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EAST ZONE MEDICO LEGAL SERVICES PVT.LTD
“Soluation for challenging situation”
Why You Should Attend Across india medical malpractice cases continue to make headlines, as
more and more claims are being brought against health care organizations and the people that
work within them. Being on the
receiving end of a lawsuit can be challenging in the extreme, and places great stress on
individuals and their organizations as they position themselves to deal with the fall-out that
invariably follows a negligence claim. Consequently, understanding your legal responsibilities,
and being able to effectively reduce and manage legal risk has never been more critical.
Now in its four year, eastzone medico legal services pvt.ltd Clinical Risk, Negligence and
Claims Management in Health EASTZONE MEDICO LEGAL SERVICES PVT.LTD is a
medico-legal consultancy firm based . Our clients include lawyers both defence and
prosecution
We offer our services to individual doctors, clinics, nursing homes and hospitals on regular
contractual basis to avoid or defend medico-legal suits. We have tie up with lawyers to
defend cases in Medical council ,consumer courts, civil courts or criminal courts. Medico-Legal
problems are so technical that it can be dealt or understood by a Medico-Legal expert only.
In defending the medical fraternity's Medico-Legal cases we have also successfully ensured
for maintaining your good name and professional reputation and providing proper guidance since
last decade through the maze of legal,insurance technicalities, so all these services can be
expected from EASTZONE MEDECO LEGAL SERVICES only
Medical Negligence cases:
We prepare and draft opinions in medical negligence cases for review in medical council/ police
investigation teams/ consumer courts/ civil courts/ criminal courts. We offer defence experts
to assist you in fighting your case in every legal proceeding.
Hospital and Nursing home care:
We offer medico-legal consultancy services to hospitals, nursing homes or polyclinic either on
retainership basis or on consultation basis. We offer to design forms to avoid negligence
Suits. We also offer our services for better medical record keeping.
, “any case of injury or ailment where, the attending
doctor after history taking and clinical examination, considers that investigations by
law enforcement agencies (and also superior military authorities) are warranted to
ascertain circumstances and fix responsibility regarding the said injury or ailment
according to the law”. (a) Assault and battery, including domestic violence and child abuse
(b) Accidents like Road Traffic Accidents (RTA), industrial accidents etc.
(c) Cases of trauma with suspicion of foul play
(d) Electrical injuries
(e) Poisoning, Alcohol Intoxication
(f) Undiagnosed coma
(g) Chemical injuries
(h) Burns and Scalds
(j) Sexual Offences
(k) Criminal abortions
(l) Attempted suicide
(m) Cases of asphyxia as a result of hanging, strangulation, drowning,
suffocation etc.
(n) Custodial deaths
(o) Death in the operation theatre
(p) Unnatural deaths
(q) Death due to Snake Bite or Animal Bite
(r) Fire Arm injuries
(s) Drug overdose
(t) Drug abuse
(u) Dead brought to the Accident and Emergency Dept / MI Room (Found
dead) and deaths occurring within 24 hours of hospitalization without
establishment of a diagnosis.
Connect nos : 7050685171, 9973106128
9504287958 ,9472956282,9472956283 ,8298177773
Key Benefits: What You Will Learn
 24@hour cover yourself for every problem which no one
 Company to provide Medico Legal Risk Management against any Medico-Legal risk ,
problems , cases under any Act or Law.
 We also provide protection against professional risk and take up the cause of Medical
Practitioners , Establishments to take over the case in offering support in terms of
defending your case on a day to day basis at every level in Consumer, Civil, Criminal
Courts and Medical Council till the final judgment of the Apex Court.
 Cover M.C.I ACT I.P.C ACT & other act as for low.
 MTP,PNDT & personal protection act 2013 cover.
 Coverage for all cases m c I act & other act.
 More over a complete peace of mind & all these services are free of cost to our
member.
 Coverage for all cases society defarmation, land, property, tpa etc.
The main factors to consider in such a case are:
Is there an established, prior diagnosis of epilepsy?
Is the alleged crime compatible with a seizure or automatisms or post-ictal confusion, in
terms of nature and complexity of actions, and duration?
Is a claim of amnesia commensurate with that individual’s seizures?
Was there evidence of motive?
Was there evidence of premeditation?
Was there evidence of attempts to escape, or concealment after the event?
Do investigations suggest a diagnosis of epilepsy
• How to deal with adverse events that can lead to organizational crisis
• Overview of a malpractice claim: what should you expect?
• The litigation process: practical demonstrations
• Defence best practices/mitigation strategies: the importance of documentation and tips
and tools regarding the preservation of evidence
• Learning from past claims, audits, self assessments and inspections
• The rising spectre of class actions in health care: how should your organization respond?
• The impact of being sued: dealing with the pressure of litigation
• Responding to risk in specialty areas, including obstetrics, diagnosis, medication and mental
health, and a practical overview of current litigation trends in these areas
• Setting the stage: current litigation trends in obstetric claims
• What types of claims are being filed?
• Impact of new technology
• Prenatal surveillance: estimated placental volume (EPV)
• Brain injury and perinatal asphyxia
• Fetal monitoring and surveillance
• Perinatal infections
• Shoulder dystocia/Erbs palsy
• Obesity in pregnancy
• Births outside hospitals
• Expert witnesses in obstetric malpractice cases
Medical negligence. Most common claims by patients against doctors involve:
Incorrect diagnosis, e.g. non-epileptic attacks diagnosed as epilepsy, with effect of loss of
driving licence and livelihood; and failure to diagnose another treatable condition such as
episodic cardiac asystole.
Failure to diagnose and treat epilepsy, and possibly avoid sub sequent serious
complications or fatality.
Failure to warn patients adequately about the effects and potential adverse effects of
prescribed medical therapy or of surgical treatment. This includes the need to inform
patients of the risks of discontinuing a medication and to have a ‘fail safe’ plan if the
change of drug does not go well.
The most common of these are: allergic reactions to medication, other chronic effects of
medication (e.g. effects of retigabine on the skin and retina, vigabatrin on visual fields,
effect of phenytoin on teeth and gums, effect of valproate on weight and menstrual cycle),
interaction of antiepileptic drugs (AEDs) with other medication (e.g. oral contraceptive
pill, warfarin), and teratogenic potential of AEDs, especially valproate.
Failure to convey important information, e.g. the need to inform the DVLA of condition;
safety issues, particularly drowning in a bath, burns from cooking; risk of death from
seizures. This is a difficult area, as other professionals, such as GPs and nurses may also
have a role in patient education and information.
Medical reports may be sought by firms of solicitors, CIVIL MATTERS
i) When he has treated the case as a second expert – when
Either the patient is referred by first ophthalmologist for
opinion or further treatment or the patient has came of his
own to the second expert for treatment and the case goes
in court under CPA. Then the first or second Doctor treating
the case may be called in the court as witness or to provide
opinion.
ii) When the patient is referred or came himself for examination
and a Certificate for compensation purposes is required.
If there is loss of vision causing disability or blindness or
disfiguration.
Under Employees Compensation Act – when there are
damages during the working in the organization. The
treating Dr. has to certify the extent of damage to the
concerned authority or the Court.
In CPA when he has treated the patient as a second expert
doctor and the court requires the extent of damages to
calculate the loss and compensation.
As a certifying expert after examination of a case – The
Court may send a case for examination and certification of
the condition of the patient.
CRIMINAL MATTERS
Accidental Trauma
When caused in vehicle accident case, doctor may be required
to give certificate to court or insurance company indicating
amount of loss of function. Record has to be kept for 3 years.
Trauma by Assault
• Patient may give history of Assault and when it is taken
on record, or when Patient is referred by police or court,
the doctor has to note the injuries in detail, in a separate
register called as MLC register, it’s simple or grievous
nature, and amount of loss of function (vision).
• When fracture is suspected X-ray, CT scan or MRI is advised
and record is kept for 3 years.
• Certificate of injury is given to patient on demand if injury
is simple injury.
• If it is grievous injury it is necessary to inform police done.
certificate is given to police or court on demand.
• Record should be kept for 3 years or till case is decided by
the court.
• The Grievous injury in Ophthalmology is defined in Section
320 of the Indian Penal Code as the Grievous injury is –
a) Permanent privation (loss)of the sight of either eye
b) Permanent disfiguration of the head or face
(Here disfiguration due to injury to lids, orbit, eye ball
etc.)
c) Fracture or dislocation of a bone or tooth
(Here Fracture of orbital bones)
d) Any hurt which endangers life or which causes the
sufferer to be during the space of twenty days in severe
body pain or unable to follow his daily routine.
As a legal expert in court of law, when he has treated the
case of criminal assault. The patient may come of his own
or may be sent by police or court for examination and or
treatment and for certificate. If the patient has come on
his own and the injury is grievous then the doctor has to
inform the police. The injury may be
a) Mechanical injury
b) Chemical injury (acid or alkali burn)
c) Heat or electrical burns.
Doctor has to make a note of every injury in detail on his
record and the investigations done with it’s record and
the treatment given and the results in detail. Doctor has
to keep the record and has to give certificate to police or
court. Injury should be noted as simple or grievous injury
and amount of loss of function TABLE DEATH
IN SOLO PRACTISE
a) Stop the surgery and try to resuscitate with the help of
Anesthetist. Call physician or shift to ICU if possible.
b) Inform Police. Insist on Post mortem.
c) Inform relations and try to take them in confidence and do
consoling.
d) If possible do not insist on bill payments.
INFORMATION TO POLICE -Inform the Police If death of the
patient occurs within 24 hrs from the admission in the hospital
or Where cause of death cannot be certified or During surgical or
interventional procedure death occurs
• Cognizable case – (cognizable offence ) – means a case in which,
a police officer can arrest without warrant
TO MAKE DOCTOR SAFE – see before operation
a) Take physical fitness from a M.D. Physician.
b) Always have a qualified stand by Anesthetist
c) O.T. should have oxygen cylinder
d) Written informed consent in patient’s language.
•ON Table Death - Inform Police. Insist on Post mortem
• The table death is generally inquired under 304-A of Indian Penal
Code in which FIR is registered. It is a Bailable offence.
• Supreme court has given guide lines that – Dr. should not be
arrested under Section 304-A unless opinion is taken from expert
Doctor or committee of doctors expert in that field
• PROTECTION TO DOCTERS & HOSPITALS
Government of Maharashtra has passed an ordinance No V 2009
Dated 30 March 2009
• Section 88 and 92 of IPC protects doctor in criminal liabilities.
• No consent protects the doctor from CPA but it protects him
from criminal liability
• Records OPD papers should be preserved for 2 years; and papers
regarding indoor surgical matter should be preserved for 3 years
(Sec. 24 A CPA Act 1986)
1Whatever the context in which medical decisions are made, you must work in partnership with
your patients to ensure good care. In so doing, you must:
a) listen to patients and respect their views about their health
b) discuss with patients what their diagnosis, prognosis, treatment and care involve
c) share with patients the information they want or need in order to make decisions
d) maximise patients’ opportunities, and their ability, to make decisions for themselves
e) respect patients’ decisions.
If patients have capacity to make decisions for themselves, a basic model applies:
a The doctors and patient make an assessment of the patient’s condition, taking into account
the patient’s medical history, views, experience and knowledge.
b The doctor uses specialist knowledge and experience and clinical judgement, and the
patient’s views and understanding of their condition, to identify which investigations or
treatment are likely to result in overall benefit for the patient. The doctor explains the
options to the patient, setting out the potential benefits, risks, burdens and side effects of
each option, including the option to have no treatment. The doctor may recommend a
particular option which they believe to be best for the patient, but they must not put
pressure on the patient to accept their advice
c The patient weighs up the potential benefits, risks and burdens
of the various options as well as any non-clinical issues that are relevant to them. The patient
decides whether to accept any of the options and, if so, which one. They also have the right
to accept or refuse an option for a reason that may seem irrational to the doctor, or for no
reason at all.
d If the patient asks for a treatment that the doctor considers would
not be of overall benefit to them, the doctor should discuss the issues with the patient and
explore the reasons for their request. If, after discussion, the doctor still considers that the
treatment would not be of overall benefit to the patient, they do not have to provide the
treatment. But they should explain their reasons to the patient, and explain any other options
that are available, including the option to seek a second opinion. discussions with patients
according to:
a their needs wishes and priorities
b their level of knowledge about, and understanding of, their condition, prognosis and the
treatment options
c the nature of their condition
d the complexity of the treatment, and
e the nature and level of risk associated with the investigation or treatment. In the case of
minor or routine investigations or treatments, if you are satisfied the patient understands
what you propose to do and why, it is usually enough to have oral or implied consent
Informed Consent in Studies with Human Subjects
For studies with human subjects include the following statement:
All procedures followed were in accordance with the ethical standards of the responsible
committee on human experimentation (institutional and national) and with the Helsinki
Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients
for being included in the study.

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WELCOME TO EASTZONE MEDICO LEGAL SERVICES

  • 1. EAST ZONE MEDICO LEGAL SERVICES PVT.LTD “Soluation for challenging situation” Why You Should Attend Across india medical malpractice cases continue to make headlines, as more and more claims are being brought against health care organizations and the people that work within them. Being on the receiving end of a lawsuit can be challenging in the extreme, and places great stress on individuals and their organizations as they position themselves to deal with the fall-out that invariably follows a negligence claim. Consequently, understanding your legal responsibilities, and being able to effectively reduce and manage legal risk has never been more critical. Now in its four year, eastzone medico legal services pvt.ltd Clinical Risk, Negligence and Claims Management in Health EASTZONE MEDICO LEGAL SERVICES PVT.LTD is a medico-legal consultancy firm based . Our clients include lawyers both defence and prosecution We offer our services to individual doctors, clinics, nursing homes and hospitals on regular contractual basis to avoid or defend medico-legal suits. We have tie up with lawyers to defend cases in Medical council ,consumer courts, civil courts or criminal courts. Medico-Legal problems are so technical that it can be dealt or understood by a Medico-Legal expert only. In defending the medical fraternity's Medico-Legal cases we have also successfully ensured for maintaining your good name and professional reputation and providing proper guidance since last decade through the maze of legal,insurance technicalities, so all these services can be expected from EASTZONE MEDECO LEGAL SERVICES only Medical Negligence cases: We prepare and draft opinions in medical negligence cases for review in medical council/ police investigation teams/ consumer courts/ civil courts/ criminal courts. We offer defence experts to assist you in fighting your case in every legal proceeding. Hospital and Nursing home care: We offer medico-legal consultancy services to hospitals, nursing homes or polyclinic either on retainership basis or on consultation basis. We offer to design forms to avoid negligence Suits. We also offer our services for better medical record keeping. , “any case of injury or ailment where, the attending doctor after history taking and clinical examination, considers that investigations by law enforcement agencies (and also superior military authorities) are warranted to ascertain circumstances and fix responsibility regarding the said injury or ailment according to the law”. (a) Assault and battery, including domestic violence and child abuse (b) Accidents like Road Traffic Accidents (RTA), industrial accidents etc. (c) Cases of trauma with suspicion of foul play (d) Electrical injuries (e) Poisoning, Alcohol Intoxication (f) Undiagnosed coma (g) Chemical injuries (h) Burns and Scalds (j) Sexual Offences (k) Criminal abortions (l) Attempted suicide (m) Cases of asphyxia as a result of hanging, strangulation, drowning,
  • 2. suffocation etc. (n) Custodial deaths (o) Death in the operation theatre (p) Unnatural deaths (q) Death due to Snake Bite or Animal Bite (r) Fire Arm injuries (s) Drug overdose (t) Drug abuse (u) Dead brought to the Accident and Emergency Dept / MI Room (Found dead) and deaths occurring within 24 hours of hospitalization without establishment of a diagnosis. Connect nos : 7050685171, 9973106128 9504287958 ,9472956282,9472956283 ,8298177773 Key Benefits: What You Will Learn  24@hour cover yourself for every problem which no one  Company to provide Medico Legal Risk Management against any Medico-Legal risk , problems , cases under any Act or Law.  We also provide protection against professional risk and take up the cause of Medical Practitioners , Establishments to take over the case in offering support in terms of defending your case on a day to day basis at every level in Consumer, Civil, Criminal Courts and Medical Council till the final judgment of the Apex Court.  Cover M.C.I ACT I.P.C ACT & other act as for low.  MTP,PNDT & personal protection act 2013 cover.  Coverage for all cases m c I act & other act.  More over a complete peace of mind & all these services are free of cost to our member.  Coverage for all cases society defarmation, land, property, tpa etc. The main factors to consider in such a case are: Is there an established, prior diagnosis of epilepsy? Is the alleged crime compatible with a seizure or automatisms or post-ictal confusion, in terms of nature and complexity of actions, and duration? Is a claim of amnesia commensurate with that individual’s seizures? Was there evidence of motive? Was there evidence of premeditation? Was there evidence of attempts to escape, or concealment after the event? Do investigations suggest a diagnosis of epilepsy • How to deal with adverse events that can lead to organizational crisis • Overview of a malpractice claim: what should you expect? • The litigation process: practical demonstrations • Defence best practices/mitigation strategies: the importance of documentation and tips
  • 3. and tools regarding the preservation of evidence • Learning from past claims, audits, self assessments and inspections • The rising spectre of class actions in health care: how should your organization respond? • The impact of being sued: dealing with the pressure of litigation • Responding to risk in specialty areas, including obstetrics, diagnosis, medication and mental health, and a practical overview of current litigation trends in these areas • Setting the stage: current litigation trends in obstetric claims • What types of claims are being filed? • Impact of new technology • Prenatal surveillance: estimated placental volume (EPV) • Brain injury and perinatal asphyxia • Fetal monitoring and surveillance • Perinatal infections • Shoulder dystocia/Erbs palsy • Obesity in pregnancy • Births outside hospitals • Expert witnesses in obstetric malpractice cases Medical negligence. Most common claims by patients against doctors involve: Incorrect diagnosis, e.g. non-epileptic attacks diagnosed as epilepsy, with effect of loss of driving licence and livelihood; and failure to diagnose another treatable condition such as episodic cardiac asystole. Failure to diagnose and treat epilepsy, and possibly avoid sub sequent serious complications or fatality. Failure to warn patients adequately about the effects and potential adverse effects of prescribed medical therapy or of surgical treatment. This includes the need to inform patients of the risks of discontinuing a medication and to have a ‘fail safe’ plan if the change of drug does not go well. The most common of these are: allergic reactions to medication, other chronic effects of medication (e.g. effects of retigabine on the skin and retina, vigabatrin on visual fields, effect of phenytoin on teeth and gums, effect of valproate on weight and menstrual cycle), interaction of antiepileptic drugs (AEDs) with other medication (e.g. oral contraceptive pill, warfarin), and teratogenic potential of AEDs, especially valproate. Failure to convey important information, e.g. the need to inform the DVLA of condition; safety issues, particularly drowning in a bath, burns from cooking; risk of death from seizures. This is a difficult area, as other professionals, such as GPs and nurses may also have a role in patient education and information. Medical reports may be sought by firms of solicitors, CIVIL MATTERS i) When he has treated the case as a second expert – when Either the patient is referred by first ophthalmologist for opinion or further treatment or the patient has came of his own to the second expert for treatment and the case goes in court under CPA. Then the first or second Doctor treating the case may be called in the court as witness or to provide opinion.
  • 4. ii) When the patient is referred or came himself for examination and a Certificate for compensation purposes is required. If there is loss of vision causing disability or blindness or disfiguration. Under Employees Compensation Act – when there are damages during the working in the organization. The treating Dr. has to certify the extent of damage to the concerned authority or the Court. In CPA when he has treated the patient as a second expert doctor and the court requires the extent of damages to calculate the loss and compensation. As a certifying expert after examination of a case – The Court may send a case for examination and certification of the condition of the patient. CRIMINAL MATTERS Accidental Trauma When caused in vehicle accident case, doctor may be required to give certificate to court or insurance company indicating amount of loss of function. Record has to be kept for 3 years. Trauma by Assault • Patient may give history of Assault and when it is taken on record, or when Patient is referred by police or court, the doctor has to note the injuries in detail, in a separate register called as MLC register, it’s simple or grievous nature, and amount of loss of function (vision). • When fracture is suspected X-ray, CT scan or MRI is advised and record is kept for 3 years. • Certificate of injury is given to patient on demand if injury is simple injury. • If it is grievous injury it is necessary to inform police done. certificate is given to police or court on demand. • Record should be kept for 3 years or till case is decided by the court. • The Grievous injury in Ophthalmology is defined in Section 320 of the Indian Penal Code as the Grievous injury is – a) Permanent privation (loss)of the sight of either eye b) Permanent disfiguration of the head or face (Here disfiguration due to injury to lids, orbit, eye ball etc.) c) Fracture or dislocation of a bone or tooth (Here Fracture of orbital bones) d) Any hurt which endangers life or which causes the sufferer to be during the space of twenty days in severe body pain or unable to follow his daily routine. As a legal expert in court of law, when he has treated the case of criminal assault. The patient may come of his own
  • 5. or may be sent by police or court for examination and or treatment and for certificate. If the patient has come on his own and the injury is grievous then the doctor has to inform the police. The injury may be a) Mechanical injury b) Chemical injury (acid or alkali burn) c) Heat or electrical burns. Doctor has to make a note of every injury in detail on his record and the investigations done with it’s record and the treatment given and the results in detail. Doctor has to keep the record and has to give certificate to police or court. Injury should be noted as simple or grievous injury and amount of loss of function TABLE DEATH IN SOLO PRACTISE a) Stop the surgery and try to resuscitate with the help of Anesthetist. Call physician or shift to ICU if possible. b) Inform Police. Insist on Post mortem. c) Inform relations and try to take them in confidence and do consoling. d) If possible do not insist on bill payments. INFORMATION TO POLICE -Inform the Police If death of the patient occurs within 24 hrs from the admission in the hospital or Where cause of death cannot be certified or During surgical or interventional procedure death occurs • Cognizable case – (cognizable offence ) – means a case in which, a police officer can arrest without warrant TO MAKE DOCTOR SAFE – see before operation a) Take physical fitness from a M.D. Physician. b) Always have a qualified stand by Anesthetist c) O.T. should have oxygen cylinder d) Written informed consent in patient’s language. •ON Table Death - Inform Police. Insist on Post mortem • The table death is generally inquired under 304-A of Indian Penal Code in which FIR is registered. It is a Bailable offence. • Supreme court has given guide lines that – Dr. should not be arrested under Section 304-A unless opinion is taken from expert Doctor or committee of doctors expert in that field • PROTECTION TO DOCTERS & HOSPITALS Government of Maharashtra has passed an ordinance No V 2009 Dated 30 March 2009 • Section 88 and 92 of IPC protects doctor in criminal liabilities. • No consent protects the doctor from CPA but it protects him from criminal liability • Records OPD papers should be preserved for 2 years; and papers regarding indoor surgical matter should be preserved for 3 years
  • 6. (Sec. 24 A CPA Act 1986) 1Whatever the context in which medical decisions are made, you must work in partnership with your patients to ensure good care. In so doing, you must: a) listen to patients and respect their views about their health b) discuss with patients what their diagnosis, prognosis, treatment and care involve c) share with patients the information they want or need in order to make decisions d) maximise patients’ opportunities, and their ability, to make decisions for themselves e) respect patients’ decisions. If patients have capacity to make decisions for themselves, a basic model applies: a The doctors and patient make an assessment of the patient’s condition, taking into account the patient’s medical history, views, experience and knowledge.
  • 7. b The doctor uses specialist knowledge and experience and clinical judgement, and the patient’s views and understanding of their condition, to identify which investigations or treatment are likely to result in overall benefit for the patient. The doctor explains the options to the patient, setting out the potential benefits, risks, burdens and side effects of each option, including the option to have no treatment. The doctor may recommend a particular option which they believe to be best for the patient, but they must not put pressure on the patient to accept their advice c The patient weighs up the potential benefits, risks and burdens of the various options as well as any non-clinical issues that are relevant to them. The patient decides whether to accept any of the options and, if so, which one. They also have the right to accept or refuse an option for a reason that may seem irrational to the doctor, or for no reason at all. d If the patient asks for a treatment that the doctor considers would not be of overall benefit to them, the doctor should discuss the issues with the patient and explore the reasons for their request. If, after discussion, the doctor still considers that the treatment would not be of overall benefit to the patient, they do not have to provide the treatment. But they should explain their reasons to the patient, and explain any other options that are available, including the option to seek a second opinion. discussions with patients according to: a their needs wishes and priorities b their level of knowledge about, and understanding of, their condition, prognosis and the treatment options c the nature of their condition d the complexity of the treatment, and e the nature and level of risk associated with the investigation or treatment. In the case of minor or routine investigations or treatments, if you are satisfied the patient understands what you propose to do and why, it is usually enough to have oral or implied consent Informed Consent in Studies with Human Subjects For studies with human subjects include the following statement: All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008 (5). Informed consent was obtained from all patients for being included in the study.