Informed Consent

It is only within the past 100 years that the concept of informed consent has appeared in health care. For a long time, the doctor just told the patient what they were going to do and then did it. In that sense, the doctor's relationship with a patient was a paternalistic one. The doctor would make the pronouncement of what would be done, much as a parent would tell a child, "Eat your broccoli because I said so."

One had faith in the doctor - credat emptor¹ - because one trusted that the doctor was a professional who made decisions based on the patient's best interest. But keep in mind that it was the doctor who determined what was in the patient's best interest. They didn't inquire about what the patient considered important. The doctor might make a decision that was completely contrary to what the patient would have decided. For example, a patient who preferred a better quality of life over quantity of life may have had a doctor working to extend their life, no matter what the quality became.

It was not until 1914 that the U.S. Supreme Court ruled that a patient had the right to determine what was done to their body. "Every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without the patient's consent commits an assault for which he is liable to damages," Justice Benjamin Cordoza wrote in Schloendorf v New York Hospital.

Obviously, we are not surgeons, and I am sure that for many of you reading this, informed consent was never discussed when you were students. It wasn't discussed when I was a student at Texas Chiropractic College, class of 1983. The patients we saw in clinic were never given any kind of informed consent. So, when I first taught ethics at the University of Bridgeport College of Chiropractic, I thought: Why would we ever tell patients about the risks from manipulation when they are so very rare?

Then in the early 1990s, I was recruited to help lead a team to revise guidelines on informed consent as part of the process to revise the Canadian Chiropractic Association's practice guidelines. The whole process was aborted after we had completed our work. Nevertheless, I read quite a bit of Canadian case law. In 1980, the Supreme Court of Canada ruled in Reibl v Hughes that patients must be told about "material risks" of a procedure. In 1986, it was the Mason v Forgie case that concerned chiropractic. The court wrote: "Even if a certain risk is a mere possibility that ordinarily need not be disclosed, yet if its occurrence carries serious consequences, as for example paralysis or even death, it should be regarded as a material risk requirement disclosure."

Reading this made me realize that no matter how rare the risk is and no matter how tenuous or strong the cause-and-effect relationship is between manipulation and stroke, the patient has the right to know. While it might be a legal right, I see now it is also an ethical right. I believe that this is true of the other side effects that have been reported in the literature.

As chiropractors, we may have personally decided that the benefits far outweigh the risks, but that doesn't mean all of our patients will decide the same. As previously discussed, the patient has the right to choose quality over quantity of life; the right to control what happens to their body. If one is going to control what happens to their body, one needs to have enough information to make an informed decision; thus to provide informed consent.

Informed consent is not mandated in all states; however, it just makes for good practice from a risk-management standpoint. If informed consent is done correctly, it may neutralize the malpractice plaintiff's claim that the chiropractor violated the standard of care by not giving the patient informed consent. This is now a common allegation.

What Is Informed Consent?

From speaking with colleagues to reading the NBCE Job Analysis of Chiropractic,² I think many do not understand what informed consent is. Too often, it seems the perception is that informed consent is giving a patient a piece of paper to sign. And while a signed form may be valuable, if the patient didn't read or understand it, the patient will contend they never really were informed, despite the signature.

A simple mnemonic to remember the consent process from an ethical standpoint is PARQ:

• Procedures: Explain to the patient the procedures one intends to provide.
• Alternative: Talk about alternative treatments that could be performed. Keep in mind one alternative that should be discussed is no treatment at all.
• Material Risks: Talk about the material risks, that is, the side effects and complications of the recommended procedures, and discuss alternatives, which include no treatment at all.
• Questions: Answer all of the patient's questions.

The results of this process should be written down and acknowledged by the patient.

For an easier option, Cevantive University³ has put together software that makes the process uniform, so all patients get to hear the same information. It even asks the patient if they have questions and provides detail as to what was explained. It also notes what questions the patient had and if they were answered to their satisfaction.

Giving patients informed consent makes sense from both an ethical and legal standpoint. Please be sure to get the advice of an attorney to ensure that your informed consent process complies with local rules and regulations.

References

1. Perle SM. Credat Emptor. Dynamic Chiropractic, Jan. 1, 2003. www.chiroweb.com/archives/21/01/16.html.
2. Christensen MG, Kollasch MW. Job Analysis of Chiropractic. Greeley, Colo.: National Board of Chiropractic Examiners, 2005.
3. www.cevantive.com.