We are keen to find out what the barriers are stopping clinicians from conducting SCEDs or N-of-1 studies with their own patients/clients.
DISCUSSION FORUM
Create an account by clicking “log in” (above right) and then log in to post a thread or reply to a post.
The biggest obstacle for clinicians is ethics/ governance in the UK/ institutional review boards elsewhere. If I as a a clinician were to suggest to a patient that we need to wait for 4 months whilst I write a protocol to be approved by internal reviewers to then obtain sponsorship by my institution and then go through ethics and the Health Research Authority and complete many questions / forms, they would rightly refuse! The patient will ask why can’t we just get on with it? I might say I am not sure if I am allowed to. We could just do it without any experimental design as a case report which is of course less rigorous in drawing inferences and knowing what works for that individual.
So, under what circumstances does a SCED require an ethics application? Clearly the nature and risks of the intervention is important - but many psychological interventions are just done by therapists in everyday clinal practice. However as soon as there is longer baseline, perhaps more frequent measures, a control intervention or randomisation to start, perhaps publish then it becomes "research", requiring ethical and governance review. Surely there must be a better way for a patient and therapist to collaborate to work out whether a treatment works for them and to then replicate the intervention in other patients? How do others get around this (or is all your SCEDs done by trainees who have to learn about ethics as part of the process of learning about research?)
David, a very important point. I will gather some views and experiences on this and get back to you.
In the Single-Case Reporting guideline In BEhavioural interventions
(SCRIBE) E&E paper (Tate et al., 2016, Archives of Scientific Psychology, 4, 10-31), item 13 addresses the issue of ethics of SCEDs.
The SCRIBE recognises that while the conduct of research generally requires formal approval from an Institutional Ethics Review Board, in the case of a SCED implemented as part of clinical care, ethics approval may not be required in order to proceed (see p.19 of the SCRIBE E&E paper).
The SCRIBE does stress, however, that written informed consent should always be secured. In cases where the participant is not able to provide consent, their assent should be sought and written consent obtained from their legally appointed guardian/parent.
The SCRIBE does NOT make comment about the following scenario,
however: It is sometimes the case that a SCED clinical study is conducted (with informed written consent, but not formally approved by an ethics committee), and the clinicians subsequently wish to write up the case for publication. In my opinion, it is at this point that the 'clinical care' study becomes 'research' (i.e., publishing results), and ethics approval would be required.
As an addendum, SCEDs should always be properly conducted, whether for clinical care or part of research, which means having appropriate baseline lengths, and implementing the intervention in a scientifically-controlled way, among other things.
- Robyn Tate
This may be helpful....
Stunnenberg BC, Deinum J, Nijenhuis T, Huysmans F, van der Wilt GJ, van Engelen BGM, van Agt F.Healthcare (Basel). 2020 Feb 27;8(1). pii: E49. doi: 10.3390/healthcare8010049. N-of-1 Trials: Evidence-Based Clinical Care or Medical Research that Requires IRB Approval? A Practical Flowchart Based on an Ethical Framework.
This is a helpful contribution for medication trials although I am not sure if I agree with it especially when combining data from patients. Clinicians will just get on with the same design but not publish their data which is not any body's interests.