Informed Consent in Medicine

Unit Four: Consent to Treat & Miscellaneous Issues (HCA 401)

• Course name: Health Care Administration
• Unit focused on consent to treat and miscellaneous issues
• Topics covered include patient consent, informed consent, forms of consent (express, implied, statutory, judicial), consent in emergency situations, patient's decision-making capacity, adequacy of consent, written consent, special forms of consent, refusal of treatment, discharge against medical advice, when in doubt, informed consent defenses, ethics of informed consent, procreation and ethical dilemmas, abortion, sterilization, artificial insemination, surrogacy, wrongful birth/life/conception, end-of-life issues, dreams of immortality, scope of ethical issues, healthcare proxies, rights of proxies, Kentucky Living Wills, advanced directives, examples of end-of-life treatments, futility of treatment, withholding/withdrawing treatment, DNR orders, ethics committee, autopsy, organ donations, research/experimentation/clinical trials, organ human genetics, stem cell research, safe medical device reporting, medical device reporting and HIPAA, medical device reporting under the Freedom of Information Act, reporting of occurrences with electronic health records, the Stark Law, anti-kickback statutes, Patient Protection and Affordable Care Act (PPACA), changes to PPACA, CARES Act, worker's compensation, emerging issues, MATCH IT Act, artificial intelligence in healthcare

Patient Consent

• Voluntary agreement by a person with sufficient mental capacity to allow something to be performed on him/her.

Informed Consent

• Legal doctrine that a patient has the right to know the risks, benefits, and alternatives of a proposed procedure.
• This includes the patient having an absolute right to choose among available treatment options.
• It's predicated on the physician's duty to disclose sufficient information allowing the patient to evaluate procedures before consenting.
• Includes disclosure of risks, benefits, and alternatives.
• What a reasonable person would consider material to the decision of whether or not to undergo treatment.

Forms of Consent

• Express consent: Explicit agreement.
• Implied consent: Presumed when immediate action is necessary to prevent death or permanent health impairment (like treating an accident victim).
• Statutory consent: Legislation allows for emergency care.
• Judicial consent: Authorized when there's concern about consent's absence or legality.

Informed Consent in Various Contexts

• Nurses: Generally no duty to advise on procedures, but may confirm physician's explanation and witness consent.
• Hospitals: Generally not responsible for informing patients about risks, benefits, and alternatives, except in specific cases like CT or MRI imaging.
• Patients: Patients must have the ability to understand risks, benefits, and alternatives, evaluate the information, and express their preferences to freely make decisions.
• Adequacy of Consent: Factors include understanding risks/benefits/alternatives, evaluating the provided information, expressing treatment preferences, and freely making decisions without undue influence.

Written Consent

• Describes the nature of the patient's illness.
• Outlines the procedure being consented to.
• Specifies risks and probable consequences of the procedure.
• Includes the probability of the proposed procedure being successful.
• Details alternative methods of treatment.
• States that the patient understands the proposed treatment.
• Includes signatures, which are dated and signed.

Special Forms of Consent

• Admission consent
• Consent for routine procedures
• Consent for specific procedures
• Implied consent
• Statutory consent
• Judicial consent

Refusal of Treatment

• Patients may refuse treatment for any reason or no reason.
• Religious beliefs may be a valid reason.

Discharge Against Medical Advice

• Completed release documents the patient's refusal to accept recommended treatment.

When in Doubt

• Err (when in doubt about patient capacity) on the side of life.

Informed Consent Defenses

• Risk not disclosed, commonly known.
• Patient did not want to know about risks.
• Consent not reasonably possible.
• Physician disclosed what he considered reasonable.

Ethics: Informed Consent

• Protects the patient's right to make decisions on their care.
• Consent forms should supplement the oral disclosure physicians typically provide.

Procreation and Ethical Dilemmas

• This section explores ethical considerations surrounding procreation.

Abortion

• Premature termination of pregnancy.
• Spontaneous or induced.
• Elective or an incidental result of medical procedures.
• Legislation varies between states (Roe v. Wade, Doe v. Bolton).

Sterilization

• Termination of an individual’s ability to produce offspring (includes: elective, therapeutic, involuntary/eugenic).

Artificial Insemination

• Introduction of seminal fluid into a woman to establish pregnancy through a medical procedure.
• Consent & confidentiality are required.

Surrogacy

• Women agree to gestational carry for another person.
• This can involve genetic mother, surrogate, and gestational carrier roles/relationships.

Wrongful Birth/Life/Conception

• Legal realm of claims associated with medical care impacting ability to conceive/bear a child.

End-of-Life Issues

• Discusses the struggles with the whole life span and from the decision to be born to the decision to die.
• The decision-making process, along with the right to one's decision.
• Considerations and legalities about refusal or acceptance of treatment.

Healthcare Proxies

• Individuals who make healthcare decisions for incapacitated patients.
• Proxies have rights including agreeing or refusing to treatment, employing or dismissing medical providers access to records, donating organs, and authorizing autopsies.
• Commonly called Healthcare Agents, Health Care Surrogates, or Durable Powers of Attorney for Healthcare.

Advance Directives

• Provides a guideline, written in advance, which provides instructions on what medical or life-prolonging treatment should be provided or withheld based on patient preferences.
• Includes types like living will health care proxies.

DNR Order

• Medical order stating to withhold resuscitation in case of cardiac or respiratory arrest.

Ethics Committee

• Committee that offers a source of counsel in complex and ethical health care situations.
• Includes diverse members/stakeholders.
• Analyzes and provides counsel.

Autopsy

• Postmortem procedure for determining the cause of death.
• Provides medical understanding.

Organ Donations

• Federal regulations govern the acquisition and procedures involved with procurement/donation.

Uniform Anatomical Gift Act

• Legal framework for organ donation.
• Individuals voluntarily choose to opt in to organ donation programs.
• Allows utilization of life support to better facilitate retrieval of organs.

Research, Experimentation, & Clinical Trials

• Regulations govern experimentation and clinical trials.
• IRB approval processes
• Risk/benefit considerations
• Informed consent is fundamentally important.

Organ Human Genetics

• Biological study of inheritance.
• Including genetic markers, and molecular genetics.

Stem Cell Research

• Highly controversial use of embryonic stem cells to create organs or tissues.

Safe Medical Devices Act of 1990/Medical Device Amendments of 1992

• Federal legislation governing medical devices.
• Reporting requirement for serious adverse events related to medical devices and their manufacture.
• Includes reporting to the FDA and device manufacturer.

HIPAA

• Federal protection for patient (medical records) privacy.
• Reporting medical devices can occur without patient authorization.

The Stark Law

• Legislation intended to prevent physician fraud and abuse.
• Prohibits financial conflicts of interest involving physicians' referrals.

Anti-Kickback Statutes

• Federally prohibited.
• No exchange of value in return for referrals in federally-funded programs.

Patient Protection and Affordable Care Act (PPACA)

• Key federal healthcare reform law.
• Mandates health insurance.
• Creates health insurance exchanges.

Essential Health Benefits (PPACA)

• 10 essential health benefits that all health plans must cover.
• Includes ambulatory services, emergency, hospitalization, maternity/pregnancy, newborn/children's care, substance use disorder(including behavioral-health), mental health, prescription drugs, along with chronic disease management and rehabilitative treatments.

Changes to PPACA

• Individual mandate was repealed in 2019, before PPACA changes were planned.

CARES Act (2020)

• Federal response to the COVID-19 pandemic.
• $2 trillion economic relief package, aimed at various areas needing assistance and economic stability from the pandemic (includes worker assistance/family assistance, small business loans/assistance, job preservation, assistance for local/state/tribal governments from unexpected COVID-19 expenses, and public health).

Worker's Compensation

• Legislation meant to support workers injured on the job.
• Ensures injured workers have a measure of support and funds to recover.

Emerging Issues

• Current and future topics affecting healthcare.
• Topics like patient matching transparency.

MATCH IT Act

• 2024 law focused on patient matching for healthcare data.

Artificial Intelligence in Healthcare

• Use of AI in non-clinical approaches/applications in healthcare.
• Reporting, developments, educational campaigns, and fund authorization are areas of focus.