Ethics Issues for Consideration by Researchers
3.3.1. Ethical justification and scientific validity 10
3.3.2. Externally sponsored research and multi centre studies 10
3.3.3. Informed consent 11
3.3.4. Inducements to participate in research 13
3.3.5. Compromised capacity for giving informed consent 13
3.3.6. Benefits and risks to study participants 15
3.3.7. Research participants from populations and communities
in which resources are limited 16
3.3.8. Equitable distribution of burdens and benefits in the
selection of participants/groups 16
3.3.9. Research involving children 17
3.3.10. Research involving pregnant women 17
3.3.11. Safeguarding confidentiality 17
3.3.12. Right of compensation 17
4. ERC Meetings
4.1. Procedure for Meetings 19
4.2. Conduct of Meetings 20
4.3. Quo rum 21
4.4. Conflict of Interest 21
4.5. Chairperson’s Review and Expedited Review 21
4.6. Exemption from Review 22
5. Elements of the Review Process
5.1. Social or Scientific Value 23
5.2. Scientific Validity 24
5.3. Fair Participant Selection 24
5.4. Favourable Risk/Benefit Ratio 25
5.5. Informed Consent Process 26
5.6. Respect for Potential and Enrolled Participants and Communities
SLMA DECLARATION ON HEALTH
FORWARD
On behalf of the Sri Lanka Medical Association I have much pleasure and even more hope in placing before you the Association’s DECLARATION ON HEALTH. Much pleasure that the Association, albeit after some period of gestation, has been able to publish it; and even more hope because it provides both a framework for affirmative action for the State, many organisations involved in health related activity and the public, as well as a vector for attitudinal change.
Colvin Goonaratna
President
SLMA 1996
PREFACE
The Declaration on Health produced by the Ethics Committee has been approved by the Council of the SLMA.
We expect that this document will help to further improve the health delivery system in Sri Lanka. It calls for action from many parties: health professionals, the public, the pharmaceutical trade, the media and the Government.
Health is everyone’s concern, everyone’s business. Let us join in working towards Health For All.
Lucian Jayasuriya
President
SLMA 1995
Sri Lanka Medical Association
DECLARATION ON HEALTH
The health of our citizens has improved to a commendable degree over the past few decades, but much remains to be done. Promotion of better understanding between doctors and patients, and promotion of closer co-operation among all categories of health professionals as well as between the State, society in general and its individual members, are factors which will ensure continued improvement in the health of the people.
As greater understanding of health related issues by the public would help to improve the standard of health,
THE SRI LANKA MEDICAL ASSOCIATION (SLMA) DECLARES THAT
People have the right
1. to life that they can enjoy in good health and with dignity;
2. to live in an environment free of pollution;
3. when ill, to be treated always with care and compassion, by the attending health professionals in particular and by the members of society in general; and
4. to expect that fees that are charged from patients and other users for services rendered are reasonable.
THE SRI LANKA MEDICAL ASSOCIATION acknowledges the limitations placed on development of the health sector by constraints due to the lack of finance, human resources and infrastructure, as well as the problems posed by the absence of a formal relationship between the private and public health care services.
As these constraints are remediable,
THE SRI LANKA MEDICAL ASSOCIATION DECLARES THAT
People are entitled to
5. receive relevant information on matters concerning health and health services, such as:
5.01- facilities available for the promotion of health, prevention of diseases and their treatment, both in the public and private sectors, at regional and central levels;
5.02- the individuals considered qualified by the State to promote health, to prevent disease and to treat the sick;
5.03- the individuals, institutions and business establishments considered competent by the State for the manufacture, sale and dispensing of medicinal drugs;
5.04- the functions of qualified medical, paramedical and other health workers in the public and private sectors;
5.05- the assistance that could be rendered to the sick by lay persons;
5.06- the duties and responsibilities of all persons in the promotion of health and the prevention of disease in the community;
5.07- one’s illness, its principal complications, available methods of investigation and treatment, and their advantages, disadvantages and costs;
5.08- medication that is prescribed, (name, cost and significant side effects etc) in a manner that is compatible with established ethical criteria and the capacity of the person to understand;
5.09- research projects concerning individuals or communities;
5.10- the constituents of cosmetics and foods;
6. be referred to an appropriate professional or institution when referral is indicated;
7. be afforded confidentiality and privacy during consultation, examination, investigation and treatment;
8. be competently and adequately assessed by their medical professionals;
9. request and to receive a second opinion, when appropriate;
10. receive, wherever possible, their preferred mode of treatment from among those proven to be effective;
11. keep in their custody reports of investigations pertaining to their illness, or where this is not feasible, a summary of pertinent investigations, together with the diagnosis and treatment; and
12. participate in influencing health related policy.
Furthermore, as all citizens have responsibilities towards each other and to the State,
THE SRI LANKA MEDICAL ASSOCIATION DECLARES THAT
People should
13. strive to do everything in their power to keep the environment free of pollution;
14. support all efforts to maintain the balance of nature and its biodiversity;
15. refrain from using, or promoting the use of, toxic substances in the preparation of food and cosmetics;
16. refrain from smoking or chewing tobacco and from abusing drugs and alcohol, and should encourage others to do likewise;
17. co-operate fully with those involved in the promotion of health, the prevention of disease and in treating the sick;
18. render assistance to the sick whenever possible; and
19. be willing to participate in approved projects researching health promotion and the prevention and cure of disease.
In pursuance of objectives embodied in the DECLARATION in Articles 1 to 19,
THE SRI LANKA MEDICAL ASSOCIATION CALLS ON:
A. all health professionals, professional organisations and institutions involved in medical undergraduate and postgraduate training to improve professional and ethical standards and thereby give effect to the provisions of this DECLARATION;
B. the Government to provide the finance, human resources and infrastructure required for effecting such improvement, and to take appropriate action as called for in this DECLARATION;
C. the pharmaceutical industry to abide by the ethical standards as laid down in, Ethical Criteria for the Promotion of Medicinal Drugs and Devices in Sri Lanka (SLMA, 1996);
D. professional bodies and non-governmental organisations to take appropriate action, within their spheres of influence, and to disseminate the information contained in the DECLARATION for the benefit of the people; and
E. the media to remain vigilant and protect the health of the people by rejecting unethical advertising and to utilise the advice of competent health professional and consumer groups in reporting health related issues.
Copyright Sri Lanka Medical Association 1995-6.
SLMA Ethics Committee Members 1995
Dr. Malik Fernando (Chairperson)
Dr. Eugene Corea (Secretary)
Dr. Lucian Jayasuriya
Prof. Colvin Goonaratna
Prof. Anoja Fernando
Dr. Saroj Jayasinghe
Dr. Lalith Mendis
Dr. Malee Fernando
Dr. Varuni de
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