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The IRB: Friend or Foe?

For graduate students, the process involving the Institutional Review Board (IRB) is often seen as confusing and frustrating. This week's episode of the 2022 Doctoral Student Support Webinar Series examines the role of the IRB and how to manage this stage of your program in a way that allows you to partner with the IRB (and make a new friend!).

IRB: Friend or foe - picutre of a group of people discussing a topic around a table.

What is an IRB?

IRB stands for Institutional Review Board, and it is a federally required, formal committee of at least 5 people with specific qualifications who oversee and review research. IRB is a common term used, but it’s important to know it may be called something else in a different organization. This is important to know because in the materials you submit to the IRB you will be asked if you need IRB approval from another organization. Other names you might see: are Ethics Review Board / Ethical Review Board, Committee for Protection of Human Subjects, Research Ethics Board, etc.

Watch the full episode here.

Why do we have IRBs?

An IRB’s job is to protect humans who are participating in research. They do this by reviewing the proposed activity and confirming that the rights and welfare of human participants are protected. In short – the IRB’s goal is to protect human participants while supporting researchers who are doing work to better understand and thereby improve the human condition.

You might be thinking: “Of course I wouldn’t do anything to hurt anyone! This seems like an extra step.” Or, you might be thinking: “For my doctoral work, I am doing something that I don’t think needs to be submitted to the IRB for review” (like a systematic literature review), BUT  – spoiler alert – regardless of the type of activity you are proposing, you will need to submit materials to an IRB for their determination. They make the determination, not you. This is worth repeating: As a doctoral candidate, you will submit something to the IRB, and the level of oversight required for your activity will depend on the activity.

One of the reasons researchers complain about the IRB process is because it can bring attention to a natural and complicated issue: Researchers use humans as an ends to a means and often don’t view their research in the same way an IRB member would. 

For example, let’s say a candidate is interested in how people cope after a natural disaster. He wants to interview people who have experienced this type of event and were diagnosed with PTSD. You can imagine that this research, if done well, could lead to many benefits for future disaster victims, but there are clearly risks involved when you ask people to relive a trauma that would require safeguards. The IRB is there to ensure such safeguards are in place. 

Again, you might be thinking: “Of course! Any research I design would have appropriate safeguards in place. I am an ethical and kind person, and my committee is made up of people who know what they are doing…does this REALLY need to be regulated by an outside board?”

Great question! Let’s spend just a moment reflecting on history. 

IRB: Friend or foe - a picture of 5 people sitting at a table together with laptops open.

 

 

 

 

 

 

History of the IRB

The need for regulation stems from historical events, in particular, human experimentation that occurred during World War II. The Nuremberg Code (1947) that followed covered issues like requiring voluntary participation, the need for consent and the right to withdraw, recruitment that was free from coercion, ensuring everyone was aware of and had a full understanding related to costs and benefits of the research, requiring qualified experimenters who were using relevant research designs, etc. And yet, unethical behavior continued.

Here are some examples:

In each of these studies, investigators were confident that the ends of research justified the means…and that is why a 3rd party trained in protecting the rights and welfare of human participants reviews research activity before it commences. 

The Belmont Report was written in response to the infamous Tuskegee Syphilis Study, in which African Americans with syphilis were lied to and denied treatment for more than 40 years. Many people died as a result, infected others with the disease, and passed congenital syphilis onto their children. Following the Tuskegee study, the government got involved, created a commission, and the result was the Belmont Report. This report summarizes the three ethical principles the commission should use to guide human research.

  • Respect for persons– Respect for the autonomy of human subjects and freedom of choice and the importance of protecting vulnerable individuals
  • Beneficence – Maximize the benefit-to-harm ratio
  • Justice – Equitable distribution of the burden and benefits

The Common Rule

The Belmont Report lead to the Common Rule, which is a short name for “The Federal Policy for the Protection of Human Subjects” and was adopted by a number of federal agencies in 1991. The Common Rule is essentially the baseline standard of ethics by which any government-funded research in the US is held; again, nearly all U.S. academic institutions hold their researchers to the Common Rule standards regardless of funding (which means even if your doctoral research is not funded it will be reviewed). 

At this point, it is important to understand that there are federal regulations and then institutional policy, and state and local regulations that may come into play. What this means is that you may design (or be a part of a team that designs) a research study that balances all three pillars and gain IRB approval, but the institution may not allow it. For example, it is quite common that online institutions do not allow certain types of activity as a matter of policy – for example, studies that require participants to ingest something, be injected with something, animal research, and things of that nature.

Let’s pause again for a quick re-cap: The takeaway here is that an IRB is an independent board that reviews research to make sure no one is harming human subjects. In this sense, I invite you to think of the IRB as a partner in your research endeavors – they are there to help you. 

What happens to my IRB application?

An IRB administrator will use a formal process based on the Common Rule (the baseline standard of ethics) to determine what happens with your IRB submission. This is best explained using a flowchart (see webinar at the 11:00 minute mark). The flowchart in the webinar is a very basic and general flowchart, using the federal regulations as the baseline – it’s important to remember that each institution can have additional policies and procedures. Remember this is the baseline – it’s not uncommon that institutions are more conservative.

Essentially a number of questions are asked to determine the next steps.

The first question – Is it research? This seems basic, but this is not always black and white. The definition used by the government is “a systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

So, think about your proposed activity, and ask yourself – is this an activity that involves a prospective plan that incorporates data collection and data analysis to answer a question? (for doctoral research, that is often yes). Then the next consideration is related to generalizable knowledge. Generalizable knowledge is information where the intended use of the research findings can be applied to populations or situations beyond those studied. Ask yourself: Is your activity designed to develop or contribute to generalizable knowledge, draw conclusions, or generalize findings beyond a single unit (organization, program, etc.)? 

If the IRB administrator answers no, then the process ends, and you receive a letter of determination.

The next question: Is it Human Subjects? This is defined as “a living individual about whom an investigator conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens, or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”

The question following that is: Is it exempt? That means the activity is a minimal risk, or as the IRB defines it – “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.” The majority of dissertations/doc projects in an online setting stop here. Exempt simply means exempt from some of the federal regulations. However, these studies are not exempt from state laws, institutional policies, or the requirements for ethical research. 

If the research is not exempt, then you move to expedited. The activity must be minimal risk and fall into 1 of 9 different categories. If the research is not eligible for expedited review, then a full board review occurs.  Examples of activity requiring a full board review are something that is more than minimal risk, targeting vulnerable populations, collecting sensitive information, etc. A full board review can be a lengthy process, so if we remember that a doctoral project or dissertation is a demonstration project, not your life’s work, it makes sense that, in general, doctoral students are encouraged to design activities that do not require full board review. 

This is a lot of information. The good news? You don’t make the decisions; a trained IRB administrator does!

To approve research, the IRB must determine that:

  •  The risks to subjects are minimized
  •  The risks are reasonable in relation to any anticipated benefits to the subject and to the advancement of knowledge
  •  The selection of subjects is equitable
  •  Informed consent will be sought
  •  Informed consent will be documented or appropriately waived
  •  When appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of the subjects
  •  There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
  •  Where any of the subjects are likely to be vulnerable to coercion or undue influence, additional safeguards have been included in the study to protect subjects

IRB common “pain points” 

It is common that doctoral students don’t realize that a study designed to target vulnerable or protected populations often requires additional safeguards. This is where the fresh set of eyes the IRB brings will help you make sure your research does not unintentionally place someone at risk.  

What is a vulnerable population? Any group that may need special considerations/protection given the research topic (pregnant women, children, prisoners, persons with a mental disability, persons who are economically/educationally disadvantaged, racial/ethnic/social minority group, older adults, veterans, people with a chronic condition/mental health challenge, etc.).

What is meant by coercion/undue influence? “the use of persuasion, authority figures, or the offer of an excessive or inappropriate reward or other overture in order to obtain research participation or compliance”. This is another area where a trained IRB perspective can point out areas of concern in a design. For example, asking your students or employees who are subordinate to you to take part in your study. This is problematic because they may not feel like they have the ability to decide whether or not to participate, so that violates one of the fundamental ethical principles: “respect for persons”.  Also, giving rewards for completing the study that may drive the decision to participate is also problematic.

These pain points are not a reason to NOT do a study. However, they are a reason to plan ahead.

Let’s pause and re-cap again: What role does the IRB play in a doctoral program? IRBs provide an independent evaluation of proposed research to ensure it is ethically acceptable, checking the researcher’s potential biases, and evaluating compliance with regulations and laws designed to protect human subjects.

IRB_ Friend or foe - a picture of a doctoral student studying_researching..jpg

 

 

 

 

 

 

Common Pitfalls to Avoid

  • Not understanding institutional policy
  • Not using resources provided (esp. templates)
  • Not planning ahead (esp. if targeting vulnerable populations)
  • Not justifying anticipated risks (above minimal) and/or use of vulnerable populations
  • Promising things you can’t promise, like anonymity/guaranteeing confidentiality, no risk
  • Compensation inappropriate
  • Submitting incomplete/problematic IRB materials – check for items skipped, supplemental documents not included, permissions not secured, application is not aligned

Things to DO

  • Think about the IRB early (esp. if targeting vulnerable populations)
  • Be diligent with your CITI training (take notes!)
  • Read all university resources (Handbooks, etc.)
  • Use templates for informed consent forms, site permission letters, etc.
  • Proofread your submission materials and triple-check that everything is complete and aligned
  • Be clear about the consent process, data protection, inclusion/exclusion criteria, etc.
  • Include all likely recruitment processes (to avoid having to submit a change request)
  • Understand that issues related to the use of human participants in research are complex 
  • See requests for modifications as a good thing 
  • Follow institutional policy re: changes, reporting unexpected events, continuing review, etc. 
  • When in doubt, ask questions! 

Conclusion

The IRB plays an important role in your doctoral program; see them as your partners in research. If you need more guidance in regards to understanding the role of the IRB, check out the FDA’s institutional review board frequently asked questions or reach out to one of your professors.

More resources 

You may also want to check out the follow past webinar episodes for more guidance and insights for your doctoral journey. 

If you want to advance your nursing career, consider Aspen University’s online DNP or ED.D doctoral programs with start dates every two weeks and tuition starting at $375 per month!


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