Research
Ethics
The following
is a very basic introduction for pharmacists not familiar with research
ethics and the research ethics committee process. This document is
divided into four main sections:
Function of NHS Research Ethics Committees
Role
of a Pharmacist on a Research Ethics Committee
How to Submit Research to a Research Ethics Committee
Do I need to submit?
The application
process
Approval or disapproval
Guidance on Research Ethics
Function
of NHS Research Ethics Committees
Research
Ethics Committees (RECs) exist to safeguard the interests of researchers
as well as those of potential research subjects. In particular,
they scrutinise research proposals to try and identify anything
that could cause patient harm, distress, wasted time or financial
worry. They want to be sure that research subjects are fully aware
what they might be letting themselves in for if they participate
in a piece of research - the good and the bad. They also need to
know that there will be no breach of patient confidentiality.
In
the UK, there is a network of local research ethics committees
(LRECs) which are usually based in a teaching hospital or large
district general hospital. These have a defined geographical area
of authority, or district, and they process health-related research
applications from both primary and secondary care. If your research
involves patients or research subjects from more than one district,
but less than five of them, you must apply individually to all the
LRECs concerned.
There
are also a series of multicentre research ethics committees (MRECs).
These exist at a regional level. They process applications that
would involve research subjects from five or more different districts.
The MRECs are not necessarily tied to research originating from
within their geographical area. MRECs process all the large multicentre
studies such as Medical Research Council (MRC) trials and large
cardiology studies. Once an MREC has approved a study, LRECs in
the affected areas are informed. LRECs are allowed to make small
changes to the research proposal to reflect local issues, but cannot
make big changes. They must also approve the local researcher and
his/her facilities.
Information
on MRECs can be found on their joint website:
http://www.corec.org.uk/
RECs
comprise a mixture of professions including doctors from primary
and secondary care, nurses and professions allied to medicine, but
it is also a DoH requirement that there should be lay members too.
Although members are required to give a lot of time to the REC,
they are not paid, although expenses can be claimed. However, members'
training is paid for, and most RECs have an administrator that is
at least partly funded.
Role
of a Pharmacist on a Research Ethics Committee
Many
pharmacists sit on local and multicentre RECs. It is interesting
and rewarding work, but it is very time-consuming. Before considering
whether to apply to sit on an REC you would be well advised to approach
an experienced pharmacist asking for a realistic estimate of the
time involved. You will probably have to undergo an interview before
membership is offered you.
For
LRECs, typically, the meeting lasts for one afternoon per month
and may extend into the evening. This will usually require at least
an equivalent amount of preparation time before the meeting, to
read the agenda and prepare for the meeting. For pharmacist members,
there is often a lot of checking to do before the meeting: reviewing
safety and legal issues, checking the licensed status of drugs,
cross-referencing local drug-related policies etc. Pharmacists are
also typically asked to review the Serious Adverse Events from clinical
trials which researchers are obliged to report to RECs regularly.
Pharmacists
on an REC join as members with an equal voice on all research scrutinised
by the committee, not just drug trials. However, their specialist
expertise means that pharmacists can help specifically with certain
issues:
- Pharmacists
have a very broad perspective on drug therapy and can often put
a drug trial in context for the committee.
- Knowledge
of local and national drug-related policies helps the pharmacist
to advise the committee on safety and administration issues.
- There
are legal issues surrounding research. For example, the pharmacist
can advise on the licensed status of drugs, supply issues and
the clinical trial exemption certificate needed.
- An
understanding of drug side effects and contra-indications helps
the pharmacist to check that researchers have constructed sufficiently
rigorous inclusion and exclusion criteria.
- A
poorly designed clinical trial will yield results which are of
no value. This is itself unethical since patients will be exposed
to purposeless research. Hospital pharmacists from a Medicines
Information background are very familiar with the pitfalls in
trial design and can offer constructive comment.
- Pharmacists
are accustomed to talking to patients and so are ideally placed
to provide a rigorous check of information given to trial participants.
It is important that such information is complete and that it
is written in a way that patients can understand.
- Practical
pharmaceutical issues play a key part in some research. Formulation
and administration issues are areas in which the pharmacist can
offer considerable insight.
- Knowledge
of local budgetary and formulary issues enable the pharmacist
to advise the committee on what likelihood there may be of drug
treatments being continued in research subjects after the trial
has ended.
Besides the benefits to the REC described above, there are a number
of benefits to the pharmacist of joining an REC:
- The
work of RECs is interesting and very varied.
- Committees
play a vital role in protecting patients from potential harmful
or unjustified research, and it is rewarding to realise that your
own experience can be used to protect them in this way.
- It
provides valuable insight into both the REC and research processes.
Identification of common pitfalls is helpful when constructing
pharmacy research proposals and submitting them for REC approval.
- It
is a practical way to help the community, within the healthcare
arena, but it broadens the horizons by revealing the work performed
in branches of healthcare outside pharmacy.
- RECs
offer an excellent opportunity for multidisciplinary working and
for networking.
How
to Submit Research to a Research Ethics Committee
Do
I need to Submit?
Often
the first question that anyone asks is: 'Do I need to submit my
research proposal to an REC?' Some LRECs produce written guidance
to help with this. The REC will want to look at any research that
involves patients directly. So if, for example, you are intervening
in patients' treatments, or asking them about it, the REC must approve
your research first. If your only involvement with patients is looking
in their case notes, then you will need to decide whether your research
is audit or not. If it is audit then you should follow your organisation's
local policy on approval of audit projects. Often there is a separate
audit committee with this function.
It
can sometimes be difficult to separate "research" and
"audit". If in doubt always approach the LREC administrator
or chairman for advice. A helpful definition of audit is this one:
The
systematic critical analysis of the quality of medical care. This
may include, for example, the procedures used for diagnosis and
treatment, the use of resources and the resulting outcome and
quality of life for the patient.
(Secretaries of State for Health etc., "Medical Audit:Working
Paper 6" 1989).
So
audit really looks at what is happening at the moment. Research
would be expected to assess or compare the change wrought by one
or more new interventions.
Surveys
of professionals in your own department or organisation concerning
services you provide usually do not require LREC approval, although
you should check for a local view on this point. However, surveys
or interviews of professionals concerning patient management (eg
breaking bad news) or emotive personal issues (eg dealing with violence)
may need to be referred to an LREC.
Non-therapeutic
research involving the administration of drugs to volunteers is
still subject to REC approval (eg single dose pharmacokinetic studies).
The Application Process
- For
LRECs, the chairman, administrator or individual members are often
amenable to an informal discussion of your proposal before an
official application. This may help you to iron out any major
problems in advance.
- Contact
the REC administrator to explain that you would like to make an
application. The contact details will be known by your Health
Authority or R&D department. Be prepared to give a concise
summary of your proposal so that the administrator can decide
whether a full application is necessary and how to process it.
-
If you are sent an application form. Follow the application process
to the letter. Do read the guidance notes which will be sent with
it. Send all the documents that you are asked for and the number
of copies that the administrator requests! If you do not follow
the procedure precisely your application will be delayed.
- RECs
are concerned with many things when scrutinising a research proposal,
but three things are uppermost in committee members' minds:
- the
benefit/risk ratio of research to the subjects,
- that
the subjects give truly informed consent,
- that
research does not breach patient confidentiality.
- You
must be able to satisfy these three points completely or your
application will fail.
-
Make your application in good time. Do not leave it until the
last minute. An REC may take 3 months or more to process an application.
It is helpful to include a reply-paid card asking for confirmation
of receipt of an application, but there is little to be gained
by nagging the administrator to speed up the application process.
- Some
LRECs have sub-committees that deal separately with student research,
questionnaire studies or the design aspects of research. Some
large hospital Trusts receive so many research applications that
they may have more than one LREC. Make sure you know which committee
or sub-committee you have been allocated to.
- You
may be sent approval or disapproval by post, or you may be asked
to appear before the LREC in person before a decision is made.
Some LRECs always ask for a personal appearance so do not assume
that this request indicates a problem with your proposal.
- At
a personal appearance, the LREC will probably ask you to summarise
the key points of your proposal and then ask you specific questions
which the committee have discussed beforehand. Sometimes this
can be a little intimidating, but keep calm, ask for clarification
where necessary and acknowledge helpful suggestions. Remember
that the LREC is seeking to protect the patient or research subjects,
and you as well.
- Whether
you are called for a personal appearance or not, the LREC or MREC
will write to you outlining its decision.
Approval
or Disapproval
It
is important to stress that you must not begin your research until
an REC has given you written approval to proceed.
In
terms of approval, the REC will make one of three decisions:
- Approval
- You can go ahead with the research as proposed, perhaps with
some minor changes.
- Conditional
Approval - You can go ahead, but only when the REC has proof
that you have changed your protocol according to certain specified
conditions. This might involve certain groups of patients being
excluded for example, or a major revision of your patient information
leaflet. This is the form of approval given to most applications.
- Not
Approved - The REC will not allow you to proceed. Reasons
will be given for this, and you are usually allowed to appeal,
but if you still want to go ahead it is often better to take note
of the reasons and have a re-think! You can completely revise
your proposal and make a fresh submission at a later date.
Once
you have approval, there may be other people to notify. You may
be obliged to inform a local research co-ordinating body, and to
request indemnity for the researchers. Any indemnity which your
employing organisation provides for you may not cover research activities,
even if research is identified in your job description. If your
organisation's position on indemnity for researchers has not been
made clear to you, then it is vital to clarify this with the REC
before beginning your research.
Guidance
on Research Ethics
DoH
bibliography of UK government papers related to ethics and research
ethics.
EU
Directive on Good Clinical Practice in Clinical Trials - DoH briefing
notes.
Advice
on how to apply to an MREC
General
Medical Council guidance on research - 'Research: The Role and Responsibilities
of Doctors'
Consumers
for Ethics in Research (CERes). A website offering support and information
to clinical trial participants.
Declaration
of Helsinki. World Medical Association Ethical Principles for Medical
Research Involving Human Subjects.
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