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Dear Members:

I am attaching a very nice article on Ethics in biomedical research

taken copied from the Indian Journal of Medical Ethics for fair use.

Please read with interest the portions on "How to ensure meaningful

ethical committees".

With regardsDr. Geer M. IshaqAssistant ProfessorDept. of Pharmaceutical SciencesUniversity of KashmirSrinagar-190006 (J & K)Ph: 9419970971, 9906673100Website: http://ishaqgeer.googlepages.com

Ethics in biomedical research

Introduction‘You cannot pluck a flower without disturbing a star.’

This

statement awakens in us a sense of the fundamental reality of the

extent of inter- elatedness within our universe. The use of freon gas

refrigerators in the northern hemisphere contributed to depletion of

the ozone layer over the Antarctic. When mundane activities can

influence remotely related phenomena, ethics becomes all the more

pertinent to all deliberate human actions. It is not possible to

subject every human action to ethical evaluation but moral and ethical

codes have - over the years - been refined to enable mankind to lead an

‘ethically just’ existence. Notwithstanding continued refinement in

ethical and moral codes, there are, and always will be, grey areas

which create dilemmas in the practice of ethics.

Unlike most

activities of everyday life, the pursuit of research is deliberate and

elective. The end product of research - new knowledge or product - can,

in turn, be harnessed for further change or manipulation bringing up an

expanding chain of possibilities. It is therefore necessary for us to

examine all the dimensions of research in terms of their implications.

We must evaluate them on the basis of careful ethical considerations.

The exercise becomes even more pertinent in case of biomedical or

biotechnological research, relating as they do to living beings in more

than one way.

Sharply focused research studies with wide ethical

implications are of special concern for the latter may, at times, range

beyond the expertise of primary concerns of the researcher. This is the

basis for the plea that all research programmes, especially those in

the fields of biomedicine and biotechnology, be subject to

multidisciplinary and holistic ethical evaluation. Such analysis must

cover each of the three principal components of the study - purpose,

material and methods and the end result. It must start with the

conception of the project and continue to the application of the

research findings.

Questions to be answered even before research is contemplatedThe

purpose of any research is to extend knowledge. Is the right to extend

knowledge absolute? At first sight, this right does appear to be

absolute. Reflection will show that since such studies and their

findings might have far- reaching influences on society, the right must

be subject to stipulations.

In his lecture on ‘Knowledge,

survival and the duties of science’ delivered in Washington on November

20, 1973, Professor Julius Stone pointed out that the liberty to extend

knowledge is not absolute but must be limited when it conflicts with

other values. (2) He further urged that scientists have a moral duty to

consider, along with others of competent knowledge, whether a line of

inquiry should be desisted from as soon as it becomes clear that it is

likely to bring about a mankind- endangering situation, which no one

has any foreseeable capacity to handle. (2) The phrases ‘along with

others’; ‘mankind- endangering situation’ and ‘which no one has any

foreseeable capacity to handle’ emphasise the role and responsibility

of (a) the State; (B) the medical professional bodies (Medical Council

of India, Indian Council of Medical Research (ICMR), medical

associations...); © the health institutions where researches are

carried out; (d) other professional bodies (legal, social sciences

etc.) in addition to medical scientists themselves to ensure that the

pursuit of research is ethically just. Thus whilst the medical

scientist (researcher) must ensure that ethics is not flouted, it is

equally important for the other competent bodies to ensure that they do

not take a bystander approach.

Questions as soon as research is contemplatedWhat

is the intent behind the contemplated research? Does ethics enter into

this area ? It certainly does. Research with mala fide intentions can

never be ethically justified. There can be variations in geographic or

societal perceptions of values. In some societies research on long

acting contraceptives may be perceived as contributing to the welfare

of the general population. Even here, ethical constraints will apply.

It must be proven that such products do, indeed, empower women and are

accepted by them for this purpose. This is particularly important

because contraceptive intervention is carried out on healthy

individuals to ward off a physiological event - pregnancy. There is no

contraceptive, as yet, which is totally free from adverse effects.

Therefore, unless women choose the contraceptive, its enforced use

would violate ethical norms. Taking this example further, it would be

necessary to hold discussions with women’s groups to elicit the

direction in which research is to be pursued and whether the products

that are likely to result from the research do meet the empowerment/

convenience/ reassurance values as they perceive them.

Choosing live subjects and other resources whilst designing experiments for researchAll

clinical research is expected to be preceded by experiments on non-

human subjects to ensure (a) safety of human beings and (B) to justify

proceeding to experiments on human beings. These subjects (animals,

plants, etc. ) and other resources (time, money, facilities like

computer- aided designing etc.) are organised based on their

availability and utility in the experiments. The design of the

experiment is expected to dictate which resource would be preferred.

Nonetheless, the ethics of such research should demand certain

responsibilities on all concerned (researchers, the institute in which

research is conducted, ethics committees or review boards and the law

makers) to ensure that the programme does not drift into flippant use

of resources.

There are many who feel that all experiments on

animals must cease. Tom Regan (3), for instance, states that all such

experiments, at whatever stage and however promising, ought to be

stopped at once. Singer (4) and Stephan (5) advocate

progressive or gradual cessation. On the other hand there are those who

feel that animals do not matter morally and would allow any animal

experiment for the benefit of mankind. R. G. Frey (6) justifies some

but not all experiments on animals, while conceding the fact that they

are of moral concern. Careful balancing of pros and cons over the use

of animals and a sincere effort at minimising harm to them should form

the golden rule.

We suggest the following guidelines for using resources ethically.

a)

Use of non- living resources instead of living resources (e. g.

computer- aided designing - of drugs) to preserve animal and plant

resources.

B) Use of micro- organisms in place of higher animals wherever possible. .

c) If higher animals are mandatory, care to ensure that the species is not threatened.

d)

When experiments on animals are unavoidable, ensure optimal utility of

the animal to be sacrificed. If Rhesus Monkeys are used, explore the

possibility of the same animal serving two or more experiments within

the institute.

e) Laws relating to protection of animals must be

applied to experiments in medical research. It is the ethical

responsibility of the law makers ( the State) to enunciate when

exceptions to laws relating to protections of animals can be made in

case of medical research. It is the ethical respon sibility of the

Medical Councils and Medical Associations to ensure that experiments

are carried out responsibly.

A callous attitude to any resource -

living or non- living - is unethical. Wastage of living resources is

callousness. Wherever possible, used resources must be replenished.

Clinical researchClinical

research starts after experiments on animals/ non- living materials

provide substantial evidence that it is safe to conduct further

researches on human beings. When such research is an extension or

variation of existing procedure, proof from animal/ non- living

experiments may be waived.

Drug researchIn addition to prior animal experiments, such research requires tests on humans in four stages.

Phase 1 conducted on normal human volunteers for validating safety in humans.

Phase 2 conducted on patients with the disease to be treated for validating efficacy under strict monitoring.

Phase

3. Multicentric trials on patients for validating safety and efficacy

under a variety of conditions but under the strict vigil of heathcare

providers and institutions.

Phase 4. Post marketing surveillance

for monitoring adverse drug reactions under actual user- conditions. In

case this proves unsafe, the drug is recalled from the market and re-

evaluated for safety:

In India, to the best of our knowledge,

there is no post marketing surveillance. A handful of Adverse Drug

Reaction Monitoring Units appear to function erratically. Under these

conditions, it is difficult to escape the conclusion that no drug has

passed Phase 4 in India thus far.

Informed consentThe

informed consent of participant volunteers in any research on human

beings endorses the spirit of respect for autonomy of the volunteers

and is an integral part of medical research. The convention of

referring to volunteers as ‘subjects’ was intended to stress the fact

that volunteers are being subjected to research procedures. Respect for

the autonomy of volunteers implies concern and respect for the

individuality of person and the provision of space for expression of

this individuality at every stage of the research programme without any

duress or impediment whatsoever and with the expectation of advice and

provision of adequate facilities to ensure the integrity of the person.

..

Let us consider the example of volunteers participating in

research on implanted contraceptives. There must be provision for them

to withdraw from the research at any stage of the programme without

duress or impediment. The volunteers have a right to expect the

facilities for removal of the implant whenever they so desire within

the period of experimentation Further they have a right to be informed

of the problems of non- removal of implants and the hazards of carrying

the implants within their bodies for extended periods before they enrol.

Informed

consent comprises two elements, (a) information and (B) consent. Each

of these has subdivisions; information comprising of the extent of

information and its veracity and consent including volition and

competence. (It is not possible to discuss details here. The interested

reader is referred to Beauchamp and Childress’ Principles of Biomedical

Ethics, 3rd edition, Oxford University Press.) Each of these aspects

poses considerable difficulties when implementing the requirement of

informed consent.

The advances in science and technology are so

rapid that a fully informed consent may be difficult in many cases.

This leads to a perfunctory attitude unless there is acute sensitively

and concern for the individual volunteer

We list some essentials when enlisting informed consent:

Information1. Purpose of the trial

2. Benefits to the patient (volunteer) and to society

3. Possible risks of treatment (intervention)

4. Treatment offered in case complications develop during the trial

5. Right to refuse or withdraw from the trial at any time without prejuducing further treatment by doing so.

6. Implications of randomisation.

The following additional information must be provided to volunteers:

a)

The expertise and capabilities of the Research Unit with special

reference to support in the event of a complication. Budgeted

provisions for interventions/ rehabilitation/ compensation in the event

of untoward manifestations.

B) Mechanisms and procedures for redressal of the volunteers' complaints.

c)

Names of persons who will contact the voiunteers during the research.

If the volunteer has serious objection to any of them, this may provide

a ground for opting out right at the start.

d) Names and addresses of the members of the Ethics Committee to be approached for redressal.

e)

The social value or implications of being associated with such a

research programme. For instance, research on contraceptives for women

may require discussion on the merits/ demerits of provider-controlled

contraceptive devices in the given social context.

Voluntariness and the competence to consentAdequate

provision must be made for the consent to be both voluntary and

competent. One way of ensuring this is for several members of the

research team, particularly the social worker, to interact with

volunteers and test whether the volunteer has appreciated the nuances

before offering consent. It has been suggested that when conducting

research trials on tribes and races where communication barriers are

evident, the informed consent of a chieftain could be adequate. (8) The

ethics of this stand are debatable.

Ethics Committee (Institutional Review Board)The

Declaration of Helsinki suggested the setting up of Ethics Committees

for reviewing research protocols with a view to ensuring the highest

ethical standards before, during, and on completion of any research

programme. It is important to ensure that ethics committees do not take

on a perfunctory status merely because agencies providing grants

require their sanction.

Ethics committees are increasingly

incorporating collective expertise from varied disciplines in order to

provide a holistic basis for evaluation, guidance and, when necessary,

correction. In addition to physicians, lawyers, social workers and the

theologist, nurses, ethicists and other professionals are being

enlisted with increasing frequency. Most Ethics Committees hone their

proficiency through intense internal debates and exchanges of

information on the subject.

How can we ensure meaningful Ethics Committees?Steps

for doing so can be based on the goals set by the ethics committee. The

principle of least restrictions for optimum practice of ethics is

generally adopted. If, from the biomedical, legal, social and humanist

perspective, the understanding and practice of ethics whilst conducting

both research and clinical practice is seriously wanting, the powers to

enforce corrective measures ought to be vested in the Ethics

Committees. If, on the other hand, the research team is assessed as

highly ethical, the Ethics Committee may play an advisory role. In any

case the functioning of the Ethics Committee must be transparent and,

itself, be subjected to review from time to time

The mission

statement of ethics committees could include: to ensure adherence to

ethical principles from the time the research programme is conceived to

its ccmpletion, publication of results and implementation of findings

a) to deepen understanding and appreciation of a holistic perspective of biomedical ethics;

B)

to ensure that the research conduct is ethically just to programme

participants (subjects) in particular and the people in general;

c)

the ethics committee should have the powers to hold/ suspend any

research project as soon as it is evident that ethical principles are

being violated. At the same time, it should be the responsibility of

the Committee to report on its assessment of each research project from

legal, biomedical, philosophical and humanistic stand point. The

minutes of the meetings of the committee should be recorded in detail

for the purpose of review;

d) the State and the institute must

provide funds and facilities for adequate functioning of the committee.

The ethics committee should preferably be autonomous and persons

involved with the administration of the institute should not be

included in it;

e) there should be periodic multicentric review

to update information on the working of these committees. The findings

of such review should be made publicly available;

f) the State

and the institute must ensure institution of adequate redressal forum

for any complaints against those conducting research.

The present

state of indifference on the part of the State as the medical

profession in India does not inspire confidence that things will

improve. Voluntary bodies must try to force debates on the ethics of

medical research and prod State and professional agencies into action.

Blatant malpracticesDiscussions

on ethics are confined, in other countries, to grey areas in medical

practice. This is how it ought to be because it is in these areas that

clarity is required. The blatant malpractices - black areas - in India

unfortunately force us to discuss what is taken for granted elsewhere.

It is not uncommon to find:

a) vested interests operating whilst allocating research grants;

B) superiors making juniors do the work and yet taking the credit for research;

c)

fraudulent research / fabrication of results We are told that the

publish- or- perish compulsion has triggered such practices. It need

not be so. The practice initiated by the Harvard University and now

widely adopted will eliminate this cause. Each applicant for any

position is asked to provide reprints of not more than five of his most

valued publications.

ConclusionThe

mad race of commerce for producing powerful tools through

biotechnological research seems to continue unabated the world over.

Ingenuity of the scientific mind will continue to accelerate the pace.

The impact of such tools cannot be confined to geographical zones.

Inadequately informed over- criticism and inadequately informed over-

enthusiasm in respect of such technologies are likely to be confusing

and misdirectional. A holistic understanding of the social and

environmental impact of technologies by professionals of every pursuit

is vital to sagacious handling of the power of information generated

through research. The exercise of ethical controls within all

professional bodies and imaginative regulatory (legislative) mechanisms

- national and international - are necessary.

In the present scenario, this is like asking for the moon. But is there an alternative ?

‘Our

knowledge of science has already outstripped our capacity to control

it. We have many men of science, too few men of God... Man is stumbling

blindly through a spiritual darkness while toying with the precarious

secrets of Life and Death. The world has achieved brilliance without

wisdom, power without conscience. ’ N. Bradley

References1. Anonymous: Medical ethics and the practitioner. Handbook of Medical Ethics Issues in Medical Ethics 1996; 4: 54- 58.2. Stone Julius: The new biology - law, ethics and biotechnology.3. Ed.: P II. J. D. New York : Platinum Press 1989 p. 9.4. Regan T: The case for animal rights Berkeley: University of California Press 1983 (cited from 6)5.

Singer P: Animal Liberation (cited from 6) SRL: The nature of the

beast Oxford: Oxford University Press 1982 (cited from 6)6. Frey

RG: The ethics of the search for benefits: animal experimentation in

medicine. In Gillon Raanan (Ed.) Principles ofHealth Care Ethics.

Chichester: Wiley & Sons 19947. Saunders Christobel M,

Baum Christobel M, Houghton Joan: Consent, research and the doctor-

patient relationship. In Gillon Raanan (Ed.) Principles of Health Care

Ethics. Chichester: Wiley & Sons 1994 p 462 +8. Bergen

Donna: Clinical trials in developing countries. In Chopra JS, Sawhney

J. (Eds.) Progress in Neurology. New Delhi : B. I. Churchill

Livingstone Pvt. Ltd. 1995

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hello,

what I learnt from Geer's attached article I am stating .

The ethics commitee should be meaningful.It should understand its role..And like Barna Ganguly said, the members need to be trained to understand the implications of their role.Else what we have read from Navneet's post, will be state of affairs everywhere.

One more aspect in all these issues is extreme poverty of the subjects who are ready to act as guinea pigs for monetary benefits. How else do we get subjects for research?

Without incentive it is difficult ,if not impossible, to get subjects. and then all ethics take a back seat.

kunda

From: Geer M. Ishaq <ishaqgeer@...>Subject: Article - Ethics in Biomedical Researchnetrum Date: Tuesday, 2 December, 2008, 2:27 PM

Dear Members:I am attaching a very nice article on Ethics in biomedical research taken copied from the Indian Journal of Medical Ethics for fair use. Please read with interest the portions on "How to ensure meaningful ethical committees". With regards

Dr. Geer M. Ishaq

Assistant Professor

Dept. of Pharmaceutical Sciences

University of Kashmir

Srinagar-190006 (J & K)

Ph: 9419970971, 9906673100

Website: http://ishaqgeer. googlepages. com

Ethics in biomedical research

Introduction‘You cannot pluck a flower without disturbing a star.’

This statement awakens in us a sense of the fundamental reality of the extent of inter- elatedness within our universe. The use of freon gas refrigerators in the northern hemisphere contributed to depletion of the ozone layer over the Antarctic. When mundane activities can influence remotely related phenomena, ethics becomes all the more pertinent to all deliberate human actions. It is not possible to subject every human action to ethical evaluation but moral and ethical codes have - over the years - been refined to enable mankind to lead an ‘ethically just’ existence. Notwithstanding continued refinement in ethical and moral codes, there are, and always will be, grey areas which create dilemmas in the practice of ethics.

Unlike most activities of everyday life, the pursuit of research is deliberate and elective. The end product of research - new knowledge or product - can, in turn, be harnessed for further change or manipulation bringing up an expanding chain of possibilities. It is therefore necessary for us to examine all the dimensions of research in terms of their implications. We must evaluate them on the basis of careful ethical considerations. The exercise becomes even more pertinent in case of biomedical or biotechnological research, relating as they do to living beings in more than one way.

Sharply focused research studies with wide ethical implications are of special concern for the latter may, at times, range beyond the expertise of primary concerns of the researcher. This is the basis for the plea that all research programmes, especially those in the fields of biomedicine and biotechnology, be subject to multidisciplinary and holistic ethical evaluation. Such analysis must cover each of the three principal components of the study - purpose, material and methods and the end result. It must start with the conception of the project and continue to the application of the research findings.

Questions to be answered even before research is contemplatedThe purpose of any research is to extend knowledge. Is the right to extend knowledge absolute? At first sight, this right does appear to be absolute. Reflection will show that since such studies and their findings might have far- reaching influences on society, the right must be subject to stipulations.

In his lecture on ‘Knowledge, survival and the duties of science’ delivered in Washington on November 20, 1973, Professor Julius Stone pointed out that the liberty to extend knowledge is not absolute but must be limited when it conflicts with other values. (2) He further urged that scientists have a moral duty to consider, along with others of competent knowledge, whether a line of inquiry should be desisted from as soon as it becomes clear that it is likely to bring about a mankind- endangering situation, which no one has any foreseeable capacity to handle. (2) The phrases ‘along with others’; ‘mankind- endangering situation’ and ‘which no one has any foreseeable capacity to handle’ emphasise the role and responsibility of (a) the State; (B) the medical professional bodies (Medical Council of India, Indian Council of Medical Research (ICMR), medical associations. ..); © the health institutions where researches are carried out; (d)

other professional bodies (legal, social sciences etc.) in addition to medical scientists themselves to ensure that the pursuit of research is ethically just. Thus whilst the medical scientist (researcher) must ensure that ethics is not flouted, it is equally important for the other competent bodies to ensure that they do not take a bystander approach.

Questions as soon as research is contemplatedWhat is the intent behind the contemplated research? Does ethics enter into this area ? It certainly does. Research with mala fide intentions can never be ethically justified. There can be variations in geographic or societal perceptions of values. In some societies research on long acting contraceptives may be perceived as contributing to the welfare of the general population. Even here, ethical constraints will apply. It must be proven that such products do, indeed, empower women and are accepted by them for this purpose. This is particularly important because contraceptive intervention is carried out on healthy individuals to ward off a physiological event - pregnancy. There is no contraceptive, as yet, which is totally free from adverse effects. Therefore, unless women choose the contraceptive, its enforced use would violate ethical norms. Taking this example further, it

would be necessary to hold discussions with women’s groups to elicit the direction in which research is to be pursued and whether the products that are likely to result from the research do meet the empowerment/ convenience/ reassurance values as they perceive them.

Choosing live subjects and other resources whilst designing experiments for researchAll clinical research is expected to be preceded by experiments on non- human subjects to ensure (a) safety of human beings and (B) to justify proceeding to experiments on human beings. These subjects (animals, plants, etc. ) and other resources (time, money, facilities like computer- aided designing etc.) are organised based on their availability and utility in the experiments. The design of the experiment is expected to dictate which resource would be preferred. Nonetheless, the ethics of such research should demand certain responsibilities on all concerned (researchers, the institute in which research is conducted, ethics committees or review boards and the law makers) to ensure that the programme does not drift into flippant use of resources.

There are many who feel that all experiments on animals must cease. Tom Regan (3), for instance, states that all such experiments, at whatever stage and however promising, ought to be stopped at once. Singer (4) and Stephan (5) advocate progressive or gradual cessation. On the other hand there are those who feel that animals do not matter morally and would allow any animal experiment for the benefit of mankind. R. G. Frey (6) justifies some but not all experiments on animals, while conceding the fact that they are of moral concern. Careful balancing of pros and cons over the use of animals and a sincere effort at minimising harm to them should form the golden rule.

We suggest the following guidelines for using resources ethically.

a) Use of non- living resources instead of living resources (e. g. computer- aided designing - of drugs) to preserve animal and plant resources.

B) Use of micro- organisms in place of higher animals wherever possible. .

c) If higher animals are mandatory, care to ensure that the species is not threatened.

d) When experiments on animals are unavoidable, ensure optimal utility of the animal to be sacrificed. If Rhesus Monkeys are used, explore the possibility of the same animal serving two or more experiments within the institute.

e) Laws relating to protection of animals must be applied to experiments in medical research. It is the ethical responsibility of the law makers ( the State) to enunciate when exceptions to laws relating to protections of animals can be made in case of medical research. It is the ethical respon sibility of the Medical Councils and Medical Associations to ensure that experiments are carried out responsibly.

A callous attitude to any resource - living or non- living - is unethical. Wastage of living resources is callousness. Wherever possible, used resources must be replenished.

Clinical researchClinical research starts after experiments on animals/ non- living materials provide substantial evidence that it is safe to conduct further researches on human beings. When such research is an extension or variation of existing procedure, proof from animal/ non- living experiments may be waived.

Drug researchIn addition to prior animal experiments, such research requires tests on humans in four stages.

Phase 1 conducted on normal human volunteers for validating safety in humans.

Phase 2 conducted on patients with the disease to be treated for validating efficacy under strict monitoring.

Phase 3. Multicentric trials on patients for validating safety and efficacy under a variety of conditions but under the strict vigil of heathcare providers and institutions.

Phase 4. Post marketing surveillance for monitoring adverse drug reactions under actual user- conditions. In case this proves unsafe, the drug is recalled from the market and re- evaluated for safety:

In India, to the best of our knowledge, there is no post marketing surveillance. A handful of Adverse Drug Reaction Monitoring Units appear to function erratically. Under these conditions, it is difficult to escape the conclusion that no drug has passed Phase 4 in India thus far.

Informed consentThe informed consent of participant volunteers in any research on human beings endorses the spirit of respect for autonomy of the volunteers and is an integral part of medical research. The convention of referring to volunteers as ‘subjects’ was intended to stress the fact that volunteers are being subjected to research procedures. Respect for the autonomy of volunteers implies concern and respect for the individuality of person and the provision of space for expression of this individuality at every stage of the research programme without any duress or impediment whatsoever and with the expectation of advice and provision of adequate facilities to ensure the integrity of the person. .

Let us consider the example of volunteers participating in research on implanted contraceptives. There must be provision for them to withdraw from the research at any stage of the programme without duress or impediment. The volunteers have a right to expect the facilities for removal of the implant whenever they so desire within the period of experimentation Further they have a right to be informed of the problems of non- removal of implants and the hazards of carrying the implants within their bodies for extended periods before they enrol.

Informed consent comprises two elements, (a) information and (B) consent. Each of these has subdivisions; information comprising of the extent of information and its veracity and consent including volition and competence.. (It is not possible to discuss details here. The interested reader is referred to Beauchamp and Childress’ Principles of Biomedical Ethics, 3rd edition, Oxford University Press.) Each of these aspects poses considerable difficulties when implementing the requirement of informed consent

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