Atlas of Procedures in Neonatology, 4th Edition
Preparation and Support
Informed Consent for Procedures on Neonates
Harold M. Ginzburg
- General Comments
Medicine is an art and a science needed by most, feared by some, and observed by all. Modern medical care in hospitals is generally provided by “teams” of medical personnel including but not limited to physicians, nurses, therapists, and technicians (e.g., extracorporeal membrane oxygenation, respiratory therapy, dialysis) (1,2 and 3). By medical tradition, the physician and the hospital have been held responsible for the actions of the team members. Today, each team member is also medically and legally responsible for his or her own actions.
It is the fundamental duty and responsibility of those who provide medical care and treatment to neonates to inform the parent or guardian appropriately and to document that relevant information has been provided, and understood, and that informed consent has been obtained. Failure to obtain fully informed consent may result in legal liability for the health care provider under either a claim of negligence or a claim of assault and battery (depending on state law) (4,5,6,7).
Neonatologists, obstetricians, and pediatricians practice in a particularly emotionally charged area of medicine. Families are more ready to accept mortality and morbidity in their senior members than in their youngest members. Options for treatment must be carefully explained and include the option, when appropriate, of no treatment. Options for treatment should be presented in terms of the immediate, intermediate, and long-term effects of the treatment on the neonate and on those who will be directly affected by the medical decisions.
The federal government and the individual states and territories have laws, regulations, guidelines, policies, and practices that directly and indirectly affect the practice of medicine care (8,9). Federal and state reimbursement, licensure, inspection, and enforcement functions vary and may even be in conflict with each other. Therefore, health care providers are encouraged to consult with hospital administrative personnel and legal counsel when potential legal issues arise because, in the final analysis, “The law does not permit [a health care provider] to substitute his own judgment for that of the patient [or guardian] (10).”
- Medical–Legal Concepts
- Legal:A duty is a legal and ethical responsibility. A breach (violation) of a duty owed to another person may result in legal liability. Duties are a reflection of the moral fiber of a community; they are codified in state and federal statutes and regulations. Public policies and laws thus become the vehicle for expressing a community's moral imperatives.
- Medical:A health care provider has a duty to conform his or her practice to a reasonable (or, in some instances, usual) standard of care specific to the type of illness and to the particular circumstances in which the care and/or treatment are being provided. This duty includes performing only procedures for which, under normal circumstances, appropriate equipment and support are available and that he or she possesses the competence to perform.
- Health care provider–patient relationship
- Fiduciary(“pertaining to or involving one who holds something in trust for another”): Health care providers and hospital care systems have a fiduciary duty to patients and their parents or guardians. A fiduciary duty is a responsibility that arises from the trust and confidence placed by the patient/parent/guardian in the health care professional. Health care providers are assumed to have superior medical knowledge; they are expected to warn their patients and to attempt to protect them from untoward or predictable harm. The fiduciary relationship is created when a health care provider responds to an expressed or implied request for treatment by the patient, his or her guardian, or a third party (e.g., emergency medical service personnel); the health care provider then has
a duty to share his or her knowledge about the nature of the illness, its prognosis, treatment options, and associated risks (these are the essential elements of an informed consent agreement). The health care provider also has a duty to protect patient information from access by those who do not have a legal right to access it.
- Contract:The health care provider–patient relationship is a contract. A health care provider and a patient (or his or her parent or guardian) enter into the contract, either implied or expressed, either verbally or written, for the performance of medical services. The contract created is based on the fiduciary relationship and not on a financial one.
- Standard of care
- Legal:The health care provider has a duty to conform his or her practice to a reasonable standard of care in the particular type of case and in the particular circumstances in which the care and treatment are being provided.
- Medical:The health care provider must not undertake any procedure that will place the patient at an unreasonably great risk of harm when weighed against the potential benefits. The health care provider must consider the consequences of his or her actions, or inactions, and exercise his or her best judgment when providing care.
- General negligence:Negligence is the failure to do something that a reasonable man or woman, guided by those considerations that ordinarily regulate the conduct of human affairs, would do or the doing of something that a prudent and reasonable man or woman would not do.
- Medical negligence:Medical negligence, or medical malpractice, is a special instance of negligence. A missed operative diagnosis, a therapeutic misadventure, a failure to arrange for follow-up care, and a failure to inform, warn, or protect the patient, or in some instances a third party, may be special instances of medical negligence. The medical care profession is held to a specific minimum level of performance based on the possession, or claim of possession, of “special knowledge or skills” that have accrued through specialized education and training. A health care provider may be sued successfully only if there was a violation of a duty or obligation, recognized by law, that required the defendant-health care provider to conform to a particular standard of conduct in order to protect others, usually the patient, against unreasonable risks of harm.
- Informed consent
- Clinical:Informed consent is educated consent; it is a cornerstone in the provision of medical care (11). Fundamentally, informed consent is a contract between the physician and the patient and/or the parent or guardian. Informed consent requires that sound, reasonable, comprehensible, and relevant information be provided by a health care professional to a competent individual (patient and/or their parent(s) or guardian) for the purpose of eliciting a voluntary and educated decision about the advisability of permitting one course of clinical action as opposed to another (12). Thus, informed consent involves (a) a clearly stated, understandable offer by the health care provider to provide services and (b) acceptance of the services by the patient or the surrogate; it is also (a) an offer, by the patient or the surrogate, to pay for the services or at least to acknowledge that they have a worth, and (b) it is the health care provider's acceptance of the payment or acknowledgment (13). Informed consent should also prevent unrealistic expectations from evolving, because all parties are made aware of the possibility of the failure of the proposed treatment plan.
Informed consent implies that not only the treating physician, but all those who are involved in the patient's care (e.g., nurse practitioners, nurses, respiratory therapists) have a responsibility to use sound judgment and provide quality care (14). To create a valid contract, there is a legal requirement that an individual providing consent be legally competent and have the legal capacity or ability to enter into that contract (15). Health care providers treating children are sometimes faced with emotionally immature, incoherent, uncooperative, absent, or intoxicated parents. In such instances, assistance from the hospital attorneys and the courts may be required.
- Research:The Declaration of Helsinki, agreed to by the World Medical Association in 1964, distinguished between “clinical research combined with professional care” (i.e., research that might directly benefit the patient) and “nontherapeutic clinical research (16).” Special and specific informed consent needs to be obtained for procedures conducted as part of research studies unless the procedures are considered to be a component of the “routine medical care” (see next section). The U.S. Department of Health and Human Services (HHS) (17) and the
U.S. Food and Drug Administration (FDA) (18) have promulgated a series of regulations to ensure that research subjects, especially children, are adequately protected when they are enrolled in clinical trials or other clinical experiments. HHS has the power to investigate and sanction investigators for violating its regulations (19).
- Obtaining Informed Consent
- The person obtaining consent should be aware that there are two levels of informed consent.
- General informed consent(often referred to as a “blanket consent”): The parent or guardian must understand that admission to a hospital entails active clinical intervention by a number of health care providers. While the parent or guardian can expect explanations of many of the procedures that will be used to help his or her child or ward, he or she cannot expect to be informed about every intervention. Routine medical care is considered to be covered under a general informed consent; each time blood is drawn or a nonexperimental medication is administered, a specific informed consent is not required. Each medical facility needs to define (within the limits of what is reasonable for the type of care provided as well as what is reasonable given the social context of the community) the components of routine care. For instance, in an intensive care nursery, placing an arterial line in a critically ill infant for the purpose of obtaining blood gases is not a unique procedure requiring a specific informed consent, whereas placing a neonate on extracorporeal membrane oxygenation would generally require specific informed consent. It is the procedures in the “gray” area that require definition by the facility and individual unit as standard or otherwise. Both a lumbar puncture and the percutaneous placement of a central venous catheter may be considered standard routine procedures in a critical care unit. However, on a general pediatric ward, the percutaneous placement of a central close-up venous line might require specific informed consent.
- Specific informed consent: The parent or guardian must recognize that beyond the routine medical care provided in a neonatal intensive care unit (NICU), there are specialized medical and surgical procedures that require that they be provided with specific additional information. This information will assist them in determining whether they should consent to the recommended procedure(s) on behalf of their infant. For each such procedure, a written description or an oral description documented in the patient's chart, describing the procedure and the risks and benefits of performing the procedure versus another procedure versus not performing the procedure should be provided.
- The person obtaining the informed consent should understand the following general concepts.
- Coercion or undue influence:The health care provider has a duty to ensure that the parent or guardian voluntarily assents to permit the treatment or clinical research. Implied threats (such as the unintended impression that the quality of the health care provided by the team to the infant will be less if the procedure is refused), or inducements (no matter how apparently insignificant, e.g., the offer of a transport subsidy contingent on their agreement to the procedure) have the potential to influence the decision and are unacceptable.
- Mental capacity of the parent or guardian:The parent or guardian is presumed to be competent and have the capacity to understand the medical information, to remember that information, and to make logical inferences and conclusions from the information. If there is a definite indication that the parent or guardian is not competent, then the health care provider should not accept consent. At that time, the hospital attorney and the local court may become intimately involved in the case.
- The level of understanding of the parent or guardian:The information must be provided in language that the parent or guardian can understand. A qualified medical interpreter should be available if English is not the parent or guardian's first language; use of untrained personnel may lead to miscommunication.
- The risk/benefit for a given therapeutic intervention:The parent or guardian must be provided with information regarding the frequency and severity of the adverse potential consequences as compared to the likelihood, duration, and degree of anticipated benefit from the treatment(s). Where relevant benefits are questionable, the option of no treatment should also be discussed.
- Information overload:There are circumstances in which too much information may prevent the parent or guardian from making a decision. The parent or guardian may become overwhelmed with the options or potential adverse consequences and be unable to make any decision. Thus, the health care
provider is not obliged to detail every statistically possible complication, even though highly unlikely (e.g., the possibility of exsanguination from an umbilical line in an infant with normal coagulation status).
- The limits of medical confidentiality:Current legal, medical, policy, and social considerations suggest that an informed consent contract with a parent or guardian needs to be defined in terms of relative rather than absolute confidentiality. Local, state, or federal regulations and laws may permit or require the reporting of medical and other information to third parties (e.g., state and federal law enforcement agencies, state and federal health agencies, insurance companies).
- The duty to warn and protect:A health care professional may have an ethical or legal duty to warn identifiable individual(s) that they have been or may have been exposed to disease or violence (contact tracing). There are some states that forbid physicians from notifying the sexual partners of patients infected with the human immunodeficiency virus (HIV). However, although the health care provider cannot force the infant's mother to inform the infant's biological father that she is infected with HIV, the health care provider can inform the infant's father that the infant is infected, regardless of whether the parents are married, especially if the father will be involved in raising the child and therefore needs to know about universal precautions.
- Duty to impute consent:There is a long-standing general medical principle that informed consent may be imputed to an unconscious accident victim who has a life-threatening condition that requires surgery. In an emergency, such rational behavior can also be imputed to the “absent parent” of an infant. When time allows, prior consultation with the hospital administration and/or hospital attorney is recommended in matters involving infants whose parents or guardians are not available or who are unable to make the necessary acute or long-term medical decisions concerning the infant. In such instances, the hospital may be forced to petition the court to appoint a legal guardian. The court may accept its historic role of parens patriae(substitute parent) and make such an appointment (22).
- Court petitions for guardianship:The court can be petitioned for the appointment of a temporary legal guardian, if the parents are unavailable or unwilling to consent to a routine medical treatment such as a life-saving blood transfusion (even if the refusal is based on sincere religious convictions such as those held by Jehovah's Witnesses ). If the parents are unavailable and a reasonable attempt has been made to contact them, then continuing to withhold the emergency treatment because of the failure to obtain their consent may be a basis for malpractice liability. Involvement of hospital administrative personnel and legal consultation may be advisable in such circumstances.
- All parties must understand the basic elements of informed consent as it pertains to neonates (13,14,16,17 and 18,20,21,22 and 23
- A clear and easily understandable description of the diagnosis, the procedure, and an explanation of why the procedure is necessary for the treatment of the neonate and what may occur if the procedure is not performed.
- A clear and easily understandable description of the reasonably foreseeable risks or discomforts.
- A clear and easily understandable description of the benefits to the neonate. In the case of participation in a research protocol, the informed consent must contain a statement that there may be no benefit to the infant or the family.
- A disclosure of appropriate alternative procedures or course(s) of treatment, if any, that might be advantageous to the neonate. This should include a description of what will happen to the neonate if the procedure is not performed.
- A statement describing the extent, if any, to which the records will be protected and whether the research subjects or their parent or guardian can be identified from the medical records during or after the conclusion of the research. The statement should also indicate that research records may be inspected by the FDA and other federal agencies.
- A statement defining who can be contacted for additional information about the treatment procedure(s).
- The signature of the health care provider who has discussed the contents of the informed consent with the parent or guardian and the signature of the parent or guardian, dated and usually witnessed by at least one person.
- In addition to a signed informed consent form, the author recommends that the health care provider write a note in the patient's chart indicating that the critical elements contained in the informed consent were explained to the parent or guardian. This note
should also include the name(s) of those who signed and witnessed the consent. The most important aspect of an informed consent is the process of communication; the hospital chart note is simply a record that such communication has occurred. It documents the major issues that have been discussed. The more significant the illness, the greater the risks of the procedure or not performing the procedure; the more information that needs to be conveyed to the treatment decision maker, the greater is the amount of detail that should appear in the medical chart.
- In instances in which written consent cannot be directly obtained, consent may be obtained by telephone. In such an instance, a copy of the consent form, co-signed by any witness(es) (at least one) who heard the explanation and the consent being given, should be legally sufficient. A separate note in the patient's chart should also document the parties involved in the informed consent process and the general content of the material provided to the parent or guardian during the telephone conversation.
- The individual who provides the necessary details of the planned procedure must be competent to communicate the necessary information adequately to all concerned.
- The health care provider who is going to perform or direct the therapeutic intervention is in the best position to obtain informed consent.
- Consent can be obtained by anyone with the necessary training to understand and explain the details of the procedure and the relevant risks.
- Allocation of scarce and costly medical resources has become a function of availability of the resources as well as financial accessibility to those resources. Third party payers such as insurance companies and health maintenance organizations (HMOs) have altered the manner in which medical treatment decisions are perceived to be made and actually are made (24,25). Under the “managed care” system, an individual or family may wish a particular procedure to be performed (e.g., the placement of a gastrostomy tube to facilitate home or institutional care), but the procedure will not be performed unless it is either approved by the third-party payer or, if disapproved, the family members or others agree to pay for it. Thus, the treating physician may also be required to obtain “informed consent” from the third-party payer as health care advocate for the patient. Thus, the individual responsible for obtaining consent for a procedure must be capable of gaining the trust of those to whom he presents information.
- Policy and Regulatory Issues
- Medical records
The U.S. federal government has enacted the Health Insurance Portability and Accountability Act (HIPPA), which is administered, in large part, by the Department of Health and Human Services (DHHS), and specifically recognizes that the manner in which medical records are kept has evolved from handwritten notes maintained in filing cabinets in individual practitioners' offices to electronic databases that can be instantaneously shared with health care providers, vendors of health services, insurance companies, and employers. Patient privacy issues have become a national concern and appear to require national legislation and enforcement to ensure adequate protection. Disclosure of identifiable information, it is recommended, should be limited to the “minimum necessary to accomplish the purpose of the disclosure and should be used within an organization only for the purposes for which the information was collected (26).” However, there is a need for a pragmatic balance; health information has to be accessible to public health and emergency medical services.
Medical records pertaining to the care and treatment of infants present several unique problems. The patient is not competent to provide informed consent or restrict access to the records. Guardians or parents may not be in agreement as to the nature and extent of the treatment or who should have access to medical records. Regardless of who has the legal responsibility for providing that authorization for access, treating health care providers, in general, are presumed to have access to their patient's records. A requirement for a signed consent for a routine referral can impair care by delaying consultation and referral. Thus, a physician may refer a patient to another physician (at another medical facility, including a hospital or HMO) without a specific requirement for a release of medical information form.
The Uniform Health Care Information Act permits disclosure “to a person who is providing health care to the patient (27).” Of note, diagnostic interpretation of radiographic and other studies, through the use of telemedicine consultations, would appear to be covered under any statutes designed to protect medical confidentiality without compromising medical care.
Telemedicine and in-hospital consultations are conceptually similar.
The Health Insurance Portability and Accountability Act (HIPAA) of 1996 (28), required the Department of Health and Human Services (HHS) to put forth national standards for electronic health care transactions in such a manner as to prevent the erosion of the privacy of health information. However, the Law and the associated Regulations are not designed to impede the transfer of critical medical information via any media (verbal, written, or electronic) in the case of a serious or life-threatening condition. In other words, the law does not contemplate or require a delay in life-saving or other significant treatment because all the paperwork has not been properly completed. Some States have enacted “patient bill of rights” legislation to protect the rights and needs of those who may not be able to protect themselves. If the state law is more restrictive than HIPAA, it will have precedence. When it comes to interpreting state and federal laws and regulations and guidelines, it is advisable to contact the hospital legal department.
- Medical confidentiality
Patient-identifiable information should not be disclosed except as authorized by the patient or his or her guardian or as explicitly required by law. Security measures should be implemented to protect patient information against reasonably anticipated threats. Locking doors and cabinets at the end of a business day, limiting access to those who actually need to know about a given patient, and not discussing a patient by name or other identifiable characteristic in a public place continue to be part of the common-sense approach to medical confidentiality.
While disclosures of identifiable information should be limited to the minimum necessary to accomplish the purpose of the disclosure, restricting information excessively may interfere with the diagnosis, treatment, and management of the patient. Parents and guardians should understand that, in a hospital or medical center setting, ready access to patient information is, of necessity, less restricted than it is in an individual clinician's office. For example, professional staff, unknown to the family, may have access to medical records for purposes of consultation or quality assurance. In addition, the tracking of medical pharmaceuticals and medical devices, legislated and required by the Federal Food, Drug and Cosmetic Act and enforced by the FDA (29), requires that physicians report information—sometimes including patient identities—to device manufacturers (30). Does the failure to provide adequate information risk compromising patient care? This is the primary question to consider in making a decision to withhold or communicate critical and sensitive medical information.
- Unresolved Problems
- When emotional stability, maturity, or sobriety (intoxication, regardless of the nature of the psychoactive substance) is an issue in obtaining informed consent for treatment, the physician has a duty to inform a third party (the hospital legal department and the hospital department of social services) and to document his or her actions in the medical record.
- Generally, if the parents are not legally married, the informed consent of the mother is considered more substantive than that of the father. Grandparents may advise the neonate's mother, but they cannot overrule her decision unless they have legal custody of the infant. When the parents are married and they are in conflict as to the course of action to be taken, both parents' consent should be obtained before proceeding. If there is no agreement, and the issue is substantive, the hospital attorney should be consulted.
- A nonpregnant teenager, living at home and attending school, is not considered emancipated. She may not have the right, under law, to make the ultimate decisions about some aspects of her own medical care. A teenager becomes emancipated when she reaches the age of majority (in most states, age 18 years), is a member of the armed forces, is living away from home and supporting herself economically, or can otherwise demonstrate financial independence from her family to the court. However, regardless of age and financial independence, once her child is born, she has the legal right, in almost all states, to make medical decisions for her child. Thus, a 13- or 14-year-old unwed mother usually has the ultimate legal and moral responsibility for the care of her child unless the court is successfully petitioned for the transfer of custody (including medical decision-making authority) to a third party such as a relative or other court-appointed guardian.
- Darling v. Charleston Community Memorial Hospital, 33 Ill.2d 326, 211 N.E.2d (1965); cert. denied, 383 U.S. 946 (1966).
- 51 Fed. Reg. 22,010 (June 17, 1986).
- 42 C.F.R. 403 et seq. (2004) (Medicare Conditions of Participation for Hospitals).
- Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), cert. denied, 409 U.S. 1064 (1972).
- Cooper v. Roberts, 286 A.2d 647, 650 (1971).
- Davis v. Wyeth, 399 F.2d 121 (9th Cir. 1968).
- Getchell v. Mansfield, 260 Or. 174, 489 P.2d 953 (1971).
- Levine RJ.Informed consent: some challenges to the universal validity of the western model. Law Med Health Care. 1991;19:207.
- Levine RJ.Ethics and Regulation of Clinical Research. 2nd ed. Baltimore: Urban & Schwarzenberg; 1986.
- Schloendorf v. Society of New York Hospital, 149 A.D. 415, 133 N.Y.S. 1143 (1912), affirmed Schloendorf v. Society of New York Hospital, 211 N.Y. 125, 105 N.E. 92 (1914).
- Ingelfinger F.Informed (but uneducated) consent. N Engl J Med. 1972;287:465.
- Zebarth v. Swedish Hospital Medical Center, 81 Wash.2d 12, 499 P.2d 1 (1972).
- Keeton WP, Dobbs DB, Keeton RE, et al., eds. Prosser & Keeton on Torts.5th ed. St. Paul, MN: West; 1984:114.
- Ginzburg HM, MacDonald MG.Law quality assurance, and risk management in the practice of neonatology. In: MacDonald MG, Mullett MD, Sechia MMK, eds. Neonatology: Pathophysiology and Management. 6th ed. Philadelphia: Lippincott Williams & Wilkins; 2005:89–110.
- Markowitz—. Arizona Parks Board, 146 Ariz. 352, 706 P.2d 365 (1985).
- Ginzburg HM.Protection of research subjects in clinical research. In: Vevaina JR, Bone RC, Kassoff E, eds. Legal Aspects of Medicine. New York: Springer-Verlag; 1989:51–60.
- 45 C.F.R. part 46.
- 20 C.F.R. part 50 (Protection of Research Subjects) and part 56 (Institutional Review Boards).
- Division of Human Subject Protections, Office of Protections from Research Risks.Findings and required actions regarding investigation of noncompliance with HHS regulations for the protection of human subjects involving the National Institutes of Health Intramural Research Program, July 3, 1991.
- 45 C.F.R. 46.201 et seq.
- 45 C.F.R. 46.401 et seq.
- Application of President and Directors of Georgetown College, 331 F.2d 1000, rehearing denied, Application of President and Directors of Georgetown College, 331 F.2d 1010, and cert. denied, Jones v. President and Directors of Georgetown College, Inc., 377 U.S. 978 (1964).
- Reiser SJ, Dyck AJ, Curran WJ.Ethics in Medicine: Historical Perspectives and Contemporary Concerns. Cambridge: MIT Press; 1977.
- Berwick DM.Part 5: payment by capitation and the quality of care. N Engl J Med. 1996;335:1227.
- Pegram v. Herdrich, 154 F.4d 362, reversed (98-1949).
- Recommendations of the Secretary of Health and Human Services, Pusuant to Section 264 of the Health Insurance Portability and Accountability Act of 1996.
- 45 CFR Parts 160–164.
- Public Law 104-191, specifically, 45 CFR Part 160 and Subparts A and E of Part 164.
- 21 U.S.C. §§301 et seq., Federal Food, Drug, and Cosmetic Act.
- 21 U.S.C. §360i, Federal Food, Drug, and Cosmetic Act.