Participant Protection: Ethical Considerations Beyond the IRB

Now that we have our research questions in hand, our class has come to the part of the study design process where we need to seek Institutional Review Board (IRB) approval. Leah Stoiber, an administrator from UWM’s IRB, joined us for the first half of class last week to help us navigate the application process. While our small groups have already begun drafting materials for our IRB protocol form, Leah offered many helpful hints. She reminded us to keep our language simple and to submit all study materials for review.
 
As we’ve already discovered, human-subject research can be messy. While it’s the IRB’s ultimate goal to protect participants, we saw in this week’s reading and discussion that IRB approval is not always synonymous with ethical research practices. While IRB standards are an important place to begin, it is important to remember they are not the pinnacle of moral excellence (Edwell 166). To perform truly ethical research, researchers often need to exceed the expectations of the IRB.
 
Before our first official class meeting, we all completed mandatory IRB ethics and compliance training, so the Belmont Principles of respect for persons, beneficence, and justice are fresh in our minds. These principles are a great place to start when discussing ethical research practices. 

Image: http://www.northeastern.edu/research/hsrp/irb/belmont-report/

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Respect for Persons: One of the most important ways to show respect for persons is to show respect for personal decisions. This is why informed consent is imperative to any ethical study. As Leah pointed out, consent is more than just a form participants sign at the beginning; consent is a process that takes place throughout the entire study. As researchers, we need to be constantly re-evaluating our participants’ consent through rhetorical listening. One thing to be on the lookout for is what Kristin Marie Bivens calls microwithdrawals of consent. Bivens defines a microwithdrawal of consent as “the implied or partial halt of a person’s willingness to participate in one or more aspects of the research process and the researcher’s awareness of the withdrawal” (138-139). Microwithdrawals can often be subtle, such as a participant’s sudden lack of engagement. As researchers, we must honor our participants’ decisions to renegotiate their consent.
 
Beneficence: As we proceed, we need to design our study in a way that minimizes risk and protects our participants. We must also show our study to be beneficial, whether that be through immediate benefit to the students, potential for future benefit to the college, or simply the benefit of filling gaps of knowledge in our field. As Leah put it, the risks of a study must correlate with the benefits—high-risk studies need to exhibit greater benefits whereas low-risk studies, such as ours, can get by with fewer benefits. As researchers, we have a responsibility for making the risks and benefits clear to our participants. In this week’s reading, Laura Maria Pigozzi warned of the danger of therapeutic misconception, which occurs when a participant overestimates the benefits and misinterprets the degree to which the study will meet their individual needs. To combat this, we will need to be clear about the intent of our study.
 
Justice: When recruiting participants, individuals must receive fair treatment. We should not base recruitment only on factors of convenience; we must take care to allow fair access. We need to be aware of the multiple roles we hold as researchers, teachers, and students and recognize how these roles play into the power dynamic with our participants.  It is also important for us not to impose unnecessary labels on participants and to avoid classifications that are irrelevant to the study. While our reading from Kelly E. Happe discussed this idea in regard to racial identity, I believe we can apply it more broadly to any kind of polarizing categorization. As we move forward in our research, we must ensure the selection and treatment of our participants is equitable. 
 
While the goal of the IRB is to help us, as researchers, think through some of the ethical considerations of our study, our class agreed that it is also important to go beyond the minimum requirements. As Dawn S. Opel states, “IRB approval does not mean that a researcher has always acted ethically” (183). As we proceed, we must continually evaluate our research process to identify relevant ethical issues that might otherwise be overlooked. As one student put it, we must be ready to make ethical decisions “in the moment.”
 
~AKS~