The difficulties in obtaining copies of research protocols
As somebody working very closely with parents whose children were
involved in clinical trials at a hospital in the North of England, I have
to say that the question of being able to obtain copies of any protocol
what-so-ever in relation to those trials, has been a horrendous ordeal for
many of the parents concerned. After months of requesting the protocols
for two studies, they have yet to materialise. One has to ask the question
why if everything was above board?
It has transpired over the last few months that not only were some
parents unaware of the fact that their children were being entered into
any research project, they were also asked to subject their children to a
specific form of treatment that they were told was a kinder and gentler
way of treating neonates, whilst in a state of extreme distress as a
result of having had a premature child. The ethics surrounding this type
of coercing without parents having any real understanding of what was
happening and also being very vulnerable and open to persuasion as a
result of the fear of losing their child, are unacceptable and repugnant.
I feel that any research being conducted at any medical establishment
should be public knowledge. All hospitals should have available in their
foyers, details of any ongoing research, details of what the projects
entail, copies of the protocols for those projects and contact numbers of
independent advisers should anyone wish to know more or even volunteer to
be entered in to any research.
Sadly it is the continuous secrecy surrounding human research that
gives rise to suspicion within the members of the public. The phrase
"human research" itself conjures up pictures of atrocoties and lies
uncomfortably with most humans as very little is ever explained and they
are left with visions of puppies with masks on with cigarette smoke being
pumped into them.
Whilst we all appreciate that for medical science to move forward it
is imperative that research is undertaken, however unpallatable that may
be to certain people, it is also of equal importance that there is total
honesty and frank discussion between all parties involved, with an
independent advisor always at hand to allay any concerns and fully explain
all matters relating to a project. I also feel that it must be an absolute
that the medical profession to have always obtained full and informed
consent from the prospective participants or their guardians.
One further observation, it is patronising of the medical
establishment that we are deemed unqualified to "understand the medical
terminology etc..." and are therefore furbished with the bare minimum in
laymans terms. This in itself breeds an air of mistrust between the public
and doctors and also is wide open to abuse and misunderstandings.
Rapid Response:
The difficulties in obtaining copies of research protocols
As somebody working very closely with parents whose children were
involved in clinical trials at a hospital in the North of England, I have
to say that the question of being able to obtain copies of any protocol
what-so-ever in relation to those trials, has been a horrendous ordeal for
many of the parents concerned. After months of requesting the protocols
for two studies, they have yet to materialise. One has to ask the question
why if everything was above board?
It has transpired over the last few months that not only were some
parents unaware of the fact that their children were being entered into
any research project, they were also asked to subject their children to a
specific form of treatment that they were told was a kinder and gentler
way of treating neonates, whilst in a state of extreme distress as a
result of having had a premature child. The ethics surrounding this type
of coercing without parents having any real understanding of what was
happening and also being very vulnerable and open to persuasion as a
result of the fear of losing their child, are unacceptable and repugnant.
I feel that any research being conducted at any medical establishment
should be public knowledge. All hospitals should have available in their
foyers, details of any ongoing research, details of what the projects
entail, copies of the protocols for those projects and contact numbers of
independent advisers should anyone wish to know more or even volunteer to
be entered in to any research.
Sadly it is the continuous secrecy surrounding human research that
gives rise to suspicion within the members of the public. The phrase
"human research" itself conjures up pictures of atrocoties and lies
uncomfortably with most humans as very little is ever explained and they
are left with visions of puppies with masks on with cigarette smoke being
pumped into them.
Whilst we all appreciate that for medical science to move forward it
is imperative that research is undertaken, however unpallatable that may
be to certain people, it is also of equal importance that there is total
honesty and frank discussion between all parties involved, with an
independent advisor always at hand to allay any concerns and fully explain
all matters relating to a project. I also feel that it must be an absolute
that the medical profession to have always obtained full and informed
consent from the prospective participants or their guardians.
One further observation, it is patronising of the medical
establishment that we are deemed unqualified to "understand the medical
terminology etc..." and are therefore furbished with the bare minimum in
laymans terms. This in itself breeds an air of mistrust between the public
and doctors and also is wide open to abuse and misunderstandings.
Penny Mellor
Competing interests: No competing interests