Home | UKMI Activities | Research | Research Ethics and Governance

Research | Research Ethics and Governance

Research Ethics and Governance

This section is an introduction to the key ethical and governance frameworks within which you should be working when you undertake research. To move down to the Research Governance section now click here.


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:

Research Ethics
      
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
Research Governance



Function of NHS Research Ethics Committees top of page

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, the structure of the research ethics network is changing. Formerly a system of local and multi-centre research ethics committees (RECs) processed applications according to the number of research sites that were involved. However, the introduction of new European guidelines on the conduct of clinical trials involving medicines (EU Directive 2001/20/EC) and new governance arrangments for RECs, have meant that the network has had to evolve. Table 1 below outlines the types of REC and their remit.

Table 1 Current structure of UK REC system

Commitee

Remit

Authorised REC

May review all applications except those relating to clinical trials of medicinal products.

Recognised REC

Legally recognised by the UK Ethics Committee Authority (UKECA) to review applications of clinical trials of medicinal products.

Main REC

Can review applications of research taking place across more than one ‘domain’ (the area covered by a strategic health authority in England, a Health Board in Scotland, a regional office of the NHS Wales Department or the whole of Northern Ireland). Main RECs may or may not be recognised

Multi-centre RECs

Plan is to phase these out as their remit is now covered by recognised Main RECs.

The nature of your research project will dictate which type of committee your ethics application will need to be submitted to. A great deal more information can be found at the National Research Ethics Service (NRES) website at http://www.nres.npsa.nhs.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 Committeetop of page

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.

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 top of page

1. Do I need to Submit?

Often the first question that anyone asks is: 'Do I need to submit my research proposal to an REC?'. There is a great deal of guidance on the NRES website to help you with this. The REC will want to look at any research that involves patients directly. So if, for example, you are intervening in patients' treatment, the REC must approve your research first. The REC also needs to approve studies where the research participants are NHS staff recruited by virtue of their professional role; this is not always understood by researchers.

It can sometimes be difficult to separate ‘research’ and ‘audit’. As a general rule, research should generate new knowledge, and audit generally measures compliance with a pre-existing standard. However, always check the NRES website at  or with your local REC administrator if you are unsure. ‘Service evaluations’ are a distinct type of research that assess services or programmes, for example, and normally do not need REC approval. Again, always double-check as there may be exceptions (e.g interviewing patients to evaluate a counselling service where personal or emotive issues may be raised).

Non-therapeutic research involving the administration of drugs to volunteers is subject to REC approval (eg single dose pharmacokinetic studies).


2. The Application Process

  • At the time of writing the ethics application process is under reform. What follows therefore, represents current practice in Summer 2006.
  • The application process varies according to the type of study you wish to conduct. If your study is a clinical trial of a medicine or if your study is taking place in more than one domain then you will need to apply for an appointment to be reviewed via the REC centralised booking system. If your study is to be conducted entirely within one domain and is not a clinical trial investigating a medicine then you should apply to your local REC. Again the NRES website has a great deal of useful guidance. 
  • All applications must be made on a standardised application form which is available on the NRES website. Before attempting to fill in this form it is strongly recommended that you read the accompanying guidance and follow this to the letter. 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. RECs have 60 days to process your application and the clock stops if your application is sent back to you for any changes to be made. On receipt of your application the REC administrator will check that your application is complete and send you a standard confirmatory letter.
  • Some RECs have sub-committees that deal separately with student research. Some large hospital Trusts receive so many research applications that they may have more than one REC. Make sure you know which committee or sub-committee you have been allocated to.
  • At the REC meeting, your application will be discussed in detail. You will be invited to attend the meeting to discuss your proposed research; this is not compulsory but is advised as you may be able to answer the committee’s questions in person rather than have to respond to them in writing, hence speeding up the process. It can be quite intimidating for a novice researcher to sit before a REC; consider taking your supervisor or co-researcher for support. Remember that the REC is seeking to protect the patient or research subjects, and you as well.

3. 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:

  1. Final opinion – this may be favourable or unfavourable. If you receive an unfavourable opinion you may 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.
  2. Provisonal approval with request for further information - 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.
  3. No opinion – The committee has decided that no opinion can be given until a specialist referee has been consulted.
    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 top of page

 

Research Governance top of page

 

Whether you are working as researcher on a multi-centre randomised clinical trial, or on a small pharmacy practice research study as part of an academic qualification, then you need to be aware of the implications of research governance.


No matter how small the risk, most research is potentially harmful whether it be to participants, researchers, or the wider community. Research governance aims to minimise this harm by ensuring high scientific, ethical and financial standards, transparent decision-making processes, clear allocation of responsibilities, and robust monitoring.


The health research governance standards for England, described in The Research Governance Framework for Health and Social Care was developed following the high-profile investigations into improperly conducted research projects in children in the 1990s. This is an important document, and you need to make yourself familar the content at the outset of your project. It incorporates a wide range of legislation and regulations, Department of Health guidance, and advice from professional bodies.

Within this framework the information is arranged in five ‘domains’ as follows;

  • Science – stresses the importance of research generating new knowledge and the requirement for an extensive search of the medical literature prior to initiation of a research project.
  • Information – highlights that there should be free access to information both on the research being conducted and on the findings of the research, once these have been subjected to appropriate scientific review. The language should be appropriate for the target population.
  • Ethics – highlights the requirement of the Declaration of Helsinki to protect life, health, privacy and dignity of human subjects in the course of research. Risk should be minimised as far as possible, and explained clearly to research participants and their families. Refer to Research Ethics section above for more information.
  • Health, Safety and Employment - recognises that research may pose potential harm to research participants, researchers and the wider community. All relevant health and safety legislation should be observed to ensure that this risk is minimised. Risks to researchers may include working with dangerous equipment, substances or organisms. For the purposes of a pharmacy practice research project this may include the safety of a lone researcher conducting interviews in patients’ homes.
  • Finance and Intellectual Property – likely to be less relevant for small scale practice research but requires that publicly funded NHS research demonstrates robust financial governance. Financial governance in NHS research involves the formulation of an approved financial plan before the commencement of the project, which should include consideration of the planned direct and indirect costs. For complex studies appropriate financial personnel should be consulted in the preparation of such a plan.

The framework recognises that poorly defined roles, responsibilities and lines of accountability may have contributed to recent adverse incidents relating to research.  This may be in part because of the large number of organisations and individuals that may be involved in a single research study. It advises that researchers have a responsibility to ensure that they, and anyone they supervise, are trained appropriately and have suitable experience in the conduct of research.



MS Word File  This section is also available as a Word download