Re: Re: Medical Research Ethics

November 30, 2008

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.

chetna2008/11/30 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/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/

> >

>

-- Dr Chetna DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmacologybjmc.org

http://pharmacbjmc.110mb.comwww.poliofoundation.org

November 30, 2008

Dear Navneet, Chetna madam and friends,

Six of the values that commonly apply to medical ethics discussions are:

Beneficence - a practitioner should act in the best interest of the patient. (Salus aegroti suprema lex.) Non-maleficence - "first, do no harm" (primum non nocere). Autonomy - the patient has the right to refuse or choose their treatment. (Voluntas aegroti suprema lex.) Justice - concerns the distribution of scarce health resources, and the decision of who gets what treatment (fairness and equality). Dignity - the patient (and the person treating the patient) have the right to dignity. Truthfulness and honesty - the concept of informed consent has increased in importance since the historical events of the Doctors' Trial of the Nuremberg trials and Tuskegee Syphilis Study.

Ref: http://en.wikipedia.org/wiki/Medical_ethics

-Anupama

From: Chetna Desai <chetna99@...>Subject: Re: Re: Medical Research Ethicsnetrum Date: Sunday, 30 November, 2008, 2:16 PM

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 ofthis debate: "Do we really care about Medical Ethics?"In my opinion, we can debate endlessly on the issue of ethical medicalresearch, but the foremost issue remains that as a researcher, as anethical committee observer, as a guide, or as an administrativeauthority do wereally care about medical research ethics?I would like to share one of my personal experiences with you tohighlight the height of mockery of ethics in medical research which, Isuppose, we all see in our professional life.I must apologize in the beginning if I have/will hurt feeling ofanyone due to this account. I have no personal grudges.I only wish tohighlight the hippocracy of our system!A few years back when I was a second year medical student in mymedical school (I must add that at that point of life I had noexposure to research, let go the

ethics attached to it). At that timeI came to know about Indian Council of Medical Research (ICMR) ShortTerm Research Studentship (STS). It was and is one of the best way tokick start as an UnderGraduate in ethical medical research in my opinion.So we (I and a couple of my friends) decided to venture in thisterritory. I must emphasize on the fact that we all were totallyunaware of the ethical aspects of medical research at this point!ICMR requires, in its requirements for STS, that the applicant mustsubmit an Institutional Ethics Committee (IEC) approval. So we appliedto the IEC for its approval. As a part of standard operating protocolsof the IEC we were required to make a presentation in front of our IECof which all departmental heads are members. So we hurriedly prepareda presentation.Now at the end of IEC meeting it was our turn to present our researchproposals. I volunteered to be the first

scape goat! Now in front of16 stalwarts of my medical school I started my presentation. Myresearch study involved testing the efficacy of an Indian herb onmemory of my fellow students. No such study was undertaken before onthe same type of sample. I was anticipating that I will be grilled onthe huge ethical aspects of my study since it required a group ofsubjects who have no use of the drug. But to my surprise all the IECasked me about was about the Good Clinical Practice (GCP)guidelines! Itold them some of the guidelines but they insisted on that I shouldprovide them with a copy of the GCP if I wanted an approval! I wasstunned to know that all these teachers of mine, who have been in thefield for years together, are not interested in any ethical or anyother aspects of my study!When I told them that I was an second year undergraduate student, theyexpressed surprise. They thought that I was some

post graduatestudent! Now their attitude changed and I was granted approval withoutany questions/objection s/doubts!Next year onwards when I applied for another ICMR STS projects I wasnot even required to make a presentation in front of the IEC. We wereall 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 IECdoes a very simple trick to gain approval. Apply for the same projectto IEC under the pretext of ICMR STS using an undergraduate student asa scape goat! And voila! There u get the IEC approval!I hope we can see where this attitude of ours can lead to? I wouldalso like to highlight the potential time bomb regarding the trainingthese undergraduate students are getting. They are the futureresearchers! So ain't we infecting the very sapling? What ethicalresearch will such

students do when they have learned there guides andthe 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> > 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 DesaiDepartment of PharmacologyB. J. Medical CollegeAhmedabad 380016Visit http://www.pharmaco logybjmc. orghttp://pharmacbjmc. 110mb.comwww.poliofoundation .org

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

December 1, 2008

Dear Dr. Chetna

First 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/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 <netrum%40>

> > > > 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.pharmacologybjmc.org

>http://pharmacbjmc.110mb.com

>www.poliofoundation.org

December 2, 2008

Dear Dr BarnaFirst, welcome to NetRUM. Its great to have a committed academician like you on this forum...this topic was discussed earlier too, but repeated on popular demand. Each time we have different views and inputs..all interesting and thought provoking. We look forward to your inputs throughout the process...

Barna. with your expertise as a MS of Ethcs committee...could you tell us how we could practically circumvent and tackle the practical difficulties where Ethics are not respected? Its always a silent battle between the sponsors and the investigators and the EC members. I too have observed a lot of compromises. Vocal EC members are not very welcome and looked upon with disdain or indulgence!

Chetna2008/12/2 BARNA GANGULY <barnaganguly@...>