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Dear Sir,
According to GCP , an impartial witness should be present for an
illiterate subject.
Can one impartial witness can be witness for group of illiterate
subjects. Is this can be
Accepted.
rgrds
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Dear sridhar,
as far as my knowledge it seems quite good to have separate impartial
witness for each illiterate volunteer because of regulatory point of
view.
i welcome further suggestions from the members regarding this point
regards
ramu
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Ramu Javvaji wrote that from a regulatory point of view an impartial
witness is required for consenting an illiterate volunteer, which is
clearly
correct, but from my European point of view I would wonder if it is
ethical
to include such a subject in the first place. For example, how can
you be
sure they understand the forms to be completed or other information
being
given to volunteers during the study? I think you will at least need
specific SOPs to deal with that situation.
Andrew Sutton.
Andrew Sutton, MBBS, MD(London), FFA
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
Tel: +44 (0)1483 455375. Direct: 688303
Mobile +44 (0) 7770 820 145 (To 5pm EST)
URL: www.gcpl.co.uk
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I concur with Dr Sutton. How can one get truly informed consent in an
ethical manner if the volunteer is illiterate? How does one explain to
such a subject the nuances of drug trials and possible risks? Medical
research should not be with vulnerable subjects such as this. Surely
there are enough subject that are literate and would more likely be able
to give informed consent that one should not have to even consider
illiterate volunteers.
James D. Prah, PhD
US EPA
Human Studies Division MD (58B)
Research Triangle Park, NC, 27711
919 966 6244
919 966 6367 FAX
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Dr Prah:
Just because a subject is illiterate,it does not necessarily mean
that they have impaired cognition or intelligence. Aside from reading
the consent, they may not have any issues with the consent and
research process. Certainly for certain types of social research, the
information gained from these subjects may be valuable. There may in
fact be instances where important and benefical scientific
information could be gained -for example studying the effect of an
antidiabetic drug in an indigenous population that has not written
language and a high mortality from diabetes. The research principles
of justice and beneficence need to be evaluate closely in this
situation but literacy should not be a blanket rejection for exclusion.
Sincerely,
Carol Collins MD,RAC
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Andrew:
There are provisions in the regulations for consenting subjects that
do not read or understand the primary language a consent is written.
The nature of the consent issues depends on the reason why the
subject can not read the consent form. For example, for subjects that
speak and read another language, the consent may be translated into
the language they speak. In this case, IRBs would need to approve
the consent form and they would require that an approved translator
be present. Since consent is an ongoing process, the issue you raise
is pertinent because both the investigators and the IRBs need to
address how ongoing consent is maintained. For subjects that are
illiterate but not impaired this would not be an issue except for
consent revisions where they would be receiving new written material.
For subjects that are illiterate and otherwise impaired such as brain
injury, stroke or mental retardation-these subjects may be considered
vulnerable and there are several regulatory issues regarding consent
and participation of vulnerable subjects that go beyond the consent
process.
Sincerely,
Carol Collins MD,RAC
University of Washington
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Dr. Collins,
Equating illiteracy with low IQ was not implied in my comment. I had my
mind more on drug trials in which volunteers are used to test new drugs
from which they may not benefit. How limited is an illiterate person's
understanding of the research process or the ramifications of being a
volunteer? One does have to consider that there is a potential for
abuse as well. Social research has is less likely to cause harm than do
clinical trials. How would the indigenous population itself actually
benefit from an antidiabetic drug? One may get useful scientific
information but in reality would they get treatment? Can one be certain
that one is getting truly informed consent from children, mentally ill,
non-English speakers? We could be getting valuable information but what
is the ethical risk?
At EPA we continuously wrestle with informed consent issues. It is an
evolving process.
Thanks for the discussion,
James D. Prah, PhD
US EPA
Human Studies Division MD (58B)
Research Triangle Park, NC, 27711
919 966 6244
919 966 6367 FAX
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Dear Dr. Collins,
My focus was not on patient care where the person consented will benefit
from treatment and it is in the patient's interest but in medical
research including drug trials that are increasingly done in third world
countries that may not have rigorous protections for volunteers literate
or not. The pressure for researchers to do the expedient to complete
their studies or contracts might contribute to your concerns while
serving on an IRB. We work closely with our IRB and they, as well as
our medical staff act as advocates for our subjects. Having a strong
IRB and medical staff will go a long way in reining in researchers who
haven't the volunteers interest in mind.
Thanks for the discussion,
James D. Prah, PhD
US EPA
Human Studies Division MD (58B)
Research Triangle Park, NC, 27711
919 966 6244
919 966 6367 FAX
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Hi Carol,
I agree that there are provisions for patients as you have so
expertly summarised, but I was thinking of my dilemma when as an
Investigator I am faced with a choice between an illiterate and a
literate subject for a volunteer study. I would have to take the
latter because consent and compliance would be more complete, I
think. In that way I welcome James Prah's agreement. I'm not saying
that the illiterate subject would have no part to play, but I do
think they are more vulnerable and should therefore be a second
choice, as it were.
Thanks
Andrew
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Andrew:
I agree with both you and Dr Prah that literacy is a very slippery
slope for investigators. The problem is that there are probably many
potential subjects that should not be entered in clinical trials
because for whatever reason they do not understand the consent and
research process (literacy, low intelligence, lack of cognition or
mental illness for example). These subjects aren't always easy to
identify-they may not admit they can't read. When I was involved in
conducting clinical trials I would ask potential subjects questions
to try to ascertain if they understood the consent form and the
research process but occasionally a subject would enter a trial that
I would later have some questions about their understanding.
My only points were that illiterate subjects are not strictly
considered vulnerable by federal regulations because those
regulations have made the provision of verbal consents available. I
also think subjects with low literacy levels would object to being
lumped with people with cognitive impairment. On a practical level, I
agree with both of you, there is a significant potential for problems
with the inclusion of these subjects and practically it is probably
best in most cases to exclude illiterate subjects from clinical trials.
Sincerely,
Carol Collins
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Dear Sridhar,
Most probably the question has been asked in context
with bioequivalence studies, where one could have some
illiterate subjects at enrollment and hence the
possibility of one impartial witness for a group of
illiterate subjects.
It is generally recommended that the participants must
choose their own witness. In this context some
organizations request the volunteer to come along with
an educated 'legally acceptable representative' or a
friend.
Some organizations use one educated volunteer from the
same study as a witness for the informed consent
process for the illiterate volunteer.
The former option appears more attractive.
It is worth wondering who this single person could be
who would witness the informed consent administration
process for a group of illiterate subjects. Maybe he
could be someone nominated by the ethics committee.
(Of course, bringing the EC in decreases the burden of
decision making :o))
If you personally dont like the idea of one single
person being the witness for a group of study
subjects, wielding the recommendation to the decision
makers, that such processes should have an audio/video
recording may help them get the right perspective.
Regards,
Vikas
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Dear all,
If a person is illeretate, he can bring one literate and legally
acceptable
person for impartial witness. Where can we capture the impartial witness
details. Is it necessary all the details of impartial witness or
signature
is sufficient. if so, how can we recognise that impartial witness at the
time of auditing. Is it necessary any proof from them?
any information is valuable.
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It would appear that a system which does not capture
the impartial witness details is not evolved, consists
of a scope for manipulations and is inviting
questions.
Some organizations ask for a proof (eg high school
certificate) and some do not ask for anything. To get
an audit observation in this regard would also depend
on the auditor and his/her background.
With regards,
Vikas
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Dear Members,
I agree with Mr. Ramu's view regarding impartial witness.
Impartial witness is a person who is not related to sponcer, CRO and
knows volunteer very well. The impartial witness can be a family
member, relative or a friend of volunteer. If he is a friend / family
member to many volunteers, then he can be used as an impartial
witness. In this case the fact should be mentioned clearly in the
Informed Consent Form of all the volunteers for whom a single person
is impartial witness. The sponcer / CRO should have strong evidence
of relationship between impartial witness and illeterate volunteer.
This procedure should only be followed in imergency cases keeping
safety of illiterate volunteer in mind.
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