I have recently had the experience of applying for research ethics approval in relation to two distinct projects. The first involves qualitative work with people accessing healthcare resources in community and forensic settings. The second involves internet based research of social media use. I’m aware that it’s now been a couple of weeks since I wrote a blog post – so I thought it was time to get back on the horse and this would be an interesting topic to reflect on and share experience.
The role of clinical research ethics committees
Guidance from my own college – Royal college of Psychiatry – states that the remit of ethics committees extends to all research conducted with human subjects. Research is distinguished from clinical practice in that the output is intended to inform understanding relating to greater than one person. So – innovative personalised treatment for one individual is not research, development of new understanding through working with groups of people, or extrapolating understanding from case reports, is.
Research ethics committees are then required to consider the nature of proposed research projects in terms of their conduct, likely benefits and possible risks.
Guidance on research ethics
There is an abundance of information available on research ethics and guiding principles. This extends from classic texts, Beauchamp, T. L., & Childress, J. F. (2001). Principles of Biomedical Ethics (5 ed.). Oxford University Press, to guidance from professional bodies [PDF]. Overall guidance in relation to ethical practice often relates to four stated guiding principles of medical ethics;
- Respect for autonomy
The Royal College of Physicians [PDF], London, lists three summary ethical considerations in relation to clinical research:
Validity and Welfare
The dignity, rights, safety and well being of actual, or potential participants is the primary consideration in any research study
The concept of validity refers to the potential value and practice of the proposed research. That is the project must add some form of value while also being conducted in an appropriate manner so as to maximise that value (while protecting welfare). An example would be to consider the number of participants necessary in each stage of a research project – initial trials, focussing primarily on safety and tolerability, require low numbers – later trials considering efficacy will require greater numbers.
Of interest is the statement in the guidance that;
What counts as worthwhile is, of course, a social value…
this highlights the need for working closely with patients / service users / public figures to ensure that research is of perceived benefit to the public.
The concept of welfare is separated and expanded upon in the following considerations.
Equipoise and Minimal Risk
The welfare of participants is promoted by the application of two principles: firstly, depending on circumstances that of either equipoise or minimal risk; secondly, that of consent.
Equipoise refers, in particular, to clinical trial scenarios – in order for the trial to be judged valid there must be some form of remaining clinical uncertainty in need for clarification. Thus – a trial in which the control arm involved the withholding of antibiotics from a patient with bacterial sepsis would be clearly unethical as there is no doubt of the benefit of antibiotics in sepsis…
The concept of equipoise does raise some interesting questions though – equipoise with what, for example? I recently wrote a post about a trial for CBT in psychosis for those not receiving antipsychotics. The nature of their control group receiving treatment of usual was of interest as the nature of care received by those who refuse to accept psychotropic medication is not always exemplary.
Minimal risk refers, obviously, to the need to ensure that risks to participants, or potential participants, are kept as low as possible. The level of risk that is acceptable will depend on the scenario – but consideration of this factor will always be necessary.
The principle of consent relates to the necessary respect for autonomy in clinical practice. If an individual is to participate in research they should be provided with adequate information on which to make their decision and be able to offer consent for their participation.
Interesting questions around consent can arise however – consider again the treatment of sepsis, this time the role of supportive interventions in a critical care setting. If the potential participant is unconscious how can they offer consent to participate? Is it always wrong to perform research in such a setting? I offer no opinion on this here, merely state the question.
The offering of consent ultimately relies on the capacity to make such a decision. Capacity law is an interesting field, but beyond the scope of this piece.
Research ethics committee hearings
For my projects I had to work with two distinct research ethics committee bodies. The first was an NHS ethics committee – responsible for overseeing research conducted within the NHS with patients and prisoners. The second was a University based ethics committee responsible for work conducted within my academic faculty.
NHS Research ethics committees
Application to NHS committees (RECs) is made through a central process where a standard form is completed that reviews the conduct of the proposed research and the ethical principles for consideration. The application is then submitted, together with supporting documentation such as information sheets. Once the application is made the research team have a choice between attending the next available REC ‘slot’, which is made available nationally, or to specify a REC that they wished to attend. If the next available meeting is accepted then a timer starts that limits the amount of time the REC has in which to complete its assessment.
In my case I submitted my application shortly prior to Christmas and the wait for a REC slot was therefore somewhat protracted – not being available till February the following year. This made me not wish to risk further delay and necessitated a long trek across the country to reach the meeting…
Attendance at the meeting is optional, but I would say that even with the long journey I would not have handled this any differently. Appearing in front of the committee I believe allowed me to answer questions quickly and to defend my project against potential misunderstanding.
The meeting itself lasted approximately 45 minutes, for which I was present for 15. During my time in the meeting I was asked a series of questions regarding the project – mainly relating to the procedures that I would be using. I, personally, felt that little was addressed in relation to the guiding ethical questions relating to the project, but accept that the validity question requires attention to methodology.
About three weeks after the meeting I then received a letter from the REC with a series of further questions and suggested amendments to my protocol and information sheets. I made these changes and addressed the questions as best possible in my response. This was followed about two weeks later by a second reply granting approval for the study to continue.
University research ethics committee
My University also requested that I complete a standard form to describe my proposed project and any arising ethical issues that I foresaw. Because this project was, in my opinion, somewhat uncertain as to whether it should continue I made sure that I clearly structured my application in keeping with some published guidance relating to the topic.
Having submitted the application I was offered a hearing with the REC approximately three weeks following submission. This was, obviously, to be hosted within University premises, so no length travel.
The meeting also lasted about 45 minutes and I was present for about 10 minutes. When I entered the room I was a bit surprised as, having been told to expect four or five panel members, there were 14 people in the room with me. An apology was offered for this and the chair explained that they had been discussing my application and that they agreed with me that a central issue in this project related to consent and anonymity of participants. I was then asked my opinion on these issues – which I offered, explaining that I could see arguments pro and counter my project and that ultimately I was not entirely certain how to continue. This was followed by some clarifying questions and then I was thanked from my time and excused with a positive phrase that seemed to imply that the project would be approved.
I received confirmation of this approval about one week later.
Having been through the process and received approval for both projects I am, obviously, happy with the outcome.
With regard to the NHS REC meeting I found this process highly convoluted. I accept that the level of detail to be provided when working with, potentially, vulnerable groups needs to be high. However, the process following submission of application was somewhat torturous. The questions asked during the REC meeting focussed almost entirely on procedural aspects relating to validity – that I felt had been covered in the application with reference to public involvement and precedent to demonstrate the appropriateness of methods used. This feeling was compounded by what, I felt, represented a lack of understanding of the nature of the proposed methods and ethical issues around working with prisoners.
Ultimately the questions raised by the REC focussed not at all on issues of consent or risk but instead entirely on procedural aspects that, to my mind, were a point of academic interest that did not impact on the ethical considerations. This obviously represents my opinion and it is possible that an alternative scenario of my written communication being so poor that it left the REC uncertain.
The University REC meeting was a complete contrast. This project was simpler in terms of protocol but raised more novel ethical considerations in my opinion. To my mind the meeting with the committee reflected this – the questioning focussed only briefly on methodology, in relation to participant anonymity, before addressing the key ethical question of consent. Most discussion of methodology simply allowed referral to the submitted application.
Overall I think what is reflected in my experience is the level of risk that committees are exposed to themselves. NHS RECs deal with clinical trial applications that need a large degree of oversight, when applications for lower risk, less standard, projects are made the safety considerations around clinical trials seem to hinder the process. The University REC with fewer commitments, and less risk, is able to focus on discussing the purely ethical issues raised by projects.
An unfortunate conclusion of this reflection would seem to be that bureaucracy is an unescapable complication of clinical research?