Vulnerable Subjects and Coercion

When vulnerable individuals (see my last post for examples) are included in a research study, the IRB will require some protections to be put in place for them. If the subjects are unable to make fully informed decisions about participating in the study, the IRB may require informed consent from a well-educated and properly motivated surrogate decision maker. Some examples may be parents of children or a family member of a dementia patient. If the possibility of coercion is at all a possibility for the vulnerable subject, an independent subject advocate may be required for the consent process. An example of this might be a homeless individual with questionable mental health status may have a social worker available to advocate for him or her. If there is specific important information that must be understood, provisions may be needed to test the subject's understanding. An example of this might be in a drug trial of a new medication, the subjects may be required to show an understanding of possible long-term side effects. 

What do I mean by coercion? This means that a person to some degree is forced or at least pushed to do something that they may not really wish to do. Another term for this concept is "undue influence." When people are coerced into participating in a research study, they lose their autonomy or their ability to make their own decisions. The IRB will examine whether there is any possible coercion in how you describe your study. Some things to keep in mind about this concept, people in any authority position (e.g., a boss, supervisor, physician, teacher) may coerce participation simply by directly asking the person to be in the study. In-person solicitation of participation is generally perceived as more coercive than a written ad or flyer (it is harder to say no in person). 

Next time I will continue this discussion by examining informed consent, privacy and confidentiality. Do you have an issue or a question that you would like me to discuss in a future post? Would you like to be a guest writer? Send me your ideas! leann.stadtlander@waldenu.edu