The ethics of research ethics committees

EDITOR - Professor Nicholl, in his Personal View, seems to believe
that three issues attributable to MRECs are currently acting as barriers
to NHS research1. These are : (i) delay in getting ethics committee
approval; (ii) inconsistency in decision-making; and (iii) lack of
concentration on the purely ethical dimension. We wish to respond to
each of these issues in turn :
(i) We note that Prof. Nicholl acknowledges that the system of approval
under the old LREC system often led to unacceptable delays in processing
studies. We presume that he would accept that the intent behind the
formation of MRECs is to streamline the system. We also presume that he
accepts that individual experiences, however frustrating, are not good
indicators of the overall benefits or problems with new innovations.
The appropriate measurement should be the overall change in effect from
the old system to the new one.
(ii) Inconsistency in decision-making continues to be a problem within
the new system. To some extent, this reflects the fluidity of notions
of right and wrong, as referred to in Prof. Nicholl's letter. However,
since the formation of the MRECs, dialogue is beginning to take place
between ethics committee members, most notably through the formation of
the Association of Research Ethics Committees. Within Trent, we have
run two regional training days to discuss ethical principles and hands-on
decision-making. We believe that this is progression and that the
benefits
of this dialogue are already beginning to filter through the system.
We would be more than happy to discuss other ways of maximising this
debate.
(iii) One of the specific points raised is the need for ethics committees
to concentrate on 'ethics'. It is
probably based on a misconception that ethics is a discipline separate and
distinct from any other.
In fact a study cannot be ethical if it is not also sound scientifically
and members of research ethics committees are tasked with checking the
scientific integrity of a study. This includes the design and power of
the study, and its capacity to recruit. Ethics committees must satisfy
themselves as far as possible that a study is sound, important enough to
be worth the degree of potential risk to participants, and that it will
yield an answer to the research question being asked. Regarding
confidentiality - it does not need to be stated that this is a
fundamentally ethical question.
The letter infers that the goalposts keep changing. They do, and will
continue to do so, because both the Law and the expectations of society
are changing. Recent controversies in NHS research should illustrate
this point beyond doubt. It is incumbent on all members of the research
community, including those who undertake research and those who serve on
ethics committees, to acknowledge that public expectations are becoming
higher, and that standards which studies will be required to adhere to
will become more rigorous over time. This is not, as the letter
implies, wilful obstruction by ethics committee members. Incidentally,
about one-third of the Trent committee are active researchers, and all of
us are constantly having to readjust our practices as the ethical
dimension of research becomes more focused. We don't claim that this is
easy - we see it as good practice.
It may be that the time has come to undertake a programme of research into
the nature and function of the system of ethics approval. We would
welcome such scrutiny, and, if it happens, we expect that the protocol
will be subject to examination under the ethical principles of the time.

Dr Susan Downe, on behalf of the Trent MREC

1 J.Nichol. Personal View - Ethics of Research Ethics Committees.
BMJ 2000;320;1217