Sometimes researchers in developing countries worry that potential participants give consent simply because they are asked by doctors or other authority figures. Are they manipulated into research participation? Fogarty bioethicist Dr. Joseph Millum and NIH Clinical Center fellow Amulya Mandava weight this issue in their paper in the Hastings Center Report.
When designing enrollment processes, researchers should consider a number of factors, the authors suggest. First, they should examine the effects of their use of knowledge about the decision-making processes of potential participants. If the researchers are deceiving people about facts relevant to their decision or causing them to make a decision based on immediate desires instead of considered preferences, the researchers are engaged in manipulation. If the manipulation involves deception about facts relevant to the study, the manipulation would render consent invalid, the authors maintain. If not, further analysis is required.
When nonmanipulative alternatives are genuinely impractical, manipulation can be justified if the study is sufficiently important, according to the authors. For example, if participation provides great benefits to participants - such as access to treatment - or produces valuable research results, it may be considered to meet the criteria.
The paper describes a scenario in which a physician receives advice from his colleague on how to boost slow recruitment of subjects for a clinical trial of hypertensive medication. "Stop having staff ask people if they want to be in the study," the colleague says. "You need to use the 'white coat effect.' Have the nurse show the patients into your office. Make them wait, like it’s a privilege to see you. Put on your coat and stethoscope and sit behind your desk. These people don’t like to say no to doctors."
If the doctor were to follow up as suggested, he would not be unethically threatening his patients or deceiving them about the study. But by playing on people's desire to please high-status individuals, the doctor would be manipulating their motives.
In this case, "It is hard to imagine that enrolling this group of people ... is both important enough to justify manipulating them into it and requires such manipulation in order to get them to consent," the authors conclude.