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Step 6: Obtain Ethical Approval

Page history last edited by Christine Urquhart 7 years, 2 months ago Saved with comment

Section 6 HEALER Research Toolkit

Step 6: Obtain Ethical and Organisation Approval

Your research needs to be trustworthy, and that means that you need to check that what you intend doing is "legal, decent, honest and truthful". Those you survey need to be reassured that you are going to treat them fairly. Fairness in the research process leads to trust between the researcher and the research participants, and the trust increases the chances that your findings will convince others. Gaining permission from the organisation also increases the visibility of the research - and that top level support is very useful.

Full - or Basic - Research Ethics Approval?
First, consult your home organisation's Research & Development Department and/or the Chair of your departmental Ethics Committee about your plans.
If your research is considered to be "service evaluation" or "service audit" then it probably will not need full ethical approval from the NHS.  For example, many impact studies can be classed as service audit, as you are (partly) evaluating whether your service is meeting the needs of the users.  You should try to discuss the possible design of your research study with the research and development department, research governance staff, or similar, at an early stage to avoid problems later on. In universities, there should be research ethics committees and the secretary to the committee will be able to advise on procedures. In other organisations, the legal department may be able to give advice.
Check That Basic Research Ethics Are Met
Even if you do not need full ethical approval from an NHS research ethics committee, or a University committee overseeing ethical approval you still need to ensure that your plans are ethical.  Good quality research design and good ethics go hand in hand.
There are many research ethics frameworks available, but for a basic check you might like to use the Economic and Social Research Council framework . Further details are provided in the published framework, available from the Economic and Social Research Council website, but the main six things to check are listed below.


  1. Research should be designed, reviewed and undertaken in a way that ensures its integrity and quality: This means that you have checked your plans with the people who need to know what you intend doing.  You should also check that you can genuinely add to the evidence base, if possible. Is your sample size large enough, are you sure that you are choosing your sample in a fair way (preferably randomly sampled)? Are you using (if possible) validated questionnaires or interview questions that enable you to compare your findings usefully with findings others may have produced? You do not want to waste your time, or the time of the people who are participants.
  2. Research staff and subjects must be informed fully about the purpose, methods and intended possible uses of the research, what their participation in the research entails and what risks, if any, are involved. Some variation is allowed in very specific and exceptional research contexts.  Basically, for much library research, this means that you explain to your participants why you are doing the research, what is in it for them, what is involved, and reassure them that their own library service will not be adversely affected if they choose not to participate. You should also explain how they will find out more about the findings. If people give up some time to help you, then you should at least tell them how they can obtain a copy of the summary of your findings.  These principles are easy to apply to most survey work but you may need to plan carefully if you were evaluating the work of a clinical librarian embedded in a clinical team. Another situation where consent cannot easily be sought is in the analysis of transaction logs. If you, or someone else, could identify a user from log statistics, in some way, then you are not dealing with an anonymised dataset.
  3. The confidentiality of information supplied by research subjects and the anonymity of respondents must be respected.  This can be a problem for librarians who wish to conduct research on their own library services.  A solution is to employ independent researchers, or for library sites to swop - staff from one conduct research at the other.  Participants need to feel free to tell the truth, without worrying that their views will upset you - many health professionals are very skilled at telling you things they think you want to know! It is important that researchers respect  the information provided. In the report, any extracts from interview transcripts, or open ended comments on a questionnaire should be presented in a way that makes it impossible to trace the individual who made the comments.  Beware that there are problems around data linkage. One individual quote might not be sufficient to identify an individual but by tracing the interviewee code throughout the report, and collecting all those quotes together, it might be easy for someone in the know to identify who said what.  There are lots of practical ways of ensuring anonymity for questionnaire responses, but you also need to plan how to organise follow-ups and reminders for surveys.  Some evidence-based advice on questionnaire design for an impact study - also applicable to other research is available from the best practice guidance (impact toolkit), available free from the Aberystwyth University repository (CADAIR) at http://hdl.handle.net/2160/648  And again, be careful about data linkage or the possibility of identification if you are dealing with small groups, when you present the findings.
  4. Research participants must participate in a voluntary way, free from any coercion.  For a questionnaire survey, you can usually assume that if someone returns the questionnaire anonymously, they have volunteered to participate. The key criterion here is that participants are free to withdraw from a study at any time - that is their right, which must be respected. For example, interviewees may decide, after seeing the transcript, that they do not want certain extracts, or even the entire transcript to contribute to your analysis.
  5. Harm to research participants must be avoided.  This is not usually a problem for most health library research, but if you are dealing with members of the public, or vulnerable groups (e.g. children, older people, those with learning difficulties, or those with some disabilities) then an ethics committee will want to discuss with you how you can do the research work so as not to harm vulnerable people. You also need to ensure that your researchers are not harmed either.  Is there a possibility that they will feel very uncomfortable in some interviewing situations? How can you minimise the risks to all concerned?
  6. The independence and impartiality of researchers must be clear, and any conflicts of interest or partiality must be explicit.  Be very careful here. For example, examine your assumptions about what your users should do, what they should be searching, how they should be searching. Prejudices are natural, but be aware how they might bias your research approach and research findings.  The research findings may confirm what you already believe to be true, but be prepared for some surprises. Try not to overlook the interesting or disturbing findings that your data analysis may reveal.


You can avoid some of these problems by obtaining independent researchers (See item 3, above).
If you do not need full research ethics approval then scroll down  to "Essentials for information sheets".
For Full Research Ethics Approval
If your research does appear to need full ethical approval, then the National Research Ethics Service (NRES) http://www.nres.nhs.uk has further advice for you.
If you do need to go through the ethical approval process then you need to build in additional time to allow this to happen, as some researchers have reported having to wait up to six months for this to be completed.
Applying to an NHS Research Ethics Committee


Research Ethics Committees (RECs) have been working to standard operating procedures since 1st March 2004. NRES gives people access to comprehensive and up-to-date information on the REC system in the UK including Guidance for applicants.

The new Integrated Research Application System (IRAS) is now in use.
Applying to NHS Organisations for R&D Approval


The NHS R&D Forum provides guidance to applying for R&D approval from the NHS.http://www.rdforum.nhs.uk/


The SSI form needs to be completed for all studies taking place in the NHS. This form is incorporated into the IRAS.


Contact your Trust R&D Department, as your R&D Department and RDDirect may be able to help you with the application process.


Essentials for information sheets


Every research project should have an information sheet, and most will need some type of consent procedure.


Prepare your information sheet and consent form.  Use NRES guidance http://www.nres.nhs.uk


Ensure your participant information meets the needs of those using it. You will find useful advice from the Plain English Campaign and other sites listed, for example, on http://www.hris.org.uk/professionals/ 

If you are using Word to produce the information sheet, you can quickly check the readability score of your text under the Tools section (spelling and grammar). You should not rely on this, but it is a useful guide.  


Research Governance


Whether you need full research ethical approval or not, you still need to negotiate separately with research governance at the NHS sites where you are conducting the research. The practical implementation of the research (for example, how a random sample can be secured for you with the help of Human Resources) will vary from place to place.  And some sites may demand some compensation for the time they spend helping you with your research.
Check on the following link for more details about research governance and how it might affect you.https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition



The UK Medical Research Council and Department of Health have developed a Clinical Trials Toolkit for use in all publicly funded academic trials. This includes guidance on Good Clinical Practice. You will only need to use this if your research design uses a clinical trial design. The Clinical Research Network site now provides information on clinical research http://www.crncc.nihr.ac.uk/


See http://www.mhra.gov.uk/#page=DynamicListMedicines for details on the registration of clinical trials.


University Ethics Committees for Research
If you are working on a dissertation, or you are working with a student who is conducting research at your site, the University has to agree to the research, as they are acting as 'sponsor' as far as the NHS is concerned.
Normally most students must have their research proposals scrutinised internally by their own department. If proposals require further review, the proposals will be passed upwards to a University committee that is normally cross-departmental. Different universities operate different sets of rules and procedures, and procedures among individual departments may vary. The research councils are trying to ensure some degree of standardisation, which means that there should be more similarities among universities in future.
If you are working with a student, then ensure that you have a copy of their approved research proposal, and that you go through the basic research ethics check with them.
Most university committees will sign off any research ethics applications that have gone through the NHS research ethics process, and been approved. The principle is that one set of eyes, within one rigorous review, should be sufficient.




Department of Health. Research governance. London: Department of Health, 2013.https://www.gov.uk/government/publications/research-governance-framework-for-health-and-social-care-second-edition accessed 4 September 2013.


Economic and Social Research Council (ESRC). Research ethics framework. Swindon: ESRC; undated. http://www.esrc.ac.uk/ accessed 4 September 2013


Health Rights Information Scotland (HRIS). Resources. Consumer Focus Scotland/Scottish Government Health Directorates. http://www.hris.org.uk/ accessed 4 September 2013


MHRA . Medicines and Healthcare Regulatory Agency. http://www.mhra.gov.uk/#page=DynamicListMedicines , accessed 4 September 2013


National Institute for Health Research/Clinical Research Network Co-ordinating Centre. Welcome to the Clinical Research Network. http://www.crncc.nihr.ac.uk/ accessed 4 September 2013.


National Research Ethics Service. Welcome to the National Research Ethics Service. London: NRES; 2012. http://www.npsa.nres.nhs.uk/ accessed 4 September 2013.


 Urquhart C, Weightman A. Assessing the impact of a health library service. Best practice guidance. Aberystwyth: Aberystwyth University; 2008. http://hdl.handle.net/2160/648 accessed 4 September 2013.





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