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The following message was posted to: PharmPK
We have been performing bioequivalence studies on healthy volunteers
as a
Drug Research Center since 2005. Our director gives lectures to Grade 3
Medical Faculty students and vice director of our center is an assistant
professor in Faculty of Pharmacy. We would like to include Medical
Faculty
students and Faculty of Pharmacy students to our studies as healthy
volunteers. However, we have to prove that we do not force these
people to
join our studies. In other words we have to exclude the conflict of
interest. We have put a claim that says that "they are always free to
leave
the study whenever they want and they will have no academical harm"
within
the informed consent form. But, we think it is not enough. If you have a
better idea to share with us, it will really be appreciated.
Assoc. Prof. Dr. Sebnem Apaydin
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There are several issues: subtle coercion - real or perceived. A
student or a member of the staff could easily interpret the solicitation
of subjects as a requirement especially if it comes from someone with
significantly greater power or control. Additionally, some of those
solicited may feel that they will receive favorable treatment if they
volunteer. Putting in a statement that they are free to leave whenever
they want to does not remove minimize the power differential and may
result in someone continuing to participate even though the wish to
cease participation. I have seen experiementers urge and cajole
subjects into continuing a study even after they said they wished to
cease. It would be much more difficult if the vice president (or
someone else with a power differential) was there. It is tempting to
solicit subjects that are convenient but there are ethical issues that
are difficult to resolve. The ethical choice is not to solicit subjects
that would feel obligated to participate and not to withdraw.
I hope these thoughts help.
James D. Prah, PhD
US EPA
Human Studies Division MD (58B)
Research Triangle Park, NC, 27711
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The following message was posted to: PharmPK
dear,
as much about the description given by is perfect about the study
population selection.
point to be covered if you go for this type of volunteers,
1.ethics committee must be aware from the volunteer participation.
2. it may be consider a vulnerable subject go for GCP definition.
3. Consent must be more precise and must be present by the PI in
manner to prove that no conflict of interest.
4. faculty member should not be incorporate as any investigator of
the study or any advisory committee member as much not involve in any
investigation.
5. should not be any of one member of any EC.
6. ICF should bound with legal aspect and be careful while writing
ICF and no required for interest of financial disclosure.
it should be enough for doing the exercise.
expert can more comment on it.
only EC should be well define and taken a help for that and if you go
from advertisement that should be approved by EC before the EC approval.
wish you all the best go a head,
regards,
paresh
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The following message was posted to: PharmPK
I agree with James and I am glad to say that in Medical Schools in
the UK
the practice of recruiting the school's own students into their own
trials
is banned. They can go to another school where the subtle influences
that
James described are seen not to apply.
--
Andrew Sutton, MBBS, MD(London), FFA
Guildford Clinical Pharmacology Ltd.
The Technology Centre, Occam Road
Guildford, Surrey, UK. GU2 7YG
URL: www.gcpl.co.uk
Registered in England & Wales
Registration No. 2934719
Registered Office: 8 Baker Street, London W1U 3LL
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