Ethics of informed consent in CT - Exercise 1

[Guest guest]

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: