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those individuals who seek clinical privileges, and many states now require nursing students to be fingerprinted before they are allowed to work with vulnerable populations. In the future, hiring someone without an adequate background check, who later commits a crime involving a patient, could be another area of liability for the manager. This is an example of the type of pending legislation with which a manager must keep abreast so that if it becomes law, its impact on future management practices will be minimized.

Unit managers must be alert to patient complaints of being handled in a rough manner or complaints of excessive force in restraining patients. In fact, performing any treatment without patient’s permission or without receiving an informed consent might constitute both assault and battery. In addition, many battery suits have been won based on the use of restraints when dealing with confused patients.

The use of physical restraints also has led to claims of false imprisonment. False imprisonment is the restraint of a person’s liberty of movement by another party who lacks the legal authority or justification to do so (Criminal Law Lawyers Source, 2003–2013).

Practitioners are liable for false imprisonment when they unlawfully restrain the movement of their patients. Physical restraints should be applied only with a physician’s direct order.

Likewise, the patient who wishes to sign out against medical advice should not be held against his or her will. This tort also is frequently applicable to involuntary commitments to mental health facilities. Managers in mental health settings must be careful to institutionalize patients in accordance with all laws governing commitment.

Another intentional tort is defamation. Defamation is communicating to a third party, false information that injures a person’s reputation. When defamation is written, it is called libel.

When it is spoken, it is called slander.

OTHER LEGAL RESpONSIBILITIES OF THE MANAGER

Managers also have some legal responsibility for the quality control of nursing practice at the unit level, including such duties as reporting dangerous understaffing, checking staff credentials and qualifications, and carrying out appropriate discipline. Health-care facilities may also be held responsible for seeing that staff know how to operate equipment safely.

Sources of liability for managers vary from facility to facility and from position to position.

For example, standards of care as depicted in policies and procedures may pose a liability for the nurse if such policies and procedures are not followed. The chain of command in reporting inadequate care by a physician is another area in which management liability may occur if employees are not taught proper protocols. Managers have a responsibility to see that written protocols, policies, and procedures are followed in order to reduce liability. In addition, the manager, like all professional nurses, is responsible for reporting improper or substandard medical care, child and elder abuse, and communicable diseases, as specified by the Centers for Disease Control and Prevention.

Individual nurses also may be held liable for product liability. When a product is involved, negligence does not have to be proved. This strict liability is a somewhat gray area of nursing practice. Essentially, strict liability holds that a product may be held to a higher level of liability than a person. In other words, if it can be proved that the equipment or product had a defect that caused an injury, then it would be debated in court by using all the elements essential for negligence, such as duty and breach. Therefore, equipment and other products fall within the scope of nursing responsibility. In general, if they are aware that equipment is faulty, nurses have a duty to refuse to use the equipment. If the fault in the equipment is not readily apparent, risks are low that the nurse will be found liable for the results of its use.

Informed Consent

Many nurses erroneously believe that they have obtained informed consent when they witness a patient’s signature on a consent form for surgery or procedure. Strictly speaking, informed consent (Display 5.3) can be given only after the patient has received a complete explanation of the surgery, procedure, or treatment and indicates that he or she understands the risks and benefits related to it.

Informed consent is obtained only after the patient receives full disclosure of all pertinent information regarding the surgery or procedure and only if the patient understands the potential benefits and risks associated with doing so.

The information must be in a language that the patient can understand and should be conveyed by the individual who will be performing the procedure. Patients must be invited to ask questions and have a clear understanding of the options as well.

Only a competent adult can legally sign the form that shows informed consent. To be considered competent, patients must be capable of understanding the nature and consequences of the decision and of communicating their decision. Spouses or other family members cannot legally sign unless there is an approved guardianship or conservatorship or unless they hold a durable power of attorney for health care. If the patient is younger than 16 years (18 in some states), a parent or guardian must generally give consent.

In an emergency, the physician can invoke implied consent, in which the physician states in the progress notes of the medical record that the patient is unable to sign but that treatment is immediately needed and is in the patient’s best interest. Usually, this type of implied consent must be validated by another physician.

Nurses frequently seek express consent from patients by witnessing patients sign a standard consent form. In express consent, the role of the nurse is to be sure that the patient has received informed consent and to seek remedy if he or she has not.

Informed consent does pose ethical issues for nurses. Although nurses are obligated to provide teaching and to clarify information given to patients by their physicians, nurses must be careful not to give new information that contradicts information given by the physician, thus interfering in the physician–patient relationship. The nurse is not responsible for explaining the procedure to be performed. The role, rather, is to be a patient advocate by determining their level of understanding and seeing that the appropriate person answers their questions. At times, this can be a cloudy issue both legally and ethically.

Informed Consent for Clinical Research

The intent of informed consent in clinical research is to give patients adequate information, through a full explanation of a proposed treatment, including any possible harms, so they can make an informed decision. Studies, however, repeatedly suggest that participants often have incomplete understanding of various features of clinical trials and issues associated with written informed consent are common. (See Examining the Evidence 5.1.)

THE PERSON(S) GIVING CONSENT MUST FULLY COMPREHEND:

1. the procedure to be performed 2. the risks involved

3. expected or desired outcomes

4. expected complications or side effects that may occur as a result of treatment 5. alternative treatments that are available

CONSENT MAY BE GIVEN BY:

1. a competent adult

2. a legal guardian or individual holding durable power of attorney 3. an emancipated or married minor

4. Mature minor (varies by state) 5. parent of a minor child 6. court order

DISpLAy 5.3 Guidelines for Informed Consent

Banner and Zimmer (2012) also underscore the importance of nurses understanding and applying ethical principles for obtaining a valid informed consent in research. This includes the clear and accurate disclosure of information, assessment of decisional capacity, and the promotion of voluntarism. Understanding and responding to these issues and criteria are important in maintaining client safety, dignity, and respect and are essential to the development of high-quality, ethically sound research that improves health outcomes.

Source: Braude, H., & Kimmelman, J. (2012). The ethics of managing affective and emotional states to improve informed consent: Autonomy, comprehension, and voluntariness. Bioethics, 26(3), 149–156.

An individual’s right to self-determination and autonomy is a core consideration in research.

Braude and Kimmelman, however, argue that surveys consistently show that patient-subjects involved in clinical research frequently harbor inflated expectations of benefit (therapeutic overe- stimation) or conflate trial participation with care (therapeutic misconception). Many commenta- tors argue that such misunderstandings raise important concerns about consent validity.

In addition, Braude and Kimmelman suggest that while consent should be free from undue influence, that some correction, persuasion, or manipulation often exists. Both directive and non- directive affective interventions raise similar ethical concerns regarding the manipulation of con- sent practices. A paradoxical tension exists in that affective interventions intended to enhance autonomy may achieve their end through bypassing conscious cognition. Thus, the increasing impact of affective interventions on the lives of researchers and subjects, who experience real affect and emotions in considering difficult decisions, is a phenomenon that requires continued rigorous and sophisticated moral reflection.

Examining the Evidence 5.1