ETHICAL COMMITTEE

Introduction:

There has been growing public concern regarding the ethical conduct of Healthcare
professionals which is often reflected as Complaints about ethical conduct and an increasing use
of litigation against health care practitioners. Although ethics as applied to medical practice date
back to the ancient civilization by the symbolic adherence to the Hippocratic oath, codes of
conduct and laws regulating the professions are devised and updated from time to time. These
codes have been included in the health professionals training curriculum in many countries and
there has been a growth in the number of ethicists and ethical committees.

Terminology:

 Ethics: The word ‘Ethics’ has been derived from greek word ‘Ethos’ which means custom
or guiding beliefs. Ethics refers to study of philosophical ideas of right or wrong behaviour.

 Consent: Permission, approval or agreement

 Bioethics: A field of ethical enquiry that examines ethical issues and dilemmas arising from
health, health care and research involving humans.

 Etiquette: It refers to guidelines which control the way a responsible individual should
behave in the society.

 Professional Conduct: The accepted manner in which a professional will act.

Defintion of Ethical Committee:

An Ethical Committee is a group of persons comprising health care professionals

and nonmembers who are officially responsible for promoting ethical practices and code of
ethics, protects the dignity, rights, safety and well-being of trial subjects and particular care to
protect vulnerable participant.

It is advisory and takes decisions regarding ethics and resolves ethical issues and
dilemmas in practice, administration, education and research.

History:

 One of the most fundamental ethical principles in human experimentation is that the
experimenter should not subject the participants in the experiment to any procedure they would
not be willing to undertake themselves.
 This idea was first codified in the Nuremberg Code in 1947, which was a result of the trials of
Nazi doctors at the Nuremberg trials accused of murdering and torturing victims in valueless
experiments. Several of these doctors were hanged.

 An important element of an ethics committee's oversight is to ensure that informed

consent of the subjects has been given. Informed consent is the principle that the volunteers
in the experiment should fully understand the procedure that is going to take place, be aware
of all the risks involved, and give their consent to taking part in the experiment beforehand.

 The principle of informed consent was first enacted in the U.S. Army's research into Yellow
fever in Cuba in 1901.

Ethical Committees in India:

 Indian Council for Medical Research(ICMR) initiated formulation of the EC in India and
prepared its first official guidelines to form an ethics committee in February 1980 for
conducting research that provided membership criteria and standards for an ethical standard
for review.

 ICMR issued guidelines for bioethics for research in medical, epidemiology and public
health in the year 2002 and revises in the year 2006.

 It is mandatory to get approval for any biomedical research on human participants by the
Institutional Ethical Committee(IEC)/Institutional review board (IRB) before its initiation.

 Therefore each institution should have its ethics committee under Amendment 2005 of the
drugs and cosmetics Act,1940.

 ICMR developed guidelines for preparing standard operating procedures (SOPs) for
Institutional Ethics Committee (IEC) for Human Research in collaboration with the Forum for
Ethics Review Committees of Asia Pacific (FERCAP).

 The Forum for Ethics Committee Review in India (FERC) has been set up under FERCAP.

 Ethics committees are concerned with derious adverse events reporting and compensation in
cases of deaths occurs during clinical trial and care of participants injured during research.

Some EC/IRB around the World

 Research Ethics Committee (REC) in the United Kingdom
 Medical Research Ethics Committee (MREC) in the Netherlands
 Comités de Protection des Personnes (CPP) in France
 Institutional Review Board in United States
 Research Ethics Board (REB) in Canada
 Human Research ethics committee (HREC) in Australia

Functions of Ethics Committee:

 Research:

 Validates research proposal from the technical, scientific, statistics and ethical point of view.

 Examines adherence of principles of research ethics.

 Reviews informed consent process

 Examines risk-benefit ratio, distribution of burden and benefits and provision of appropriate
compensation.

 Examines compliance with all regulating requirements, applicable guidelines and laws.

 Decides to solve actual or anticipated ethical dilemmas in research.

 Quality of Care:

 Evaluates the quality of care with respect to ethical principles and rights of patients in various
areas.

 Some of areas of care include the art of bedside care, relief of suffering, cure of disease,
incidence, trend over time of iatrogenic disease cost to patient in terms of tests, drugs, other
costs, prompt attention to the needs of the patient and care of the seriously ill, dying and dead
patients.

 Education:

 Plans and conduct in-service training programs, seminars/workshops/mini-conferences on

various topics related to biomedical ethics, ethical principles, rights of patients, code of ethics
and quality research.

 Other roles of the ethics committee:

 Policy development

 Providing consultation in cases of ethical dilemma and resolving ethical conflicts.

 Preparing guidelines, manual on bioethics, principles of ethics, code of ethics, a method of

dealing with ethical dilemmas etc. for staff.

 Preparing guidelines to patients, families regarding their rights, responsibilities, means of

seeking redress for any harm.

 Disclosure of diagnosis
 Diagnosis of brain death

 Requesting permission to harvest organs for transplantation.

 Informed consent process.

 Guiding and supporting patients, families and health care providers.

 Conducting surveys regarding any malpractices/deficiency in care practices.

 Setting a supportive framework/forum to guide and monitor the proper functioning of a forum
for redress of complaints from patients, families, employees.

 Resolving conflicts about what is right things to do to patients at the end of life.

 Getting feedback regarding the functioning of the EC.

Composition:

 The committee should be multidisciplinary.

 The hospital EC must ensure representatives from the administrators, clinicians, social worker,
priest/philosopher,lawyer, rehabilitation personnel, a layperson from the community and
statistician.

 Each department should also constitute a departmental EC to deal with its respective ethical
issues.The size of EC vary according to the size of the institution and function of ECs.

 According to guidelines for preparing SOPs for IEC for Human research by ICMR, the
committee should have 7 to 9 members and maximum 12-15.

 The minimum 5 members are required to compose a quorum.

 The IEC for research should comprise the following members:

 Chairperson ,preferably be from outside the institution.

 Basic medical Scientists - 1 or 2

 Clinicians from various institutes - 1 or 2

 Legal expert/retired judge - 1

 Social scientist/representative of nongovernmental voluntary agency - 1

 Philosopher/ethicist/theologian - 1

 Layperson from community - 1

 Member- Secretary(same institute)

 Subject expert from a related discipline (If required)

Duration:

The committee is constituted by the Head of Institution initially for 2 - 3 years.

Meeting Procedure:

 Committee meetings held on scheduled intervals as prescribed and also as and when required.

 The chairperson chairs the session and member secretary is the convener.

 Convener organizes meetings, maintains records, writes and prepares minutes of the meetings
and get it approved by the chairman and communicates to all concerned.

CODE OF ETHICS

Introduction:

The code is a collection of laws or a system of rules and regulations. A code adopted
by profession is to regulate the profession and to promote high standard of competence among its
members.

Code of ethics is a formal statement of an organization’s values on certain ethical and

social issues derived from the dignity and rights of the patient as a person.Within any given
profession, a code of ethics serves as a means of self regulation and a source of guidelines for
individual behaviour and responsibility.

Definition of Code of Ethics:

A code of ethics is a set of ethical principle that

A} is shared by members of a group

B} reflects their moral judgments over time

C} serves as a standard for their professional actions.

-Barbara Kozier

Purposes of Code of Ethics:

 It directs nurses to take ethical decisions in day-to-day situations.

 Means for self evaluation.

 Provides a framework for peer review initiatives.

 Educate nurses about their ethical responsibilities.

 Conveys the commitment of nurses to health care professionals and public towards service.

Code of ethics for Nurses by ICN

The ICN code of Ethics for Nurses most recently revised in the year 2012 is a guide for action
based on social values and needs. The code has served as the standard for nurses worldwide since it
was first adopted in the year 1953.The code makes it clear that inherent in nursing is respect for
human rights including the right to life, to dignity and to be treated with respect.

ICN Code:

The ICN Code of Ethics for Nurses has four principal elements that outline the standards of ethical
conduct. Elements of the code are:

 Nurses and People

 The nurse’s primary professional responsibility is towards 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 judgement in sharing this
information.

 The nurse shares with society the responsibility for initiating and supporting action to meet the
health and social needs of public in particular those of vulnerable populations.

 Nurses and Practice

 The nurse carries personal responsibility and accountability for nursing practice and for
maintaining competence by continual learning.

 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.
 Nurse and the Profession

 The nurse assumes major role in determining and implementing acceptable standard 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 organization, participates in creating and
maintaining safe,equitable social and economic working condition in nursing.

 Nurses and Co-Worker

 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 coworker or any other person.

Code of Ethics for Nurses in India (INC)

1. The nurse respects the uniqueness of Individual in provision of care.

Nurse:

 Provides care for individual without consideration of caste, creed, religion, culture, ethnicity,
gender, socio-economics and political status, personal attributes or any other grounds.

 Individualizes the care considering the beliefs, values and cultural sensitivities.

 Appreciates the place of individual in the family and community and facilitates participation of
significant others in the care.

 Develops and promotes trustful relationship with Individual.

 Recognizes uniqueness of response of individual to interventions and adapts accordingly.

2. The nurse respects the rights of individuals as partner in care and help in making
informed choices.

Nurse:

 Appreciates individuals right to make decisions about their care and therefore gives adequate
and accurate information for enabling them to make informed choices

 Respects the decisions made by individual regarding their care.

 Protects public from misinformation and misinterpretations.

 Advocates special provisions to protect vulnerable individuals/groups.

3. The nurse respects individual’s right to privacy, maintains confidentiality and shares
information judiciously.

Nurse:

 Respects the individual’s right to privacy of their personal information.

 Maintains confidentiality of privileged information except in life threatening situations and

uses discretion in sharing information.

 Takes informed consent and maintains anonymity when information is required for quality
assurance/academic/legal reasons.

 Limits the access to all personal records written and computerized to authorized persons only.

4. Nurse maintains competence in order to render quality nursing care.

Nurse:

 Nursing care must be provided only by registered nurse.

 Nurse strives to maintain quality nursing care and upholds the standard of care.

 Nurse values continuing education, initiates and utilizes all opportunities for self development.

 Nurse values research as a means of development of nursing profession and participates in

nursing research adhering to ethical principles.

5. The nurse is obliged to practice within the framework of ethical, professional and legal
boundaries.

Nurse:

 Adheres to code of ethics and code of professional conduct for nurses in India developed by
Indian Nursing Council.

 Familiarizes with relevant laws and practices in accordance with the law of the state.

6. Nurse is obliged to work harmoniously with members of the health team.

Nurse:

 Appreciates the team efforts in rendering care.

 Cooperates,coordinates and collaborates with members of the health team to meet the needs of
people.

7. Nurse commits to reciprocate the trust invested in nursing profession by society.

Nurse:
 Demonstrates personal etiquettes in all dealings.

 Demonstrates professional attributes in all dealings.

CODE OF PROFESSIONAL CONDUCT IN VARIOUS ASPECTS IN

NURSING

A. Professional responsibility and accountability

Nurse:

 Appreciates sense of self worth and nurtures it.

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

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

 Is accountable for maintaining practice standards set by INC.

 Is accountable for own decisions and actions.

 Is compassionate

 Is responsible for continuous improvement of current practices.

 Provides adequate information to individuals that allows them informed choices.

 Practices healthful behavior.

B. Nursing Practice

Nurse:

 Provides care in accordance with set standards of practice.

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

 Ensures safe practice.

 Consults, co-ordinates, collaborate and follows up appropriately when individual care needs
exceed the nurse’s competence.

C. Communication and Interpersonal relationships

Nurse:

 Establishes and maintains effective interpersonal relationships with individuals, families and
communities.
 Upholds the dignity of team members and maintains effective interpersonal relationship with
them.

 Appreciates and nurtures professional role of team members.

 Co-operates with other health professional to met the needs of individuals, families and
communities.

D. Valuing Human being

Nurse:

 Takes appropriate action to protect individuals from harmful unethical practice.

 Considers relevant facts while taking conscience decisions in the best interest of individuals.

 Encourages and support individuals in their right to speak for themselves on issues affecting
their health and welfare.

 Respects and supports choices made by individuals.

E. Management

 Ensures appropriate allocation and utilization of available resources.

 Participates in supervision and education of students and other formal care providers.

 Uses judgement in relation to individual competence while accepting and delegating

responsibility.

 Facilities conducive work culture in order to achieve institutional objectives.

 Communicates effectively following appropriate channels of communication.

 Participates in performance appraisal.

 Participates in evaluation of nursing service.

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

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

F. Professional Advancement

Nurse:

 Ensures the protection of human rights while pursuing the advancement of knowledge.

 Contributes to development of nursing practice.

 Participates in determining and implementing quality care.

 Take responsibility for updating own knowledge by conducting and participating in research.

Summary:

An Ethics committee is a body responsible for ensuring that medical experimentation and
human subject research are carried out in an ethical manner in accordance with National and
International law. This idea was first used in the Nuremberg Code in 1947 with the emphasis on
informed consent.In India ICMR initiated formulation of Ethical Committee and issued guidelines
in the year 2002 for bioethics for research in medical, epidemiology and public health which again
revised in the year 2006.

The ethics of professional nursing center on the care of the patient. The code of ethics
for nurses was developed as a guide for carrying out nursing responsibilities in a manner consistent
with quality in nursing care and the ethical obligations of the profession.

Code of ethics provide guidelines for safe and compassionate care.Ethical values can protect a
society not the law.

Conclusion:
Since nurses address complex ethical and human rights issues on a regular basis, the
American Board of Directors and the congress on Nursing practice first initiated the code of ethics
for nurses in the year 1985 to delineate the code of responsibilities and conduct expected from
nurses in their practices. Advancement in the globalization, modernization and technology has an
impact in nursing. Increased complexity in the professional role and awareness among the clients
for their rights required nurses to pay attention to understand and follow strictly ethical
responsibilities about their jobs and clients.

Abstract:

1.Thirunavukarasu M.R.;Velmurugan conducted a hospital based descriptive study on Knowledge

regarding law and ethics among nurses at a tertiary care hospital in rural India (2018). A
pretested questionnaire covering socio-demographic information and questions regarding law and
ethics was used to collect the information. Nurses with more than one year experience and those
who offered voluntary informed consent were included in the study. The study covered 50 staff
nurses from both gender. The study showed that majority of the participants (78%) had inadequate
knowledge, nearly 7% of them are having moderate knowledge and only 4% are having
adequate knowledge regarding law and ethics in Nursing.
2. S. P. Subashini conducted an observational cross sectional study on Indian Nursing Council –
It’s role in evolving and administering paramedical professional ethics.(2020) The main aim
was to assess the knowledge on nursing professional code of ethics in practice among nurse
educators, final year nursing students and nurse clinicians and on the role of Indian Nursing Council
in evolving and administrating the paramedical professional ethics.: Observational cross sectional
study design with a total of 1200 respondents were assessed from college of nursing, school of
nursing and their affiliated hospital in various districts around Tamil Nadu.The level of knowledge
assessment on the nursing professional ethical codes among nurse educators reveals 63.0%
adequate knowledge, among final year nursing students 13.3% adequate knowledge and
among nurse clinicians 7.0% adequate knowledge.

Bibliography:

 Vati Jogindra.Principles and Practice of Nursing Management &Administration.Second

edition.New Delhi:Jaypee Brothers Medical Publishers(P) Ltd;2020.p.31 - 35
 Masih Shannan.Essentials of Nursing Management in Service and Education.2nd edition.New
Delhi:Lotus Publishers; 2017.p. 334 - 341.
 Basheer Shebeer P. ,Khan S. Yaseen.A concise Text book of Advanced Nursing Practice.2nd
edition.Bangalore:EMMESS Medical Publishers;2019.p.9 - 12.
 Brar Navdeep kaur,Rawat HC.Textbook of Advanced Nursing Practice.1st edition.New
Delhi:Jaypee Brothers Medical publishers;2015.p.25
 K Deepak et.al.A Comprehensive Textbook on Nursing Management.2nd edition.Bangalore:
EMMESS Medical Publishers;2018.p.493 - 495.
 Clement I.Management of Nursing Services and Education.1st edition.ELSEVIER
Publication;2011.p.493 - 497
 Vati Jogindra.Nursing Foundation Concepts and Perspectives.1st edition.New Delhi:Jaypee
Brothers Medical Publishers(P) Ltd;2015.
Journals:
 R., Thirunavukarasu & A., Velmurugan. (2018). Knowledge regarding law and ethics among
nurses at a tertiary care hospital in rural India. International Journal Of Community Medicine
And Public Health. 10.18203/2394-6040.ijcmph20183421.
 Subashini SP. Indian Nursing Council–It’s role in evolving and administering paramedical
professional ethics. Santosh University Journal of Health Sciences. 2020 Dec 15;4(1):41-4.
 Sauer JE: Ethical problems facing the Industry. Hospital and Health services Administration
1985.
 Zahedi, F., et al.The Code of Ethics for Nurses. Iranian Journal of Public Health, vol. 42, no.
Supple1, Jan. 2013.
 Woods, Martin.Exploring the Relevance of Social Justice within a Relational Nursing Ethics:
Social Justice and Nursing Ethics Article.Nursing Philosophy, vol. 13, no. 1, Jan. 2012,
DOI.org (Crossref), doi:10.1111/j.1466-769X.2011.00525.x.
Websites:
 Dr.Nilima Sonawane. Code of Ethics for the Nursing Professionals.
https://www.slideshare.net/Ashins/code-of-ethics-for-the-nursing-professionals.
 sweetharry71. Ethical Committee, Code of Ethics Ppt.
https://www.slideshare.net/sweetharry71/ethical-committee-code-of-ethics-ppt.
 Pristyn Research Solutions. Ethics Committee.
https://www.slideshare.net/azherkhan5916/ethics-committee-141264056.
 “Ethics Committee.” Wikipedia, 23 Feb. 2021. Wikipedia, https://en.wikipedia.org/w/index.php?
title=Ethics_committee&oldid=1008470940.