Code of Ethics Types of Law

J G COLLEGE OF NURSING

SUBJECT: NURSING MANAGEMENT

TOPIC: CODE OF ETHICS, PROFESSIONAL

CONDUCT,TORT LAW AND ETHICAL

COMITTEEE

SUBMITTED TO

MRS. VASHUDHA MADAM

INCHARGE PRINCIPAL SUBMITTED BY

JG COLLEGE OF NURSING, BINAL JOSHI

S Y M SC NURSING

J G COLLEGE OF NURSING

INTRODUCTION

Health care delivery system has undergone notable changes during the

last few decades, including increased client participation, shorter hospital stays,

and restructuring services to provide care in settings such as outpatient clinics,

short-stay units, and long-term care and in home-care. For nurses, these

changes have contributed to the development of new clinical environment and

expanded practice. Nurses today frequently encounter difficult situations

involving decisions about the best course of action. Nurses are obligated to

provide ethical and legal client care that demonstrates respect for others. Both

fundamental principles of health care ethics and laws governing the scope of

nursing guide nursing practice in all situations.6

ETHICAL & LEGAL CONSIDERATIONS IN NURSING Page 2

TERMINOLOGY

Assurance : A promise that you will definitely do something1

Health: A state of dynamic balance of an individual’s ability to perform personally valued roles and responsibilities, to deal and cope with physical, biological, psychological and social stresses and challenges throughout the life while continuing to maintain a sense of well-being.1

Nurse: Nurse is a person who has completed prescribed course in Nursing from an institution recognized by Indian Nursing Council and registered herself/himself under the State Nursing council as Nurse and midwife.

Nursing: Nursing is a professional service for enabling a person to maintain and sustain health and wellbeing.

Performance criteria: Selected behaviors which illustrate how the standard is achieved.

Practice standards: Set of Activities expected from professional group of workers.

Personal etiquettes: Being polite & soft spoken, honest, sincere, cheerful, dignified, affectionate, compassionate and courteous.

Professional etiquettes: Being attentive listener, keen observer, objective, non-judgmental, empathetic, confident, assertive, disciplined, prompt and efficient.

Professional body or Regulatory body: Indian Nursing Council / State Nursing Council is statutory body which regulates the Nursing Education and practice in India.

Professional Worker: A person who confirms to a level of practice that is expert and ethical after completing an authorized educational programme.

Provider: Same as nurse

Quality Nursing Practice: Quality of nursing practice is achieved when organization’s processes and activities are designed and implemented to meet the needs and expectations of the receiver on a competent, consistent and continuous basis.


Quality Assurance in Nursing: Quality Assurance is a program for formal guarantee for provision of quality nursing care against set standards.

Rationale: Reasoning for the standards.

Receiver: Receiver(s) refer to those individual persons/ families/ groups/ communities who are in need of assistance from Nurse to maintain and sustain their health and well-being.

Standards: Level of performance required for obtaining a specified desired outcome.

Vulnerable: vulnerable persons are those who are disadvantaged due to physical, emotional and social and economic reasons e.g.,

Mentally and physically challenged person. Emotionally traumatized persons. Women, children, marginalized groups.

Well Being: It is an active state of a person with maximum potential by maintaining balance and is at peace with inner and outer world.

Code - “A code may be defined as conventionalized set of rules or expectations devised for a specific purpose.”6

Ethics-Word ethics is derived from the word “Ethos”. It is a Greek word and meaning of this word is customs, character or conduct. It may be related to a person or a profession or a professional body. When we study beliefs and assumptions it is moral philosophy and principles of morality tell us how human beings should behave with each other. Ethics is the branch of philosophy that examines the difference between right and wrong. Ethics are meant for holistic development of a professional.

“The term refers to the consideration of standards of conduct or the study of philosophical ideals of right and wrong behavior”. (American Heritage Dictionary, 2007)5

Code of Ethics-“A specific set of professional behaviors and values the professional interpreter must know and must abide by, including confidentiality, accuracy, privacy, integrity.”3

“What professionals ought or ought not to do, how they ought to comport themselves, what they, or the profession as a whole, ought to aim at…….” (Litchenberg 1996)

Negligence: The commission (doing) of an act or the omission (not doing) of act

that a reasonably prudent person would have done in a similar situation that

leads to harm to another person.


Slander: Malicious or untrue spoken words about another person that are

brought to the attention others.

Tort: A type of civil law that involves wrongs against a person and/or property;

torts include negligence, assault, battery, defamation, fraud, false

imprisonment, and invasion of privacy.

Co-operative: A professional relationship based on collegial

Relationship and reciprocal actions, and behaviour that aim to achieve certain

goals.

Family: A social unit composed of members connected through blood, kinship,

emotional or legal relationships.

Nurse: shares A nurse, as a health professional and a citizen,with society

initiates and supports appropriate action to meet the health and social needs of

the public.

Personal health: Mental, physical, social and spiritual wellbeing of the nurse.

Personal Information obtained during professional information contact that is

private to an individual or family, and which, when disclosed, may violate the

right to privacy, cause inconvenience, embarrassment, or harm to the individual

or family.

CODE OF ETHICS

A code of ethics often focuses on social issues. It may set out general

principles about an organization's beliefs on matters such as mission, quality,

privacy or the environment. It may delineate proper procedures to determine

whether a violation of the code of ethics has occurred and, if so, what remedies

should be imposed. The effectiveness of such codes of ethics depends on the


2

extent to which management supports them with sanctions and rewards.

Violations of a private organization's code of ethics usually can subject the

violator to the organization's remedies. The code of ethics links to and gives rise

to a code of conduct for employees.7

CODE OF CONDUCT (EMPLOYEE ETHICS)

A code of conduct is a document designed to influence the behavior of

employees. They set out the procedures to be used in specific ethical situations,

such as conflicts of interest or the acceptance of gifts, and delineate the

procedures to determine whether a violation of the code of ethics occurred and,

if so, what remedies should be imposed. The effectiveness of such codes of

ethics depends on the extent to which management supports them with

sanctions and rewards. Violations of a code of conduct may subject the violator

to the organization's remedies which can under particular circumstances result

in the termination of employment.7

CODE OF PRACTICE (PROFESSIONAL ETHICS)

A code of practice is adopted by a profession or by a governmental or non-

governmental organization to regulate that profession. A code of practice may

be styled as a code of professional responsibility, which will discuss difficult

issues, difficult decisions that will often need to be made, and provide a clear

account of what behavior is considered "ethical" or "correct" or "right" in the

circumstances. In a membership context, failure to comply with a code of

practice can result in expulsion from the professional organization.7

CODE OF ETHICS FOR NURSES

Ethics gives the professionals various guidelines that how should they

behave with each other, with the public and with governments. These are

guideline which the professional should follow when they are dealing with their

clients or patients. Ethics also tell the public that what they can expect from a


http://en.wikipedia.org/wiki/Professional_responsibility




http://en.wikipedia.org/wiki/Code_of_conduct

http://en.wikipedia.org/wiki/Code_of_conduct

http://en.wikipedia.org/wiki/Business_ethics

professional and tells the professionals that what the public expects from them.

Ethics are needed for every profession so that nobility and respect of that

profession remains undiminished.

“Nursing ethics refers to ethical issues that occur in nursing practice”4

ELEMENTS OF THE CODE

NURSES AND PEOPLE

The nurse’s primary professional responsibility is

to people requiring Nursing care.

In providing care, the nurse promotes an

environment in which the human rights, values,

customs and spiritual beliefs of the individual, family and community

are respected.

The nurse ensures that the individual receives sufficient information

on which to base consent for care and related treatment.

The nurse holds in confidence personal information and uses

judgments in sharing this information.


Nursing is a great profession, giving a healing touch to patients along

with taking care of their diseases and maintaining their health. This profession is

held in high esteem but this esteem varies in different countries. This difference

is not without reasons. In some countries the associations of nurses have their

own code of ethics. These associations lay stress on the following of ethical

codes. Strict following of the codes in some countries leads to credibility of that

profession and esteem of that profession rises automatically. This leads us to

believe that there is no alternative to following of the codes of ethics. Ethics are

needed both for the nurses as well as the nursing students. For nurses in India

the Indian Nursing Council (INC) has laid down code of ethics and professional

conduct.

The nurse shares with society the responsibility for initiating and

supporting action to meet the health and social needs of the public, in

particular those of vulnerable populations.

The nurse also shares responsibility to sustain and protect the natural

environment from depletion, pollution, degradation and destruction.

NURSES AND PRACTICE

The nurse carries personal responsibility and

accountability for nursing practice, and for

maintaining competence by continual learning.

The nurse maintains a standard of personal

health such that the ability to provide care is

not compromised.

The nurse uses judgement regarding individual competence when

Accepting and delegating responsibility.

The nurse at all times maintains standards of

personal conduct which reflect well on the

profession and enhance public confidence.

The nurse, in providing care, ensures that use of

technology and scientific advances are

compatible with the safety, dignity and

rights of people.

NURSES AND THE PROFESSION

The nurse assumes the major role in determining and implementing

acceptable standards of clinical nursing practice, management,

research and education.

The nurse is active in developing a core of research-based

professional knowledge.

The nurse, acting through the professional organisation, participates

in creating and maintaining safe, equitable social and economic

working conditions in nursing.


NURSES AND CO-WORKERS

The nurse sustains a co-operative

relationship with co-workers in nursing and

other fields.

The nurse takes appropriate action to

safeguard individuals, families and

communities when their health is endangered

by a co-worker or any other person.

The Use of the Code

Acknowledges the rightful place of Individuals in health care delivery system.

Contributes towards empowerment of individuals to become responsible for their health and well-being.

Contributes to quality care. Identifies obligations in practice, research and relationships. Informs the individuals, families, community and other professionals about

expectations of a nurse.

PROFESSIONAL CONDUCT (INDIAN NURSING COUNCIL)

Introduction

The code of professional conduct for nurses is critical for building professionalism and accountability. Ethical considerations are vital in any area dealing with human beings because they represent values, rights and relationships. The nurse must have professional competence, responsibility and accountability with moral obligations. Nurse is obliged to provide services even if it is in conflict with her/his personal beliefs and values.

Purpose

The purpose of professional conduct is to inform both the nurse and the society of the minimum standard for professional conduct. It provides regulatory bodies a basis for decisions regarding standards of professional conduct.

The code of ethics helps to protect the rights of individuals, families and community and also the rights of the Nurse.


Code of Professional Conduct for Nurses in India (INC)

1. Professional Responsibility and accountability

Nurse

1.1 Appreciates sense of self-worth and nurtures it.

1.2 Maintains standards of personal conduct reflecting credit upon the profession.

1.3 Carries out responsibilities within the framework of the professional boundaries.

1.4 Is accountable for maintaining practice standards set by Indian Nursing Council

1.5 Is accountable for own decisions and actions

1.6 Is compassionate

1.7 Is responsible for continuous improvement of current practices

1.8 Provides adequate information to individuals that allows them informed choices

1.9 Practices healthful behaviour

2. Nursing Practice

Nurse

2.1 Provides care in accordance with set standards of practice

2.2 Treats all individuals and families with human dignity in providing physical, psychological, emotional, social and spiritual aspects of care

2.3 Respects individual and families in the context of traditional and cultural practices and discouraging harmful practices

2.4 Presents realistic picture truthfully in all situations for facilitating autonomous decision-making by individuals and families

2.5 Promotes participation of individuals and significant others in the care

2.6 Ensures safe practice

2.7 Consults, coordinates, collaborates and follows up appropriately when individuals’ care needs exceed the nurse’s competence.


3. Communication and Interpersonal Relationships

Nurse

3.1 Establishes and maintains effective interpersonal relationship with individuals, families and communities

3.2 Upholds the dignity of team members and maintains effective interpersonal relationship with them

3.3 Appreciates and nurtures professional role of team members

3.4 Cooperates with other health professionals to meet the needs of the individuals, families and communities

4. Valuing Human Being

Nurse

4.1 Takes appropriate action to protect individuals from harmful unethical practice

4.2 Consider relevant facts while taking conscience decisions in the best interest of individuals

4.3 Encourage and support individuals in their right to speak for themselves on issues affecting their health and welfare

4.4 Respects and supports choices made by individuals

5. Management

Nurse

5.1 Ensures appropriate allocation and utilization of available resources

5.2 Participates in supervision and education of students and other formal care providers

5.3 Uses judgment in relation to individual competence while accepting and delegating responsibility

5.4 Facilitates conducive work culture in order to achieve institutional objectives

5.5 Communicates effectively following appropriate channels of communication

5.6 Participates in performance appraisal


5.7 Participates in evaluation of nursing services

5.8 Participates in policy decisions, following the principle of equity and accessibility of services

5.9 Works with individuals to identify their needs and sensitizes policy makers and funding agencies for resource allocation

6. Professional Advancement

Nurse

6.1 Ensures the protection of the human rights while pursuing the advancement of knowledge

6.2 Contributes to the development

6.3 Participates in determining and implementing quality care

6.4 Takes responsibility for updating own knowledge and competencies

6.5 Contributes to the core of professional knowledge by conducting and participating in research1

Autonomy

The term autonomy comes from the Greek word autos (meaning ‘self’) and

nomos (meaning ‘rule’, ‘governance’ or ‘law’). I.e. autonomy means ‘self-

governing’ or “right to make one’s own decisions”. In contemporary discourse it

has broad meanings, including individual rights, privacy, and choice. Autonomy

entails the ability to make a choice free from external constraints.3

Autonomy basically mean that people should be free to choose and

entitled to act on their preferences provided their decisions and actions do not

stand to violate or impinge on, the significant moral interest of others. Nurses

who follow this principle recognize that each client is unique, has the right to be

what that person is, and has the right to choose personal goals. Honoring the

principle of autonomy means that the nurse respects a client’s right to make

decisions even when those choices seems not to be in the client’s best interest.

Adults with capacity (physical and mental) to make healthcare decisions have

the right to consent to or refuse treatment. Even if healthcare providers do not

agree with a client’s decision, they must respect the client’s wishes (Beauchamp

& Childress, 2001)3. Infants, young children, people who are severely mentally


handicapped or incapacitated, and people in a persistent vegetative stage or

coma do not have the capacity to participate indecision making about their

healthcare. For such people, a surrogate decision maker must be identified to

act on their behalf.2

National League of Nursing Statement on Patients' Rights

To health care that is accessible and that meets professional standards,

regardless of the setting.

To courteous and individualized health care that is equitable, humane, and

given without discrimination as to race, color, creed, sex, national origin,

source of payment, or ethical or political beliefs.

To information about their diagnosis, prognosis, and treatment including

alternatives to care and risks involved in terms they and their families can

readily understand, so that they can give their informed consent.

To informed participation in all decisions concerning their health care.

To information about the qualifications, names, and titles of personnel

responsible for providing their health care.

To refuse observation by those not directly involved in their care.

To privacy during interview, examination, and treatment.

To privacy in communicating and visiting with people of their choice.

To refuse treatment, medications, or participation in research and

experimentation, without punitive action being taken against them.

To coordination and continuity of health care.

To appropriate instruction or education from health care personnel so that

they can achieve an optimal level of wellness and an understanding of

their basic health needs.


To confidentiality of all records (except as otherwise provided for by law or

third party payer contracts) and communications, written or oral, between

patients and health care providers.

To access to all health records pertaining to them, and the right to

challenge and correct their records for accuracy, and the right to transfer

all such records in the case of continuing care.

To information on the charges for services, including the right to challenge

these.

To be fully informed as to all their rights in all health care settings.4

Accountability

“Accountability is the obligation of being answerable for one's own

judgments and actions to an appropriate person or authority recognized as

having the right to demand information and explanation”. (A dictionary of

nursing, 2008)4

Integral to the practice of any profession is the inherent need to be

responsible for actions taken and for omissions.

The professional nurse must be proactive and take all appropriate

measures to ensure that her own practice is not lacking, remiss, or

deficient in any area or way.

Useful proactive measures include:

o Maintaining familiarity of relevant, current hospital policies, procedures, and

regulations as they apply to the nurse's practice and specialty area.

o Providing for self-audit.

o Providing for peer review to assess reasonableness of care in a particular

setting for a particular problem.

o Working with local nursing organizations to make certain that local standards

of practice are met.


o Examining the quality (accuracy and completeness) of documentation.

o Establishing open working relationships with colleagues wherein honest

constructive criticism is welcomed for the greater goal of quality patient care.

Local standards of practice normally coordinate with those of nationally

accepted standards.

Assertiveness

“Assertiveness is the quality or state of bold or confident self-expression,

neither aggressive nor submissive” (Dorland’s medical dictionary, 2007)8

“Assertiveness is the ability to express yourself and your rights without

violating the rights of others”9

It means that we have respect both for ourselves and for others. We are

consciously working toward a "win-win" solution to problems. A win-win

solution means that we are trying to make sure that both parties end up with

their needs met to the degree possible. An assertive person effectively

influences, listens, and negotiates so that others choose to cooperate

willingly.

Specific Techniques for being Assertive

*Be as specific and clear as possible about what you want, think, and feel. The following statements project this preciseness:

a. "I want to..."

b. "I don't want you to...”

*Allow others to complete their thoughts before you speak.

* Make your own decisions based on what you think is right

* Look to friendships as opportunities to learn more about yourself and others and to share ideas.

* Spontaneously and naturally enter into conversations using a moderate tone and reasonable volume of voice.


* Try to understand the feelings of others before describing your own.

* Try to avoid harm and inconvenience by talking out your problems before they occur or finding rational means for coping with unavoidable harm or inconvenience.

* Face problems and decisions squarely.

* Consider yourself strong and capable, but generally equal to most other people.

* Face responsibility with respect to your situation, needs and rights.

On being Non-assertive

* Stay in the back of groups.

* Always stick to the middle-of-the road position.

* Allow others to make decisions for you.

* Always keep your voice low or avoid eye contact to keep from calling attention to yourself

* Verbally agree with others despite your real feelings.

* Bring harm or inconvenience to yourself to avoid harming or inconveniencing others.

* Procrastinate to avoid problems and to keep from making decisions.

* Always consider yourself weaker and less capable than others.

* Always escape responsibility with excuses and "good" reasons.

Problems with being non-assertive

* You may end up with shoddy merchandise and service.

* You bottle up your feelings.

* You are not doing anything to improve a bad situation.

* You get involved in situations you would rather not be in.

* You end up being a "yes" person - having to do all the work while others sit by and watch.


* You run into communication barriers because nobody is willing to say what he or she really wants.9

Visibility

Nurses remain as the “invisible partner in health care". According to a study in

about twenty thousand articles published in magazines and newspapers

selected in the United States, identifying that nurses were mentioned in only 4%

of the articles related to heath, while physicians were present in 43%.

Recommendations to give more visibility to the nursing role include the need for

professionals to position themselves strategically towards the communication

means and also to educate the journalists.

According to Borenstein M. (2002), "We understand by professional image a

network of social representations of Nursing which, by means of a set of

concepts, affirmations and explanations, reproduces and is reproduced by

ideologies originated in the daily social practices internal/external to it. The

professional image leads us to professional identity itself, in its intricate network

of meanings that intend to be exclusive and, therefore, inherent to that specific

profession. Hence, the professional meaning consubstantiates in its own

representation of professional identity"11

LEGAL CONSIDERATIONS IN NURSING

Nursing practice is governed by many legal concepts. It is important for nurses to know the basics of legal concepts, because nurses are accountable for their professional judgments and actions.

“Laws are rules or standards of human conduct established by government through legislative bodies and interpreted by court to protect the rights of the citizens.”

Functions of law in nursing

It provides a framework for establishing which nursing actions in the care of clients are legal.

It differentiates nurse’s responsibilities from those of other professionals.

It helps establish boundaries of independent nursing action.


It assists in maintaining a standard of nursing practice by making nurses accountable under the law.4

Sources of Laws

Three kinds of laws have the potential to affect nursing practice:

Civil law generally governs actions by one individual or corporation against another. E.g. A client or family member sues the nurse or nurse’s employer for malpractice because of a claim of client injury caused by nursing care.

Criminal law involves actions by the state against an individual by the state against an individual for violations of criminal statutes. E.g. drug diversion, client assault, mercy killing etc.

Administrative law involves actions by state administrative agencies against individuals or organizations. E.g. administrative agencies govern the practice of nursing through boards or commissions of nursing in each state.6

Regulation of nursing practice

Credentialing

Credentialing is the process of determining and maintaining competence in nursing practice. It includes:

Licensure: Licensures are legal permits a governmental agency grants to individuals to engage in the practice of a profession and to use a particular title.

Registration: it is the listing of an individual’s name and other information on the official roster of a governmental or non-governmental agency. Nurses who are registered are permitted to use the title “Registered Nurse”.

Certification: certification is the voluntary practice of validating that an individual nurse has met the minimum standards of nursing practice in specialty areas such as MCH nursing, gerontology etc.

Accreditation: Accreditation is a process by which a government or private agency appraises and grants accredited status to institutions, programmes, or services that meet predetermined structure, process, and outcome criteria.

Legal roles, rights and responsibilities of nurses

Role-Provider of service


Responsibilities:

To provide safe and competent care commensurate with the nurse’s preparation, experience, and circumstances.

To inform clients of consequences of various alternatives and outcomes of care.

To provide adequate supervision and evaluation of others for whom the nurse is responsible.

To remain competent.

Rights:

Right to adequate and qualified assistance as necessary.

Right to reasonable and prudent conduct from clients, e.g., provision of accurate information as required.

Role-Employee or contractor for service

Responsibilities:

To fulfill the obligations of contracted service with the employer.

To respect the employer.

To respect the rights and responsibilities of other health care providers.

Rights:

Right to adequate working conditions (e.g. safe equipment and facilities)

Right to compensation for services rendered.

Right to reasonable and prudent conduct by other health care providers.

Role-citizen

Responsibilities:

To protect the rights of the recipients of care.

Rights:

Right to respect by others of the nurse’s own rights and responsibilities.


Right to physical safety.

Torts and crimes

Crime: A crime is an act committed in violation of the public(criminal) law and

punishable by a fine or imprisonment.

Tort: A tort is a civil wrong committed against a person or a person’s property.

Torts are usually litigated in the court by civil action between individuals. Torts

may be classified as intentional or unintentional.

A. Unintentional torts

Negligence: is the misconduct or practice that is below the standard expected of an ordinary, reasonable, and prudent practitioner.

Malpractice: is a professional negligence, that is , negligence that occurred while the person was performing as a professional.

B. Intentional torts

Assault: is the threat of touching another person without his or her consent.

Battery: battery is the actual carrying out of such a threat. E.g. a nurse may be sued for battery if he or she fails to obtain consent for a procedure.

Defamation: is communication that is false, or made with a careless disregard of the truth, and results in injury to the reputation of the person.

Fraud: fraud is the willful, purposeful misinterpretation of self or an act that may cause harm to a person or property.

Invasion of privacy: disclosing confidential information to an inappropriate third party subjects the nurse to liability for invasion of privacy, even the information is true.

False imprisonment: prevention of movement or unjustified retention of a person without consent may be false imprisonment.

Legal protection in nursing practice

Good Samaritan Acts


Good Samaritan acts are laws designed to protect healthcare providers who provide assistance at the scene of an emergency against the claims of malpractice unless it can be shown that here was a gross departure from the normal standards of care or willful wrongdoing on their part.

Guidelines for nurses who choose to render emergency care are:

Limit actions to those normally considered first aid as possible.

Do not perform actions that you do not know how to do.

Offer assistance, but do not insist.

Do not leave the scene until the injured person leaves or another qualified person takes over.6

Legal precautions for Nurses

Function within the scope of your education, job description and area of nursing practice.

Follow the procedures and policies of the employing agency.

Build and maintain good rapport with the clients.

Always identify the clients, particularly before initiating major interventions.

Observe and monitor the client accurately. Communicate and record significant changes.

Promptly and accurately document all the assessment and care given.

Be alert when implementing nursing interventions and give each task your full attention and skill.

Perform procedures appropriately.

Follow 5 rights while administering medications.

When delegating responsibilities, make sure that the person who is delegated a task understands what to do and that the person has the required knowledge and skill.

Protect clients from injury.

Report all incidents involving clients.


Always check any order that a client questions and ensure that verbal orders are accurate and documented appropriately.

Know your strengths and weaknesses.

Maintain your clinical competence.4

ETHICAL COMMITTEE

Sometimes making the right decision in the face of serious illness can

be complicated. When there is uncertainty or disagreement, the *Ethics

Committee can help.

The Ethics Committee is a group of Medical Center staff (physicians,

nurses, social workers, chaplains and others) and members of the

community who are available to help patients, families, doctors, and

other healthcare providers when they face difficult ethical decisions.

The Ethics Committee meets free of charge to provide a safe,

supportive, confidential forum in which you and others can think

through a problem, consider different points of view and sort through

options. Every attempt is made to involve key members of the health

care team as well as the patient and family, as appropriate, in the

process.

After discussing the ethical issues at stake, the Ethics Committee

offers advice in the form of a non-binding recommendation. It is then up

to those involved to decide what to do next.


The need for Institutional Ethics Committee (IECs) in medical and

research establishments resulted from the realization that affirms

human rights as a prerogative of all members of society.

Individual physicians and research workers may not be able to do

what is right in all instances as evidenced by the number of cases on

record.

Institutional ethics committees vary widely in their composition,

usually in an attempt to assure a broad based multi-disciplinary

membership. In addition to those with research and clinical experience,

many committees include representation from Pastoral Care, Social

Work, and Law backgrounds, and often a member with a more academic

orientation. Moreover, most committees find it important to include

individuals from the lay community to help provide a patient's and

public perspective.

The present medical and research scene in India is rather chaotic and

irregular and therefore vulnerable to unethical practices. With

globalization and shift of research focus from the developed countries

to developing countries, the protection of vulnerable populations in

countries like India is of utmost importance and urgency.

The apex medical and research bodies at best have played a passive

role till recently on ethical issues by not making a strong enough stand

in public and not being persuasive enough to motivate all institutions to

establish ethics committees.

There has been no concerted move to either educate the public on

ethical issues confronting medical practice and research or importantly,

to incorporate bioethics as a subject in the medical, nursing,

paramedical and biotechnology courses.

The Indian Council of Medical Research (ICMR) has published detailed

guidelines on the composition and responsibilities of IECs and


established ethical guidelines for biomedical research on human

subjects (Published in 2006).

A survey of existing IECs of various institutions in the country was

initiated recently by the ICMR. Unfortunately this effort received a very

unenthusiastic response. This sorry situation reflects an inadequate

form of control and governance in the practice of medicine and research

because the overseeing institutions are not given the necessary

authority to take action against offenders, and society as a whole has

not established a sensitive and interactive approach to the whole

question of unethical practices.

Role of IEC

IEC will review and approve all types of research proposals involving

human participants with a view to safeguard the dignity, rights, safety

and well being of all actual and potential research participants. The

goals of research, however important,should never be permitted to

override the health and well being of the research subjects.

The IEC will take care that all the cardinal principles of research

ethics viz.Autonomy, Beneficence, Non - maleficence and Justice are

taken care of in planning,conduct and reporting of the proposed

research.

For this purpose, it will look into the aspects of informed consent

process, risk benefit ratio, distribution of burden and benefit and

provisions for appropriate compensations wherever required.

It will review the proposals before start of the study as well as monitor

the research throughout the study until and after completion of the

study through appropriate well documented procedures for example

annual reports, final reports and site visits etc.

The committee will also examine compliance with all regulatory

requirements, applicable guidelines and laws.


The mandate of the IECs will be to review all research projects

involving human subjects to be conducted at the Institute, irrespective

of the funding agency. The role of IEC can be modified according to the

requirement of each Institute Composition of IEC

IECs should be multidisciplinary and multisectorial in composition.

Independence and competence are the two hallmarks of an IEC.

COMPOSITION OF IEC

The number of persons in an ethical committee should be kept fairly

small (7-9 members). It is generally accepted that a minimum of five

persons is required to compose a quorum. There is no specific

recommendation for a widely acceptable maximum number of persons

but it should be kept in mind that too large a Committee will make it

difficult in reaching consensus opinions. 12-15 is the maximum

recommended number.

The Chairperson of the Committee should preferably be from outside

the Institution

And not head of the same Institution to maintain the independence of

the Committee.The Member Secretary who generally belongs to the

same Institution should conduct thebusiness of the Committee. Other

members should be a mix of medical / non-medicalscientific and non-

scientific persons including lay public to reflect the differed

viewpoints.

The composition may be as follows :-

1. Chairperson

2. 1-2 basic medical scientists.

3. 1-2 clinicians from various Institutes

4. One legal expert or retired judge

5. One social scientist / representative of non-governmental

voluntary agency

6. One philosopher / ethicist / theologian


7. One lay person from the community

8. Member-Secretary

The ethical committee at any institution can have as its members,

individuals from other institutions or communities if required. There

should be adequate representation of age, gender, community, etc. in

the Committee to safeguard the interests and welfare of all sections of

the community / society.

Members should be aware of local, social and cultural norms, as this is

the most important social control mechanism. If required, subject

experts could be invited to offer their views, for example for drug

trials a pharmacologist, preferably a clinical pharmacologist, should

be included. Similarly, based on the requirement of research area, for

example HIV, genetic disorders etc. specific patient groups may also

be represented in the Committee.

The membership of IEC will include Epidemiologist(s), Sociologist(s),

Lawyer(s), Theologian, Statistician(s),Clinician(s), Basic scientists,

Pharmacist(s)/Clinical Pharmacologist(s) etc They should be appointed

by the Head of the Institute based on their competencies and

integrity, and could be drawn from any public or private Institute from

anywhere in the country.

IEC should be constituted in the following pattern :

i) A Chairperson

ii) A Deputy Chairman if need be,

iii) A Member Secretary,

iv) 5-15 members from different Departments / Specialties / disciplines

or areas etc

Authority under which IEC is constituted:

The Institutional Head constitutes the IEC.

Membership requirements:

a. The duration of appointment is initially for a period of 2-3 years


b. At the end of 2-3 years, as the case may be, the committee is

reconstituted, and 50% of the members will be replaced by a defined

procedure.

c. A member can be replaced in the event of death or long-term

nonavailability or for any action not commensurate with the

responsibilities laid down in the

Guidelines deemed unfit for a member.

d. A member can tender resignation from the committee with proper

reasons to do so.

e. All members should maintain absolute confidentiality of all discussions

during the meeting and sign a confidentiality form.

f. Conflict of interest should be declared by members of the IEC

Quorum requirements:

The minimum of 5 members are required to compose a quorum. All

decisions should be taken in meetings and not by circulation of

project proposals.

Offices

The Chairperson will conduct all meetings of the IEC. If for reasons

beyond control,the Chairperson is not available, the Deputy

Chairperson or an alternate Chairperson will be elected from the

members by the members present, who will conduct the meeting.

The Member Secretary is responsible for organizing the

meetings,maintaining the records and communicating with all

concerned. He/she will prepare the minutes of the meetings and get it

approved by the Chairman before communicating to the researchers

with the approval of the appropriate authority.

Documentation:

For a thorough and complete review, all research proposals should be

submitted with the following documents:


1. Name of the applicant with designation

2. Name of the Institute/ Hospital / Field area where research will be

conducted.

3. Approval of the Head of the Department / Institution

4. Protocol of the proposed research

5. Ethical issues in the study and plans to address these issues.

6. Proposal should be submitted with all relevant enclosures like

proformae, case

report forms, questionnaires, follow - up cards, etc.

7. Informed consent process, including patient information sheet and

informed

consent form in local language(s).

8. For any drug / device trial, all relevant pre-clinical animal data and

clinical

trial data from other centres within the country / countries, if

available.

9. Curriculum vitae of all the investigators with relevant publications in

last five

years.

10. Any regulatory clearances required.

11. Source of funding and financial requirements for the project.

12. Other financial issues including those related to insurance

13. An agreement to report only Serious Adverse Events (SAE) to IEC.

14. Statement of conflicts of interest, if any.

15. Agreement to comply with the relevant national and applicable

international

guidelines.

16. A statement describing any compensation for study participation

(including expenses and access to medical care) to be given to research

participants; a description of the arrangements for indemnity, if

applicable (in study-related injuries); a description of the arrangements

for insurance coverage for research participants, if applicable; all

significant previous decisions(e.g.,those leading to a negative decision


or modified protocol) by other ECs or regulatory authorities for the

proposed study (whether in the same location or elsewhere) and an

indication of the modification(s) to the protocol made on that account.

The reasons for negative decisions should be provided.

17. Plans for publication of results – positive or negative- while

maintaining the

privacy and confidentiality of the study participants.

18. Any other information relevant to the study

Review procedures:

a. The meeting of the IEC should be held on scheduled intervals as

prescribed and additional meetings may be held as and when the

proposals are received for

Review.

b.The proposals will be sent to members at least 2 weeks in advance.

c. Decisions will be taken by consensus after discussions, and whenever

needed

voting will be done.

d. Researchers will be invited to offer clarifications if need be.

e. Independent consultants/Experts will be invited to offer their opinion

on specific research proposals if needed.

f. The decisions will be minuted and Chairperson’s approval taken in

writing.

Element of review

a. Scientific design and conduct of the study.

b. Approval of appropriate scientific review committees.

c. Examination of predictable risks/harms.

d. Examination of potential benefits.

e. Procedure for selection of subjects in methodology including inclusion/

exclusion,withdrawal criteria and other issues like advertisement details.

f. Management of research related injuries, adverse events.

g. Compensation provisions.


h. Justification for placebo in control arm, if any.

i. Availability of products after the study, if applicable.

j. Patient information sheet and informed consent form in local language.

k. Protection of privacy and confidentiality.

l. Involvement of the community, wherever necessary.

m. Plans for data analysis and reporting

n. Adherence to all regulatory requirements and applicable guidelines

o. Competence of investigators, research and supporting staff

p. Facilities and infrastructure of study sites

q. Criteria for withdrawal of patients, suspending or terminating the

study

Expedited review

All revised proposals, unless specifically required to go to the main

committee, will be examined in a meeting of identified members

convened by the Chairman to

expedite decision making. Expedited review may also be taken up in

cases of

nationally relevant proposals requiring urgent review. The nature of the

applications, amendments, and other considerations that will be eligible

for expedited review should be specified.

Decision-making

a. Members will discuss the various issues before arriving at a consensus

decision.

b. A member should withdraw from the meeting during the decision

procedure concerning an application where a conflict of interest arises

and this should b indicated to the chairperson prior to the review of the

application and recorded in the minutes.

c. Decisions will be made only in meetings where quorum is complete.

d. Only members can make the decision. The expert consultants will only

offer their opinions.


e. Decision may be to approve, reject or revise the proposals. Specific

suggestions for modifications and reasons for rejection should be given.

f. In cases of conditional decisions, clear suggestions for revision and the

procedure for having the application re-reviewed should be specified.

g. Modified proposals may be reviewed by an expedited review through

identified

members.

h. Procedures for appeal by the researchers should be clearly defined.

Communicating the decision

a. Decision will be communicated by the Member Secretary in writing.

b. Suggestions for modifications, if any, should be sent by IEC.

c. Reasons for rejection should be informed to the researchers.

d. The schedule / plan of ongoing review by the IEC should be

communicated to

the PI.

Follow up procedures

a. Reports should be submitted at prescribed intervals for review.

b. Final report should be submitted at the end of study.

c. All SAEs and the interventions undertaken should be intimated.

d. Protocol deviation, if any, should be informed with adequate

justifications.

e. Any amendment to the protocol should be resubmitted for renewed

approval.

f. Any new information related to the study should be communicated.

g. Premature termination of study should be notified with reasons along

with

summary of the data obtained so far.

h. Change of investigators / sites should be informed.

Record keeping and Archiving

a. Curriculum Vitae (CV) of all members of IEC.


b. Copy of all study protocols with enclosed documents, progress

reports, and

SAEs.

c. Minutes of all meetings duly signed by the Chairperson.

d. Copy of all existing relevant national and international guidelines on

research

ethics and laws along with amendments.

e. Copy of all correspondence with members, researchers and other

regulatory

bodies.

f. Final report of the approved projects.

g. All documents should be archived for prescribed period.

CONCLUSION:

The topic of ethical and legal issues is very important in nursing

because as a nurse practioner, nurse educator or nurse

administrator you have to understand all the aspects of legal

issues. Same way ethical issues are also attracts because we are

working with the live human beings.

This presentation makes all of us to aware about this issues and

guides us in our practice. As masters nursing this topic helps us

to face major critical situations as a nurse administrator and

nurse educator as well as nurse practitioner

I thank our respected madam to give me the opportunity to

present this topic.


Thank you

BIBLIOGRAPHY:

B s shah,”Principles of Management”second edition;b s shah

prakashan,2007.pp:231=236.

K aswathppa,”Organizational behaviour”eight edition,himalaya

publishing house,2008.pp:489-518.

Kooz hardlod”Essential Of Management” fifth edition,high cowon

publishers,2003,pp:134-139

Mamoria c.d ‘personal management”first edition,himalaya

publishing house,Mumbai.2003pp:108-136

P.N.Reddy “Principles of management” 3rd edition, Tata Mc Glaw

Hill publishing company limited, New Delhi PP

Weirich Heinz”principles of management”10 edition,macgrew hills

publication,ne delhi.2004.pp:243-247

Zwemer J. Ann (2006), "Professional Adjustments And Ethics For

Nurses in India"-rt Edition, BI Publishers,Chennai,pp.216-220

Ellis Rider Janice (2001), "Nursing In Today's

World:Challenges,Issues And Trends"7th Edition,Lippincott

Publishers,Pp. 206-245


Feldman -R (2005), "Educating Nurses For Leadership" Springers

Publishers,Newyork,Pp.219-230

References:

1. Code of Ethics and Professional Conduct. Indian Nursing Council. New Delhi. Page 1-17

2. Ford Gary G. Ethical Reasoning for Mental Health Professionals. New Delhi: Sage Publications;2006.Page 1-13

3. Johnstone, Megan- Jane. Bioethics: A Nursing Perspective. 4TH edition. Australia:Elsevier;2004. Page 18-46

4. Kozier, Erb, Berman, Burke. Fundamentals of Nursing: Concepts, Process and Practice.6 TH edition. Singapore: Pearson Education (Pte.Ltd); 2003.Page 70-83

5. Pattricia.A.Potter, Anne Griffin Perry, Moshy. Basic Nursing:Essentials for Practice. 6TH edition. St.Louis,Missouri: Elsevier;2008. Page 67-70

6. Ruth F. Craven, Constance J. Hirnle. Fundamentals of Nursing: Human Health and Function.5TH

edition. Philadelphia: Lippincott Williams & Wilkins; 2007. Page 87-106

7. www.en.wikipedia.org/wiki/Assertiveness

8. www.encyclopedia.com

9. www.medical-dictionary.thefreedictionary.com/assertive

10. www3.interscience.wiley.com/journal/119304526/abstract?CRETRY=1&SRETRY=0

11. www.scielo.br/scielo.php?script=sci_arttext&pid=S0104-11692007000200002


http://www3.interscience.wiley.com/journal/119304526/abstract?CRETRY=1&SRETRY=0

http://www.medical-dictionary.thefreedictionary.com/assertive

http://www.encyclopedia.com/

http://www.en.wikipedia.org/wiki/Assertiveness

Date post:	22-Oct-2014
Category:	Documents
Upload:	susangrace123
View:	463 times
Download:	3 times

Code of Ethics Types of Law

Documents