Health Literacy Before Returning Individual Results

Technological advances have altered clinical practice and the way individuals view human research. While these advancements have the potential to be beneficial for the scientific community, individuals and society as a whole, with great benefits, also comes great risks. One risk of returning individual results in research, is psychological trauma to the participant. In this essay, I argue that individual research results should not be returned, until certain conditions are met. Before explaining my position, it is important to distinguish three views, i.e., the opportunity for participants to look at their individual results, participants who will not look at their individual results and clinical sharing of trial data. My focus is the former. After determining whether participants should be able to look at their individual results, the second question is, “do we have an obligation to provide health literacy before returning individual results” (Professor Lynch). My answer is yes. Not only is this a
moral obligation, it should also be a legal obligation. Some people will disagree, but taken into account that the healthcare system is becoming more complex and most patients already are unable to understand medical terminology, I think that the problem of health literacy is exacerbated in human research. One of the risks involved in returning individual results is the participant being unable to fully understand their results and the problem of therapeutic misconception. We have to remember that there is a difference between research and treatment. The aim of research is not to provide personal treatment for participants, rather, research is “a systematic investigation…designed to develop or contribute to generalizable knowledge” (CFR). While some people argue that therapeutic misconception can be mitigated by improving the informed consent process, my counter argument is that consent forms are already an-x-number of pages long and to able to disclose all risks of the study, determine whether a participant would want to know about incidental findings, what that means and whether that same participant would want their individual results returned, is hard. Especially, when the individual does not have the literacy to fully comprehend the research.
In arguing that individual results should not be returned, until certain conditions are met, I argue for researchers and IRB’s to collaborate in creating a system for returning individual results.
As a policy, all institutions and centers within the United States conducting human research should outline a health literacy plan for specific types of research (example: clinical, genomic, social behavioral). A plan for health literacy is not required for exempt research. Additionally, all consent forms will have the same basic information, but each type of research should have a different format, in order for the participant to understand the implications of choosing if they would want to have individual results or incidental findings returned and what that means. Furthermore, if a researcher notices something strange with a participant’s results, the researcher has an obligation to provide that participant with the number of an expert, so their results can be
validated.