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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 JG COLLEGE OF NURSING, SUBMITTED BY 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

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TERMINOLOGY Assurance: A promise that you will definitely do something1 Health: A state of dynamic balance of an individuals 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

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Quality Nursing Practice: Quality of nursing practice is achieved when organizations 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
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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
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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 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)

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A code of practice is adopted by a profession or by a governmental or nongovernmental 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

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ELEMENTS OF THE CODE 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 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 practice4 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. NURSES AND PEOPLE
The nurses 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.

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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. 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.

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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 and

safeguard

individuals,

families

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.

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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

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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 nurses 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

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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 communication effectively following appropriate channels of

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
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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 selfgoverning or right to make ones 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 clients right to make decisions even when those choices seems not to be in the clients 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 clients decision, they must respect the clients 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.

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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

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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:

Maintaining familiarity of relevant, current hospital policies, procedures, and regulations as they apply to the nurse's practice and specialty area. Providing for self-audit. Providing for peer review to assess reasonableness of care in a particular setting for a particular problem. Working with local nursing organizations to make certain that local standards of practice are met. Examining the quality (accuracy and completeness) of documentation. Establishing open working relationships with colleagues wherein honest constructive criticism is welcomed for the greater goal of quality patient care.

o o

o o

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 (Dorlands medical dictionary, 2007)8 Assertiveness is the ability to express yourself and your rights without violating the rights of others9

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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.

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* 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.

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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 nurses 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 nurses employer for malpractice because of a claim of client injury caused by nursing care.

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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 individuals 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 nurses 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.

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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 nurses 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.

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Tort: A tort is a civil wrong committed against a person or a persons 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.

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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.

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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

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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 h u m a n r i g h t s 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.

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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.

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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.

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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

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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:

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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

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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.
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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:

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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 Chairpersons 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.

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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

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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.


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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.

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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

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BIBLIOGRAPHY: B s shah,Principles of Managementsecond edition;b s shah

prakashan,2007.pp:231=236. K aswathppa,Organizational behavioureight edition,himalaya publishing

house,2008.pp:489-518. Kooz hardlodEssential Of Management fifth edition,high cowon

publishers,2003,pp:134-139 Mamoria c.d personal managementfirst 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 Heinzprinciples of management10 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

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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.6TH 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

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