Issue 8 / 5 March 2018

THE daily life of a practising GP is not something I am familiar with, except when I visit my doctor because I’m sick or to discuss a health-related issue. All I see is what happens in the waiting room, and then, what happens inside the consulting room with her. I do not know the hours she spends behind a computer entering information for Medicare or completing a Mental Health Care Plan. I do not know the demands of compulsory professional development, nor the pressures of a full waiting room. Likewise, I do not know the expectations of participating in research, nor the ambition or professional goal of being published.

What I know is that I’m sick.

When I visit my GP, I take it as a given that my 15 minutes (or thereabouts) are about me, my interests and my health. I presume that during my 15 minutes, I have my GP’s undivided attention as they try to work out what’s going on inside my blotchy, fluey, scratchy, painful body. I also presume that I can trust them to act in my best interest only.

It is with these assumptions that I take the packet of information from my GP, who has just told me about a local research study that I may be interested in.

In my role as community representative on a human research ethics committee, which advises on and approves research in which GPs enrol their patients, what I know and bring is the lived experience and perspective of a patient. It has been my experience that sometimes GPs conducting research might not include all factors that are considered a “conflict” when it comes to enrolling or informing their patients about a study.

The conflict

It seems easy to recognise a conflict of interest in politics, employment or the corporate world, when we read about a deal being done or a decision being made that smells of unfairness. What we recognise as a conflict is when someone who stands to benefit, played a significant or key role in making a decision. We bristle at not knowing of this involvement, having presumed that the process was fair and transparent.

However, the person who benefits may not have the same understanding of the word conflict. Indeed, they might not feel conflicted at all when they do or agree to do something that is actually in their own self-interest. Rather, the conflict reflects that person’s capacity to be free from that self-interest when making the decision. Therefore, the risk that GPs recruiting their patients into research will do so with some form of conflicting interest is real.

The GP recruiter

GP research is not always in the form of a large clinical trial, but can be small in scale, involving only a few practices or clinics, or even only their own patient base. If this is the case, then it is likely that the GP will have conflicts of interest. That does not necessarily imply that patients will be harmed or disadvantaged if they participate, nor that they should not be approached to do so.

However, given that I am unwell, my antenna is down and I trust the GP’s judgement because they are my doctor, will I be able to recognise a conflict? Not likely, which is why my GP should.

There are multiple ways in which research may benefit GPs. The publication of research the GP has taken part in provides professional recognition. Their clinic may be being paid to participate in research, or the GP may earn compulsory education points. These benefits are not just a “function of research”, they can create a conflict.

A GP who is asking patients to be in a study should also understand the trust they’ve been given, and how that trust affects their patient’s decision to sign a consent form (here and here). Their patient will reasonably presume that they’re being asked to participate in this particular research because it will be to their benefit, and not just the GP’s.

I don’t mind that she or he would derive a benefit, but I want to know what that benefit will be.

Specifically, I would like to know that my GP is aware that these factors may potentially create a conflict for them, and that at a vulnerable time, the person sitting in front of them is going to think what they’ve been given to consider is directly linked to their patient’s wellbeing, and not only their own.

GPs need to carefully consider the benefits they themselves gain from recruiting patients into research, and when obtaining informed consent, they need to explicitly make their patients aware of any potential personal gains as well as the benefits and risks to the individual of participating in the research.

Amanda Lyons is one of the community members of the Royal Australian College of General Practitioners’ Research Ethics and Education Committee.

 

To find a doctor, or a job, to use GP Desktop and Doctors Health, book and track your CPD, and buy textbooks and guidelines, visit doctorportal.

 

2 thoughts on “General practice research and the patient

  1. Anonymous says:

    Amanda: you are right that these are important issues. They also apply to specialists who do clinical research: and there are far more specialist clinic based research studies, since they are much more likely to gain professional recognition or promotion and increased income as a result of their research than a GP can ever do. So there is much more risk to patients attending specialists, especially in public hospital clinics. it is great that the RACGP is considering such issues. How many hospital, university,or specialist college based ethics committees do so?

  2. Anonymous says:

    My MDO asked me to pay a premium for hosting researchers ……the researchers would not pay……I cancelled the research visits to our facility.
    My patient said “am I on the placebo?” and should I be taking the proper medication ?…….I said he should take the real medication due to his risk profile.
    We send de-identified data to GHRanite and MDInsights but there’s no clarity regarding who uses this data and for what purpose…….
    Does research like this make sense any more??
    New models for research are needed, to keep pace with the rapid advances in medical innovation.
    Selecting a subset of high risk individuals and treating all would be more useful and arguably more ethical.
    Cancer treatments are now being individualised – the therapy is bespoke and the cancer could amazingly be novel !! ….
    The next challenge is to ensure “best practice” is rolled out as soon as it’s available….not THAT’S a GAME CHANGER …

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