.

Although completing the IRB application for secondary research studies is typically somewhat less involved than those for primary studies, there is still quite a bit of complexity involved in these applications, as you will undoubtedly come to recognize.

If you feel unsure about how to get started on your IRB application for your dissertation and would like help with this big step in your research, give us a call or send a quick email to ask about how we can help. We’ll definitely be here to do that, and can help with IRB applications no matter how tricky they might be!

With our vast experience providing this assistance with thesis and dissertation research, especially from the major online universities, we often help to navigate this rather complicated and lengthy process. And, although our specialty is crafting IRB applications to support qualitative research, we also have vast experience with completing these documents for all types of quantitative thesis and dissertation projects.

As this discussion will soon highlight, having this sort of comfortable familiarity with your methodology will definitely pay off when it comes time to fill out these IRB forms!

And, when you see all of the possible pitfalls associated with filling out these documents, you’ll see how awesome it is that we include unlimited revisions for this work. But, I’m getting ahead of myself!

Okay, back to the IRB application, and what this distinction means for your IRB is that secondary studies are much more straightforward to get to IRB approval — you’re not recruiting or collecting data from participants, and it’s just the access to the data set (if not publicly available) that you’ll need to demonstrate.

For primary research studies, though, issues abound, and trouble lurks around each corner.

I have a table here that will help walk us through it! First up is eliminating conflicts of interest. Unfortunately, there are about as many potential conflicts as there are interests! Thankfully, they cluster in certain areas, particularly for doctoral candidates, and targeted dissertation help allows you to get through them. Without incredibly large budgets, candidates are often left sampling from around them. Within education, it might be teachers that you know or work with, or perhaps that you manage. It might be middle managers in your company or in a colleague’s company. It might be nurses in your unit. In all of these cases, your relationship with the (potential) participants isn’t simply a researcher-participant one.

Often, this is permissible, but problems arise when you manage or are in some way in charge of potential participants, and often no IRB protections can help to overcome this conflict for your dissertation. In most other situations, though, and even in the last one, there are options that can help.

For this study again, we’re working with a group of nurses and other mental health care workers. Let’s say that, for this study, you work at the facility as an intern as you complete your doctoral degree. That’s common! In this case, your relationship goes outside the bounds of just researcher-participant. Right, you work with them. However, you’re by no means a superior. As a result, they aren’t likely to feel as though there is any cost in participating. There is the chance that confidentiality won’t be observed, and that you’ll report the content from their interview to colleagues or to a superior.

Problems, then, might be your dual relationship or potential disclosure of information. For this reason, it’s important to provide potential participants with protections. Often, these are done in the informed consent form, where the participant is apprised of the benefits, if any, and the ways that you’ll ensure that ethical boundaries are enforced. In the informed consent form, it will be necessary to make clear that participants can opt out of the study at any time, should they feel uncomfortable or for any other reason. In addition, they should be notified that all information they will provide may be viewed by you and perhaps by your chairperson, from here identifying all the ways that their information will be protected from intentional or accidental revelation…

…Specifically, through an opt-out clause, confidentiality guarantee, or both.

If you’re struggling with a conflict of interest of this kind, please let us know! We’re so happy to provide the help needed to help you move forward and without having to reconceptualize your dissertation research.

Now if you were to be a superior, further protections would be needed, as the other relationship turns those participants into a vulnerable population — they might feel pressure to participate, that there will be costs if they don’t, and also that there might be costs if they do participate and say the wrong thing.

More traditionally, though, people such as minors, the elderly/infirm, and people with some form of physical or mental disability or disorder are considered vulnerable, irrespective of any additional relationships with the researcher. This is because they “depend on” others in some sense, and without due care, can be or feel taken advantage of or under duress. In our consulting for the dissertation, we often see clients who may initially want to sample from a population of elementary, middle, or high school students, and this can often be difficult for this reason.

Within psychology and nursing, working with patients in some way can also be difficult because of the vulnerability inherent in being a patient — whether suffering from mental illness of contending with a physical ailment. In these cases, getting “distance” from the participants can often be helpful, and one way to do this is to interview clinicians who work with those patients or use anonymous secondary data, if available. The right participants for a dissertation help to make approval a great deal easier.

To apply this to our study, no traditionally vulnerable populations are being sampled from, at least not by design. Instead, it might be that pregnant women are included in the sample. And again, the ability to opt out and protection from disclosure of any information provided as part of the study or the publication of your dissertation would be helpful protections offered here.

So again here, problems might be the pressure to participate and the costs of with participation and non-participation, and solutions might be that opt out clause and a confidentiality guarantee.

Next is risk. According to the landmark Belmont Report (1979), by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (that’s a mouthful!), all participants are, by definition, exposed to at least minimal risk. It’s moving beyond this that we should worry about — it’s those kinds of “expected risks” that apply in a given situation and with given participants. Estimating the risks to participants can be tricky, and a consultant can shed light on the many possible issues for your dissertation. Such risk might involve psychological stress that exceeds everyday stress that people encounter. It might extend to unintended disclosure of confidential information, like educational or medical records, and it might be the perceived pressure to participate in itself — such as when the participant is a subordinate of the researcher.

So again here, risks abound here: financial, occupational, and psychological.

Again, that’s not the case here with our study, but we are asking nurses and other mental health care workers to engage with recalled stress — this might involve psychological stress that exceeds what they might encounter in their day-to-day lives. Actually, they might recall trauma in participating, particularly in the interviews normally part of qualitative research, and it will be critical to protect them from that.

Again, just like with our other protections, the ability to stop participating at any time, even in the middle of the interview, will be really important, as well the guarantee of confidentiality. However, because the study exposes participants to significant risk by design, more protection might be required.

So in addition to the very standard opt out clause and confidentiality guarantee, there is something called an interview break. Specifically, the researcher should be attuned to gestures or other non-verbal cues that signal distress and, when seeing them, offer to the participant to stop or take a break.

In addition, the researcher should not provide counseling services him or herself, and particularly not during the interview, but the researcher can provide the participant with one or more counseling resources to take advantage of.

Finally, the researcher can offer to debrief with the participant after the interview, allowing them to ask questions and so the researcher can share more information about the purpose of the study and other issues that might be germane to participation.

Once people do agree to participate, one it’s necessary to make sure that their information will be anonymous — both when reported in the dissertation manuscript and when the researcher engages with third parties, such as a statistician or consultant, about that research. The same applies for confidentiality — information other than what is needed should not be reported, and all information, regardless of relevance, will be protected from being revealed, on purpose or on accident, and in all its forms, both physical and digital.

Let’s apply these to our study. Again, we’ll be interviewing mental health workers, and we’re interviewing them about their experiences of victimization and their decisions regarding reporting. The interviews will be recorded by a program on a personal computer, transcribed via an online service, and then analyzed using NVivo.

So that means third party assistance and computer vulnerability are potential problems here.

For this study, then, protections will need to be in place first on the computer — it should be password-protected, and the researcher should be the only person with access to that password. The informed consent should note that a third party will be utilized to transcribe, and all records should be de-identified prior to that transcription. I think you can see now that the informed consent is an important document for your dissertation! Before you submit it with your IRB application, consulting with a professional about its contents and language can be really helpful.

I hope this has been helpful! It does help with the work of considering more fully some of the issues and concerns that are part of the IRB application process, particularly those ethical issues that often arise in the course of planning for even a normal study!

Again, we did refer to at least one form — the informed consent form — that should be submitted in addition to the IRB application here. Since the methodology and IRB application should, together, provide enough information that anyone else can complete your study for you, it’s necessary to also include the following:

Completing the many different documents necessary to secure IRB approval with your university can be an extremely challenging process, and it is easy to overlook required forms or specific content required to obtain approval.

Of course, submitting an incomplete or improperly completed IRB application packet can result in significant delays in your study, as this requires that you revise and resubmit various documents in your application often repeatedly before being allowed to move forward to data collection.

To prevent this headache during an already long dissertation process, many of our clients reach out before their IRB application phase to receive help with this process from the start.

We can assist with completing the IRB packets for thesis and doctoral candidates from any university, although we have particularly extensive experience with the major online universities’ application packets.

Again, we can help with your IRB application itself, your informed consent forms, your CITI or NIH certificates, recruitment materials, and permissions from all the sites that you might be partnering with in your research. We can even help with editing for APA style — a requirement that doesn’t go away here!

And remember, as I was saying earlier, our assistance will involve unlimited revisions with no extra charge as needed to make sure that you receive approval at any stage of your dissertation. Even the pickiest of IRBs — and we’ve had experience with the pickiest of them — you can be assured of getting past this hurdle successfully!

Then you’ll be on to your data collection and the rest of your study! Thanks for watching!