Regarding LAR(legally acceptable rep) & Impartial Witness

[ketan_bhagalia]

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Hi guys a question...

Wen a subject is illiterate at that time the LAR(legally acceptable representative) can explain the subject abt the study & sign on his behalf.
But wen the subject and his LAR both are illiterate at that time an Impartial Witness is called...This is what  the Industry follows...

But i would like to say that when the subject is illiterate 1st the Impartial witness should be consider and he should explain and sign the ICF and then the LAR if required.
Coz at time the LAR sign the ICF coz he might be benefited in terms of Money or some thing else...Example, Bioequivalence  studies the subject are compensated so for that interest the LAR can influence the subject and as the LAR family members the subject could also get influenced, or the LAR will not give the full details of the study to the subject.

So my take on this topic is if the subject is illiterate then firstly the impartial witness should be called and he will explain the entire details of the study to the subject and then if required the LARs consent to be taken..

Guys please give your Suggestion & Feedback

Regards
  KB

[drnitinnagrecha]

Hello !

I will throw some light on this.

The example you have asked about is BA/BE studies...where in each and every case Impartial Witness is present during the consenting procedure.

AFter the procedure impartial witness signs and the subject puts his thumb impression. I have never seen LAR being asked to sign in case of BA/BE studies.

As far as clnical trials are concerned , there are no direct benefits to subjects in terms of money.....

Hence i guess u got answer of question that u were asking!

Cheers !

Dr NiTin

[UKB]

Hello ketan,

this is nice suggestion, but do u think that impartial witness will take more care to the subject than LAR.Now u tell me who will select the impartial witness?There are two parties in a clinical trial.One is investigative party and other is subject.

Now clear me ,subject will select for impartial witness or Investigative team. If Investigative team will select than again chances of bias will increase. So I think there is something missing.......


what others view?

Feedback welcome

Regards
UKB

[nikita]

The question of an LAR COMES ONLY WHEN SUBJECT IS BELOW 18 YRS OF AGE....acc to me almost all BA /BE study protocols  involve adults and so if that adult is illiterate an impartial witness is called for and LAR is not required(as mentioned by DR.Nitin)

In case of studies involving minor subjects i dont think that LARs (closest relative in most cases) try to influence minors for money


regards
Nikita

[ketan_bhagalia]

Hey thanks nikita...but in case of minors assent form comes in to picture...

[nikita]

ur rite , bt ur query was related to illiterate subjects, so i did nt go into the assent thng

Regards
Nikita

[srikanthk]

As you know in case of illiterate or minor subjects LAR signs on the ICF and LAR (Legally Acceptable Representative) is defined by the local / regional laws. Obviously anybody can not sign on the ICF, only blood relatives can, who are more concerned about the patient than Impartial witness. So I think LAR should be given priority over Impartial witness.

[parvisingh]

I concur with Srikant comments. and anyway, we have to follow the "Law of the land"

[Darshana Patel]

hii,

if the subject is not in a condition to give consent like minor, unconsious etc, then only LAR will come into the picture.

Healthy subjects are enrolled in BA-BE trials & can give consent on their own, hence LAR is not needed.

However if the subject is illitrate then ICF should be conducted in presence of Impartial witness as per GCP.

Regards,

Darshana

[sajan]

Hi Friends...

This is the topic which is always giving me confusion  SC:>...whenever I raise this question to somebody there will be always an argument AR:> like this...but I never got a satisfying answer... B:>

So Senior members of CRF  A:> kindly help me in giving me a final answer...

"If a subject is illiterate...should we go for Legally accepted representative or an Impartial witness?" H:>


The highlighted "or" in the below mentioned sentence from GCP is making me confusion...if the "or" is replaced with "and", then everything will be fine....Butttt the "or" is there naaa? D)... D).... D)

4.8.9 If a subject is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the entire informed consent discussion.

If u do have any confusion in my question please ask.....but please never close your eyes to my question.

Thanks and Regards,
Sajan