In the US, colon cancer is the
third most common cancer and the second leading cause of cancer death. It usually
affects men and women of all racial and ethnic groups alike, and is most common
in people 50 years or older. Colon cancer is highly treatable when discovered
early. It first develops as polyps (abnormal growths in the colon or rectum),
but can become cancerous if not removed (medical news today, 2017).
The New England Journal of
Medicine published a study regarding ethical issues and the overgeneralizations
of research conventions, such as informed consent. A health system (name of
health system not provided) has proposed to send birthday cards to patients
when they turn 50 to promote colorectal screenings. The health system has three
different reminder interventions and randomizes each patient to one
intervention; however, since the word “randomization” is in play, should the
IRB be involved in this study?
The three interventions
implemented by this healthy system consists of 1) a whimsical card (“it’s your
birthday, treat yourself to a colonoscopy”), 2) a birthday card with a
prescheduled colonoscopy appointment, or 3) a usual message (control
intervention). The health system is obviously conducting research by
randomizing patients to different interventions with the hope of seeing a
change in screening rates which can implemented in other healthy system; thus promoting justice. However, the IRB from this health system indicates
that by not asking for permission, the patient’s rights not to participate is
violated. Patients who turn 50 will be receiving a reminder from this health
system anyways; therefore, the IRB insists on receiving consent from the patients.
The IRB is essential in protecting
patient rights, but when the word “randomization” is used, it alarms the IRB to
request consent. Asch et al., (2017), argues that the IRB is misdirected since
the plan implemented by the health system does not involve more than minimal
risk, the rights and welfare of subjects are not affected, and if patients were
to consent, it would throw off the purpose of the research. Furthermore, the
approaches are well-meaning, plausible, safe, and are consistent with clinical
guidelines; thus, they are promoting the ethical value of beneficence.
These regulations when conducting
low-risk science studies, can make it difficult to do better science such as
randomized studies which yield better results. Thus, it would leave scientist
to rely on uncontrolled projects with pre-and post-evaluations which may not
give accurate results of the general population. What is your opinion on the
ethical issue? Should informed consent be required for low-risk science
studies, such as the colorectal screening reminders?
References
Asch,
D. A., Ziolek, T. A., & Mehta, S. J. (2017). Misdirections in Informed
Consent - Impediments to Health Care Innovation. The New England Journal Of
Medicine, 377(15), 1412-1414.
doi:10.1056/NEJMp1707991
Informed consent should always be required; there should never be an exceptions to this rule, even if it is being considered a small randomized test. The blurring of the line may lead to further lines being blurred later in that study or another one. Well intentions aren’t always in the best interests of all parties involved. The Kennedy Krieger Institute’s “Lead-Based Paint Abatement and Repair and Maintenance Study”, the thievery of Henrietta Lacks’ cells or the Tuskegee syphilis study are all studies where informed consent was taken away from the parties involved. These are only a few of a multitude of studies that were conducted toward a vulnerable population where some profited while others suffered greatly. The removal of informed consent damns history to be repeated and vulnerable populations to once again undergo unnecessary hardships. Overall, patients should always have the right to stay autonomous over their body.
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