Advice for independent researchers and small charities
Advice for independent researchers and small charities without access to sponsorship and research ethics review services.
Ethics review of research is part of research governance more widely. All research should be underpinned by sound governance provided by a suitable Sponsor. Any researcher undertaking research without a Sponsor will be personally liable for the management and conduct of the research. A favourable ethics review/opinion/approval is not permission to proceed with the research project. Permission to proceed is typically provided by the Sponsor. Some Sponsors, including some contract research organisations, do not have internal ethics review services; in any event, many seek the reassurance of an external ethics review. There are sources of independent ethics review for organisations that have in place all research governance systems.
Independent researchers might decide to progress their work without the support of a Sponsor recognising the attendant risks. It is still possible to obtain an independent ethics review, but that review will be limited to an opinion as to whether the proposed research is ethical. Whilst evidence of a favourable ethics opinion is required by most publishers, they typically seek information about the researcher’s academic affiliation, so in essence, the Sponsor.
Is it research?
It is helpful firstly to consider whether the project is research. Different definitions of research exist – a good starting point is the OECD Frascati definition. The Frascati manual and the glossary of terms can be found here. Research is generally about the acquisition of new knowledge; if the project in question is service evaluation, product testing, or a survey/market research, then it need not be classified as research.
If it is not deemed to be research, there will still be ethical issues and risks to consider, but the requirements appropriate for a research project will not apply.
Assuming that you are carrying out research, as noted above, you will need to consider two separate but related issues before you can proceed.
The first of these is the consideration of the ethical issues involved in the research, including information provision, consent and the right to withdraw, potential harm to participants and researchers. For independent researchers, or those working in organisations without an independent research ethics committee, organisations are available to offer an independent ethical opinion, two examples of which are the Social Research Association and the Association of Research Managers and Administrators. UKRIO does not endorse any organisation to provide this service. These bodies will provide a view on whether the research you are planning to conduct is ethical.
The British Psychological Society has some guidance for independent researchers, including the availability of advice, which can be found here.
Sponsorship, governance and permission to proceed
In addition to an ethical appraisal/opinion on the research, other elements will need also to be in place. Research needs a sponsor and good governance in place, including data storage and protection, risk assessment and insurance. This will also mean there is some way to respond to adverse events and complaints about the research both while it is underway and subsequently, for example after it is published.
The sponsorship of research would normally cover the following areas (this is not an exhaustive list):
Resources to conduct the study – do you have all the resources to carry out the study from start to finish?
Ensuring that all approvals are in place – there may be approvals other than ethics needed.
Ensuring that the study is managed and conducted according to all relevant local, national and international law and good practice guidance – you will be responsible for ensuring you operate in accordance with all relevant laws such as on data protection.
Responding to complaints etc in conduct of the study – what arrangements are in place to resolve complaints about the study or researcher; this needs to be independent of the researcher. Mistakes and difficulties can arise in the most rigorously conducted research and you will need to consider how you manage such difficulties.
Indemnity arrangements in the event of harm to researchers or participants – a sponsor would normally have this in place. Is there insurance cover any issues relating to the conduct of research?
Management of the risks involved in the research. You will need to consider the impact of risks/problems on yourself as researcher, both whilst undertaking the research and subsequently. Where there is no sponsor other than the researcher, is there any surety that the risks of the project are fully assessed, for example to yourself as possible sole researcher?
Responding to, dealing with, managing and keeping records of adverse events that may occur.
Record keeping and data storage – are appropriate and legally compliant arrangements in place to store the data gathered safely and securely? Have you considered GDPR and data protection law (you will be liable for any breaches).
Quality assurance and accountability – ensuring that the research is conducted in accordance with the ethical opinion and that arrangements are in place for dealing with any necessary amendments. How do you make sure that you do what you say you are going to do and what are the consequences if you don’t do what you say you are going to do?
Dissemination – ensuring that the findings are appropriately disseminated. With publishing – how will you ensure that there is an appropriate and permanent contact to be responsible for queries and difficulties? This also applies to data storage. You may have provided contact information, but these may change over time.
If the study involves any health or medical element but is not to be conducted in the NHS, then it may be possible to find an NHS Research Ethics Committee to provide an ethics review. This is typically at the discretion of the chair of the NHS REC.
If you have any honorary or other link with a university partner, you may wish to contact them to see if they would be willing to collaborate with you.
Written by Nicola Sainsbury, Research Integrity Manager, UKRIO
Thanks to UKRIO expert volunteers for reviewing this advice.