Dear All
You might find the following interesting
and useful (with thanks to David Hunter, a member of the UUREC, for persevering
with this).
Nick Curry
University of Ulster
From: HTA Enquiries
[mailto:
Sent: 16 January 2007 08:24
To: David Hunter
Subject: RE: Research ethics
approval
Dear David,
Thank you for your enquiry. Your interpretation
of the Human Tissue Act 2004 requirements is correct. In summary, the
storage of human tissue or cells for the scheduled purpose of research requires
a licence unless appropriate ethics approval is in place. There is no
requirement under the Human Tissue Act 2004 for you to obtain ethics approval
from a REC recognized under the Act if you are storing the tissue and cells
under a licence.
In cases where consent has not been
obtained to store and use tissues or cells for research, tissue or cells will
need to be anonymised and ethics approval for the research from a committee
recognized under the Act will be required. However it is always good practice
to seek consent where possible. Please see our Code of Practice on
consent for more information
http://www.hta.gov.uk/guidance/codes_of_practice.cfm.
Where appropriate consent is not in place,
ethics approval may be required.
1. The human tissue act/authority does not require
all research involving human tissue to seek ethical approval. (Though it may
regard it as good practise)
This is correct.
2. It does require ethical approval from an
appropriate committee in two cases; firstly when human tissue research is being
done without a license, secondly when research is being done on suitably anonymous
residual tissue samples acquired without specific consent for their use in
research. (If there are other cases where ethical approval is required I would
appreciate being informed about them)
This is correct.
3. When the human tissue act/authority does require
approval from an appropriate ethics committee, these committees must be
independent, which effectively means either a COREC or ORECNI committee, and
not a committee based in the institution carrying out the research.
This is correct.
4. However if an institution has a good practice
policy of requiring ethics approval for all research projects then the
requirement that these approvals comes from an independent approved committee
only holds true if the research is the sort described under 2. In other words,
the requirement of the independence and approved status of the ethics committee
giving approval is only a requirement when the human tissue act/authority
requires ethical approval.
This is correct.
This last point is the crucial point that needs to be
clarified for us. Our institution requires all research receives ethical
approval before it commences. In the past this has meant that medical research
(ie that falling into the remit of NHS research ethics committees) is sent to an
ORECNI committee for approval and all other research is reviewed by one of the
University’s research ethics committee. A significant proportion of the
applications reviewed in the past by the University’s committees involved
human tissue collection and storage for research on nutrition for example.
We are presently now routing all research involving
human tissue to an ORECNI committee for approval. I believe that this is not
the intent nor the requirement of the human tissue act/authority which I read to
require only in those cases described in 2 to require independent ethical
review from an approved research ethics committee. Is this correct?
Yes, this is correct.
Regards
Human Tissue Authority
Finlaison House
Phone: 020 7211 3400
Email: enquiries@hta.gov.uk
Web: www.hta.gov.uk
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From: David Hunter
[mailto
Sent: 11 October 2006 15:49
To: HTA Enquiries
Subject: Research ethics approval
Unfortunately there is still some confusion at my
institution in regards to the requirements of the human tissue act/authority in
terms of seeking research ethics approval, and who is qualified to give it. As
such, my institution is currently playing it safe and requiring that all
research involving human tissue receives independent ethical approval from an
ORECNI committee. This involves significant time wastage for both individual
researchers and of ORECNI committee members who have to read through applications
which really are outside their remit.
I would therefore like to enquiry whether the
description I give below is correct.
1. The human tissue act/authority does not require
all research involving human tissue to seek ethical approval. (Though it may
regard it as good practise)
2. It does require ethical approval from an
appropriate committee in two cases; firstly when human tissue research is being
done without a license, secondly when research is being done on suitably
anonymous residual tissue samples acquired without specific consent for their
use in research. (If there are other cases where ethical approval is required I
would appreciate being informed about them)
3. When the human tissue act/authority does require
approval from an appropriate ethics committee, these committees must be
independent, which effectively means either a COREC or ORECNI committee, and
not a committee based in the institution carrying out the research.
4. However if an institution has a good practice policy
of requiring ethics approval for all research projects then the requirement
that these approvals comes from an independent approved committee only holds
true if the research is the sort described under 2. In other words, the
requirement of the independence and approved status of the ethics committee
giving approval is only a requirement when the human tissue act/authority
requires ethical approval.
This last point is the crucial point that needs to be
clarified for us. Our institution requires all research receives ethical
approval before it commences. In the past this has meant that medical research
(ie that falling into the remit of NHS research ethics committees) is sent to
an ORECNI committee for approval and all other research is reviewed by one of
the University’s research ethics committee. A significant proportion of
the applications reviewed in the past by the University’s committees
involved human tissue collection and storage for research on nutrition for
example.
We are presently now routing all research involving
human tissue to an ORECNI committee for approval. I believe that this is not
the intent nor the requirement of the human tissue act/authority which I read
to require only in those cases described in 2 to require independent ethical
review from an approved research ethics committee. Is this correct?
Yours sincerely
David Hunter
Lecturer in Bioethics