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Online sharing could undermine results
Blogs, message boards, and patient communities are being used not only by patients, but also by research participants. In some cases, this reveals whether or not a participant is taking actual medication or placebos, compromising the study’s validity.
"Some research participants are using social media to have public discussions on the enrollment process and side effects experienced," says Katrina A. Bramstedt, PhD, a clinical ethicist and professor at Bond University School of Medicine in Australia, and former faculty in the Department of Bioethics at Cleveland (OH) Clinic Foundation.
"Some people even attempt to use clinical trials as a second opinion,’" says Bramstedt.1 "All of this creates the potential to impact the integrity of a study due to the risk of the injection of bias."
This can lead to breaking of study blinding, or inappropriate participants falsifying information in order to meet inclusion criteria.
"The most important thing is to never violate the integrity of a study," says Jonathan L. Halperin, MD, director of Clinical Cardiology Services in the Zena and Michael A. Wiener Cardiovascular Institute at The Mount Sinai Medical Center in New York City.
Participants’ communication on social media could alter the behavior of study participants, compromising the study’s findings. For instance, if researchers are evaluating a treatment for hypertension and know that people are often non-compliant with the recommendation for an exercise regimen, social media could potentially skew the results.
"If suddenly the behavior of a group of participants was changed as a result of communication, the study would no longer reflect the real world," says Halperin. "That would reduce the generalizablity of results."
The study’s findings would no longer apply to the typical patient with hypertension. "We would then need to quantify the results, to reflect that 93% of participants were engaged in a social network that potentially influenced their concomitant management," says Halperin.
Researchers go to great pains to validate outcomes, he says, and if social media use undermines scientific integrity, "it can be harmful and wasteful."
The goal of research is to create reliable new knowledge, free of researcher bias and based on accurate information obtained from willing participants, says Edward Goldman, JD, associate professor of the ObGyn Program in Sexual Rights and Reproductive Justice at the University of Michigan Health System in Ann Arbor.
"To the extent that participants do things to undermine the validity of the research, the results are not useful," says Goldman.
If participants try to find out which arm of a study they are in, or compare information with other participants, they can harm the study’s validity.
"The ethical goal of research is therefore damaged," says Goldman. While a participant can always decide to discontinue being involved in research, this does not mean a participant can decide not to follow the rules while continuing in the study.
"Of course, participants have rights to autonomy," says Goldman. "But in deciding to participate, they are agreeing to follow the rules of research — even if that means limiting autonomy."
Some participants use social media to discuss adverse events, instead of bringing these to the attention of researchers. "Truly important matters that should be discussed with the research team can, instead, be taken directly to the Internet for community consultation,’" says Bramstedt.
Researchers should be proactive to limit harmful effects of social media use, says Goldman, by stating prior to enrollment, "If you decide to participate in this research, you agree that you will not share information or use social media to attempt to determine which arm of a study you are in," he says. "You understand that research is not treatment, but rather, is a scientific approach to see if a theory has practical application, and that research only produces reliable results if the scientists and participants rigorously follow the rules."
Most research participants are likely unaware of the potential of their social media use to impact study integrity. Bramstedt recommends including a section in the consent form titled "Participant Responsibilities," or using the confidentiality section to specify participant requirements.
"Research teams and sponsors may need to patrol the Internet while their study is in operation to ensure adherence to confidentiality requirements," she adds. "This should be disclosed in the consent form."
During the enrollment process, the research team can carefully review these sections of the consent form with the participant. Researchers could make participants aware that sharing information on social media could potentially lead to participants’ loss of insurance or employment.
"We cannot prevent a participant or a patient from sharing medical or research information through social media," says Goldman. "But we can and should make it clear what the dangers of such sharing could be."