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Biomedical Ethics & Patient Safety

This guide serves to provide information and resources on clinical or research ethics.

Essential Legal Categories for Health Care Professionals

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There are numerous legal situations you may encounter in your career as a health care professional. This guide serves to provide information and resources on clinical and research ethics. See below for an overview of the most common types of legal issues in the health care arena. Ask a Librarian for assistance in finding the right information for your purpose. Expert help is just a click away!

Essential Ethical Tenets and Regulations


The basic definitions of each of the four principles of health care ethics are commonly known and used often in the English language, but they take on special meaning when being utilized in a medical setting. All of these principles play a key role in ensuring optimal patient safety and care.

1. Autonomy: In medicine, autonomy refers to the right of the patient to retain control over his or her body. A health care professional can suggest or advise, but any actions that attempt to persuade or coerce the patient into making a choice are violations of this principle. In the end, the patient must be allowed to make his or her own decisions – whether or not the medical provider believes these choices are in that patient’s best interests – independently and according to his or her personal values and beliefs.

2. Beneficence: This principle states that health care providers must do all they can to benefit the patient in each situation. All procedures and treatments recommended must be with the intention to do the most good for the patient. To ensure beneficence, medical practitioners must develop and maintain a high level of skill and knowledge, make sure that they are trained in the most current and best medical practices, and must consider their patients’ individual circumstances; what is good for one patient will not necessary benefit another.

3. Non-Maleficence: Non-maleficence is probably the best known of the four principles. In short, it means, “to do no harm.” This principle is intended to be the end goal for all of a practitioner’s decisions, and means that medical providers must consider whether other people or society could be harmed by a decision made, even if it is made for the benefit of an individual patient.

4. Justice: The principle of justice states that there should be an element of fairness in all medical decisions: fairness in decisions that burden and benefit, as well as equal distribution of scarce resources and new treatments, and for medical practitioners to uphold applicable laws and legislation when making choices.

The Health Insurance Portability and Accountability Act (HIPAA) was passed by Congress in 1996. According to the U.S. Department of Labor,  "HIPAA offers protection for millions of America's workers that improves portability and continuity of health insurance coverage." While the rights and protections related to coverage, anti-discrimination, and the states' role in regulating health insurance (among others) are important parts of HIPAA, they do not directly impact healthcare workers to the extent of the HIPAA Privacy Rule. Familiarizing yourself with the implications of the Privacy Rule relative to patient confidentiality is a crucial component to your success as a future healthcare provider. 

The HIPAA Privacy Rule applies to all forms of individuals' protected health information (PHI), whether electronic, written, or oral. If you follow the guidelines below, you will protect your patients' confidentiality and remain in compliance with the Privacy Rule:

  • Do not discuss a patient with anyone not directly related to the patient's medical care.
  • Do not discuss a patient's progress with anyone but the patient, without express permission of the patient or legal guardian. 
  • Do not tell your friends, family, or acquaintances about your patients in any way that they may be identified.
  • Do not discuss a patient's case, even with a colleague, if you are in an area where the conversation may be overheard (such as on a bus, in the cafeteria, etc.)
  • Do not read a chart or patient information belonging to someone who is not under your care. 

The HIPAA Privacy Rule applies to those who work in:

  • Health plans (insurance companies, HMOs, etc.)
  • Healthcare providers (anyone who provides any type of medical or health service)
  • Healthcare clearinghouses (such as billing services)

Protected information may not be shared with anyone who is not directly working with the patient without the patient's (or legal guardian's) express permission. This includes:

  • The individual's past, present, or future physical or mental health condition;
  • The provision of health care to the individual; or
  • The past, present, or future payment for the provision of health care to the individual.

Protected health information (PHI) includes many common identifiers, such as name, address, birth date, and Social Security Number. 

The Privacy Rule also gives patients rights over their health information, including rights to examine and obtain a copy of their health records, and to request corrections. 

The Patient Self-Determination Act (PSDA) was passed by the U.S. Congress in 1990. The purpose of this act is to ensure that a patient's right to self-determination in health care decisions be communicated and protected. Through advance directives—the living will and the durable power of attorney—the right to accept or reject medical or surgical treatment is available to adults while competent, so that in the event that such adults become incompetent to make decisions, they would more easily continue to control decisions affecting their health care. 

Who Must Comply With This Law?

Certain provider entities must comply with the Patient Self-Determination Act in order to receive Medicare or Medicaid payment from the federal government. However, the requirements of the law apply for all individuals in these facilities (or treated through these providers), not only for people who are on Medicare or Medicaid. Provider entities covered under the law are:

  • Hospitals
  • Skilled nursing homes
  • Nursing homes
  • Providers of Medicare and Medicaid home health care
  • Medicaid personal care providers
  • Health maintenance organizations, competitive medical plans, and healthcare prepayment plans
  • Hospice programs certified by Medicare and Medicaid

What Hospitals and Other Institutions Must Do

The law requires that these entities meet certain requirements in order to be paid under Medicare or Medicaid. The entity must:

  • Maintain written policies and follow certain procedures with respect to advanced directives 
  • Document in the patient's medical records whether or not the patient has executed an advanced directive (including a psychiatric advanced directive)
  • Comply with all state laws regarding advanced directives (this includes complying with any state law on psychiatric advanced directives)
  • Not condition the provision of care or otherwise discriminate against an individual based on whether or not the individual has executed and advanced directive. This does not mean, however, that a provider is required to provide care that conflicts with an advanced directive
  • Inform the individual that complaints concerning implementation of these advanced directive requirements may be filed with the state agency that surveys and certifies Medicare and Medicaid providers
  • Provide staff and community education on issues related to advanced directives

Source: Federal Law on Advanced Directive

Infection Control

Healthcare workers are occupationally exposed to a variety of infectious diseases during the performance of their duties. 

Several OSHA standards and directives are directly applicable to protecting workers against transmission of infectious diseases. See the links below for complete information.

Prevention of Work-Related Injuries

Did you know that healthcare is one of the most hazardous occupations? According to the report "Health Care Workers Unprotected: Insufficient Inspections and Standards Leave Safety Risks Unaddressed" issued by the nonprofit consumer advocacy group Public Citizen, no other industry in the U.S. has higher worker injury rates than healthcare. Despite the successful progress toward greater protections, including the Nurse and Health Care Worker Act of 2013 and the release of Safe Patient Handling and Mobility: Interprofessional National Standards, OSHA has failed to produce standards that address work-related injuries in healthcare settings that do not directly involve exposure to infectious diseases. Here are OSHA's guidelines for Protecting Workers: Guidance on Mitigating and Preventing the Spread of COVID-19 in the Workplace.

See the link below for OSHA's general guidelines on the prevention of work-related injuries.

Essential Ethical Categories

According the the Encyclopedia of Aging, assisted suicide is defined as "the premature death of an individual at the hands of that individual, using the means supplied by the physician (usually a lethal dose of medication)." Euthanasia is the practice of killing an individual, in a painless or minimally painful way for merciful reasons, usually to end suffering. In contrast to assisted suicide, euthanasia is defined as "the premature ending of a persons life by a second person (usually the physician)." This is an important distinction between the two commonly confused practices.

Perhaps the biggest ethical quandary is whether or not there is a moral difference between killing someone and letting them die. 

See the resources linked below for more information about assisted suicide.

Life support refers to techniques and procedures used to artificially replace the function of vital organs.

Chief forms of life support are:

  • Mechanical ventilation—assists or replaces a person's breathing through the use of a machine called a ventilator.
  • Cardiopulmonary resuscitation—provides blood and oxygen to body tissues, especially the brain, when a person's heart and/or breathing stop. It involves various basic maneuvers, as well as the use of defibrillators, drugs, and pacemakers at advanced levels. 
  • Artificial nutrition and hydrationessential for life when a person cannot eat or drink. It is administered through a tube that is inserted into the stomach, intestine, or a vein. 
  • Dialysissubstitutes for lost kidney function.

While people who argue for life support say that it is morally wrong to let someone die, those who are against it argue that it is morally wrong to keep someone alive without their consent, possibly prolonging their suffering. Their have been a number of landmark cases that have people split over ethical issues, which each side feeling passionately about their moral stance. These include Barber v. Superior Court, Cruzan v. Director, the Gilgunn case, and perhaps most famous, the Terry Schiavo case.

Ethical panels have been put together and a number of situations arise that cause the debate to continue. As the ethics debate progresses, it is important to stay abreast of the issues and facts about life support.

Informed consent is the process by which the treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment. It originates from the legal and ethical right the patient has to direct what happens to his or her body and from the ethical duty of the provider to involve the patient in his or her health care. 

The following resource for the University of Washington School of Medicine provides a detailed overview of all aspects of informed consent, including the elements of full informed consent, how much information is considered adequate, interventions that require informed consent, and what should occur if the patient cannot give informed consent. 

Organ transplantation is the process of surgically transferring a donated organ into a patient with end-stage organ failure.

Privacy is an individual's ability to control the release of private facts and the individual's ability to live life without being stalked or otherwise being the subject of intrusion. 

Confidentiality is the legal or ethical exception that another person will protect information that the first individual wishes to be kept within the boundaries of that particular relationship.

Disclosure is voluntary sharing of specific information. Sharing information about others without their consent may be ethically problematic even if the facts themselves fall within the pubic realm.

Source: Elliott, D., & Spence, E. (2018). Privacy and Confidentiality. In Ethics for a digital era (pp. 119–120). essay, John Wiley & Sons, Inc. 

Issues related to reproductive technologies have become a chief concern of a branch of applied ethics called bioethics. Below you will find the most common ethical issues related to reproduction that you may encounter as a heath care professional.


Abortion refers to the purposeful termination of pregnancy and is a unique moral dilemma. While antiabortion advocates take an absolutist stand on the right to life of the fetus, those who support abortion argue that each woman has an overriding right to her own body and that abortion is a way of exercising this right.

Abortion laws and restrictions (both for the patient and the healthcare provider) vary from state-to-state and are subject to change. It is important to stay on top of developments regarding patients' rights as well as your right to refuse to provide certain medical services for reasons of religion or conscience.


Surrogacy describes the arrangement in which a woman gestates a fetus for another after artificial insemination. There are two types of surrogacy—traditional surrogacy and gestational surrogacy

In traditional surrogacy, the surrogate mother is artificially inseminated with the sperm of the intended father or sperm donor. Since the surrogate's own egg is used, she will be the genetic mother of the resulting child.

In gestational surrogacy, the surrogate mother is not genetically related to the child. Eggs are extracted from the intended mother or egg donor and mixed with sperm from the intended father or sperm donor in vitro. The embryos are then transferred into the surrogate's uterus. 

Some ethical issues that are pertinent in the surrogacy process include:

  • Attachment issues with the gestational mother, who after carrying the baby for nine months must emotionally and physically detach from the child once it is born.
  • The disposal, medical use, or "gifting" of unused embryos.
  • The growing number of commercial surrogacy arrangements, particularly the "surrogacy farms" of India, where poor women carry children for healthy couples in the West.
  • Issues of personal identity faced by the child.

Found in very young embryos, stem-cells have the potential to divide and differentiate to create the wide variety of cells in a fully developed organism. For this reason, they are highly prized by medical and biological researchers across many disciplines. Supporters of stem-cell research argue that it has the potential to cure any number of human illnesses, injuries, and medical conditions, from spinal cord damage to Alzheimer's disease. Recognizing the moral implications of such efforts, supporters point out that cells used in laboratory research are excess embryos from fertility clinics that will never develop into a fetus or baby. Opponents say that the use of human embryos for research still violates the will of God, as well as professional ethics, because it undermines the sanctity of human life. 

Embryonic stem-cell research poses a moral dilemma. It forces one to choose between two moral principles:

  • The duty to prevent or alleviate suffering
  • The duty to respect the value of human life