Re: Unethical Research at LNJP/MAMC ART Center, New Delhi !?.

[Guest guest]

/message/10507

Thanks for bringing this to our notice. I have asked our nodal officer of ART

centre to give me the facts on the issue. NACO has a duly constituted research

and ethics committee.

Dr B.B.Rewari MD,FICP,FIACM,FIMSA,FGSI

Sr.Physician,Dr RML Hospital & National Programme Officer (ART)

National AIDS Control Organistion, 6th Floor, Chandralok Building, 36,

Janpath, New Delhi-110001

Tel; 011-23731954, 43509999(O) Mobile ; 91-9811267610

Fax : 011-23731954,23731746

e-mail: <drbbrewari@...>

[Guest guest]

Dear FORUM,

Great to hear ethics in research from a common person!

Don't get scared with this simple problem! In India research ethics is violated

in most of the research activities.

1) First what happened to you is really bad - They should have common sense to

introduce themselves to you. Which might involve oral consent-enough for

questionnaire, if there is no controversy between you and the researcher but it

should be with your consent. 

2) Don't blame PhD scholars,Because they may not have the adequate knowledge

about the consent process and the way of rapport building and how to begin a

interview.

3) Don't blame on Dean next, most of the time they may not know about research

ethics. They are having lot of administrative procedures to bang their head.

4) Don't blame NACO at last for each and everything. They can train people,

providing fund to protect PLHA's and they are fighting all the way to solve

problems.

5) Solution is simple - Contact the PhD students make them to understand their

mistakes and let them to improve their knowledge by your gentle request.No one

in the world is born intelligent. Don't bang the head of ART MO, Dean or NACO.

Dr Jayakumar

e-mail: <drjayakumar1999@...>

[Guest guest]

Dear FORUM,

/message/10561

Dr Jayakumar's response to Snehansu Bhaduri seems outrageous to me.

What he did through his mail was to hold Snehansu Bhaduri responsible for this

unethical conduct.

By saying don't blame PhD scholars, or the dean, or NACO you seem to be saying

that they are not responsible when in fact they are responsible for conducting

ethical research. And by saying there is a " simple solution " you are implying

that he was so simple minded not to take the easy way out and not bring up this

issue, ignore the issue was what you are implying he should do.

I am glad that Mr Snehansu brought up this issue. No matter how you wish to view

this, this is a big issue. This is nothing short of violation of patient rights.

To conduct research in a medical institution by someone from a different country

requires several permissions and written communication.

This requires government approval, hospital approval and should have NACO

approval for the research to be conducted in the ART center and last but not the

least the patient approval.

There is difference between being assertive and being passive. You want him to

be passive in this situation and try a " gentle request " while this calls for

assertiveness on the patient's part.

Also he very clearly said even the doctor who is working the ART center does not

know what to do if a dean is giving permission, implying there is so much of

power issues in a hospital set up.

And you expect a patient to walk up to the researcher and say this

is not right?

Blaming the victim seems to be your convenient approach! this is just like

blaming the rape victim for getting raped!

Dr Riwari, thank you for being understanding.

Magdalene Jeyarathnam

--

http://centerforcounselling.blogspot.com/2009/02/write-up-on-center-for-counsell\

ings.html

--------

Magdalene Jeyarathnam

Director - Center For Counselling

18 Radhakrishnan Salai, 9th Street,

3rd Floor, Mylapore, Chennai 600 004

www.centerforcounselling.org

email- magdalene@...

Telephone - 044- 42080810, mobile - 9884100135

[Guest guest]

Dear Forum members,

Re: /message/10564

I would like to clarify that research is an important component of Medical

profession and it has to be done in clinical settings, laboratories, research

institutes etc etc.

It is quite essential for upgradation of knowledge ultimately translating to

better therapeutic options for patients. However there are definite norms for

research and informed consent is a very important component of any research.

Institutions like Maulana Azad Medical College and LNJP hospital do have ethic

committees to approve research proposals and faculty is definately aware of need

for ethical clearence.

It has been verbally communicated that this particular project had institutional

ethical clearence but definately the consent part was not followed as it should

have been done.

 

NACO has asked for an official reply from the MAMC and we will ensure that

research is carried out following proper protocol.

For the first time , an R & D and an ethics committee has been formed at NACO

chaired by scholars of eminence.

 

NACO is committed to highest standards of ethical research

 

Thanks

Dr B.B.Rewari MD,FICP,FIACM,FIMSA,FGSI

Sr.Physician,Dr RML Hospital &

National Programme Officer (ART)

National AIDS Control Organistion,

6th Floor, Chandralok Building,

36, Janpath, New Delhi-110001

Tel; 011-23731954, 43509999(O)

Mobile ; 91-9811267610

Fax : 011-23731954,23731746

e-mail: <drbbrewari@...>

[Guest guest]

Dear FORUM,

Re: /message/10561

I fully agree with Ms Magdalene regarding all the points she put forth on the

seriousness of this particular incident as well as all similar researches

happening in this country.

Dear Dr Jayakumar: I don't know whether you are a medical doctor or Ph.D Doctor.

Whatever you are, my first answer to you is that " Ignorance of Law is no

Excuse " . What you are saying is that you can kill somebody and say that you

didn't know that it's a legal issue.

In the name of ignorance-of-law, people are humiliated, insulted, taken for

granted, molested, raped and assaulted. Sorry Dr Jayakumar, whatever you are, to

accept your " simple solution " .

Oral explanation to the client is mandatory, written consent from the client is

mandatory, written permission from authorities is mandatory, clearance from the

Ethical Review Board of the institution is mandatory and above all, NACO's

knowledge of this research is essential.

If I were in the place of Snehansu Bhaduri, I would have filed an FIR by now for

breaching my basic human rights by extracting information from me, (maybe to use

it against me, who knows??) under the pretext of a survey within the premises of

a leading medical institution.

I think the issue should get more publicity so that people like Dr Jayakumar

will get educated and understand that " ignorance of law is no excuse. " If MAMC

doesn't have an ERB, I think this incident will educate the Dean about having

one.

C. Varghese

Development Sector Consultant

e-mail: jacobcv@...

[Guest guest]

Dear FORUM,

Re: /message/10561

Glad that NACO is asking for an official reply from MAMC and also the formation

of ethical comittee.

However, i believe that in any ethics comittee the Invovlment/participation of

affected community is a must.

Eg. If a research is done in the field of HIV, then PLHIV reps must be in the

ethics comittee, or if it's related to sex work, then sex workers reps must be

invovled. Isn't it?

Loon

E-mail: Loondnpplus@...

[Guest guest]

Dear Forum,

Re: /message/10561

We at AAG are aghast at the advice given by Dr. Jayakumar.

Every one is responsible for the conduct of a research. The mentor for not

guiding the researchers for their thesis, the HOD for not ensuring that legal

and ethical issues are addressed and explained at length to the would be Ph.Ds.

Any one doing research with PLHAs must know what Mr. Varghese has

described so aptly.

We at AAG are shocked that Dr Jayakumar can condone all the lapses and make

excuses for the faculty for not ensuring that research is done ethically and

legally and in accordance with NACOs and WHOs guidelines.

What are we teaching the students? It is all right that A, B, C did not tell you

what is right and it is OKay to condone the lapses. What will these new Ph.Ds

teach the next generation? Just what they have learnt from their Mentors!!

We fully agree with the comments by Ms Magdalene and Mr. Varghese.

Siddhartha,

For AIDS Awareness Group (AAG)

e-mail: <aag94@...>

[Guest guest]

Dear FORUM,

Re: /message/10561

It is saddening to learn of ethical lapses in research. Informed consent is

really critical.

However, I'd like to also point out (without diminishing the requirement for a

full and complete explanation to research participants) that obtained signed

consent is not always recommended as this may make people who are non-literate

worry about whether they are signing away their property rights, etc., and add

to their worries and concerns.

We do not have a recent spelled-out policy at the governmental level.

But scholars and activists who are interested may wish to read the following

article from the Indian Journal of Medical Ethics published in 2000 (Vol 8, No.

2) " Ethics in social sciences and health research: a draft code of conduct " It

gives some guidance about when to obtain written consent, and when verbal

consent may be more appropriate (Article available free at http://www.ijme.in).

My understanding of the original issue is that the researcher in question only

divulged the reason for their questioning of the patient after the patient

explicitly asked why.

This certainly does not indicate a good-intentioned, well-thought-out informed

consent procedure.

Sincerely

Melita Vaz Ph.D.

e-mail: <melitavaz@...>