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Re: bioethics: Protocol Review Charges
Dear Diana,
I will answer some of the questions.
Ombudsman is suggested by us as a mechanism to obtain true informed consent
and post ethical approval surveilance. We have proposed him to be appointed by
the researcher and the ethics committee but functions independently of both
with independent financial mechanism.
In the case of Sri Lankan Twin Registry a person from the Multiple Birth
Association can perform as an ombudsperson.
As the mechanism of ombudsperson is not in position yet there are no examples.
It is yet hypothetical. In ethically sensitive trials an ombudsman will be
there physically when the investigator takes informed consent. Especially
valuble as the scientific literacy is low and there is no national debate on
these issues and the level of health care is mainly preventive and inadequate
as in developing countries.
This should be in the trial document and written and agreed before with a
mechanism for reimbursement.
Hope to send you more details soon,
Sisira
-----Original Message-----
From: "Diana Berlinerblau" <di_berlinerblau@yahoo.com>
Date: Saturday, December 21, 2002 13:29:28 -0500
All and Sisira Siribaddana & Nipuna Siribaddana:
I have a some questions regarding the role of "Ombudsman" in your community:
is this person part of an independent ethics commitee, or would they work
separately? What specific task would he perform? Would you be so kind as to
describe examples?
Is there a general agreement or a definition of "ethically sensitive trials",
for example: AIDS research, vulnerable community research (psychiatric
patients - children)? If defined previously, would it automatically pose an
extra burden on Ethics Commitees that would also automatically require the
monitoring of the protections of subjects, for example, visiting patients?
Witnessing the process of informed consent? Is this procedure writen in any
document, before the trial begins? Is it a standard procedure?
Do you visit patients to ask in person what they feel like regarding their
protections as subjects?
Is this a sensitive matter regarding investigators? How do they feel regarding
this possibility?
Kind regards to all
Diana Berlinerblau
Psychiatrist
Buenos Aires
Argentina
Further elaborating on the role of Ombudsman we have said "Granting of ethical
clearance alone is inadequate and on going monitoring of the progress,
developments and adherence to the protocol is essential. The role of an
ombudsman will be beyond ensuring freely given informed consent and also for
monitoring any significant departures from the protocol for which the ethical
clearance is granted."
This concept was also extensively discussed in this forum (discussion group)
sometime ago. So, in ethically sensitive trials, ombudsman or an ombudsman
agency can be separately budgeted.
-----Original Message-----
From: "Sisira Siribaddana & Nipuna Siribaddana" <nipuna@stmail.lk>
Dear Ames,
We from Sri Lankan Twin Registry has formulated guidelines on ethics titled
"research ethics from developed world perspective" and addressed this issue of
post-trial obligations and oversight. Our proposal is to appoint an third
party ( ombudsman ) for ethically sensitive trials to ensure freely given
informed consent and ongoing monitoring of research.
Further elaborating on the role of Ombudsman we have said " Granting of
ethical clearance alone is inadequate and on going monitoring of the progress,
developments and adherence to the protocol is essential. The role of an
ombudsman will be beyond ensuring freely given informed consent and also for
monitoring any significant departures from the protocol for which the ethical
clearance is granted."
This concept was also extensively discussed in this forum (discussion group)
sometime ago. So, in ethically sensitive trials, ombudsman or an ombudsman
agency can be separately budgeted.
This document is in print and we will send you a copy as soon as it becomes
available.
Hope this will help
sisira & athula
Dr. Sisira Siribaddana & Dr Athula Sumathipala
Research co-ordinator Sri Lankan Twin Registry
Registered as an Association under the Companies Act No. 17 of 1982
Staff Specialist in Medicine Sri Jayewardenepura Post-graduate Teaching
Hospital
Endocrinologist
Secretary Osteoporosis Associations of Sri Lanka
259, Temple Road
Thalapathpitiya
Nugegoda
10250
Sri Lanka
Fax-00 94 1 778661
Phone 00 94 1 779354
Mobile 94 77 326 940
http://www:infolanka.com/org/twin-registry
www.siribaddana.yourmd.com (Endocrinology web site)
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