29
Jun2018

Being a Certified IRB Professional at a university that does not have its own IRB and whose research is focused on engineering has given me the unique opportunity to understand how engineering products are studied on humans or animals. Most of the funded research at my university comes from engineering and most of the unfunded research comes from liberal arts. All human subjects research proposals are reviewed by the main campus at Texas A&M University in College Station. I assist researchers and liaise with IRBs locally for the review of their research proposals in accordance with local IRB regulations.

I am an external member of a local institutional IRB and also serve as a primary reviewer on that committee. The committee I belong to is diverse in terms of regulatory requirements; we have scientists, lawyers, and religious scholars, and diverse nationalities, religious affiliations, genders, and cultural backgrounds. This IRB embraces diversity and lends its ears to all members.

Duke Morrow, MDiv, DMin, one of the speakers of the recent PRIM&R webinar Exploring and Enhancing Diversity for IACUCs and IRBs, presented registrants with a helpful metaphor for conducting a comprehensive IRB/IACUC review of a proposal—bread making. Bread making is a step-by-step process that takes time, care, love, and some elbow grease. This wonderful analogy helped us understand the influence of diverse viewpoints as the “ingredients” for a complete review of research proposals. So, let us review IRB/IACUCs through the lens of making bread.

Step 1: The few ingredients required for bread making need to be carefully chosen in order to get the best bread. A modern IACUC/IRB requires careful recruitment and selection of members of diverse age, gender, education, ethnicity, languages, culture, race, religion, etc.

Step 2: Mixing proper amounts of bread flour and water (at the correct temperature) with salt and yeast creates the perfect gluten network for impeccable dough. Recognizing the importance of each member can help mitigate unconscious biases and stereotype threats that affect their ability to participate with 100% effectiveness. Committee members need to talk and listen to one another.

A few years back, I served as an IRB coordinator in an institutional IRB. I was a scientific member on this committee. Members of that committee like myself did not feel comfortable speaking up during meetings for fear of being overruled by those with “loud voices.” Support of diversity was not practiced. As the webinar speaker Donna Matthews Jarrell noted, IRBs and IACUCs need to “walk the talk,” and serve as societal role models of justice and autonomy by allowing diverse opinions.

Step 3: Yeast helps dough to rise beautifully. Diverse opinions from IRB/IACUC members help these boards rise up to their goals of protecting human subjects and animals in research.

Step 4: After fermentation, the dough is pre-shaped into a loose mold of the final shape the dough might take. Diversity discussions in IRBs shape the final IRB outcome by navigating member fears of unknown viewpoints and people, fear of changes to the status quo, and unconscious biases.

Step 5: Resting the dough is an important step of breadmaking. The gluten is allowed to relax and become elastic. Similarly, diverse committees conduct high quality, flexible reviews that enhance the quality of the final research.

Step 6: To turn bread dough into a baguette, bun, or traditional bread shape, the baker uses different tools like soft linen, wooden boards, or baskets, which keeps the dough in shape. Institutional policies and regulations on diversity help keep IRBs in character, determining the outcomes of the research itself.

Step 7: This step is a combination of resting and more fermentation, which is a time decided by the baker’s baking experience.

Step 8: Scoring the dough is important; this step ensures that carbon dioxide is released when the bread is baked. Allowing all voices to speak at IRB and IACUC meetings brings diverse opinions from marginalized populations to the table.

Step 9: The baking of bread at the correct temperature is an important step toward baking the perfect bread. Guidance and tone—like temperature—are provided by dedicated and passionate committee chairs and institutional officials.

Step 10: Baked bread needs time to cool down, so that any excess water vapor and carbon dioxide are dissipated. Taking the time to review research proposals and allowing members to speak up and express views will help board members, the institution, the research, the community, and the world at large. Here again, the role of IRB and IACUC chairs cannot be overemphasized in helping quiet members open up, and in creating an atmosphere of trust and acceptance.

Just like bread baking is hugely satisfying for the baker, there is a sense of fulfilment and achievement from working on an IRB/IACUC that embraces diversity. My work in a multicultural, multiethnic branch campus of a major US university in the Middle East has allowed me to interact with people from diverse backgrounds. Our IRBs/IACUCs often reflect the society in which we live in terms of membership, but, just like in society outside, sometimes speaking up for the truth or the right thing is the most difficult thing to do. Ethics committees like IRBs and IACUCs need to work towards putting every member at ease, so they can state their ideas and share their life experiences. Good bread can satisfy a hungry person, and an IRB/IACUC review by a diverse and free-speaking IRB/IACUC can satiate society’s need for good quality research conducted in an ethical manner.

A medical doctor by training and research administrator by accident, research ethics became Anjum John’s forte by design. A few years of working as a specialist in research methodology in a medical research center in the Middle East gave her an opportunity to train students in research ethics. Deep reading about any topic Anjum teaches is a hobby of hers and thus she delved into the history of research ethics. Her interest grew and she started studying research ethics in earnest. In 2012 she took the CIP exam, during one of the first times the exam was conducted outside the US. Since obtaining her CIP credential, Anjum has participated in four AER conferences and one Ethical Issues in Global Health Research Conference. The opportunity to meet like-minded research ethicists is one of the highlights of her year. Writing keeps her grounded in reality, just like conferring with other ethicists does. Anjum is currently pursuing a Master’s Degree in Public Health and plans to take “Regulatory Compliance” as one of her electives.

Members of PRIM&R’s Blog Squad and other guest contributors are valued members of our community willing to share their insights. The views expressed in their posts do not necessarily reflect those of PRIM&R or its employees.

Leave a Reply

Your email address will not be published. Required fields are marked *