Re: Medical Research Ethics

[Guest guest]

Dear All,

As rightley said by Chetana Madam, this has been a very important issue in Medical Research.

Here I would like to add, whenever we talk about ethics in medical research it covers both aspects. One being ethics related to Human Trials and another being related to Animal Experimentation.

There is constant non ending debate about the scope and limits of ethics.

Hence there are guidelines from governing bodies.

For Humans: we all know we have ICMR, ICH GCP and WHO guidelines.

For Animals: we follow CPCSEA guidelines.

But a further catchy issue I would like to touch is the "Need of Acquiring Morality" among researchers, the need for imbibing the knowledge of these guidelines and being adept in them during trials/experimentation rather than doing mere paper work.

Ehtics for me is: Whenever we try to do any trial, Put ourselves in the shoe of the Participants. If we feel its right, then its right....ethical...

Regards,

Dr Kiran Chaudhari

Lecturer, (Member IEC)

Dept of Pharmacology,

GMC, Nagpur.

From: Chetna Desai <chetna99@...>Subject: Medical Research Ethicsnetrum Date: Friday, 28 November, 2008, 10:03 PM

Dear Friends...Ethics in general and in Medical Research in particular is a touchy yet important subject..one that evokes an extreme reaction most times. Hence its with pleasure that i initiate this debate; leave the field open for a head on frontal attack, a debate with no one holding back while expressing their ideas, concerns and solutions to this issue. Some cues...

Why do you think Ethics is particularly important in medical research?

What are the guidelines for ethics in medical research

Are there any regulations? If yes, do they matter/are they implemented?

How do you ensure/implement ethics in medical research?I shall be away till late evening tomorrow for a lecture at Bhavnagar, but leaving the field open for all to come forward and respond. IWarm wishes and keep postingChetna

-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. orghttp://pharmacbjmc. 110mb.comwww.poliofoundation .org

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[Guest guest]

Hi,

Since I belong the medical profession, I rate this as the most

demanding for observance of ethics. For ethical conduct it is more

of self restraint rather than compulsion of written set of rules. No

compulsions can bring about ethical conduct unless the individual

decides to lead ethical way of professional life, research included.

Vijay

>

> From: Chetna Desai <chetna99@...>

> Subject: Medical Research Ethics

> netrum

> Date: Friday, 28 November, 2008, 10:03 PM

>

>

>

>

>

>

>

> Dear Friends...

> Ethics in general and in Medical Research in particular is a

touchy yet important subject..one that evokes an extreme reaction

most times. Hence its with pleasure that i initiate this debate;

leave the field open for a head on frontal attack, a debate with no

one holding back while expressing their ideas, concerns and

solutions to this issue. Some cues...

>

>

>

> Why do you think Ethics is particularly important in medical

research?

> What are the guidelines for ethics in medical research

> Are there any regulations? If yes, do they matter/are they

implemented?

> How do you ensure/implement ethics in medical research?I shall be

away till late evening tomorrow for a lecture at Bhavnagar, but

leaving the field open for all to come forward and respond. I

> Warm wishes and keep posting

> Chetna

>

>

>

> --

> Dr Chetna Desai

> Department of Pharmacology

> B. J. Medical College

> Ahmedabad 380016

>

>

>

> Visit

> http://www.pharmaco logybjmc. org

> http://pharmacbjmc. 110mb.com

> www.poliofoundation .org

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

>

> Add more friends to your messenger and enjoy! Go to

http://messenger./invite/

>

[Guest guest]

Hi,

I guess its time to debate on one of the most challenging questions of

this debate: " Do we really care about Medical Ethics? "

In my opinion, we can debate endlessly on the issue of ethical medical

research, but the foremost issue remains that as a researcher, as an

ethical committee observer, as a guide, or as an administrative

authority do we

really care about medical research ethics?

I would like to share one of my personal experiences with you to

highlight the height of mockery of ethics in medical research which, I

suppose, we all see in our professional life.

I must apologize in the beginning if I have/will hurt feeling of

anyone due to this account. I have no personal grudges.I only wish to

highlight the hippocracy of our system!

A few years back when I was a second year medical student in my

medical school (I must add that at that point of life I had no

exposure to research, let go the ethics attached to it). At that time

I came to know about Indian Council of Medical Research (ICMR) Short

Term Research Studentship (STS). It was and is one of the best way to

kick start as an UnderGraduate in ethical medical research in my opinion.

So we (I and a couple of my friends) decided to venture in this

territory. I must emphasize on the fact that we all were totally

unaware of the ethical aspects of medical research at this point!

ICMR requires, in its requirements for STS, that the applicant must

submit an Institutional Ethics Committee (IEC) approval. So we applied

to the IEC for its approval. As a part of standard operating protocols

of the IEC we were required to make a presentation in front of our IEC

of which all departmental heads are members. So we hurriedly prepared

a presentation.

Now at the end of IEC meeting it was our turn to present our research

proposals. I volunteered to be the first scape goat! Now in front of

16 stalwarts of my medical school I started my presentation. My

research study involved testing the efficacy of an Indian herb on

memory of my fellow students. No such study was undertaken before on

the same type of sample. I was anticipating that I will be grilled on

the huge ethical aspects of my study since it required a group of

subjects who have no use of the drug. But to my surprise all the IEC

asked me about was about the Good Clinical Practice (GCP)guidelines! I

told them some of the guidelines but they insisted on that I should

provide them with a copy of the GCP if I wanted an approval! I was

stunned to know that all these teachers of mine, who have been in the

field for years together, are not interested in any ethical or any

other aspects of my study!

When I told them that I was an second year undergraduate student, they

expressed surprise. They thought that I was some post graduate

student! Now their attitude changed and I was granted approval without

any questions/objections/doubts!

Next year onwards when I applied for another ICMR STS projects I was

not even required to make a presentation in front of the IEC. We were

all granted approval without any questions.

This dangerous practice has provided grounds for a bigger black hole.

Now if any body whose research has been constantly rejected by IEC

does a very simple trick to gain approval. Apply for the same project

to IEC under the pretext of ICMR STS using an undergraduate student as

a scape goat! And voila! There u get the IEC approval!

I hope we can see where this attitude of ours can lead to? I would

also like to highlight the potential time bomb regarding the training

these undergraduate students are getting. They are the future

researchers! So ain't we infecting the very sapling? What ethical

research will such students do when they have learned there guides and

the authorities don't care about ethics!

The debate is open...But the question still looms...What needs to be done?

Navneet

> >

> > From: Chetna Desai <chetna99@>

> > Subject: Medical Research Ethics

> > netrum

> > Date: Friday, 28 November, 2008, 10:03 PM

> >

> >

> >

> >

> >

> >

> >

> > Dear Friends...

> > Ethics in general and in Medical Research in particular is a

> touchy yet important subject..one that evokes an extreme reaction

> most times. Hence its with pleasure that i initiate this debate;

> leave the field open for a head on frontal attack, a debate with no

> one holding back while expressing their ideas, concerns and

> solutions to this issue. Some cues...

> >

> >

> >

> > Why do you think Ethics is particularly important in medical

> research?

> > What are the guidelines for ethics in medical research

> > Are there any regulations? If yes, do they matter/are they

> implemented?

> > How do you ensure/implement ethics in medical research?I shall be

> away till late evening tomorrow for a lecture at Bhavnagar, but

> leaving the field open for all to come forward and respond. I

> > Warm wishes and keep posting

> > Chetna

> >

> >

> >

> > --

> > Dr Chetna Desai

> > Department of Pharmacology

> > B. J. Medical College

> > Ahmedabad 380016

> >

> >

> >

> > Visit

> > http://www.pharmaco logybjmc. org

> > http://pharmacbjmc. 110mb.com

> > www.poliofoundation .org

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> >

> > Add more friends to your messenger and enjoy! Go to

> http://messenger./invite/

> >

>

[Guest guest]

Dear Dr. Chetna Desai:

Over the past few years, India has turned to be the hub of global

outsourcing and hosting of clinical trials. This has led to a

proportionate rise in the concerns over rights and safety of

volunteers. Pharma giants are getting increasingly lured towards India

owing to the cost advantage clubbed with large availability of a ready

pool of skilled medical personnel as well as volunteers motivated

enough to freely render their bodies for medical research. Amidst this

fast changing scenario and rush for results, ethics and human rights

seem to be getting pushed to the backburner, unfortunately. What is

needed is more strict regulations, their firm implementation and sever

penal action. Colleges and Universities should be accredited on the

basis of inter-alia performance of their ethical review committees.

Way back in the middle of 2005, ICMR had launched a maiden national

survey of over 1000 scientific institutions and medical colleges to

assess their ethics committees. Considered to be the biggest and first

of its kind nationwide study, it was supposed to throw light on the

status of ethics committes at various institutions including medical

colleges, research institutions, ayurvedic colleges and voluntary

agencies, so as to accredit them on the grounds of effective and

unbiased functioning of their ethical committees. Does anybody have

some information about the present status of this countrywide survey

that had provided a silver lining in the dark clouds three years back.

In my opinion, my personal experience tells me that not all decision

making by various ethical committees can be termed unbiased,

unequivocal and reasonably fair. I have witnessed in the meetings

attended by me that members do not really bother to look into the

intricacies of various research proposals. Their decision making is

rather overshadowed by personal interests, endorsements, appeasement

and sometimes even vendetta. Hardly any proposals are rejected on

technical and reasonable grounds. Under these circumstances there is

dire need of a watchdog as proposed by ICMR in the said study, that

could monitor and evaluate the performance of these commitees and

subsequently reward or penalise them by say accreditation, approval

etc. This becomes more important in the wake of progressively falling

standards/values in the society in general. Ethical committees cannot

remain untouched by this sporadic wave of moral degradation prevailing

in the society and hence the need for a watchdog and effective, strict

regulations.

With Kind regardsDr. Geer M. IshaqAssistant ProfessorDept. of Pharmaceutical SciencesUniversity of KashmirSrinagar-190006 (J & K)Ph: 9419970971, 9906673100Website: http://ishaqgeer.googlepages.com From: BARNA GANGULY <barnaganguly@...>Subject: Re: Re: Re: Medical Research Ethicsnetrum Date: Tuesday, 2 December, 2008, 11:15 AM

Dear Dr. ChetnaFirst

let me congratulate you and the team members for taking up this issue,

which is the need of the hour for the researchers. For most of us in

medical fraternity, research is a secondary thing which we sometimes

consider this as aright if not a privilege. At that time it becomes

difficult for the researcher to accept some of the issues related to

carrying out the work which may not/should not be applicable in course

of that. Thus IEC & IEc members never become a pleasant

body. This I am commenting with authority out of my

experience as IEC Member secretary since last few years.Before that I

was also having a lot of quetions & grudges on ethical reveiew,

which still is prevalent in other researchers.

Me being trained thro ICMR-NIH( fogarty international) long term

training course on Bioethics, felt that there should be a part on

bioethics in post graduate training before planning for dissertation

topic. Once people come to know innumerabale unethical practices in

reearch, automatically they will open their eyes and will venture for

sound scientific resaerch be it small....... needless to mention that

IT IS UNETHICAL TO GO FOR UNSOUND SCIETIFIC RESEARCH.

We can continue discussion on various issues as raised

Warm regards

Barna Ganguly

On Sun, 30 Nov 2008 Chetna Desai wrote :

>Well Navneet,

>Lack of awareness about "Ethics" or ignoring them certainly worked in your

>favor at that time, but obviously this is not desirable. It also brings out

>an important issue...a young budding researcher is learning ALL the WRONG

>lessons in research.... thats equally undesirable. For the undiscerning, it

>can send out wrong signals and built wrong foundations. When the youngster

>is senior and in a decision making position, history may repeat. In

>organisations, Committees, etc, it is very important for the seniors and

>mentors to be "role models" if they wish to see a right environment today

>and tomorrow.

>The impact and appreciation of ethics, the right values and action, fair

>play and fair behavior...whether in research or in life, is not known

>immediately. It is felt and noticed years later when these bear fruits in

>the form of well trained researchers and good human beings.

>chetna

>

>2008/11/30 navneet_malviya <navneet_malviya>

>

> > Hi,

> > I guess its time to debate on one of the most challenging questions of

> > this debate: "Do we really care about Medical Ethics?"

> > In my opinion, we can debate endlessly on the issue of ethical medical

> > research, but the foremost issue remains that as a researcher, as an

> > ethical committee observer, as a guide, or as an administrative

> > authority do we

> > really care about medical research ethics?

> > I would like to share one of my personal experiences with you to

> > highlight the height of mockery of ethics in medical research which, I

> > suppose, we all see in our professional life.

> > I must apologize in the beginning if I have/will hurt feeling of

> > anyone due to this account. I have no personal grudges.I only wish to

> > highlight the hippocracy of our system!

> > A few years back when I was a second year medical student in my

> > medical school (I must add that at that point of life I had no

> > exposure to research, let go the ethics attached to it). At that time

> > I came to know about Indian Council of Medical Research (ICMR) Short

> > Term Research Studentship (STS). It was and is one of the best way to

> > kick start as an UnderGraduate in ethical medical research in my opinion.

> > So we (I and a couple of my friends) decided to venture in this

> > territory. I must emphasize on the fact that we all were totally

> > unaware of the ethical aspects of medical research at this point!

> > ICMR requires, in its requirements for STS, that the applicant must

> > submit an Institutional Ethics Committee (IEC) approval. So we applied

> > to the IEC for its approval. As a part of standard operating protocols

> > of the IEC we were required to make a presentation in front of our IEC

> > of which all departmental heads are members. So we hurriedly prepared

> > a presentation.

> > Now at the end of IEC meeting it was our turn to present our research

> > proposals. I volunteered to be the first scape goat! Now in front of

> > 16 stalwarts of my medical school I started my presentation. My

> > research study involved testing the efficacy of an Indian herb on

> > memory of my fellow students. No such study was undertaken before on

> > the same type of sample. I was anticipating that I will be grilled on

> > the huge ethical aspects of my study since it required a group of

> > subjects who have no use of the drug. But to my surprise all the IEC

> > asked me about was about the Good Clinical Practice (GCP)guidelines! I

> > told them some of the guidelines but they insisted on that I should

> > provide them with a copy of the GCP if I wanted an approval! I was

> > stunned to know that all these teachers of mine, who have been in the

> > field for years together, are not interested in any ethical or any

> > other aspects of my study!

> > When I told them that I was an second year undergraduate student, they

> > expressed surprise. They thought that I was some post graduate

> > student! Now their attitude changed and I was granted approval without

> > any questions/objection s/doubts!

> > Next year onwards when I applied for another ICMR STS projects I was

> > not even required to make a presentation in front of the IEC. We were

> > all granted approval without any questions.

> > This dangerous practice has provided grounds for a bigger black hole.

> > Now if any body whose research has been constantly rejected by IEC

> > does a very simple trick to gain approval. Apply for the same project

> > to IEC under the pretext of ICMR STS using an undergraduate student as

> > a scape goat! And voila! There u get the IEC approval!

> > I hope we can see where this attitude of ours can lead to? I would

> > also like to highlight the potential time bomb regarding the training

> > these undergraduate students are getting. They are the future

> > researchers! So ain't we infecting the very sapling? What ethical

> > research will such students do when they have learned there guides and

> > the authorities don't care about ethics!

> > The debate is open...But the question still looms...What needs to be done?

> >

> > Navneet

> >

> >

> > > >

> > > > From: Chetna Desai <chetna99@>

> > > > Subject: Medical Research Ethics

> > > > netrumgroups (DOT) com <netrum%40group s.com>

> > > > Date: Friday, 28 November, 2008, 10:03 PM

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > > Dear Friends...

> > > > Ethics in general and in Medical Research in particular is a

> > > touchy yet important subject..one that evokes an extreme reaction

> > > most times. Hence its with pleasure that i initiate this debate;

> > > leave the field open for a head on frontal attack, a debate with no

> > > one holding back while expressing their ideas, concerns and

> > > solutions to this issue. Some cues...

> > > >

> > > >

> > > >

> > > > Why do you think Ethics is particularly important in medical

> > > research?

> > > > What are the guidelines for ethics in medical research

> > > > Are there any regulations? If yes, do they matter/are they

> > > implemented?

> > > > How do you ensure/implement ethics in medical research?I shall be

> > > away till late evening tomorrow for a lecture at Bhavnagar, but

> > > leaving the field open for all to come forward and respond. I

> > > > Warm wishes and keep posting

> > > > Chetna

> > > >

> > > >

> > > >

> > > > --

> > > > Dr Chetna Desai

> > > > Department of Pharmacology

> > > > B. J. Medical College

> > > > Ahmedabad 380016

> > > >

> > > >

> > > >

> > > > Visit

> > > > http://www.pharmaco logybjmc. org

> > > > http://pharmacbjmc. 110mb.com

> > > > www.poliofoundation .org

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > > Add more friends to your messenger and enjoy! Go to

> > > http://messenger. / invite/

> > > >

> > >

> >

> >

> >

>

>

>

>--

>Dr Chetna Desai

>Department of Pharmacology

>B. J. Medical College

>Ahmedabad 380016

>

>

>

>Visit

>http://www.pharmaco logybjmc. org

>http://pharmacbjmc. 110mb.com

>www.poliofoundation .org

Add more friends to your messenger and enjoy! Invite them now.