inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
inform consent form before participate in clinical trials.for purpose of understanding the nature of research,risk,benefits,and decision about participation
An informed consent form is a document that is provided to prospective participants in a research study. It is a crucial component of the informed consent process and serves to ensure that participants are fully informed about the study and its potential risks and benefits before they decide to participate. Here are the key elements typically included in an informed consent form
inform consent form in clinical research process.defination of inform consent form .documents required for inform consent form
elements required for inform consent form
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
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inform consent form in clinical research process.defination of inform consent form .documents required for inform consent form
elements required for inform consent form
A presentation on INFORMED CONSENT FORM which is easy to understand and easy to explain and in very understandable language. Do give it a heart if you like this presentation and do give your valuable comments on it. I will be reading them all. Do contact me if you want some other presentation related to pharmaceutical science.
Medical Malpractice Ganim Injury Lawyers have far-reaching experience representing medical malpractice claims. If your health care provider has failed to take proper care of you or a loved one, you may have a medical error claim.
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In this presentation it has been tried to give a glimpse of different type of consent, how it should be taken, how the patient to be explained, when consent is must and conditions where consent is not required, so as to guide you in your every day practice.
CHAPTER 9 CONSENTConsent is an ethical imperative of great impo.docxchristinemaritza
CHAPTER 9 CONSENT
Consent is an ethical imperative of great importance to managers and clinicians. It is clear that patients want to be more involved in medical decision making. The issues that consent raises suggest both a problem and a goal for health services providers.
The concept of consent in medical care evolved to protect patients from nonconsensual touching. Although the ethical and legal dimensions overlap, the legal requirements of consent are the minimum expected. The ethics of consent are grounded in the principle of respect for persons, specifically the element of autonomy, which reflects a view of the equality and dignity of human beings. In addition, the ethics of consent reflect the special relationship of trust and confidence between physician and patient and between organization and patient. This fiduciary relationship is supported by the principles of beneficence and nonmaleficence. The manager's virtues of trustworthiness, honesty, integrity, and candor also support the ethics of consent.
According to the law, failure to obtain consent can support a legal action for battery, an intentional tort. Beyond this, an action for negligence can be brought if the physician breaches the duty to communicate information necessary for the patient to give informed consent.
Paternalism stems from beneficence and is the ethical value that competes with patient autonomy in implementing consent. Paternalism arises naturally from the relationship between physician and patient because psychologically, technically, and emotionally, the physician is in a position of superior knowledge and is expected to help choose the best course of action for the patient. This reflects the ethics of care discussed in Chapter 1. The paternalism inherent in the physician–patient relationship was first described in the Hippocratic oath. Beneficence, nonmaleficence, and paternalism continue to be important and are implicit elements of the practice of medicine. The revisions of the Principles of Medical Ethics adopted by the American Medical Association (AMA) in 1980 moved organized medicine from paternalism toward autonomy and patient rights, themes that continued in the 2001 revision. The AMA's Council on Ethical and Judicial Affairs amplified these themes in its Fundamental Elements of the Patient–Physician Relationship statement. This document and the 2001 Principles of Medical Ethics are reproduced in Appendix B.
Specialized codes that guide biomedical research (e.g., the Declaration of Helsinki) also recognize the importance of consent. The emphasis on patients' rights or sovereignty in documents such as these are ideals toward which managers and organizations should strive.
LEGAL ASPECTS
Legally, consent must be voluntary, competent, and informed. The law presumes that persons unable to give consent in an emergency want to receive treatment. The presumption of wanting treatment can be rebutted if a competent patient declines it or if the person requiring ...
Ethical Issues in Obtaining Informed Consent.pptxAhmed Mshari
Medical ethics is a set of moral principles, beliefs and values that guide decisions about patient care.
It is an integral part of good medical practice.
The health care professional uses knowledge, experience, and judgment and considers the ethical principles to make decisions on management recommendations.
True professionals and doctrine of informed consent Ruby Med Plus
Abstract
The clinical practices around informed consent in healthcare settings have undergone a revolution for the better over recent decades. However the way doctor obtains informed consent still remains problematic. A number of factors have contributed to the continued dominance of the traditional dentist-patient imbalance of power, but, demands for more patient autonomy are increasing. The reasons for this ambiguity are varied. The complexity of communication in clinical encounter, the role of autonomy and the changing nature of the doctor-patient relationship, have also contributed to this uncertainty which still remains in many clinical settings. The uncertainty is partly due to the conceptual dullness of important core concepts.
Running head IMPORTANCE OF INFORMED CONSENT .docxcowinhelen
Running head: IMPORTANCE OF INFORMED CONSENT 1
IMPORTANCE OF INFORMED CONSENT 11
The Importance of Informed Consent
Student's Name
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University Affiliation
In the course of offering treatement, a patient might be in dire need of serious medical attention. In such a scenario, the patient needs to sign some documents, which say that before undergoing the treatement, the patient was aware of all the possible injuries or effects that could occur from this treatement. The process of getting the patient to sign these form of documents, is what is referred to as the process of acquiring an informed consent (Ruth, 1986).
By definition, informed consent refers to the process of granting permission to go through with a form of treatement, in which the patient says that he or she is aware of all the risks that come with the treatement procedure that is going to be administered. Following the granting of permission to go ahead with the medical procedure, the doctors do their best to do their work perfectly. However, in the instance that something were to go wrong, and the procedure doesn’t produce only the positive effects, the doctor is by law exempted from taking any of the blame, and the hospital is also protected by the law (Jessica, 2001).
In this case, the informed consent is important because, it acts as proof that the patient was aware of the risks, before undergoing the procedure and therefore, if something went wrong, the doctors and the hospitals are not to blame. The risk was simply part of the equation from the very beginning and therefore that it occurred is no one’s fault.
Arguably, there have been concerns among popular groups of people, concerning the method in which the doctor gets the patient to sign the various documents, constitution the informed consent documents. To some patients, especially those who were undergoing a complicated procedure, claim that they were not fully made aware of all the different problems that could arise out of the procedure.
In this case, the doctors find themselves under a spotlight since, probes will be raised over their ability to clearly inform the patients of the procedure they are undergoing, the possible risks involved with the current procedure, the alternative treatement modes, and the risks and benefits of those other methods too.
There have been concerns also, over the time that the patient is given, prior to the signing of the documents. Some researchers have reported that, the patients need to be given time to read through and understand the documents given, and then, allow him or her to deliberate on the issue, before coming to a decision. In some practices, the documents are only signed a few minutes before surgery is administered, clearly giving the patient no say in the matter as they have no other option but to sign the document.
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WINDING UP of COMPANY, Modes of DissolutionKHURRAMWALI
Winding up, also known as liquidation, refers to the legal and financial process of dissolving a company. It involves ceasing operations, selling assets, settling debts, and ultimately removing the company from the official business registry.
Here's a breakdown of the key aspects of winding up:
Reasons for Winding Up:
Insolvency: This is the most common reason, where the company cannot pay its debts. Creditors may initiate a compulsory winding up to recover their dues.
Voluntary Closure: The owners may decide to close the company due to reasons like reaching business goals, facing losses, or merging with another company.
Deadlock: If shareholders or directors cannot agree on how to run the company, a court may order a winding up.
Types of Winding Up:
Voluntary Winding Up: This is initiated by the company's shareholders through a resolution passed by a majority vote. There are two main types:
Members' Voluntary Winding Up: The company is solvent (has enough assets to pay off its debts) and shareholders will receive any remaining assets after debts are settled.
Creditors' Voluntary Winding Up: The company is insolvent and creditors will be prioritized in receiving payment from the sale of assets.
Compulsory Winding Up: This is initiated by a court order, typically at the request of creditors, government agencies, or even by the company itself if it's insolvent.
Process of Winding Up:
Appointment of Liquidator: A qualified professional is appointed to oversee the winding-up process. They are responsible for selling assets, paying off debts, and distributing any remaining funds.
Cease Trading: The company stops its regular business operations.
Notification of Creditors: Creditors are informed about the winding up and invited to submit their claims.
Sale of Assets: The company's assets are sold to generate cash to pay off creditors.
Payment of Debts: Creditors are paid according to a set order of priority, with secured creditors receiving payment before unsecured creditors.
Distribution to Shareholders: If there are any remaining funds after all debts are settled, they are distributed to shareholders according to their ownership stake.
Dissolution: Once all claims are settled and distributions made, the company is officially dissolved and removed from the business register.
Impact of Winding Up:
Employees: Employees will likely lose their jobs during the winding-up process.
Creditors: Creditors may not recover their debts in full, especially if the company is insolvent.
Shareholders: Shareholders may not receive any payout if the company's debts exceed its assets.
Winding up is a complex legal and financial process that can have significant consequences for all parties involved. It's important to seek professional legal and financial advice when considering winding up a company.
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ALL EYES ON RAFAH BUT WHY Explain more.pdf46adnanshahzad
All eyes on Rafah: But why?. The Rafah border crossing, a crucial point between Egypt and the Gaza Strip, often finds itself at the center of global attention. As we explore the significance of Rafah, we’ll uncover why all eyes are on Rafah and the complexities surrounding this pivotal region.
INTRODUCTION
What makes Rafah so significant that it captures global attention? The phrase ‘All eyes are on Rafah’ resonates not just with those in the region but with people worldwide who recognize its strategic, humanitarian, and political importance. In this guide, we will delve into the factors that make Rafah a focal point for international interest, examining its historical context, humanitarian challenges, and political dimensions.
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Introduction-
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In 2020, the Ministry of Home Affairs established a committee led by Prof. (Dr.) Ranbir Singh, former Vice Chancellor of National Law University (NLU), Delhi. This committee was tasked with reviewing the three codes of criminal law. The primary objective of the committee was to propose comprehensive reforms to the country’s criminal laws in a manner that is both principled and effective.
The committee’s focus was on ensuring the safety and security of individuals, communities, and the nation as a whole. Throughout its deliberations, the committee aimed to uphold constitutional values such as justice, dignity, and the intrinsic value of each individual. Their goal was to recommend amendments to the criminal laws that align with these values and priorities.
Subsequently, in February, the committee successfully submitted its recommendations regarding amendments to the criminal law. These recommendations are intended to serve as a foundation for enhancing the current legal framework, promoting safety and security, and upholding the constitutional principles of justice, dignity, and the inherent worth of every individual.
1. Informed Consent
o It is both a process and paperwork
o Informed consent begins after the doctor has gathered all necessary
information and has determined the necessary intervention
o The doctor must give the information he or she knows that may play a role in
the patients decision about his or her health or health care choices
Although informed consent for clinical treatment has become a vital part of
contemporary medical practice, it means different things in different contexts is
variably practised and rarely achieves the theoretical ideal. In this review, we focus on
the clinical practice of informed consent.
2. Although we had hoped to identify high-quality studies that would provide a strong
quantitative base of evidence for recommendations around informed consent, much
of the quantitative literature on this topic is descriptive in nature. Informed consent is
primarily a legal and ethical concept; although often informed by data, the standards
of scholarship in law and ethics focus on the strength of analytical argument rather
than the weight of empirical data. Therefore, we sought to synthesize the available
knowledge on this subject, referencing empirical data when possible, summarizing
relevant arguments that are particularly prevalent, persuasive or insightful.
What is the purpose of informed consent?
Informed consent has become the primary paradigm for protecting the legal rights of
patients and guiding the ethical practice of medicine. It may be used for different
purposes in different contexts: legal, ethical or administrative (Figure ). Although these
purposes overlap, they are not identical, thus leading to different standards and
criteria for what constitutes “adequate” informed consent.
• Prospective Subject Will ..
Understand nature of research
Be informed of purpose, risks, and benefits, and alternative therapies
Make a Voluntary Decision about Participation
Legal
Although the concept of consent is rooted in ancient legal and philosophical
precepts, the modern legal precedent for “simple” consent was written in
1914, establishing a patient’s “right to determine what shall be done with his
body.”
The further obligation for physicians to disclose details about treatment in a
process of informed consent did not emerge until the 1950s, when courts first
required physicians to disclose information customarily disclosed by
3. experienced clinicians (e.g., the reasonable physician standard). It was not until
1975 that American courts articulated the reasonable person standard, which
required that physicians disclose the information that a “reasonable person”
would want to know in a similar situation.
Regardless of the standard used, informed consent is further predicated on the
patient’s or surrogate’s capacity to make decisions — not only should the
decision-maker understand the relevant information, he or she should also be
able to appreciate the information’s importance and use it to weigh treatment
options in light of their values.
Legally, simple consent protects patients against assault and battery in the form
of unwanted medical interventions. The higher standard of informed consent
further safeguards patients’ rights to autonomy, self-determination and
inviolability.However, the legal standards that apply to obtaining informed
consent vary across jurisdictions, and their interpretation continues to evolve.
Some jurisdictions use the reasonable person standard, whereas others
continue to use the older standard of the reasonable physician.
Therefore, it is important for clinicians to determine the precise standard used
in their jurisdiction and to adapt their practice accordingly.
The Canadian Medical Protective Association provides detailed information on
Canadian standards (www.cmpa-acpm.ca). Even when the standard is clear,
interpretation is required to apply the standard to a particular case; thus, most
litigation regarding informed consent focuses on precisely what information
satisfies the applicable standard.
Fortunately, in most cases, legal interpretation is pragmatic; evidence of a
good-faith effort to inform is usually found to be adequate.
Ethical
The ethical purpose of informed consent is somewhat more abstract and ideological,
seeking to respect patient autonomy by ensuring that treatment is directed toward
4. the ends desired and is chosen by the patient. In this context, informed consent is
intended to shift the ethical paradigm for decision-making away from physician-
centred models to more patient-centred approaches. The ethics literature regarding
informed consent also emphasizes that it is not an event, but a process that precedes
the “signing” of the document and continues for as long as the choice remains
relevant. Thus, the consent to undergo dialysis or continue with chemotherapy is
continually re-evaluated (and may change). The consent form should not be confused
with the consent process; the form merely documents that the process has occurred.
Importantly, other parts of the patient record (e.g., clinic and/or operative notes)
should corroborate details of the process.
Administrative
For the sake of compliance, the informed consent document serves the administrative
purpose of a systems-level check to ensure that a consent process has occurred.
Patients simply do not advance to the operating room, for example, without a signed
consent form. Unfortunately, pressures for efficient workflow may shift the focus of the
informed consent process from robust conversation to the mere requirement of
getting a signature.
Although legal and ethical debate persists, most stakeholders in the informed consent
process agree on at least four basic elements for discussions of informed consent: the
decision-maker (i.e., the patient or a surrogate) should have the capacity to make
decisions; the physician should disclose sufficient details for the decision-maker to
make an informed choice; the decision-maker should show his or her understanding
of the disclosed information; and the decision-maker should freely authorize the
treatment plan.
In current clinical practice, these four elements translate into five components that
should be included in a discussion seeking to obtain informed consent: the diagnosis,
the proposed treatment, the attendant risks and benefits of the treatment, alternative
5. treatments and their risks and benefits, and the risks and benefits of declining
treatment.
6. INFORMED CONSENT ELEMENTS
There are 5 important elements of the informed consent process:
1. Diagnosis/Clinical Impression Patient wants to know:
“What is wrong with me?” This must be given in understandable terms
2. Treatment/Intervention
The patient wants to know
3. Risks or complications associated with the treatment or with the diagnosis
In some states, you are required to explain in writing
For example, you must give lifting restrictions to a patient with an acute disc
herniation
4. Alternative treatments, concurrent treatments, or additional diagnostic procedures
This is the time to tell the patient if more treatments or tests are needed (either within
or outside of your office)
5. Successes and Failures
The patient wants to know: “What is my prognosis?”
This information is based upon personal experiences of the doctor, literature,
research, classroom knowledge
7. TWO RULES
Additionally, there are two rules associated with informed consent that you should be
aware of:
The Doctor’s Rule
The Patient’s Rule
The Doctor’s Rule
In ALL states, the Doctor’s Rule applies: The doctor determines what information is
important to deliver to the patient. Example: Kidney stone
The Patient’s Rule
In SOME states, the Patient’s Rule applies:
The doctor must give any and all information to the patient in order for him or
her to make an informed decision about his or her health care options
Example: Kidney stone
It is not a rule that the patient must tell the doctor everything about the
complaint
8.
9.
10.
11.
12. Conclusion
Having emerged from multiple disciplines,research concerning informed consent
does not afford sufficient clarity or consensus regarding the purposes this process
serves or the standards by which it should be judged. Our pragmatic suggestions
aim to facilitate — and document — a good-faith effort to involve patients in
medical decisions to whatever degree they are interested and able. Such practice
complies with the ethical spirit of informed consent and should minimize legal
conflict by fostering a deep and nuanced respect for patients.
Key points
Informed consent means different things in different contexts, is variably practised
and rarely achieves the theoretical ideal.
Simple consent entails that a patient (or surrogate) with decision-making capacity
freely authorizes a treatment plan aimed at a mutually acknowledged treatment
goal.
13. The authorization is “informed” when the physician discloses and the patient
understands the diagnosis, the relevant options for treatment (including no
treatment) and any respective risks and benefits.
The informed consent process should be documented thoroughly, using an
electronic medical record, procedure-specific consent forms, patient education
materials and other options whenever possible.
14. Patient Consent
CONSENT
Consent refers to the provision of approval or agreement, particularly and
especially after thoughtful consideration and understanding
As per jurisprudence prior provision of consent signifies a possible defense
(justification) against civil or criminal liability by the doctor.
Practitioners who use this defense claim that they should not be held liable
for a tort or a crime, as the consequence in question occurred with the
prior consent and permission of the patient without realising whether it is a
commission or an omission and the extent of negligence.
MEDICAL CONSENT
Consent is one of the critical issues in the area of medical treatment.
The earliest expression of this fundamental principle, based on autonomy, is
found in the Nuremberg Code of 1947.
The Nuremberg Code was adopted immediately after World War II in response
to medical and experimental atrocities committed by the German Nazi regime
The code makes it mandatory to obtain voluntary and informed consent of
human subjects.
Medical Council of India (MCI) has laid down guidelines that are issued as
regulations in which consent is required to be taken in writing before
performing an operation.
The MCI guidelines are applicableto operations and not cover to the extent
other treatments or procedures
These are covered under Implied and expressed consent
15. Consent is perhaps the only principle that runs through all aspects of health
care provisions today.
It also represents the legal and ethical expression of the basic right to have
ones autonomy and self-determination.
If a medical practitioner attempts to treat a person without valid consent, then
he will be liable under both tort and criminal law
Patient must give valid consent to medical treatment; and it is his prerogative
to refuse treatment even if the said treatment will save his or her life.
LAW AND MEDICAL CONSENT
The rights (autonomy) of the patient have deeply eroded the old model of
doctor-patient relationship.“Doctorsare no more Gods.
There have been significant changes in the doctor patient relationship with the
advancement of technology in day-to-day practice.
More and more patients are becoming aware of their rights and are keen to
make free choice and decision on their treatment.
This helps them to choose the treatment of their choice from the options
available and to select a physician of their choice
Informed consent was practically non-existent till the time COPRA (Consumer
Protection Act) came into existence.
This is seen as more of a legal requirement than an ethical moral obligation on
part of the doctor towards his patient.
The patient has now the ability to select or dismiss their doctors and to choose
the treatment of their choice from the options available.
Important aspect of several Medical Consumer litigations is improper consent .
CONSENT AND MEDICAL PRACTICE
16. There exists a duty to obtain prior consent (with respect to living patients) for
the purpose of diagnosis, treatment, organ transplant, research purposes,
disclosure of medical records, and teaching and medico-legal purposes.
With respect to the dead with regard to pathologicalautopsy, organ transplant
(for legal heirs), and for disclosure of medical record, it is important that prior
informed consent of the patient, or relative is obtained after death.
The HippocraticOath prevalent for centuries has granted doctors the right to
decide in the best interest of the Patient. But the same has been conflicted with
the trend of twentieth century right of “freedom to control health aswell as
avoiding non-consensual medical treatment.”
Clinical ethics teaches physicians, a wide range ofspecific ethical issues.
o Informed consent, truth telling,
o End-of-life decisions,
o Advance directives (substitute decision making for incompetent patients)
o Emergency consent
17. 1.INFORMED CONSENT:
It is defined as voluntary acceptance after full understanding, by a competent
patient , of a plan for medical care after physician adequately discloses the
proposed plan, its risks and benefits, and alternative approaches.
The decision-making capacity is free from coercion or manipulation by the
patient/doctor
COMPONENTS :
Informed consent must contain four vital components:-
Mental capacity of the patient to enter into a contract (This also includes his
ability to understand information given)
Complete Information to be provided by doctor
Voluntary acceptance of the procedure by the patient
Should be person and the procedure specific
CONTENTS OF THE CONSENT:
Condition (Disease) of the patient
Purpose and Nature of intervention
Consequences of such intervention
Any alternatives available
Risks involved
Prognosis in the absence of intervention
The immediate and future cost
The knowledge regarding the intervention should bein an understandable language
and format so that decision in the form of authorization by patient can be made.
ELIGIBILITY FOR CONSENT:
Age,
18. Soundness of mind,
Ability to understand
Remember the information given,
Ability to deliberate and decide the treatment choices,
Believes that the information applies to the said patient and specific purpose.
2. EXPRESSED CONSENT:
It may be oral or in writing.
Though both these categories of consents are of equal value, written
consent can be considered as superior because of its evidential value.
Oral;
Oral consent should be taken in the presence of uninterested third party
Mainly in cases where intimate examination of female is required.
Tests necessitating removal of body fluids, radiological examination can be
done after securing oral consent.
Written:
It is advisable to take written consent in the presence of disinterested third
party (this third party is only to attest the signature of the patient).
Consent should be taken in the patients own language.
Written consent is mandatory in every invasive diagnostic/ therapeutic
procedures or any medico legal examination.
3. IMPLIED CONSENT:
Implied consent may be implied by patients conduct.
So it is basicallythe conduct of the patient when he comes tothe doctor
for examination / treatment.
Doctor should remember that this is only for routine examination as well
as treatment.
19. This does not extend to the performance of intimate examination or
diagnostic procedures.
If there is slightest chance of any complication express consent should
be taken
4. TACIT CONSENT:
Tacit consent means implied consent understood without being stated.
Usually the way a patient present him self for treatment imply consent.
5.SURROGATE CONSENT:
This consent is given by family members for minors or dead.
Generally, courts have held that consent of family members with the written
approval of 2 physicians sufficiently protects a patients interest.
6. ADVANCE CONSENT :
It is the consent given by patient in advance before death
7. PROXY CONSENT :
It indicates consent given by an authorized person before or after death.
If an unconscious patient brought by police from road and operation
essential to save life 2 or 3 doctors to give consent by signing on consent
form, preferably along with police.
Informed consent obtained after explaining all possible risks and side
effects is superior to all other forms of consent and legally defensive.
20. WHO CAN GIVE CONSENT
Simple medical examination the minimum age of consent is 12 years.
For consenting to have any major diagnostic or therapeutic procedure or
surgery the age is above 18 years (I.P.C. Sections 87-93).
The patient should be mentally sound and he/she should not be under any fear
or threat or any false conception.
The patient should not be intoxicated or sedated.
Incomplete information about the patients diagnosis, therapeutic plan etc. is a
commission than misconception of omission.
CONSENT REQUIRED
21. i) Some body else other than the “patient” wants him to be medically
examined and a medical certificate to be issued (employers,),
ii) Consent of the concerned person must be obtained otherwise the doctor
runs the risk of liability to pay damages. Such as:-
a. Issuing certificate involving complicated process of examination or
infertility in women.
b. When the process is likely to affect the physical ormental well being of
the patient e.g financial loss,
c. damage to reputation, social status (STD, HIV etc.).
d. Procedures violating rights of spouse is in cases such as Sterilisation,
artificial insemination.
Even after the consent is taken the examination should be done in presence of third
person (nurse ,Female attendant) while examining a female patient.