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Running head: INFORMED CONSENT 1
Informed Consent In Emergency Situations
Course Project Final
Dave Rennalls
William woods University
April 13, 2013
INFORMED CONSENT 2
Informed Consent In Emergency Situations
INTRODUCTION
In healthcare, the Legal and Regulatory issues involve a complex interaction of laws,
rules, regulations and guidelines to which all healthcare professionals are expected to understand
and must follow. Its purpose is to achieve an efficient and effective healthcare system as well as
to protect the rights of all parties involved in that system. Even though they’re many situations
that generate both legal and ethical dilemmas to which the interplay of law and healthcare
practices serves as a tool for its resolution, there is one situation where a resolution may or may
not lead to a desired result despite all efforts involved. This aspect of the legal and regulatory
issues in healthcare involves acquiring “Informed Consent in Emergency Situations”.
What is Informed Consent? According to McWay (2010), informed consent is “The legal
doctrine that requires the healthcare provider to disclose information to the patient about
treatment options and risks so that the patient may knowledgably consent to treatment” (p.410).
This is a doctrine with involves shared decision making where both the patient and the healthcare
provider are a part of. As patients possess a limited understanding of medicine, it is expected that
the healthcare provider discloses sufficient information by explaining complex medical
procedures enough for the patient to understand and therefore make informed decisions based on
their understanding. In emergency situations, this doctrine may not be easily applied which
causes the potential risk of liability against the healthcare provider. The legal implications,
protection and the advantages and disadvantages of that protection surrounding this situation will
be discussed in the hope to establish the relevance of this aspect of the issue as it relates to
providing better service in Healthcare.
INFORMED CONSENT 3
DOCTRINE OF INFORMED CONSENT
HISTORICAL DEVELOPMENT & SCOPE OF DOCTRINE
In understanding the nature of the doctrine of informed consent, an examination of its
origin will reveal how this concept came to being and how it impacts healthcare in terms of the
practices of providing quality care to patients from the healthcare provider.
The doctrine of informed consent is supported on the ethical concept of autonomy where
during the 1900s, the issue of acquiring consent from patients wasn’t a priority provided that
physicians sole duty is to treat patients whether they approve of not. It was the thinking that this
is in the patient’s best interest since physician know more about their medical condition. As a
result of this, a number of cases were presented to the courts as battery lawsuits against the
healthcare providers where patients never got the opportunity to exercise their autonomy to
decide. Over the years, the basis of lawsuits concerning battery cases changes from the issue of
giving patient’s consent to the patient’s understanding of the details, risks and/or alternatives of
the medical treatment. This is where the change from the known battery theory used in lawsuits
has been refined to negligence principles to which the consent concept was added. This resulted
in a separate legal theory of “Informed Consent” to which negligence became its grounding
principle.
As the evolution in healthcare progressed, aspect of this doctrine manifests in not only
standard clinical treatments but also in biomedical research where ethical issue arises as to the
patient’s involvement in any treatment or research. The evolution of this doctrine is influenced
by advancement of technology and medicine where changes in research ethics fuels further
changes in medicine and technology. Earlier cases such as the Nuremburg Medical Tribunal
conducted in 1947 where 16 individuals were found guilty of abuses under the cover of medical
INFORMED CONSENT 4
research during the Holocaust of World War II. This is one of many cases in history that
according to Informed consent background (2013), “influence the development and regulation of
informed consent processes. The discovery of unethical research and the public outcry
contributed to the institution of informed consent policies in research.”(p.6). Also, according to
Informed consent background (2013), “One result of the trials was the 1947 establishment of the
Nuremberg Code, which stresses the necessity of informed consent to research.”(p.6).
Furthermore, many other cases over the years such as the Syphilis Study conducted in Tuskegee,
Alabama in 1932, the U.S. Public Health Service sexually transmitted disease studies are
conducted in Guatemala between 1946-1948, the 1962 Thalidomide tragedy and others have
paved the way over the years to establish necessary evolving conceptions of informed consent
practices to match the consequences of medical and technological advancements. A full
description of the historical development can be referenced under Informed consent background
on Timeline, between pages 7 to 9.
As to the extent of how informed consent practices is measured in our present day, the
scope of informed consent involves the level of disclosure that the healthcare provider supplies
to the patient given the situation that require informed consent and the individual who consents
to treatment. It is reported that often times in medical malpractice cases has an uncertain “grey”
area as to the exact scope to with the healthcare provider discloses the benefits and/or risk of
medical procedures and alternatives. These are situations that sometimes occur as a result of the
healthcare provider’s failure to determine if the patient is competent under law to give consent or
to determine that the situation is an emergency or not an emergency to which both option can
produce liability to the healthcare provider if he/she makes an incorrect determination of that
situation. Currently as a standard, the law involving this doctrine is measured by the duty of
INFORMED CONSENT 5
disclosure where they’re approached from the perspective of both the healthcare provider and the
patient. As to the disclosure of patient health information (PHI), the scope of informed consent
has it limits where the doctrine doesn’t directly determine the disclosure of PHI. According to
Hanks T. (2001), “Consent must refer to the covered entity's notice of privacy practices and must
inform the patient of his or her right to review the notice before signing the consent. However,
the consent does not need to specify the PHI used or disclosed, or the recipients of the PHI.” (p.
9).
LEGAL AND REGULATORY ISSUES
INFORMED CONSENT 6
EMERGENCY SITUATIONS
Given the nature of the doctrine of informed consent and how it’s developed and applied
in the healthcare system, there is an exception to the rule where there’s difficulty applying
informed consent to situations where the patient lacks or completely looses his/her ability to self-
determine the decision to grant consent to the healthcare provider after understanding the
treatment involved. These situations are emergency situations which are governed under specific
conditions to define the nature of how the healthcare provider applies medical treatment to the
patient without consent. These conditions are noted under law for the courts to determine if a
lawsuit is justified related to an alleged emergency situation. According to Informed
consent:What must a physician disclose to a patient? (2012), “The courts have noted two
additional exceptions to the requirement that physicians elicit and document informed consent.
The first applies when both (1) the patient is unconscious or otherwise incapable of consenting
and (2) the benefit of treating the patient outweighs any potential harm of the treatment. Under
these circumstances, the physician is not required to obtain informed consent before treating, but
must do so as soon as it is medically possible”. This is a situation where the healthcare provider
acts under presumed consent which has a legal and ethical precedence. Furthermore, according
to Informed consent:What must a physician disclose to a patient? (2012), “an exception applies
when the disclosure of medical information would pose a threat to the patient where for example,
a patient has become so emotionally distraught that he or she would become incapable of making
a rational decision, courts generally do not require disclosure”. These conditions provide
guidelines as to the procedure of how to act in emergency situations where informed consent
cannot be given. The legal implications involved in this situation deals with the facts mentioned
earlier where by law, these exceptions takes precedence in establishing legal procedures for
INFORMED CONSENT 7
similar cases involving emergency situations like these and the formulation of a law to protect
healthcare providers from liability when they justifiably act in good conscience (volunteer aid
with no motive involved) and within the rule and regulation of standard medical practice.
In terms of legal protection, the legal term “Good Samaritan” refers to, according to
Good samaritans law & legal definitions.(2015), “someone who renders aid on a voluntary basis
in an emergency to an injured person”. The concept of this legal term is then applied as a law to
ensure the protection of healthcare providers from liability as a result of negligence lawsuits. As
this law provides immunity in some states, there are others that don’t provide that protection
when a negligence lawsuit is filed against a healthcare provider. The main advantage this law
provides is legal recourse in which health and emergency professionals get immunity from
liability resulting from rendering emergency medical care based on certain condition being met.
According to Good samaritans law & legal definitions.(2015), “ two conditions usually must be
met; 1) the aid must be given at the scene of the emergency, and. 2) if the "volunteer" has other
motives, such as the hope of being paid a fee or reward, then the law will not apply.” Another
advantage deals with encouraging help where the law ensures that people who are injured and in
need of help receive the help that they require. The main disadvantage deals with the expectation
of the healthcare provider to render his/her expertise in the course of applying medical treatment.
It is expected that certain errors shouldn’t appear in the course of treatment which may cause
further harm to the patient. If they occur, the healthcare provider is subject to liability resulting
from a negligence lawsuit. Another disadvantage deals with the misinterpretation of the law
where some healthcare providers may believe that the law guards them is situations to which
they act with good intentions. Instead, this may convince some of them to assist in that manner
which may leave them open to liability.
INFORMED CONSENT 8
A known case that involves informed consent in emergency situations is the case of
Barnett vs. Bacharach in which this case involves a female patient where according to Hartman
(1999). “A patient who complained of abdominal pains was diagnosed with a tubal pregnancy.
The patient consented to undergo surgery only for the removal of the ectopic pregnancy. On
incision, however, the surgeon discovered that the patient did not have an ectopic pregnancy but
the symptoms were instead from acute appendicitis. The surgeon determined that, in the best
interest of the patient, the appendix should be removed, and an appendectomy was performed.
Following the patient’s uneventful recovery, the patient refused to pay for the surgical services
provided because informed consent was not first obtained and thus the procedure was
unauthorized. At trial, the court found that the surgeon acted properly because of the seriousness
of the patient’s condition”. The exception to informed consent is illustrated where according to
Hartman (1999), “the court held that, in a medical emergency in which the patient lies
unconscious on the operating table, the surgeon may lawfully carry out the duties of a physician
in the best interest of the patient even if these duties entail the performance of a procedure that
was not originally contemplated”. Given the court’s decision, it is important to establish the
situation as an emergency to set precedence for all healthcare providers in a similar situation.
INFORMED CONSENT 9
CONCLUSION
After reflecting on the details of the evolution of doctrine of informed consent using
historical events and the scope of how it currently impacts healthcare as well as the issues
involved as an exception in emergency situations, this is one of many concepts that provide a
foundation for establishing equitable laws, rules, regulations and procedures in the advent of
Biomedical research and medical practices. It is the hope that all parties involved gain the
understanding of this aspect of the legal and regulatory issue in healthcare from an ethical
perspective where better decisions are made for the benefit of mankind.
INFORMED CONSENT 10
References
Good samaritans law & legal definitions. (2015). Retrieved from USLegal.com website:
http://definitions.uslegal.com/g/good-samaritans/
Hanks, T. (2001). HHS privacy guidance establishes policy for protecting patient information.
Journal of Health Care Compliance, 3(6), 8-62. Retrieved from Health Policy Reference
Center database. (Accession No. 7114233)
Hartman, K. M., & Liang, B. A. (1999). Exceptions to informed consent in emergency medicine.
Retrieved from Perspectives in Legal Medicine and Health Law website:
http://www.turner-white.com/pdf/hp_mar99_emergmed.pdf
Informed consent background. (n.d.). Retrieved September 6, 2013, from Presidential
Commission for the Study of Bioethical Issues website:
http://www.bioethics.gov/sites/default/files/Informed%20Consent%20Background%2009
0413.pdf
Informed consent requirements in emergency research. (1996, October 31). Retrieved from
HHS.gov U.S. Department of Health & Human Services website:
http://www.hhs.gov/ohrp/policy/hsdc97-01.html
Informed consent:What must a physician disclose to a patient? (2012, July). Retrieved from
American Medical Association: AMA Journal of Ethics website:
http://journalofethics.ama-assn.org/2012/07/hlaw1-1207.html
McWay, D. C. (2010). Legal and ethical aspects of health information management (3rd ed.).
New York, NY: Cengage Learning.

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Dave Rennalls Course Project Final

  • 1. Running head: INFORMED CONSENT 1 Informed Consent In Emergency Situations Course Project Final Dave Rennalls William woods University April 13, 2013
  • 2. INFORMED CONSENT 2 Informed Consent In Emergency Situations INTRODUCTION In healthcare, the Legal and Regulatory issues involve a complex interaction of laws, rules, regulations and guidelines to which all healthcare professionals are expected to understand and must follow. Its purpose is to achieve an efficient and effective healthcare system as well as to protect the rights of all parties involved in that system. Even though they’re many situations that generate both legal and ethical dilemmas to which the interplay of law and healthcare practices serves as a tool for its resolution, there is one situation where a resolution may or may not lead to a desired result despite all efforts involved. This aspect of the legal and regulatory issues in healthcare involves acquiring “Informed Consent in Emergency Situations”. What is Informed Consent? According to McWay (2010), informed consent is “The legal doctrine that requires the healthcare provider to disclose information to the patient about treatment options and risks so that the patient may knowledgably consent to treatment” (p.410). This is a doctrine with involves shared decision making where both the patient and the healthcare provider are a part of. As patients possess a limited understanding of medicine, it is expected that the healthcare provider discloses sufficient information by explaining complex medical procedures enough for the patient to understand and therefore make informed decisions based on their understanding. In emergency situations, this doctrine may not be easily applied which causes the potential risk of liability against the healthcare provider. The legal implications, protection and the advantages and disadvantages of that protection surrounding this situation will be discussed in the hope to establish the relevance of this aspect of the issue as it relates to providing better service in Healthcare.
  • 3. INFORMED CONSENT 3 DOCTRINE OF INFORMED CONSENT HISTORICAL DEVELOPMENT & SCOPE OF DOCTRINE In understanding the nature of the doctrine of informed consent, an examination of its origin will reveal how this concept came to being and how it impacts healthcare in terms of the practices of providing quality care to patients from the healthcare provider. The doctrine of informed consent is supported on the ethical concept of autonomy where during the 1900s, the issue of acquiring consent from patients wasn’t a priority provided that physicians sole duty is to treat patients whether they approve of not. It was the thinking that this is in the patient’s best interest since physician know more about their medical condition. As a result of this, a number of cases were presented to the courts as battery lawsuits against the healthcare providers where patients never got the opportunity to exercise their autonomy to decide. Over the years, the basis of lawsuits concerning battery cases changes from the issue of giving patient’s consent to the patient’s understanding of the details, risks and/or alternatives of the medical treatment. This is where the change from the known battery theory used in lawsuits has been refined to negligence principles to which the consent concept was added. This resulted in a separate legal theory of “Informed Consent” to which negligence became its grounding principle. As the evolution in healthcare progressed, aspect of this doctrine manifests in not only standard clinical treatments but also in biomedical research where ethical issue arises as to the patient’s involvement in any treatment or research. The evolution of this doctrine is influenced by advancement of technology and medicine where changes in research ethics fuels further changes in medicine and technology. Earlier cases such as the Nuremburg Medical Tribunal conducted in 1947 where 16 individuals were found guilty of abuses under the cover of medical
  • 4. INFORMED CONSENT 4 research during the Holocaust of World War II. This is one of many cases in history that according to Informed consent background (2013), “influence the development and regulation of informed consent processes. The discovery of unethical research and the public outcry contributed to the institution of informed consent policies in research.”(p.6). Also, according to Informed consent background (2013), “One result of the trials was the 1947 establishment of the Nuremberg Code, which stresses the necessity of informed consent to research.”(p.6). Furthermore, many other cases over the years such as the Syphilis Study conducted in Tuskegee, Alabama in 1932, the U.S. Public Health Service sexually transmitted disease studies are conducted in Guatemala between 1946-1948, the 1962 Thalidomide tragedy and others have paved the way over the years to establish necessary evolving conceptions of informed consent practices to match the consequences of medical and technological advancements. A full description of the historical development can be referenced under Informed consent background on Timeline, between pages 7 to 9. As to the extent of how informed consent practices is measured in our present day, the scope of informed consent involves the level of disclosure that the healthcare provider supplies to the patient given the situation that require informed consent and the individual who consents to treatment. It is reported that often times in medical malpractice cases has an uncertain “grey” area as to the exact scope to with the healthcare provider discloses the benefits and/or risk of medical procedures and alternatives. These are situations that sometimes occur as a result of the healthcare provider’s failure to determine if the patient is competent under law to give consent or to determine that the situation is an emergency or not an emergency to which both option can produce liability to the healthcare provider if he/she makes an incorrect determination of that situation. Currently as a standard, the law involving this doctrine is measured by the duty of
  • 5. INFORMED CONSENT 5 disclosure where they’re approached from the perspective of both the healthcare provider and the patient. As to the disclosure of patient health information (PHI), the scope of informed consent has it limits where the doctrine doesn’t directly determine the disclosure of PHI. According to Hanks T. (2001), “Consent must refer to the covered entity's notice of privacy practices and must inform the patient of his or her right to review the notice before signing the consent. However, the consent does not need to specify the PHI used or disclosed, or the recipients of the PHI.” (p. 9). LEGAL AND REGULATORY ISSUES
  • 6. INFORMED CONSENT 6 EMERGENCY SITUATIONS Given the nature of the doctrine of informed consent and how it’s developed and applied in the healthcare system, there is an exception to the rule where there’s difficulty applying informed consent to situations where the patient lacks or completely looses his/her ability to self- determine the decision to grant consent to the healthcare provider after understanding the treatment involved. These situations are emergency situations which are governed under specific conditions to define the nature of how the healthcare provider applies medical treatment to the patient without consent. These conditions are noted under law for the courts to determine if a lawsuit is justified related to an alleged emergency situation. According to Informed consent:What must a physician disclose to a patient? (2012), “The courts have noted two additional exceptions to the requirement that physicians elicit and document informed consent. The first applies when both (1) the patient is unconscious or otherwise incapable of consenting and (2) the benefit of treating the patient outweighs any potential harm of the treatment. Under these circumstances, the physician is not required to obtain informed consent before treating, but must do so as soon as it is medically possible”. This is a situation where the healthcare provider acts under presumed consent which has a legal and ethical precedence. Furthermore, according to Informed consent:What must a physician disclose to a patient? (2012), “an exception applies when the disclosure of medical information would pose a threat to the patient where for example, a patient has become so emotionally distraught that he or she would become incapable of making a rational decision, courts generally do not require disclosure”. These conditions provide guidelines as to the procedure of how to act in emergency situations where informed consent cannot be given. The legal implications involved in this situation deals with the facts mentioned earlier where by law, these exceptions takes precedence in establishing legal procedures for
  • 7. INFORMED CONSENT 7 similar cases involving emergency situations like these and the formulation of a law to protect healthcare providers from liability when they justifiably act in good conscience (volunteer aid with no motive involved) and within the rule and regulation of standard medical practice. In terms of legal protection, the legal term “Good Samaritan” refers to, according to Good samaritans law & legal definitions.(2015), “someone who renders aid on a voluntary basis in an emergency to an injured person”. The concept of this legal term is then applied as a law to ensure the protection of healthcare providers from liability as a result of negligence lawsuits. As this law provides immunity in some states, there are others that don’t provide that protection when a negligence lawsuit is filed against a healthcare provider. The main advantage this law provides is legal recourse in which health and emergency professionals get immunity from liability resulting from rendering emergency medical care based on certain condition being met. According to Good samaritans law & legal definitions.(2015), “ two conditions usually must be met; 1) the aid must be given at the scene of the emergency, and. 2) if the "volunteer" has other motives, such as the hope of being paid a fee or reward, then the law will not apply.” Another advantage deals with encouraging help where the law ensures that people who are injured and in need of help receive the help that they require. The main disadvantage deals with the expectation of the healthcare provider to render his/her expertise in the course of applying medical treatment. It is expected that certain errors shouldn’t appear in the course of treatment which may cause further harm to the patient. If they occur, the healthcare provider is subject to liability resulting from a negligence lawsuit. Another disadvantage deals with the misinterpretation of the law where some healthcare providers may believe that the law guards them is situations to which they act with good intentions. Instead, this may convince some of them to assist in that manner which may leave them open to liability.
  • 8. INFORMED CONSENT 8 A known case that involves informed consent in emergency situations is the case of Barnett vs. Bacharach in which this case involves a female patient where according to Hartman (1999). “A patient who complained of abdominal pains was diagnosed with a tubal pregnancy. The patient consented to undergo surgery only for the removal of the ectopic pregnancy. On incision, however, the surgeon discovered that the patient did not have an ectopic pregnancy but the symptoms were instead from acute appendicitis. The surgeon determined that, in the best interest of the patient, the appendix should be removed, and an appendectomy was performed. Following the patient’s uneventful recovery, the patient refused to pay for the surgical services provided because informed consent was not first obtained and thus the procedure was unauthorized. At trial, the court found that the surgeon acted properly because of the seriousness of the patient’s condition”. The exception to informed consent is illustrated where according to Hartman (1999), “the court held that, in a medical emergency in which the patient lies unconscious on the operating table, the surgeon may lawfully carry out the duties of a physician in the best interest of the patient even if these duties entail the performance of a procedure that was not originally contemplated”. Given the court’s decision, it is important to establish the situation as an emergency to set precedence for all healthcare providers in a similar situation.
  • 9. INFORMED CONSENT 9 CONCLUSION After reflecting on the details of the evolution of doctrine of informed consent using historical events and the scope of how it currently impacts healthcare as well as the issues involved as an exception in emergency situations, this is one of many concepts that provide a foundation for establishing equitable laws, rules, regulations and procedures in the advent of Biomedical research and medical practices. It is the hope that all parties involved gain the understanding of this aspect of the legal and regulatory issue in healthcare from an ethical perspective where better decisions are made for the benefit of mankind.
  • 10. INFORMED CONSENT 10 References Good samaritans law & legal definitions. (2015). Retrieved from USLegal.com website: http://definitions.uslegal.com/g/good-samaritans/ Hanks, T. (2001). HHS privacy guidance establishes policy for protecting patient information. Journal of Health Care Compliance, 3(6), 8-62. Retrieved from Health Policy Reference Center database. (Accession No. 7114233) Hartman, K. M., & Liang, B. A. (1999). Exceptions to informed consent in emergency medicine. Retrieved from Perspectives in Legal Medicine and Health Law website: http://www.turner-white.com/pdf/hp_mar99_emergmed.pdf Informed consent background. (n.d.). Retrieved September 6, 2013, from Presidential Commission for the Study of Bioethical Issues website: http://www.bioethics.gov/sites/default/files/Informed%20Consent%20Background%2009 0413.pdf Informed consent requirements in emergency research. (1996, October 31). Retrieved from HHS.gov U.S. Department of Health & Human Services website: http://www.hhs.gov/ohrp/policy/hsdc97-01.html Informed consent:What must a physician disclose to a patient? (2012, July). Retrieved from American Medical Association: AMA Journal of Ethics website: http://journalofethics.ama-assn.org/2012/07/hlaw1-1207.html McWay, D. C. (2010). Legal and ethical aspects of health information management (3rd ed.). New York, NY: Cengage Learning.