For our latest blog post we are privledged to have Karen Charlesworth from the Northern College of Acupuncture discussing the issue of ethical approval in CAM. At RCCM we often receive queries asking whether we can provide ethics approval -sadly this is beyond our capabilities, but hopefully here Karen can shed light on some of the alternatives. We would also recommend visiting the excellent NHS Research Ethics Service that has a wealth of information and even dates of REC meetings in the UK: Search Research Ethics Committee Directory – Health Research Authority (hra.nhs.uk). We also have a section in our members’ area on ethics https://www.rccm.org.uk/members/research-guidance/cam-research-ethics/
Ethics for the independent researcher, by Karen Charlesworth
It’s an enduring fact that much research in UK-based complementary and integrative medicine (I’ll call it CIM for convenience) happens outside the traditional academic and/or commercial pathways. Despite this, there are plenty of excellent research ideas out there, often generated by CIM practitioners themselves. In my role as research director at the Northern College of Acupuncture (NCA) I’ve talked with, and supported many, practitioners who come across an interesting aspect of their practice and want to turn it into a piece of research.
But how to move these ideas forward if you aren’t affiliated to a university? Perhaps surprisingly, it’s not too difficult to get an independent research study up and running, especially if the researchers don’t need to apply for funding. A bit of nous about project management, some practice in data analysis, a few ounces of goodwill from practitioners delivering the interventions, and a lot of legwork – for independent CIM researchers the world over, this approach is a time-honoured tradition. For instance, I’ve recently been talking with a group of local yoga teachers who banded together a year ago to provide free Iyengar yoga classes for people suffering from Long Covid, and who now want to publish the rather spectacular outcomes. For researchers taking this kind of quick-and-dirty approach, the results will likely be underpowered and probably won’t be published in a peer-reviewed journal, but – as with the yogis – that’s not usually the intended audience anyway.
But even if all these elements can be brought together, there’s still one major hurdle that indie researchers can’t clear easily: ethics. All research involving participants should include informed consent with approval from a Research Ethics Committee, or REC, along the lines of “This research has received a favourable opinion from the XXX Research Ethics Committee (ref. 3856/LO/B620, dated 11/12/21)”. It’s a guarantee that the research has been approved by an independent body dedicated to ensuring that research meets high standards of trustworthiness and validity.
What is research integrity?
Rather than simply being a single application-and-outcome at the start of a project, ethical principles should be embedded throughout. Increasingly, ethics is being absorbed into the principles and practice of research integrity, which in the last 10 years or so has become a dominant theme across all types of research in all kinds of sectors and industries. At its most basic, research integrity ensures that research is carried out to the highest standards of scientific and ethical practice.
Independent researchers are well-advised to embed the principles of research integrity into their study protocol, design and implementation – not least because attention paid to research integrity at the early stages automatically sets a project on a path towards smoother ethical approval. The UK Research Integrity Office (UKRIO) Checklist for Researchers is an excellent, concise statement of the basic principles of research integrity, downloadable from https://ukrio.org/publications/checklist-for-researchers/.
Ethics for the independent CIM researcher
For independent CIM researchers, few questions are more difficult to answer than the seemingly simple “Where can I find a Research Ethics Committee to review and approve my project?” By their nature, RECs are not generally available for independent applications. The average REC is a big beast peopled by research experts – academics or professionals with specialist ethics training and expertise. Its work is skilled and exacting, the personnel are highly experienced, and outcomes are often achieved via thorough debate and consensus. All of this makes the work time-consuming and expensive, so a REC usually exists for the benefit of its parent organisation, whether that’s a charity, a university or the NHS. So how can independent CIM researchers who aren’t allied to one of these organisations apply for ethical approval?
- Affiliated team member
The most popular route is to assemble a team of researchers, one of whom is affiliated to a university (student or staff member), and who can access the relevant REC within that university. University RECs are used to this kind of approach and will want proof that their affiliate has an ongoing and central responsibility. Some researchers become students themselves, turning their research into an academic project and therefore automatically gaining access to their institution’s REC. Clearly not many researchers will want to turn student simply to access a REC – but if you’re somebody who’s always hankered after that MSc/PhD anyway, now might be the time to go for it!
- NHS ethics approval
A similar approach can also be made to an NHS REC, operating under the aegis of the UK Health Research Authority, assuming that (i) the project is eligible, and (ii) that it can/should be carried out with NHS involvement. Few independent CIM projects will tick these boxes, but if they do, advice should be sought from the local NHS R&D department (usually sited within the local NHS Trust) on how to go forward: NHS ethics review is not for the faint-hearted, and requires persistence, dedication and a lot of guidance.
- UK Research Integrity Office
While it doesn’t offer an ethics review service, the independent charity UKRIO can provide advice on specific issues of ethical practice in research. The service is open to all, including research students and members of the public, and can be accessed via: https://ukrio.org/our-work/advice-services/.
- Useful ethics resources for indie researchers
Helen Kara, whose thought-provoking book Research Ethics in the Real World is highly recommended for all indie researchers in CIM, published a 2020 blog post on research ethics for independent researchers at https://helenkara.com/2020/07/22/research-ethics-for-independent-researchers/. It contains a few different approaches arguably more relevant to Kara’s own social research work with indigenous communities in Australia and NZ than to medical research in the UK, but which nonetheless make for interesting reading. The post also cross-references another Kara blog post containing links to free online resources for research ethics training (https://helenkara.com/2018/01/18/free-online-research-ethics-resources/).
- NCA ethics support
For UK-based independent CIM researchers, the Northern College of Acupuncture (NCA) has an active programme of supporting research into the therapies it teaches: acupuncture, Chinese herbal medicine and nutritional therapy. Researchers with a project in one of these areas are welcome to contact the College by emailing researchethicscommittee@nca.ac.uk. In line with general principles of research integrity, the NCA’s programme includes support from experienced CIM researchers to embed the principles of research integrity and scientific rigour from the initial design stages onwards; it also includes access to ethics review and ongoing ethics compliance, and support for publication. The NCA, which is an educational charity, prioritises its own graduates, but has a principle of giving every project a fair hearing – one of its charitable objectives is to promote high quality research into its disciplines, and it recognises the difficulties caused by lack of access to ethics committees. One example of this is the College’s ongoing work with Acu-Track, the acupuncture/Chinese herbal medicine clinical audit data capture software: NCA is working with the Acu-Track developers to ensure the ethical standing of their informed consent materials for users and patients, data gathering processes, and the journal articles that Acu-Track publishes using its datasets.