Presenter: Dr. Swati Jarole

Moderator : Dr. P . R.Deshmukh

Ethics in Health care and Research

Introduction History Medical ethics principles Codes and regulation General principles of ethics Respect for persons Beneficence Justice Public health ethics Challenges

Framework

Ethics is defined as a set of principles of right conduct

In medical sense it is principle and norms of proper professional conduct concerning rights and duties of health care professionals themselves and their conduct towards patients and fellow practioners including action taken in care of patients and family members

Introduction

Hippocratic oath

John Gregory and Thomas Percival (nineteenth century)

Concept of bioethics

History

Nazi Medical Experiments in WWIIConcentration Camps

Nuremberg code

Nuremberg codeVoluntary consentGenerlizable knowledgeAnimal experimentationUnnecessary mental & physical sufferingNo experiment conductedDegree of riskRisk minimizedScientifically qualified investigatorsLiberty to withdrawReady to end experiment

1964 - Declaration of Helsinki (1975, 1983, 1989, 1996, 2000, 2008)

12 basic principles

Declaration of Helsinki

Basic principles Clinical research combined with professional care

1. Moral and scientific principles2. Scientifically qualified person3. Importance of objective is out

of proportion to risk4. Careful assessment of risk5. Special caution

1. In the treatment of sick person doctor must be free to use new therapeutic measure if his judgement offers hope of saving life.

2. Doctor can combine clinical research with professional care, objective being acquisition of new medical knowledge

Recommendations guiding doctors in clinical research

Non therapeutic clinical research

1. Remain protector of life and health2. The nature, purpose and the risk of clinical research must be

explained3. Consent4. Power of choice5. Consent in written6. Respect the right of individual7. Free to withdraw

1980 - Policy Statement on Ethical Considerations involved in Research on Human Subjects ( ICMR)

1982 - International Guidelines for Biomedical Research involving Human Subjects (WHO & CIOMS )

1991 - International Guidelines for Ethical Review in Epidemiological studies (CIOMS)

1993 - International Ethical Guidelines for Biomedical Research Involving Human Subjects (revised 2002) (CIOMS)

2000 - 'Ethical guidelines for Biomedical Research on Human Subjects (ICMR)

2003 - The International Declaration on Human Gene Data (UNESCO)

2005 -Universal Declaration on Bioethics and Human Rights (UNESCO)

In 2006, ICMR published “Ethical guidelines for biomedical research on human participants”

History

Syphilis study at Tuskegee

1979 Belmount report identified three principles to conduct research

Codes and regulation

1 •Respect for persons

2 •Beneficence

3 •Justice

1. Essentiality2. Voluntariness, informed consent and

community agreement3. Non exploitation4. Confidentiality and privacy5. Precaution and risk minimization6. Professional competence

General principal of ethics

7. accountability and transparency8.maximisation of the public interest and of distributive justice9.Institutional arrangements10. Public domain11. Totality of responsibility12. Compliance

The principle of respect for persons can be broken down into two basic ideas:1. Individuals should be treated as

autonomous agents2. Persons with diminished autonomy are

entitled to additional protections

Respect for persons

be completely voluntary

should give informed written consent

no inducement but compensation( risk benefits, out of pocket expenses)

No unjustifiable assurance

Anonymity & confidentiality

Selection of as research participants

Pregnant or nursing womenChildrenVulnerable group

Selection of special group as research participants

Three fundamental aspects of informed consent

1. Voluntariness2. Comprehension3. Disclosure

Informed consent

1. Patient information sheet---Nature and purpose of study

2. Duration of participation with number of participants

3. Procedures to be followed4. Investigations, if any5. Foreseeable risks and discomforts 6. Benefits to participant/ community /medical

profession 7. Policy on compensation8. Medical treatment for injuries or risk 9. Alternative treatments if available10. Steps taken for confidentiality

11.No loss of benefits on withdrawal12. Benefit sharing in event of commercialization13. Contact details of PI or local PI/Co-PI in Multicentric14. Contact details of Chairman of IEC for appeal against violation of rights15. Voluntary participation16. If test for genetics & HIV, counseling for consent for testing must be given as per national guidelines17. Storage period of biological sample and related data 18. Copy to participant

Written consent not possible? Third person, audio-visual but needs approval

of IEC

Fresh or re-consent Deviation of protocol Regains consciousness from unconscious Change in treatment modality, procedures, site, visits Before publication

Waiver of consent Not more than minimal risk Do not come into contact When it is necessitated in emergency situations Research on anonymised biological samples from deceased

individuals

During period of research requires treatmentParticipant withdrawn from research for

medical reasonsParticipant withdraw for other reasons

Compensation for participation

Protections against risks

• Definition of minimal risk

• Methods of weighing risks against anticipated benefits

• Potential benefits for the research participants

Equipoise and need for there to be genuine uncertainty about whether one treatment is superior to another

Beneficence

Privacy & Confidentiality of research participants and research data

• Use of coded private information to protect confidentiality

• Use of an IRB to provide oversight for research involving human subjects

• Situations that allow for an IRB expedited review procedure

• Data and Safety monitoring for clinical trials

Functions

To resolve ethical dilemmasTo safeguard dignity, rights, safety & well

being of actual & potential participantsTaking care of principle of ethicsTo support the researcher in ethical issuesTo examine compliance with all regulatory

requirements, applicable guidelines and lawsEthical clearance irrespective of funding

agency

Institutional Ethics Committee (IEC)

7-9 members

1. Chairperson2. 1-2 basic medical scientists.3. 1-2 clinicians from various Institutes4. One legal expert or retired judge5. One social scientist / representative of NGO6. One philosopher / ethicist / theologian7. One lay person from the community8. Member-Secretary Subject expert/ Independent consultants

Duration of Membership – 2-3 years

Composition of IEC

Prescribed application formName of applicant with designation Name of Institute/ Hospital / Field area where

research will be conducted.Approval of HOD/ InstitutionProtocol of proposed researchEthical issues in study & plans to address these

issues.Proposal should be submitted with all relevant

enclosures like proformas, case report forms, questionnaires, follow - up cards, etc.

Informed consent process, including patient information sheet and informed consent form in local language(s).

Application Procedures & Documents

For any drug / device trial, all relevant pre-clinical animal data and clinical trial data from other centres within country / countries, if available.

Curriculum vitae of all the investigators with relevant publications in last five years.

Any regulatory clearances required. Source of funding and financial requirements for the

project.Other financial issues including those related to

insuranceAn agreement to report only Serious Adverse Events

(SAE) to IEC.Statement of conflicts of interest, if any.Agreement to comply with the relevant national and

applicable international guidelines.A statement describing any compensation for study

participation (including expenses and

Proposals sent to members at least 2 wks in advance

Meetings on scheduled intervals

Minimum 5 member for decision

Decision by meeting not by circulation

Researchers will be invited to offer clarifications if need

Minute & notification by member secretary

Communicating decision

Record keeping & Archiving

Review procedures:

Minimal risk: defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of general population

Exemption from review

Expedited review

Full review

Decision in writing to PIIf member has conflict of interestMembers own proposalNegative decisionReverse positive decisionDiscontinuation of trialPremature termination of study

Decision making process

Data can be disclosedCourt of lawThreat to person’s lifeSevere adverse reactionRisk to public health it takes precedence over

personal right to privacy

Safeguarding confidentiality

Fair procedures and outcomes are used to select research participants, and

There is a fair distribution of benefits and burdens to populations who participate in research

Justice

Individual justice requires that:Benefits of participation in research are offered to a

diverse eligible population , andRisks of participation in research are shared by a

diverse populationSocial justice requires that consideration is given to classes of subjects that ought,and ought not, to participate in research. Considerations are based on:The ability of members of that class to bear burdens

andThe appropriateness of placing further burdens on

already burdened persons

Subdivided into field of study and field of practice

Three core functions1. Identifying and clarifying the ethical dilemma

posed2. Analyzing in terms of alternative courses of

action and their consequences3. Resolving the dilemma by deciding which

course of action best incorporates and balances guiding principles and values

PUBLIC HEALTH ETHICS

Focuses on design & implementation of measures to monitor and improve the health of population

1. Public health should address principally the fundamental causes of disease and requirements for health, aiming to prevent adverse health outcomes.

2. Public health should achieve community health in a way that respects the rights of individuals in the community.

3. Public health policies, programs, and priorities should be developed and evaluated through processes that ensure an opportunity for input from community members.

4. Public health should advocate for, or work for the empowerment of, disenfranchised community members, ensuring that the basic resources and conditions necessary for health are accessible to all people in the community.

5. Public health should seek the information needed to implement effective policies and programs that protect and promote health.

6. Public health institutions should provide communities with the information they have that is needed for decisions on policies or programs and should obtain the community’s consent for their implementation.

Principles of ethical public health practice

7. Public health institutions should act in a timely manner on the information they have within the resources and the mandate given to them by the public.

8. Public health programs and policies should incorporate a variety of approaches that anticipate and respect diverse values, beliefs, and cultures in the community.

9. Public health programs and policies should be implemented in a manner that most enhances the physical and social environment.

10. Public health institutions should protect the confidentiality of information that can bring harm to an individual or community if made public. Exceptions must be justified on the basis of the high likelihood of significant harm to the individual or others.

11. Public health institutions should ensure the professional competence of their employees.

12. Public health institutions and their employees should engage in collaborations and affiliations in ways that build the public’s trust and the institution’s effectiveness.

Who responsible for healthDisparities in health statusDisparities in access to quality health care

and benefits of medical researchResponding to threat of infectious diseasesInternational cooperation in health

monitoring and surveillanceExploitation of individualsParticipation, transperancy and

accountability

Issues in public health ethics

World medical association. Medical ethics manual. 2nd Ed. UK: The World Medical Association Inc; 2009.

World Medical Association. Declaration of Helsinki: 2008. Seoul: TheWorld Medical Association Inc; 2008.

ICMR. Ethical guidelines For Biomedical research On Human participants. New Delhi: ICMR; 2006.

WHO. Operational Guidelines for Ethics Committees That Review Biomedical Research. Geneva: World health organization; 2000.

Amnesty International. Ethical codes & declarations relevant to the health

professions. 4th Ed. London: Amnesty international; 2000.

CM Francis. Medical Ethics. 2nd ed . New Delhi: Jaypee brothers, 2004.

Ravindran GD. Medical ethics education in India. Indian journal of medical ethics 2008 Jan-Mar;5(1):18-26.

References