Just before entering the Arena to participate in Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist moderated by Christine Grady, RN, PhD, and panelists Michelle H. Biros, MD; Neal Dickert Jr., MD, PhD; and Robert Silbergleit, MD, I recalled the three questions that I formulated upon registering for the AER16 conference:
- How will I apply this subject matter to my work in social, behavioral, and educational research (SBER)?
- How will I apply this subject matter particularly in a Latin American context where the same barriers exist but the regulation is little to none?
- How will the theoretical and conceptual elements presented help me transform my knowledge and better articulate my position with my peers and others in my institution?
As the panelists presented their arguments I reflected on, and considered the barriers to, informed consent within Columbia's indigenous populations.
When the panelists repeatedly made mention of the need to respect the autonomy of the subjects participating in studies and broke down the concept of informed consent (using the FDA informed consent guidance sheet from July 2014) highlighting keywords such as adequate information, comprehension, adequate opportunity, and voluntary agreement, I started my “journey” of identifying three major barriers to obtaining informed consent from indigenous populations in my Latin American context.
First: informed consent for research with indigenous groups is given only by the great leader of such populations, on behalf of the whole community. Second: there is not, in my country, adequate regulation in SBER that allows respect for the autonomy of other members of indigenous communities. And third: in the pursuit of results, some researchers forget about the autonomy of the members of indigenous communities, arguing that the only the leader needs to understand what is going to be done, and what the risks and benefits of the research are.
These barriers that identified during my participation in the panel also fueled me to recall how, during evaluation sessions of my research ethics committee (REC), members frequently question the abuse that, on many occasions, has occurred with members of the indigenous communities of our region—they are a continuous object of study, and because of lack of adequate regulation, continue to be affected and have their rights violated, especially their right to autonomy. I sincerely hope what I have learned at AER16 gives me the chance to change this.
It is precisely these questions, along with the lessons learned during my participation in the AER16 Conference, which motivate me to continue not only evaluating research protocols, but also to strengthen the training in research ethics provided to researchers at my institution and members of the Network of Human Research Ethics Committees in Cali (the project I presented in poster No. 6 in the category Education and Training
"If we can identify the barriers in time and work together to avoid them, the subjects participating in our research will benefit the most."
Arturo Herreño Marin, MA, is a university professor in Cali, Colombia. He has a master's degree in education with a focus on human development; is an educational research specialist in the context of university teaching; and has a degree in philosophy and religious science. He has worked with the IRB of Universidad de San Buenaventura Cali for the past five years, primarily on social, behavioral, and educational research activities.