INFORMED CONSENT

DEFINITION/INTRODUCTION
Informed consent is when a healthcare provider (like a doctor, nurse, or other healthcare
professional) explains a medical treatment to a patient before the patient agrees to it. Informed
consent is the process in which a health care provider educates a patient about the risks, benefits,
and alternatives of a given procedure or intervention.
This type of communication lets the patient ask questions and accept or deny treatment.
Informed consent is a process that’s required for most medical procedures. However, there’s
often confusion about what informed consent is, what it means, and when it’s needed.
In a healthcare setting, informed consent allows one to participate in one’s own medical care. It
enables one to decide which treatments one do or do not want to receive.
Also, informed consent allows one to make decisions with the healthcare provider. This
collaborative decision-making process is an ethical and legal obligation of healthcare providers.
In this article, we’ll help explain what informed consent is, when it’s needed, what it should
include, and why it’s important.
In a healthcare setting, the process of informed consent includes:
 Ability to decide.
 Explanation of information needed to make the decision.
 Understanding of the medical information
 Voluntary decision to get treatment.
These components are essential elements of the shared decision-making process between one and
the healthcare provider. Most importantly, it empowers one to make educated and informed
decisions about one’s health and medical care.
The patient must be competent to make a voluntary decision about whether to undergo the
procedure or intervention. Informed consent is both an ethical and legal obligation of medical
practitioners in the US and originates from the patient's right to direct what happens to their
body. Implicit in providing informed consent is an assessment of the patient's understanding,
rendering an actual recommendation, and documentation of the process. The Joint Commission
requires documentation of all the elements of informed consent "in a form, progress notes or
elsewhere in the record." The following are the required elements for documentation of the
informed consent discussion:
(1) The nature of the procedure,
(2) The risks and benefits and the procedure,
(3) Reasonable alternatives,
(4) Risks and benefits of alternatives, and
(5) Assessment of the patient's understanding of elements 1 through 4.
It is the obligation of the provider to make it clear that the patient is participating in the decision-
making process and avoid making the patient feel forced to agree to with the provider. The
provider must make a recommendation and provide their reasoning for said recommendation.
The law recognizes that a person can only legally consent to something, whether that is to allow
something to occur, or to perform some act, if that person has been informed of, and understands
the facts of the situation. It is only with a full comprehension of the risks and benefits of the

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decision, as well as an understanding of the possible alternatives, that any individual can
consider whether an action would be in his best interests.
The obtaining of informed consent is especially important in the medical field, as failing to
receive such approval leaves medical professionals liable for injuries that may occur. Informed
consent is also vital when entering a contract, as if one party is not fully informed, or if all
information has not been disclosed, that uninformed party may be able to back out of the
contract.

TYPES OF PROCEDURES NEEDING INFORMED CONSENT

The following scenarios require informed consent:
 Most surgeries
 Blood transfusions
 Anaesthesia
 Radiation
 Chemotherapy
 Some advanced medical tests, like a biopsy
 Most vaccinations
 Some blood tests, like HIV testing

ADEQUACY OF INFORMED CONSENT

The required standard for informed consent is determined by the state. The three acceptable legal
approaches to adequate informed consent are:
(1) Subjective standard: What would this patient need to know and understand to make an
informed decision?
(2) Reasonable patient standard: What would the average patient need to know to be an
informed participant in the decision?
(3) Reasonable physician standard: What would a typical physician say about this procedure?
Many states use the "reasonable patient standard" because it focuses on what a typical patient
would need to know to understand the decision at hand. However, it is the sole obligation of the
provider to determine which approach is appropriate for a given situation.

WHAT IT SHOULD INCLUDE

An informed consent agreement should include the following information:
 Diagnosis of your condition
 Name and purpose of treatment
 Benefits, risks, and alternative procedures
 Benefits and risks of each alternative
With this information, one can make an educated choice about the procedures one receives.

THE NEED TO SIGN A CONSENT FORM

When the healthcare provider recommends specific medical care, one can agree to all of it, or
only some of it.

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Before the procedure, one’ll have to complete and sign a consent form. This form is a legal
document that shows one’s participation in the decision and an agreement to have the procedure
done.
When one sign the form, it means:
 You received all the relevant information about the procedure from the healthcare
provider.
 You understand this information.
 You used this information to determine whether you want the procedure.
 You agree, or consent, to get some or all the treatment options.
Once you sign the form, the healthcare provider can move forward with the procedure.
If you don’t want a procedure or treatment, you can choose to not sign the form. The healthcare
provider won’t be able to provide specific types of treatment if you don’t agree to it.

OTHERS SIGNING A CONSENT FORM ON YOUR BEHALF

In some cases, another person can sign a consent form for you. This is appropriate in the
following scenarios:
 You aren’t of legal age. In most states, if you’re younger than 18, a parent or guardian
will need to give consent on your behalf. But some states allow teens who are
emancipated, married, parents, or in the military to provide their own consent.
 You want someone else to make the decisions. If you’d like to let another person, make
your future medical decisions, you can fill out a form called an advance directive. This
allows someone else to give consent on your behalf if you’re unable to.
 You can’t give consent. Another person can make your medical decisions if you can’t
provide consent. This may happen if you’re in a coma or have a condition like advanced
Alzheimer’s disease.
HOW INFORMED CONSENT DIFFER FROM IMPLIED CONSENT
Implied consent is a type of informed consent. This consent is suggested, or implied, by the
patient’s actions. It isn’t explicitly stated or written down.
For example, if you have a fever and see a healthcare provider, your visit implies that you want
treatment. Another example is if you break an ankle and visit a healthcare provider for crutches.
Compared to informed consent, implied consent is less formal. It doesn’t need to be legally
recorded.

OTHER WAYS IS INFORMED CONSENT CAN BE USED

Informed consent for research or clinical trials is also required. It informs the participants about
the trial and lets them make educated decisions about taking part in the study.
The process is like informed consent in healthcare.
In a research setting, it involves discussing the following:
 Purpose and procedure of the study.
 Relevant information about the study, including risks and benefits.
 Your ability to understand this information.
 Your voluntary decision to participate.

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Informed consent continues until the study is completed.

EXCEPTIONS TO INFORMED CONSENT

Several exceptions to the requirement for informed consent include:
(1) The patient is incapacitated,
(2) Life-threatening emergencies with inadequate time to obtain consent, and
(3) Voluntary waived consent.
If the patient's ability to make decisions is questioned or unclear, an evaluation by a psychiatrist
to determine competency may be requested. A situation may arise in which a patient cannot make
decisions independently but has not designated a decision-maker. In this instance, the hierarchy
of decision-makers, which is determined by each state's laws, must be sought to determine the
next legal surrogate decision-maker. If this is unsuccessful, a legal guardian may need to be
appointed by the court.

CHILDREN AND INFORMED CONSENT

Children (typically under 17) cannot provide informed consent. As such, parents must permit
treatments or interventions. In this case, it not termed "informed consent" but "informed
permission." An exception to this rule is a legally emancipated child who may provide informed
consent for himself. Some, but not all, examples of an emancipated minor include minors who
are:
(1) under 18 and married,
(2) serving in the military,
(3) able to prove financial independence or
(4) mothers of children (married or not). Legislation regarding minors and informed consent is
state based as well. It is important to understand the state laws.

INFORMED CONSENT FOR BLOOD TRANSFUSION

Informed consent is essential to patient autonomy. Informed consent requires a thorough
understanding of transfusions and the ability to convey this information to a patient in a way that
they can understand it. However, obtaining consent often has deficiencies in the explanation
where benefits may not be entirely true, and risks related are omitted. It has been shown that
involving experts from transfusion units in obtaining informed consent for transfusion results in
patients having a better understanding of the risks and benefits. However, always involving an
expert may not be the most efficient way to obtain consent, although new graduate physicians
have a knowledge deficit when it comes to transfusion medicine. However, physicians that had
previous transfusion medicine education displayed more understanding than those who did not.
As most physicians will need to obtain informed consent for a transfusion at one point in their
career, it could be argued that physicians should have enough education regarding transfusion
medicine.

INFORMED MEDICAL CONSENT

In a doctor’s office, hospital, or other medical setting, healthcare providers are required to obtain
informed medical consent before treating a patient. In general, informed medical consent means

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advising the patient of reasons the treatment is needed, the benefits of having it done, the risks of
harm that may occur, and any alternative treatments that may be considered.
There are legal requirements for obtaining informed medical consent, as well as its
documentation, though they vary from state to state. Typically, the information presented to the
patient or legal guardian must be fully understood. The patient and medical professional share
this responsibility, since the doctor does not automatically know what the patient does and does
not understand. Informed medical consent must be given willingly, as it is not valid if obtained
under pressure or duress.
In most states, it is the responsibility of the physician treating a patient to confirm that informed
consent has been obtained. When discussing the course of treatment, the physician should
disclose:
 The patient’s diagnosis
 The nature and reason for the treatment or procedure
 The benefits of the procedure or treatment
 The risks of the procedure or treatment
 The alternative treatments available
 The risks and benefits of forgoing the proposed treatment or procedure.
The patient, or legal guardian, must sign and date the informed consent documents, and be given
a copy. There are, of course, certain situation in which it is not required of healthcare
professionals to obtain consent before acting. These are considered emergency situations in
which the patient’s health or safety may be at risk if treatment is delayed because consent cannot
be obtained.
Such a situation occurs if the patient is unconscious or otherwise unable to understand or
acknowledge consent. It also applies to seriously ill or injured minor patients whose parents or
legal guardian cannot be reached beforehand. Even in emergency situations, medical personnel
are generally allowed only to provide the level of treatment that is necessary to alleviate the
worst of the problem, until proper consent can be obtained.

RISKS OF TREATMENT THAT MUST BE DISCLOSED

When obtaining informed consent, doctors do not have to inform the patient of every possible
risk, but he must advise of the important risks. In most states one of two is used to determine just
what risks are required to be disclosed.
Would other doctors disclose that risk? If a medical case becomes the subject of a civil lawsuit,
this issue will boil down to whether the undisclosed risk was statistically important enough to be
disclosed, and whether it is commonly disclosed by other doctors in similar circumstances. This
question would be answered by expert witnesses for each party, who are asked in court whether
they would have personally informed a patient of the risk in question.
Would another reasonable patient have made a different decision if informed of that particular
risk? This question could only be compared to a patient with the same medical condition and
medical history as the plaintiff, asking whether he would have made a different choice regarding
the treatment if he had been advised of that particular risk.
A valid consent form must contain the following specific elements:
 It must be written in plain language that any reasonable patient can understand.

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  It must inform the patient that his information may be used for treatment, payment, or
future care.
 It must inform the patient of his right to review the form before signing.
 It must indicate the patient’s right to request restrictions on release of his health
information.
 It must inform the patient he has a right to revoke the consent in writing, but those actions
taken prior to the signing are not subject to revocation.
 It must include the patient’s signature and date.
 The original signed form must be kept by the provider for a minimum of six years.

ENHANCING HEALTHCARE TEAM OUTCOMES

As mentioned previously, there is a deficit in providing necessary information to patients when
obtaining informed consent. Providers should be educated on common procedures and
interventions from experts and should be able to relay this information to patients as well as
other members of the healthcare team. Members of the healthcare team, such as nurses and
patient care assistants, should also be educated about all potential adverse reactions so that they
are able to identify them and notify a provider so that any immediate intervention that is needed
can be performed in a timely manner. Members of the healthcare team involved with the care of
a patient should also be informed about procedures and interventions as they may be used as
witnesses in obtaining informed consent. They would be able to evaluate whether all necessary
information was given to the patient and provide any information the provider obtaining
informed consent may have forgotten.

WHEN INFORMED CONSENT IS NOT REQUIRED

Informed consent isn’t always required in emergencies.
In an emergency, your provider may look for your closest blood relatives for consent. But if your
relatives aren’t available, or if you’re in a life-threatening situation, a healthcare provider can
perform the necessary life-saving procedures without consent.

EXAMPLES OF INFORMED CONSENT PROBLEMS

Informed consent is not just another form a patient or client needs to sign so the provider can get
on with his job. Unfortunately, in a world that relies on pages and pages of information, many of
which require a signature or acknowledgement, this has become a serious issue. The fault lies,
not only with the providers, but with the patients and clients who are unwilling to wade through a
complicated, and lengthy, document that they are unlikely to understand, before signing and
moving forward.
The following are examples of informed consent problems that commonly occur. When it comes
to providers’ responsibilities in obtaining informed consent, there are certain thinks to keep in
mind.
Method of Disclosing Risks – the most likely risks, including the most severe risks, such as
death, or brain damage, should be specifically disclosed, though a lengthy description of how
this might occur is not necessary. When providers skip through the risks, without encouraging a

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discussion about the procedure and the risks, the patient or client cannot truly give informed
consent.
Skipping the Details – a surprisingly large number of doctors and other professionals are too
casual about the details of properly obtaining informed consent. Many fail to explain the risks
with a healthcare professional present as a witness, or to have the patient and/or witness sign and
date the necessary consent forms. Doctors are also cavalier about signing the consent documents
as the treating physician or fail to fully complete the patient’s information.
Asking a Sedated Patient to Give Consent – it is not uncommon for patients to be given a mild
sedative, or a narcotic pain reliever to make them more comfortable while arrangements are
made for further treatment, such as surgery, or admission to the hospital. This makes the patient
legally incapable of giving informed consent, so consent forms should be signed prior to such
sedation, or they should be signed by the patient’s nearest relative, such as his spouse or parent.
In this case, the name and relationship should be clearly documented.
Obtaining Consent for Only One Procedure: When a Second Procedure May be Needed – if
informed consent is obtained for a procedure or surgery which may bring about additional
information that makes it necessary to do an additional procedure, the second procedure cannot
be performed without consent.
For example:
Emily has been having severe abdominal pain and bleeding, and her OB/GYN has determined
that she has fibroid tumours that must be removed. As she is being prepared for the surgery, the
staff has her sign a consent form for the fibroid removal, but there is no mention on the form of a
hysterectomy. If, while the surgeon is operating, he determines that a hysterectomy is necessary,
he has no consent for the procedure.
Doing the procedure without explicit consent exposes the doctor, and the hospital, to serious
liability if something goes wrong, or if Emily is upset because she may have chosen an
alternative treatment. If he decides not to proceed with the surgery, with the thought of
rescheduling a hysterectomy, Emily is exposed to the additional risks of another major surgery.
This example of informed consent could have been made legal had the doctor discussed the
possibility of needing to do a hysterectomy with Emily, as well as the potential risks and
alternatives beforehand. Both procedures could have been included on the consent form for
Emily’s signature.

MALPRACTICE LAWSUIT OVER FAILURE TO OBTAIN INFORMED CONSENT

In 1964, Ralph Cobbs was treated by his family doctor, Jerome Sands, for an ulcer. Even with
treatment, his symptoms worsened to the point that Dr. Sands deemed it necessary to perform
surgery, a decision which was confirmed by another doctor. Dr. Sands advised Cobbs of the
general risks of undergoing general anaesthesia for surgery, and what would be done in the
surgery, though he failed to mention risks of the surgery itself. A two-hour surgery repaired the
ulcer, though after Cobbs had been discharged eight days later, he again began having severe
abdominal pain.
Cobbs returned to the hospital and went into shock, requiring emergency surgery. He was
experiencing bleeding caused by an artery near his spleen that had been severed, and the spleen
had to be removed. There were further complications, including the too-rapid absorption of an

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internal suture, and other issues. About a month later, Cobbs experienced another gastric ulcer, so
doctors operated and removed half of his stomach.
Cobbs filed a medical malpractice lawsuit against the surgeon as well as the hospital, claiming
that the surgeon failed to inform him of the serious risks involved in the surgery on his stomach.
Cobbs claimed that, had he known of those risks and potential alternative treatments, he may had
made a different choice. At trial, the jury ruled in favour of Cobbs, awarding him over $68,000 in
damages between the hospital and doctor.
The defendants appealed the trial court’s decision on the issues of
(1) the jury’s disregard of expert testimony in determining the doctor’s actions to be negligent
(2) whether the jury had been properly instructed on the doctor’s duty to properly obtain
informed consent. The appellate court reversed the judgment of the trial court, remanding the
case to the trial court for a new trial. The appellate court specifically suggested principles for
creating guidelines in determining the issue of informed consent.

RELATED LEGAL TERMS AND ISSUES

Civil Lawsuit – A lawsuit brought about in court when one person claims to have suffered a loss
due to the actions of another person.
Damages – A monetary award in compensation for a financial loss, loss of or damage to personal
or real property, or an injury.
Defendant – A party against whom a lawsuit has been filed in civil court, or who has been
accused of, or charged with, a crime or offense.
Liable – Responsible by law; to be held legally answerable for an act or omission.
Medical Malpractice – Any unskilled, improper, or negligent treatment of a patient, or failure to
provide appropriate treatment, by a healthcare professional, which results in injury to the patient.
Plaintiff – A person who brings a legal action against another person or entity, such as in a civil
lawsuit, or criminal proceedings.

WHAT YOU NEED TO KNOW ABOUT INFORMED CONSENT

Informed consent is a process that’s required for most medical procedures. However, there’s
often confusion about what informed consent is, what it means, and when it’s needed.
In a healthcare setting, informed consent allows you to participate in your own medical care. It
enables you to decide which treatments you do or do not want to receive.
Also, informed consent allows you to make decisions with your healthcare provider. This
collaborative decision-making process is an ethical and legal obligation of healthcare providers.
In this article, we’ll help explain what informed consent is, when it’s needed, what it should
include, and why it’s important.

EXAMPLE OF INFORMED CONSENT DOCUMENT FROM THE PARAMOUNT

TRIAL
Informed consent is a principle in medical ethics and medical law and media studies, that a
patient must have sufficient information and understanding before making decisions about their
medical care. Pertinent information may include risks and benefits of treatments, alternative
treatments, the patient's role in treatment, and their right to refuse treatment. In most systems,

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healthcare providers have a legal and ethical responsibility to ensure that a patient's consent is
informed. This principle applies more broadly than healthcare intervention, for example to
conduct research and to disclose a person's medical information.
Within the US, definitions of informed consent vary, and the standard required is generally
determined by the state. Informed consent requires a clear appreciation and understanding of the
facts, implications, and consequences of an action. To give informed consent, the individual
concerned must have adequate reasoning faculties and possess all relevant facts. Impairments to
reasoning and judgment that may preclude informed consent include intellectual or emotional
immaturity, high levels of stress such as post-traumatic stress disorder or a severe intellectual
disability, severe mental disorder, intoxication, severe sleep deprivation, dementia, or coma.
Obtaining informed consent is not always required. If an individual is considered unable to give
informed consent, another person is generally authorized to give consent on their behalf—for
example, the parents or legal guardians of a child (though in this circumstance the child may be
required to provide informed assent) and conservators for the mentally disordered. Alternatively,
the doctrine of implied consent permits treatment in limited cases, for example when an
unconscious person will die without immediate intervention. Cases in which an individual is
provided insufficient information to form a reasoned decision raise serious ethical issues. When
these issues occur, or are anticipated to occur, in a clinical trial, they are subject to review by an
ethics committee or institutional review board.
Informed consent is codified in both national and international law. 'Free consent' is a cognate
term in the International Covenant on Civil and Political Rights, adopted in 1966 by the United
Nations, and intended to be in force by 23 March 1976. Article 7 of the covenant prohibits
experiments conducted without the "free consent to medical or scientific experimentation" of the
subject. As of September 2019, the covenant has 173 parties and six more signatories without
ratification.
Assessment
Informed consent can be complex to evaluate because neither expressions of consent, nor
expressions of understanding of implications, necessarily mean that full adult consent was in fact
given, nor that full comprehension of relevant issues is internally digested. Consent may be
implied within the usual subtleties of human communication, rather than explicitly negotiated
verbally or in writing. If a doctor asks a patient to take their blood pressure, for example, a
patient may demonstrate consent by offering their arm for a blood pressure cuff. In some cases,
consent cannot legally be possible, even if the person protests, he does indeed understand and
wish. There are also structured instruments for evaluating capacity to give informed consent,
although no ideal instrument presently exists.
Thus, there is always a degree to which informed consent must be assumed or inferred based
upon observation, or knowledge, or legal reliance. This especially is the case in sexual or
relational issues. In medical or formal circumstances, explicit agreement by means of signature
(normally relied on legally) regardless of actual consent, is the norm. This is the case with certain
procedures, such as a "do not resuscitate" directive that a patient signed before onset of their
illness.

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Brief examples of each of the above:
A person may verbally agree to something from fear, perceived social pressure, or psychological
difficulty in asserting true feelings. The person requesting the action may honestly be unaware of
this and believe the consent is genuine and rely on it. Consent is expressed, but not internally
given.
A person may claim to understand the implications of some action, as part of consent, but in fact
has failed to appreciate the possible consequences fully and may later deny the validity of the
consent for this reason. Understanding needed for informed consent is present but is, in fact
(through ignorance), not present.
A person signs a legal release form for a medical procedure, and later feels he did not really
consent. Unless he can show actual misinformation, the release is usually persuasive or
conclusive in law, in that the clinician may rely legally upon it for consent. In formal
circumstances, a written consent usually legally overrides later denial of informed consent
(unless obtained by misrepresentation).
Informed consent in the U.S. can be overridden in emergency medical situations pursuant to
21CFR50.24, which was first brought to the general public's attention via the controversy
surrounding the study of Polyheme.

VALID ELEMENTS
For an individual to give valid informed consent, three components must be present: disclosure,
capacity, and voluntariness.
Disclosure requires the researcher to supply each prospective subject with the information
necessary to make an autonomous decision and to ensure that the subject adequately understands
the information provided. This latter requirement implies that a written consent form be written
in lay language suited for the comprehension skills of subject population, as well as assessing the
level of understanding through conversation (to be informed).
Capacity pertains to the ability of the subject to both understand the information provided and
form a reasonable judgment based on the potential consequences of his/her decision.
As children often lack the decision-making ability or legal power (competence) to provide true
informed consent for medical decisions, it often falls on parents or legal guardians to provide
informed permission for medical decisions. This "consent by proxy" usually works reasonably
well but can lead to ethical dilemmas when the judgment of the parents or guardians and the
medical professional differ about what constitutes appropriate decisions "in the best interest of
the child". Children who are legally emancipated, and certain situations such as decisions
regarding sexually transmitted diseases or pregnancy, or for unemancipated minors who are
deemed to have medical decision-making capacity, may be able to provide consent without the
need for parental permission depending on the laws of the jurisdiction the child lives in. The
American Academy of Paediatrics encourages medical professionals also to seek the assent of
older children and adolescents by providing age-appropriate information to these children to help
empower them in the decision-making process.
Research on children has benefited society in many ways. The only effective way to establish
normal patterns of growth and metabolism is to do research on infants and young children. When
addressing the issue of informed consent with children, the primary response is parental consent.

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This is valid, although only legal guardians can consent for a child, not adult siblings.
Additionally, parents may not order the termination of a treatment that is required to keep a child
alive, even if they feel it is in the best interest. Guardians are typically involved in the consent of
children; however, several doctrines have developed that allow children to receive health
treatments without parental consent. For example, emancipated minors may consent to medical
treatment, and minors can also consent in an emergency.
Waiver of the consent requirement may be applied in certain circumstances where no foreseeable
harm is expected to result from the study or when permitted by law, federal regulations, or if an
ethical review committee has approved the non-disclosure of certain information.
Voluntariness: The person should have the power of the will or of motivation to get to act at
will. He /she should have the freedom of power to exercise, determine what to do as regarding
accepting or not.

DIRECTLY BENEFIT SUBJECTS.

Advance the development of a medical product necessary to the military.
Be carried out under all laws and regulations (i.e., Emergency Research Consent Waiver)
including those pertinent to the FDA.
While informed consent is a basic right and should be carried out effectively, if a patient is
incapacitated due to injury or illness, it is still important that patients benefit from emergency
experimentation.(better source needed) The Food and Drug Administration (FDA) and the
Department of Health and Human Services (DHHS) joined[when?] to create federal guidelines to
permit emergency research, without informed consent. However, they[who?] can only proceed
with the research if they obtain a waiver of informed consent (WIC) or an emergency exception
from informed consent (EFIC).

OBTAINING INFORMED CONSENTS

To document that informed consent has been given for a procedure, healthcare organisations
have traditionally used paper-based consent forms on which the procedure and its risks and
benefits are noted and is signed by both patient and clinician. In several healthcare organisations
consent forms are scanned and maintained in an electronic document store. The paper consent
process has been demonstrated to be associated with significant errors of omission, and therefore
increasing numbers of organisations are using digital consent applications where the risk of
errors can be minimised, a patient's decision making and comprehension can be supported by
additional lay-friendly and accessible information, consent can be completed remotely, and the
process can become paperless. One form of digital consent is dynamic consent, which invites
participants to provide consent in a granular way and makes it easier for them to withdraw
consent if they wish.
Electronic consent methods have been used to support indexing and retrieval of consent data,
thus enhancing the ability to honour to patient intent and identify willing research participants.
More recently, Health Sciences South Carolina, a statewide research collaborative focused on
transforming healthcare quality, health information systems and patient outcomes, developed an
open-source system called Research Permissions Management System (RPMS).

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COMPETENCY OF THE PATIENT
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The ability to give informed consent is governed by a general requirement of competency. In
common law jurisdictions, adults are presumed competent to consent. This presumption can be
rebutted, for instance, in circumstances of mental illness or other incompetence. This may be
prescribed in legislation or based on a common-law standard of inability to understand the nature
of the procedure. In cases of incompetent adults, a health care proxy makes medical decisions. In
the absence of a proxy, the medical practitioner is expected to act in the patient's best interests
until a proxy can be found.
By contrast, 'minors' (which may be defined differently in different jurisdictions) are generally
presumed incompetent to consent, but depending on their age and other factors may be required
to provide Informed assent. In some jurisdictions (e.g., much of the U.S.), this is a strict standard.
In other jurisdictions (e.g., England, Australia, Canada), this presumption may be rebutted
through proof that the minor is 'mature' (the 'Gillick standard'). In cases of incompetent minors,
informed consent is usually required from the parent (rather than the 'best interests standard')
although a parens patriae order may apply, allowing the court to dispense with parental consent
in cases of refusal.

DECEPTION
Research involving deception is controversial given the requirement for informed consent.
Deception typically arises in social psychology, when researching a particular psychological
process requires that investigators deceive subjects. For example, in the Milgram experiment,
researchers wanted to determine the willingness of participants to obey authority figures despite
their personal conscientious objections. They had authority figures demand that participants
deliver what they thought was an electric shock to another research participant. For the study to
succeed, it was necessary to deceive the participants, so they believed that the subject was a peer
and that their electric shocks caused the peer actual pain.
Nonetheless, research involving deception prevents subjects from exercising their basic right of
autonomous informed decision-making and conflicts with the ethical principle of respect for
persons.
The Ethical Principles of Psychologists and Code of Conduct set by the American Psychological
Association says that psychologists may conduct research that includes a deceptive compartment
only if they can both justify the act by the value and importance of the study's results and show
they could not obtain the results by some other way. Moreover, the research should bear no
potential harm to the subject as an outcome of deception, either physical pain or emotional
distress. Finally, the code requires a debriefing session in which the experimenter both tells the
subject about the deception and gives subject the option of withdrawing the data.

CONFLICTS OF INTEREST
Other, long-standing controversies underscore the role for conflicts of interest among medical
school faculty and researchers. For example, in 2014 coverage of University of California (UC)

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medical school faculty members has included news of ongoing corporate payments to
researchers and practitioners from companies that market and produce the very devices and
treatments they recommend to patients. Robert Pedowitz, the former chairman of UCLA's
orthopaedic surgery department, reported concern that his colleague's financial conflicts of
interest could negatively affect patient care or research into new treatments. In a subsequent
lawsuit about whistleblower retaliation, the university provided a $10 million settlement to
Pedowitz while acknowledging no wrongdoing. Consumer Watchdog, an oversight group,
observed that University of California policies were "either inadequate or unenforced...Patients
in UC hospitals deserve the most reliable surgical devices and medication…and they shouldn't be
treated as subjects in expensive experiments." Other UC incidents include taking the eggs of
women for implantation into other women without consent and injecting live bacteria into human
brains, resulting in potentially premature deaths.
A patient agrees to a health intervention based on an understanding of it.
The patient has multiple choices and is not compelled to choose a particular one.
The consent includes giving permission.
These practices are part of what constitutes informed consent, and their history is the history of
informed consent: 60 They combine to form the modern concept of informed consent—which
rose in response to particular incidents in modern research: 60 Whereas various cultures in
various places practiced informed consent, the modern concept of informed consent was
developed by people who drew influence from Western tradition.: 60

INFORMED CONSENT FORM

An informed consent form is used to protect doctors and other professionals from being held
liable in the event something goes wrong. Each facility or entity may design its own forms,
though there are certain elements that should be included in the forms to ensure its effectiveness
should it be referred to later. Consent forms are used by a variety of industries, though they are
most commonly and widely used in the medical field. An informed consent form for medical use
is generally more detailed and specific than forms for other purposes.
A well-made informed consent form clearly outlines the service or treatment to be performed, as
well as the risks and benefits involved. The language should be clear and easy to understand, and
the form should be printed on plain paper in a font that is comfortable to read. The provider of
the service or treatment should be clearly identified on the form, including contact information,
and the client or patient’s name should be clearly printed.
It is important to provide enough room for the patient to fill in any information required, such as
address and phone number, and the signature and date blocks should be clearly labelled. While
some providers use the same informed consent form for adults and children alike, it is a good
idea to provide a separate consent form for children, in which the parent or guardian is informed
of the required information, and the signature and date block allows the person signing the form
to clearly state his or her relation to the child.
When a healthcare provider recommends a specific procedure, you have the right to accept or
refuse it. If you decide to move forward, you’ll need to give informed consent first.

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Informed consent means that you made a voluntary and educated decision. It also means that
your healthcare provider has fully explained the medical procedure, including its risks and
benefits.

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