HCM 3080 Module 6 Informed Consent Assignment Example

A Signature Is Not Consent: The Reasonable Patient Standard, a Missed Risk and the Consent Process at Riverbend

Student Name

B.S. in Healthcare Management, Thomas Edison State University

HCM-3080: Healthcare Legal and Ethical Considerations

Mentor Name

Month Day, Year

A Signature Is Not Consent: The Reasonable Patient Standard, a Missed Risk and the Consent Process at Riverbend

A 58-year-old man at Riverbend, the course's composite hospital near the Delaware River,, underwent a cardiac catheterization through the wrist. He signed a consent form listing bleeding, infection, allergic reaction and a rare risk of heart attack or stroke. The procedure went well, but afterward he developed numbness and weakness in his hand from a blocked radial artery, a recognized complication that the form did not list and that, he says, no one mentioned. He works as a carpenter. This paper analyzes his right to informed consent, the legal standard that applies in New Jersey, the patient's own responsibilities, and how the hospital's consent process should change.

The Right to Informed Consent

Informed consent rests on the patient's right to decide what happens to his body. It requires that the patient have capacity, that the decision be voluntary, and that the clinician disclose the information needed to make it, covering what will be done, the significant risks and expected benefits, and the other options, including doing nothing. A signed form is evidence that a consent discussion took place, but it is not the consent itself. If the discussion omitted information the law required, the signature does not cure the omission.

Which Standard Applies

Courts have used two standards to judge what must be disclosed. Under the professional standard, a physician must disclose what a reasonable physician would disclose in similar circumstances. The patient-centered test asks instead what someone in this patient's situation would want to know before deciding. The landmark case for the patient standard is Canterbury v. Spence (1972), where the District of Columbia Circuit held that the scope of disclosure is measured by the patient's need for information material to the decision, not by the custom of physicians, because the right being protected belongs to the patient.

New Jersey adopted that approach in Largey v. Rothman (1988), holding that the duty to disclose is measured by what a reasonably prudent patient would consider material to the decision. The patient must still prove causation: that a reasonable patient, properly informed of the risk, would have declined the procedure or chosen differently, and that the undisclosed risk actually caused the injury.

Applying the Standard

Radial artery occlusion is uncommon and often causes no symptoms, but when it does, it can affect hand function. For most patients, a small risk to the hand might not be material. For a carpenter who depends on his hands, a reasonable person in his position could well consider it significant, and an alternative existed: the catheterization could have been done through the femoral artery in the groin, which carries different risks. Whether he would have chosen that route is a question of fact, but his claim is plausible under the reasonable patient standard. The hospital's consent form, built around the risks physicians usually mention, illustrates exactly the gap the standard was designed to address.

The Patient's Responsibilities

Patients have responsibilities as well as rights. They are expected to provide accurate information about their health, ask questions when they do not understand, and follow agreed instructions. A patient who does not mention his occupation or ask about effects on his hands may share responsibility for the gap. But the burden of disclosure rests mainly on the clinician, who knows the risks, and a good process invites patients to say what matters to them rather than assuming they will volunteer it.

Improving the Consent Process

The administrator can strengthen the process in three ways. First, consent discussions should begin by asking what the patient's work and daily life require, so that material risks can be identified for that person. Second, procedure-specific information sheets should list risks that may matter to particular patients, including radial artery occlusion. Third, clinicians should confirm understanding using teach-back, asking patients to explain the key risks and alternatives in their own words. Schenker et al. (2011) reviewed 44 controlled studies and found that a range of interventions, including written materials, multimedia, extended discussions and quizzing patients and correcting their answers, usually left patients understanding more, with the biggest gains in what they knew about risks. Documenting the discussion, not just the signature, completes the change.

Conclusion

Under the reasonable patient standard, the question is not what physicians usually say but what this patient needed to know. A process designed around that question protects patients' rights and the hospital alike.

References

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

Largey v. Rothman, 110 N.J. 204, 540 A.2d 504 (1988).

Schenker, Y., Fernandez, A., Sudore, R., & Schillinger, D. (2011). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: A systematic review. Medical Decision Making, 31(1), 151-173. https://doi.org/10.1177/0272989X10364247