Norah
★    

Tunisia,
2018-01-16 09:31
(2345 d 06:06 ago)

Posting: # 18175
Views: 7,631
 

 IRB reserves [Design Issues]

Hello every body I need your advice regarding a BE study where I planned to perform a drug (cannabis, THC, ... ) screening to volunteers before confinement. The Ethic committee rejected this because local laws require the person who discovers a consumer to declare him for imprisonment.
Is the drug screening mandatory??
thanks a lot


Edit: Category changed; see also this post #1. [Helmut]
Helmut
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Vienna, Austria,
2018-01-16 12:18
(2345 d 03:19 ago)

@ Norah
Posting: # 18176
Views: 7,042
 

 Screening for illicit drugs

Hi Norah,

❝ […] a BE study where I planned to perform a drug (cannabis, THC, ... ) screening to volunteers before confinement. The Ethic committee rejected this because local laws require the person who discovers a consumer to declare him for imprisonment.


Interesting. Since the job of the ethics committee is to protect volunteers from risks, this makes sense. The WHO’s guideline states:

3.2 Ethics committee
When reviewing a clinical trial proposal the ethics committee should consider the following:
b) The suitability of the protocol including the objectives of the study and the justification of predictable risks and inconveniences weighed against the anticipated benefits for the subjects and/or others …
3.3 Informed consent
b) The subject must be made aware and consent that personal information may be scrutinized during monitoring, auditing or inspection of the trial by properly authorized persons, the sponsor or relevant authorities, and that participation and personal information in the trial will be treated as confidential and will not be publicly available. This principle may be modified by national laws and regulations.


Getting imprisoned is inconvenient at least. :stop:

❝ Is the drug screening mandatory??


Not mandatory but I never ever have seen a BE study without one.

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Norah
★    

Tunisia,
2018-01-16 12:54
(2345 d 02:43 ago)

@ Helmut
Posting: # 18177
Views: 7,098
 

 Screening for illicit drugs

Hello Helmut
thanks a lot for your quick reply, it is the same for me, I do not find any guideline mentionning that it is mandatory and why, but all BE studies contain this illicit drug screening
Best regards :)
ElMaestro
★★★

Denmark,
2018-01-16 13:44
(2345 d 01:53 ago)

@ Norah
Posting: # 18179
Views: 6,944
 

 Screening for illicit drugs

Hi Norah,

there are no well-defined rules. But I assure you that you don't want to be in a situation where you haven't done it and it then causes issue downstream. It is going to be your problem and the sponsor's problem regardless of IEC+regulatory approval.
Section 3 of ICH E6 in a way gives the IEC/IRB some "responsibility" for rights, well-being, safety of trial participants. In practice though this is a bit messy and does not mean the CROs/Sponsor's responsibility is offloaded on a bureaucratic parallel universe if something happens.

Chest Xray and ECG are a bit in the same category. They are not done routinely in certain parts of Asia.

I don't know where the limit is. You can die from infection from an in-grown toe nail, yet I never saw any source or CRF mentioning a specific check for this condition was done. :-)

Pass or fail!
ElMaestro
Norah
★    

Tunisia,
2018-01-16 14:57
(2345 d 00:39 ago)

@ ElMaestro
Posting: # 18183
Views: 6,955
 

 Screening for illicit drugs

Thank a lot ElMAESTRO, so you mean that it is possible to skip this step?
Relaxation
★    

Germany,
2018-01-16 19:18
(2344 d 20:18 ago)

@ Norah
Posting: # 18186
Views: 6,943
 

 IRB reserves

Hello to all.

To add my 2 cents.
As far as I know (better "remember", my training on the protocol template was admittedly not recent), there is only one relevant reason for drug screening: to have a test for subjects with an increased risk of non-compliance to study conditions. It's not fair to assume that all drug users are unreliable (and for me a little bit inadequate), but it is a point.
In addition, it might be that subjects will misbehave during the stay at the clinical side if drugged, so there is another point.

I personally agree with the approach to exclude subjects that may consume drugs as I would consider this as a specific kind of concomitant medication. Maybe there could be a PK interaction, maybe not, but you would have to implement additional checks or at least a discussion on any analytical interference at your bioanalytical department in any case.

Still, all these are issues that are basically organisational problems of the sponsor, can be handled in other ways and may not make a drug test mandatory.

On the other hand, I also have no example of a clinical trial, where such tests were not part of the protocol.
But they also were always explicitly mentioned in the subject information I know of (OK, subjects do not read them - we had several cases ourself, if only people smoking right in front of the entrance and then complaining on the test for cotinine ;-) we enforced "in case of suspicion").

I am not sure how the IEC would react to this argument, but actually, if the subjects are informed and still show up for the test ... its not really your fault, is it?

Best regards,

Relaxation.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe]
ElMaestro
★★★

Denmark,
2018-01-16 23:16
(2344 d 16:21 ago)

@ Relaxation
Posting: # 18187
Views: 6,872
 

 IRB reserves

Hi Relaxation,

❝ As far as I know (better "remember", my training on the protocol template was admittedly not recent), there is only one relevant reason for drug screening: to have a test for subjects with an increased risk of non-compliance to study conditions. It's not fair to assume that all drug users are unreliable (and for me a little bit inadequate), but it is a point.


It goes beyond that.
WHO is defining substance abuse and alcoholism as disease in its own right. Many if not most countries assign a psychiatric diagnosis to people with substance abuse.
If you are positive for the drug screen/alcohol test you are potentially not healthy (as in a healthy adult volunteer, which coincidentially fits the description of the typical BE subject quite well). A regulator who hasn't slept well would also throw the term "vulnerable" at you - check the definition in ICH E6, along with the regard to "well-being".
Checking for these things really isn't something you do for the sake of the trial or for the sponsor or for the CRO's smooth operation - it is first and foremost something you do in the interest of the subject.

Pass or fail!
ElMaestro
Norah
★    

Tunisia,
2018-01-17 16:08
(2343 d 23:29 ago)

@ ElMaestro
Posting: # 18191
Views: 6,958
 

 IRB reserves

Thank you Relaxation,Thanks you Elmaestro
Helmut
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Vienna, Austria,
2018-01-17 16:31
(2343 d 23:06 ago)

@ ElMaestro
Posting: # 18192
Views: 6,855
 

 Recreational use ≠ abuse; definition of health

Hi ElMaestro,

❝ WHO is defining substance abuse and alcoholism as disease in its own right. Many if not most countries assign a psychiatric diagnosis to people with substance abuse.


Recreational use abuse.
In a few countries recreational use of cannabis is legal (even in in some states of Trump-[image]).

❝ If you are positive for the drug screen/alcohol test you are potentially not healthy (as in a healthy adult volunteer, which coincidentially fits the description of the typical BE subject quite well).


See the WHO’s definition:

Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.

(my emphasis)
How healthy are students in the “1st world” living in the precariat and many people in developing countries?

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xtianbadillo
☆    

Mexico,
2018-01-18 09:32
(2343 d 06:05 ago)

@ Norah
Posting: # 18199
Views: 6,786
 

 IRB reserves

❝ Is the drug screening mandatory??


In Mexico for BE you have to perform abuse test by law
"8.7.14 Qualitative evidence of drug abuse and pregnancy must be performed during the selection process and prior to admission in each study period" NOM-177-SSA1-2013.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5! Document linked. [Helmut]
Norah
★    

Tunisia,
2018-01-18 09:35
(2343 d 06:02 ago)

@ xtianbadillo
Posting: # 18200
Views: 6,805
 

 IRB reserves

Thanks xtianbadillo
Helmut
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Vienna, Austria,
2018-01-18 11:01
(2343 d 04:35 ago)

@ xtianbadillo
Posting: # 18201
Views: 6,915
 

 Norma = Ley?

Hi Christian,

❝ In Mexico for BE you have to perform abuse test by law […]



Can you confirm that it is a Ley (law) and not – what I assumed and is stated as such in the document – just a Norma (rule/guideline)?

My Spanish is practically nonexistent. Does “deben realizar” rather mean “should be performed” than “must be performed”?

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xtianbadillo
☆    

Mexico,
2018-01-18 20:51
(2342 d 18:46 ago)

@ Helmut
Posting: # 18218
Views: 6,774
 

 Norma = Ley?

❝ ❝ In Mexico for BE you have to perform abuse test by law […]



Maybe I made a lost in translation.
NOM, The Official Mexican Standards are the latest mandatory observation techniques issued by the competent agencies, according to the purposes established in Article 40 of the Federal Law on Metrology and Standardization.

❝ Can you confirm that it is a Ley (law) and not – what I assumed and is stated as such in the document – just a Norma (rule/guideline)?


In Mexico we have to Normas
Norma Oficial Mexicana: Mandatory, like NOM-SSA1-177-2013
Norma Mexicana: they are of voluntary application, like NMX-AA-115-SCFI-2015
Normas can be differentiated by their nomenclature: NOM vs NMX

❝ My Spanish is practically nonexistent. Does “deben realizar” rather mean “should be performed” than “must be performed”?


"Las pruebas cualitativas de abuso de drogas y de embarazo se deben realizar durante el proceso de selección y previo al ingreso en cada periodo del estudio"

My humble opinion is that mean must; other opinions are welcome

Debe = implies that something is to do, it is imminent, mandatory; must be performed
Debe de = ideally, should be performed
Helmut
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Vienna, Austria,
2018-01-19 01:21
(2342 d 14:16 ago)

@ xtianbadillo
Posting: # 18220
Views: 6,914
 

 Norma Oficial Mexicana (NOM): Mandatory

Hi Christian,

❝ In Mexico we have to Normas

❝ Norma Oficial Mexicana: Mandatory, like NOM-SSA1-177-2013

❝ Norma Mexicana: they are of voluntary application, like NMX-AA-115-SCFI-2015

❝ Normas can be differentiated by their nomenclature: NOM vs NMX


THX; this is very useful!

❝ "Las pruebas cualitativas de abuso de drogas y de embarazo se deben realizar durante el proceso de selección y previo al ingreso en cada periodo del estudio"


❝ Debe = implies that something is to do, it is imminent, mandatory; must be performed

❝ Debe de = ideally, should be performed


THX also for improving my very, very poor Spanish. Wasn’t sure.

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