Ethics in Medical Research

Dr.Cyriac Thomas
HOD, Dept. of Forensic Medicine & Toxicology
Govt. Homeopathic Medical College.Calicut

Introduction
The word ethics is derived from Ethos.
Ethos means the distinctive attitude which characterize the the cultural outlook of a professional group.
Every profession has an ethical code

It includes

1. definite tradition
2. sharing of customs and common experience
3. commitment to a particular system of values

 Ethos of the physician has always noted for its DEDICATION to the service of ailing humanity

In the past, it was always characterized by close personal relationship with patient and his family

Medical Ethics
Medical ethics is a systemic effort to elaborate the perspectives and ethical norms governing the medical profession.

History
We have evidence from as far back as about 4000 BCE of physicians practicing medicine.

For example, in prehistoric Egypt medical practices included using malachite as an eye salve. There is evidence of dentistry, too: a mandible (jaw bone) was found in a Fourth Dynasty (2900-2750) tomb that had an alveolar process pierced to drain an abscess under the first molar.

Written codes of ethics for doctors may have existed in those times; however, the earliest evidence we have is the Ebers Papyrus from 3,550 years ago.

There are Egyptian medical papyri (such as Ebers and Smith) that describe the accepted medical practices and codes of ethics dating from about 2000 to 1090 BC . Imhotep is the earliest recorded name of a physician. When Imhotep died, he was deified as the Egyptian “God of Medicine”, and later as a universal God of Medicine. He was so important to the early Egyptians that in honor they built the Temple of Imhotep, the “first hospital”, and engraved his picture on the walls.

From even the earliest records through the present, physicians are exhorted to try to end human suffering.

They should do this in a disinterested manner, without concern for remuneration, status or personal reputation. Physicians should use all means available to them,

and be open to learning more methods from other physicians. Moreover, they should appreciate all life and treat all patients equally.

Such exhortations are found not only in ancient Egyptian records, but also in other early records. For example, we know of the 5th Century BC Greek Oath of Hippocrates and his On Epidemics (the source of the injunction, Primum non nocere!, or “First, do no harm!”),

• the First Century Indian Oath of Initiation,
• the 12th Century Jewish Daily Prayer of the Physician (Moses Maimonides),
• the 16th Century Japanese 17 Rules of Enjuin.

Perhaps the earliest documented evidence of concerns about experimental medicine may be in Thomas Percival’s code, which appeared in England in 1803.

According to this code, the physician may try experimental treatments when all else fails, and when it can serve the public good.

In 1833 in America, William Beaumont’s code acknowledged the importance of experimental treatments, but added requirements stipulating that the subject must give voluntary, informed consent and the subject should be able to end the experiment at will. (Note: it is not clear that Beaumont, himself, heeded these requirements.)

Claude Bernard is often regarded as the founder of experimental medicine

In his Introduction to the Study of Experimental Medicine (1865), Bernard wrote that one should never perform an experiment “which might be harmful to [the subject]”; that experiments “that can only harm are forbidden”, that “innocent [experiments] are permissible”, “and those that may do good are obligatory.”

In 1898 in the United States of America, Walter Reed introduced a contract to augment and confirm oral informed consent. More significantly, Reed used healthy volunteer subjects in his medical experiments involving the transmission of Yellow Fever.

Increasing medical experimentation highlighted the increasing need for concern for subject consent and safety. In the 1900 Berlin Code, or Prussian Code, capacity to give consent was the central focus. In this code, if a subject is not competent to consent, or doesn’t completely understand the information being explained, or does not give unambiguous consent, the experiment may not be performed.

The 1931 Reich Circular reminded physicians that in medical experiments, physicians must be concerned primarily with the consent and well-being of the subjects.

The 1947 Nuremberg Code demonstrated increased concern, stating in its first sentence that, “the voluntary consent of the human subject is absolutely essential.”

In 1948, in the Physician’s Oath of the Declaration of Geneva, the primary concern returns to that which was expressed in even the most ancient documents: one must put health of the patient first, be unbiased in attitude toward the patient, and have the “utmost respect for human life.”

In 1954, the World Medical Association produced a set of Principles for Those in Research and Experimentation. Respect — for the rules of scientific research (constructed by convention) and the subjects — is presented as central.

In 1964 the world medical assembly meet at Helsinki and set a code of conduct ,known as Helsinki Declaration.

It was modified by the world medical assembly at Tokyo in 1975

The council for international organization of medical science 1982 along with World Health Organization has given international guidelines for Bio medical research.

In the 2000 Declaration of Helsinki, the primacy of patient health and well-being is reasserted. Also made explicit is the vulnerability and resulting need for special protection for research populations, especially for persons who cannot give or refuse consent.

In 1980 Indian council of medical research given guidelines for conduct of human experiment and research and was modified in 2000.

Even after Helsinki Declaration, Unethical human experimentation continued.Eg.is Tuskegee Study of untreated Syphilis, sponsored by U.S Public Health Service from 1932 to 1974.

Medical Experimentation In Man
 From the earliest time to our own day Medicine has been able to progress only by tentative steps and by successive experiment on living bodies, including human body

AIMS

1. Experimentation for the good of the patient
2. Experiment for the good of others ( long term benefit of Humanity )
3. Benefit of a group of people suffering from that disease.
4. Contribution to human knowledge.

1. EXPERIMENT FOR THE GOOD OF THE PATIENT
This includes any experiment on

(a) Diagnostic procedures

(b) Surgical procedures

(c) Clinical trials of medicine or any therapeutic agent or methods

Clinical Trial of Medicine :   As regards to therapy of new remedy, following principles are regulated

• The remedy must be sufficiently
• Tested in the laboratory and on animal
• It may not be used if a certainly effective remedy is available
• May not be used this new remedy is too long ,difficult or expensive
• It is the only available treatment which most likely to help patient
• Consent from patient or legal guardian

EXPERIMENT FOR THE GOOD OF OTHERS

• Consent from patient or legal guardian
• Research confirms moral and scientific principles based on lab. And animal experimentation or other scientifically established facts
• Precaution against injury
• Careful assessment of risk
• Avoid disability

Important Requisites for medical Research

1. ESSENTIALITY
The proposed project must be necessary for the benefit of the people and advancement of knowledge. The principles of essentiality respect the ethical principle of beneficence.

2. INFORMED CONSENT
The rsearch subject or guardian or legal proxy should be fully apprised of the proposed research ,including the risk, benefit and the alternate procedure available.

• The free informed consent should be obtained before the commencement of the research.
• The research subject has the right to abstain from the research at any time.
• Research involves any community or groups of people, the principles of informed consent applies to the community as a whole
• The principle of Autonomy is observed by informed consent. It protects the individual’s freedom of choice. 

3.CONFIDENTIALITY
The identity and particulars of the research data should kept confidential. This may disclosed only for valid reasons.

• Legal ( court orders)
• Scientific ( therapy)
• With written consent of the subject

4.  COMPENSATION
The research protocol shall include mechanisms for compensation through Insurance or other means to cover all risk and provide for remedial action and after care.

• Provide compensation for mental and physical injury.
• Rehabilitative measures should be taken
• Paid for-inconvenence, time away from work-imbursement of expenses and free medical service.
• In case of death material compensation to the dependents. 

5. COMPETENCE
The research should be conducted only by competent and qualified persons aware of ethical research

6. ACCOUNTABILITY, RESPONSIBILITY AND TRANSPARENCY
All person involved in the research (directly or indirectly) are responsible and accountable for observing all ethical principles and guidelines

• Such persons are
• The researcher
• The sponsors and founders
• Institutions
• Those who use the result of research 
• The research should be conducted in a fair, honest, impartial and transparent manner
• All records should be retained for reasonable period for post research monitoring and evaluation.

7. RISK MINIMISATION
The subject should have minimum risk and should not suffer from irreversible adverse effect

8. SCENTIFIC COMMITTEE
The proposal must be submitted to to a scientific committee, who may or may not approve the proposal with or without modification

The scientific committee may review the protocol periodically.

9.ETHICS COMMITTEE
Ethical committee looks all the ethical aspect of the proposed research that may or may not approve the proposal with or without modification.  Committee may review research periodically

Responsibility of Ethical Committee

• Protect right, safety and wellbeing of subject
• Obtain following documents
• Trial protocol, written informed consent, subject recruitment procedure, safety information, compensation available, biodata of investigators.
• Ensure ethical principle in relation to local values and customs
• Provide consultation to professional staff, patients, families on    ethical issues and problems
• Provide education and advice to staff, patient/families
• Formulate policies on ethical aspect of clinical care at organizational level
• Coduct of seminars and wokshops periodically regarding ethical concern. 

Composition of Etical Committee

• Clinicians
• Basic scientist
• Social worker
• Nurse
• Rehabilitation person
• Priest/philosopher/ethicist
• Lawyer or retired judge
• A respected member of public 

10.INSTITUTIONAL ARRANGEMENT
The institutions make all arrangements for proper conduct of research and store and use of data and for ensuring confidentiality.

11.PUBLICATION OF RESULTS
The results of research (positive or negative) should available to public through scientific and other publications. The information should be accurate.

2.SPECIAL GROUP AS RESEARCH SUBJECTS
Pregnant and nursing should not be the subject of any clinical trial except such trials are designed to protect or promote their health  and for which non-pregnant or non nursing women’s are not suitable.

Children will be involved if the purpose of the research is to obtained specific information to the health needs of children

Venerable groups with reduced autonomy such as students, employees, service personas and prisoners may involve in research only if there is adequate justification.1

Right and welfare of the mentally ill or mentally retarded should be protected at all times.