Re: Re: Ethics of informed consent in CT - Exercise 1

[Guest guest]

Dear Sir,

Compensation should be provided to the patient if minor, and if death, the family should be given the compensation. Treatment can be given in local hospital and if need be, shifted to a larger centre with better facilities.

Anupama

From: Vijay <drvijaythawani@...>Subject: Re: Ethics of informed consent in CT - Exercise 1netrum Date: Wednesday, 6 January, 2010, 6:47 PM

Hi Tarun,Thanks for daring to do the exercise first.From your answers: one correct and one wrong.There is nothing wrong in seeking consent for publishing the data of the trial in research paper, as long as ethics of not revealing the identification of the participant. After all the research must go to public domain through medical journals, then only it will be utilized by others."No other compensation, in any form, called by any name what so ever; will be available to me / my parents / dependents / legal heirs" statement is harsh and stealing the rights of participants. In case of ADE, serious injuries during the trial, permanent disability, delayed ADE, compensations can be claimed and should be paid. Consent forms taking signatures on such statement indicate how investigators try to save their skins at the cost of participants. Vijay> > > From: Vijay <drvijaythawani@ ...>> Subject: Ethics of informed consent in CT - Exercise 1> netrumgroups (DOT) com> Date: Wednesday, 6 January, 2010, 5:58 AM> > > > > > > Hi,> Please remember that we are in the workshop and hence every discussion needs some work!> So gear up. Here is the first exercise for you. If we get sufficient response to this, another will follow today evening.> Given below is the consent form from an actual study which was done when the EC in our institution was in its first year of inception. This was a ICMR UG short term studentship research project. You have to find faults with the consent form and report back. Only polite objections please.> Vijay> ------------ --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- --------- ---------

--------- --------- --> > > Confidential> > Effect of Bacopa Monniera on Memory in Medical Students> > Participant Consent Form> > I, ____________ _________ _________ _ /o ____________ _________ , aged _____ years, exercising my free will / choice, without any duress / pressure/ lure of incentive in any form, hereby record my consent to be included as a participant in the study to test the "Efficacy of Bacopa Monniera on Memory in Medical Students". I hereby confirm that I am over 18 years of age and have been suitably informed to my satisfaction by the investigators, the meaning, purpose and procedure of this trial. I hereby confirm that I have been supplied with participant information sheet. I am aware that during blinding I may get placebo, which may not have any beneficial effect on me. I agree to let my blood samples be drawn for investigation purpose. I agree not to

mix any other treatment during the period of this trial without informing the investigators. Knowing all above, I record my consent for participating in this trial. I am aware of my right to withdraw any time> during the course of this trial, without being bound to give any reasons. I agree to cooperate fully with the investigators and to immediately inform if I suffer any unusual symptoms. I hereby record my permission to release the information obtained as a result of my participation in this study for publication. If during the course of this trial I am physically injured because of any substance or procedure, I agree for my subsequent free medical treatment at Government Medical College Hospital / Super Speciality Hospital Nagpur. No other compensation, in any form, called by any name what so ever, will be available to me / my parents / dependents / legal heirs.> > Signature of the

participant:…………………………….> Name: …………………………………………………….College roll No.:> Date:…………> > The participant was explicitly explained all the contents of this Consent Form and then signed before me.> > Signature of the impartial witness:> Name:………………………> Date: …………> > I confirm that I have explained the nature, purpose and possible hazards of the above study to the participant Mr/Ms…………………………………………………> > > Signature of the Investigator:> Name: N Kumar> Date: > > > > > > > > > The INTERNET now has a personality. YOURS! See your Homepage. http://in..

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The INTERNET now has a personality. YOURS! See your Homepage.