Understanding the IRB: An Interview with Assistant Dean of Research Protection, Dr. Laura Brewer
Understanding the IRB: An Interview with Assistant Dean of Research Protection, Dr. Laura Brewer
“Whatever is my right as a man is also the right of another; and it becomes my duty to guarantee as well as to possess.”
― Thomas Paine,
The Institutional Review Board (IRB) serves the community of scholars through ensuring ethical standards and practice of human subject research for students, faculty, and alumni. From the Tuskegee syphilis experiments in the 1930's to more recent controversy regarding enhanced interrogation techniques conducted by psychologists who were members of the American Psychological Association (APA), history reminds us of the need to have rigorous standards for protecting human subjects. As a researcher and IRB committee member, I value the service of the IRB. As a doctoral faculty, I understand student uncertainty in approaching the IRB, particularly in an asynchronous environment where meeting the individuals running the IRB is not that easy. In the spirit of enhancing our growing community of health and nursing scholars through bringing members together, I invited Assistant Dean of Research Protection, Dr. Laura Brewer, to introduce herself to our community, and share her perspective on the IRB at UOPX. Enjoy the interview!
Dr. Ladd: Tell us a little about yourself. Background, research interests, teaching, etc.
Dr. Brewer: I’m a sociologist first and foremost. After graduating from UC Santa Barbara with a double major in psychology and sociology, I moved to Washington DC for a few years and worked administering public assistance. In this position, I learned that I really cared about issues related to inequality and that educational differences appeared to be closely correlated to other types of inequity. I ended up moving west to Arizona and pursued a Ph.D. in sociology where I conducted a grounded theory dissertation on the development of online learning in higher education.
Following the completion of my Ph.D. in 2001, I have consistently conducted applied educational research and have worked for a large public university, a higher education technology consulting firm, for a small education evaluation company, and then the University of Phoenix. Throughout my career, I have most enjoyed teaching social science research methods and theory. My most recent research was a collaboration with University librarians to study the design and online student use of co-curricular resources, which we presented at the Sloan OLC Accelerate conference last year and later published in the Online Learning Journal.
On the personal side, I am married with three children aged 9, 11 and 13 and I am happy living in Phoenix where I’m still close to my California family and friends (and the ocean) and where I can encourage my family in colder climates to come visit in the winter. I love to cook, do yoga, and run regularly at 5:30 am with some wonderful friends. In 2018, I am trying to start meditating regularly.
Dr. Ladd: What draws you to your work with the IRB?
Dr. Brewer: I’ll be completely honest, I never thought I’d work with the IRB, let alone become the Assistant Dean of Research Protection. I started at the University as a full-time research faculty member and was I really enjoyed working across disciplines teaching doctoral research methods. I knew that researchers typically dread the IRB process, and at times, I had experienced obstacles trying to get my own research through an IRB review. When I took the job, I was excited about the challenge of making the IRB process at the University of Phoenix easier to navigate. I’ve truly enjoyed learning about the federal regulations and institutional policies and working to improve how researchers experience the IRB process at the University of Phoenix. During my tenure with the IRB, I’ve developed over 25 different guidance documents to support researchers through the IRB process and we have an awesome team in the IRB Office that I appreciate working with every day. In short, I’ve learned that I thrive in the “grey areas” of human research ethics and the fact that there is typically not one right way of approaching human research protections.
Dr. Ladd: How would you describe is the purpose of an IRB?
Dr. Brewer: An Institutional Review Board (IRB) is an administrative committee of members with diverse backgrounds and areas and levels of scientific experience. The diversity of perspectives is a critical component of the IRB committee. The University of Phoenix IRB is responsible for ethical oversight and the protection of human subjects who are recruited to participate in research conducted by, or supported by, the University of Phoenix. The University’s IRB is registered with the federal department of Health and Human Services (HSS) and has a Federalwide Assurance (FWA). More information about the University’s IRB can be found on the Research Hub here: https://research.phoenix.edu/content/institutional-review-board.
Dr. Ladd: What are common myths or misconceptions about the IRB process?
I’m sure there are a number of myths or misconceptions that I may not even hear about – ha! My interaction with University of Phoenix faculty researchers suggests that some may believe that the IRB review is an academic review for students, which is incorrect. In fact, the University of Phoenix IRB is responsible for reviewing any research conducted by faculty, staff or students affiliated with our organization. Student researchers sometimes confuse the IRB review with their academic research method and design reviews like QRM and QRF; however, the focus of the IRB review is to assess the risk to the human subjects who will be recruited and who will participate in research. Sometimes a proposed research design creates risk or does not mitigate risk to human subjects and the IRB will provide recommendations to modify a study design; but, our focus is exclusively on the ethical components involving the human subjects. Finally, another misconception is that the IRB is an obstacle to conducting research. Although the research review process can take longer than a researcher would like, and longer than the IRB Office would like, the IRB review process is designed to ensure that the research conducted by University of Phoenix researchers is ethically sound and the IRB rarely disapproves a study. Instead, the IRB committee and reviewers take time to provide researchers important feedback so that researchers can mitigate risks to the human subjects in their research.
Dr. Ladd: What are the differences between scholarship and research? Is there research that doesn’t need to be sent to IRB?
Dr. Brewer: I’d venture to say that while all research is likely scholarship, not all scholarship is research. Although the University of Phoenix, typically refers to Boyer’s Model of Scholarship, which typically places empirical research under a category of “discovery”; the IRB uses the federal definition of research. Under 45 CFR 46, research is…a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Typically, empirical studies involving the systematic collection and analysis of data, with a goal to share findings with a larger audience, would be considered “research” by the federal definition. Of course, the research must involve human subjects to be under the purview of the IRB.
The IRB Office understands that it can be tricky sometimes to determine if an activity is “research” and requires an IRB review. We do provide support for our GUIDANCE – What Projects Require an IRB Review? OR What is Human Subjects Research?, which is located in the IRBNet Forms and Templates library from the left menu when you log in to IRBNet (http://irbnet.org). It’s always a best practice to have the IRB review your work if you are uncertain whether your study should have an IRB review. Our IRB Coordinators will review the material submitted and determine if the activity does not meet the federal definition of “human subjects research” and in these cases, a “Not Human Subjects Research” decision is made, and a board letter is provided to the researcher to verify the study was reviewed.
Dr. Ladd: What were the historical events leading to the installment of the federal regulation of research with human subjects?
Dr. Brewer: There are whole courses and programs that examine the extensive history of the development of federal regulations for human subjects research. In fact, the University of Phoenix requires their researchers take training on some of this history with the CITI program course (http://citiprogram.org) before submitting a project for IRB review. The short story is that researchers are humans and humans sometimes have challenges with ethical decisions. The history of these challenges include the Nazi Nuremberg experiments, the Tuskegee Syphilis Study, Zimbardo’s Prison Experiment and Milgram’s Study of Obedience, to name just a few of the most well-known cases in the 20th century. In retrospect, the risk to the human subjects in every one of these studies seems very obvious, but at the time the researchers designed and conducted the research, they believed that the benefits from study findings out-weighed the risks to the human subjects. In 1979, the US government commissioned a committee of experts to examine these serious ethical issues in medical and social research and this committee produced the Belmont Report (see https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html). The three principles from the Belmont Report provided the foundation of our federal regulations for human subjects research: 1) Respect for persons; 2) Beneficence, and 3) Justice.
Dr. Ladd: How does an IRB committee work?
Dr. Brewer: Organization changes at the University during the fall of 2017 resulted in a loss of IRB committee members and staff and these changes have forced us to rethink how our IRB committee works. We have recently recruited 12 new IRB committee members and have been training these excellent researchers on the federal regulations and the institutional policies for reviewing studies. All our reviews are conducted in IRBNet (for more, see https://research.phoenix.edu/content/institutional-review-board/using-irbnet). Our committee members review our minimal risk studies individually or in pairs outside of our actual meeting times. And decisions on these minimal risk (exempt or expedited studies) are released as review are completed.
Studies that are deemed greater than minimal risk are assigned to the full committee. The full committee meets twice a month, typically on the 1st and 3rd Monday, as long as we have full committee reviews. The IRB committee members are assigned the full committee reviews at least 5 days before a scheduled meeting. We must have a quorum of greater than half of the IRB committee members in attendance. Each member comes to the meeting having already completed their review in IRBNet and then we discuss the project and the potential risks to the human subjects. We use the three principles from the Belmont Report, the federal regulations and the institutional policies to guide our discussion. We also discuss ways that risks to the human subjects might be mitigated. Ultimately, there will be a motion for a decision and each member will vote in favor of the motion, or against. Occasionally, a Board member must abstain from a vote. If the risks to human subjects are sufficiently addressed, the Board will approve the study, but if the project requires modification or the Board needs additional information, the decision will be a deferral and the researcher is required to resubmit a revised project plan to the IRB that addresses the risks to the human subjects. Only the full committee can disapprove a study and typically this will only happen if the Board determines that the researcher will be unable to modify the study design to protect the human subjects.
Dr. Ladd: How have you seen attitudes about IRB change? What might be reasons for those changes?
Dr. Brewer: Yes, attitudes within the IRB community change and attitudes about the IRB review processes change. Some changes result from changes to how we conduct research with human subjects. New technologies and increased availability of social data have created innovate research opportunities and these opportunities have also created new risks to human subjects. Recently the federal regulations underwent an extensive process that has resulted in a change federal human subjects research policy for the first time in decades. The new regulations will go into effect in 2018. Researchers should look forward to hearing more about these changes from the University IRB Office.
I definitely think University of Phoenix researchers are becoming more aware of ethical issues involved with conducting research with human subjects or human subjects data. Although we are currently in a transition within our IRB Office and the new federal regulations will result in additional changes, I look forward to a community of researchers ready for changes and I hope that University researchers understand that the IRB exists to support their research goals.
Thank you, Dr. Brewer, for sharing your insights and experience. I encourage readers to use the comments to ask questions of Dean Brewer.