Professor Christine Coughlin quoted in Medical Ethics Advisor December 2013 issue

Informed consent is the “bedrock of patient care,” even when the patient is a health care provider consenting to a mandatory vaccination, says Christine Nero Coughlin (’90), professor and director of legal analysis, writing, and research at Wake Forest University School of Law.

“Informed consent has two prongs — that the patient is informed, and that consent is voluntarily given,” she says. “Voluntariness, in this context, means that the decision maker should make his or her own autonomous choice.”

Where vaccination is a condition of employment, that autonomous patient choice is taken away. Thus, when the vaccine is mandated as a condition of employment, the health care worker is being coerced into the choice — even if they agree in principle with the vaccine.

“Coercion, in and of itself, is not necessarily unethical,” says Coughlin. “When we look at public health legislation and legislation that surrounds the police power of the state, much of it is coercive and it is still ethical and necessary for the common good.”

However, when the employee is faced with choosing between vaccination and the loss of employment, says Coughlin, consent to vaccinate is coerced and cannot be considered voluntary.

“While it may be necessary for the common good, it rises to the level of unethical behavior when the hospital or health care institution requires the health care worker/patient to sign the same consent form as those voluntarily seeking the flu shot,” she says.

While it is not necessarily unethical to mandate the vaccine, says Coughlin, if the employer chooses to do so, the employer needs to acknowledge that it is a mandate in order to be ethical. “This significant fact should not be disguised by means of a consent form,” she says.

While the employee can sign a form that sets forth the risks of the procedure, it should not be labeled a consent form, says Coughlin. “Health care employers can easily fashion an alternative form to satisfy institutional and liability concerns about a health care worker/patient’s adverse reaction,” she adds.

Some employers allow for exceptions, but then require a change in the health care worker’s employment status. For example, they might require unvaccinated workers to use masks, respirators, or different colored badges or name labels during flu season; to take a leave of absence during flu season; or to be reassigned to a non-patient care area.

“If the health care worker refuses this change in employment status, in some cases, the health care worker’s employment may be terminated,” says Coughlin. “The severity of the sanction will increase the level of concern.”

The determination of whether this rises to the level of an ethical concern will require an examination of whether the sanction is really necessary to improve public health and decrease the risk of infection, or whether it is simply punitive in nature, stigmatizes the employee, or somehow violates the employee/patient’s confidentiality rights, says Coughlin.

“In the end, this decision would likely require a balancing of the risk of harm to the health care worker versus the risk of harm to the patients,” says Coughlin.

EXECUTIVE SUMMARY

Informed consent is a key ethical concern when health care providers are consenting to a mandatory vaccination, since autonomous patient choice is not possible where vaccination is a condition of employment.

• Employers should not require the health care worker/patient to sign the same consent form as those voluntarily seeking the flu shot.

• The employer needs to acknowledge the fact that the vaccination policy is a mandate.

• The risk of harm to the health care worker needs to be weighed against the risk of harm to patients.

SOURCE

• Christine Nero Coughlin, Professor and Director, Legal Analysis, Writing, and Research, Wake Forest University School of Law, Winston-Salem, NC. Phone: (336) 758-5504. E-mail: coughlcn@wfu.edu.