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To tell or not to tell?

If you were taking part in a research project that also happened to identify other possible health or reproductive problems, would you want to know? This is a tricky question and to some extent is dependent on the type of study, how likely it is that other problems (or ‘health related findings’) might occur, their severity as well as personal preference.

This week, the Wellcome Trust and Medical Research Council launched a framework to help researchers decide whether and how to report these health related findings to the public taking part in research. This is a really important step as it sets out how researchers might wish to deal with unexpected findings coming out of research. AMRC was involved during its development and we are encouraging charities funding clinical research to tell their researchers to consider it when designing their proposals.

Background

The UK is a fantastic place for research - we have much to be proud of, not least in terms of our excellent clinical infrastructure and high rates of patient participation in research but also because, as of 1st April, NHS England’s standard contract for NHS organisations commissioning research for 2014/15 includes the word “research”. This marks a significant change and last year, we blogged about how research active organisations provide better standards of care. Hopefully this will translate to improvements in the NHS as well as more opportunity for patients to take part in research.

But should we be thinking about some of the more lateral issues over patients being involved in research studies? For example, what happens if a researcher finds evidence that a patient taking part in a particular study also shows signs of other health or reproductive problems not part of the investigation? Should the researcher tell the patient? How? And what happens if it the results aren’t conclusive or are false positives? These are all really important questions to consider. In April 2012, the Wellcome Trust published a report on public attitudes towards health related findings showing overwhelming support for the return of this information and now, for the first time, researchers have a framework to help them.

The framework, developed by the Wellcome Trust and Medical Research Council with help from the Health Research Authority aims to support researchers and research ethics committees in pinpointing the relevant issues around feedback in a study. It identifies specific questions to consider such as the nature of the findings in context of the study, whether telling participants would be in their best interest and how feedback might be given. The framework also details what is expected of researchers as well as practical points to consider in designing a policy, the consent process and feedback pathway.

What does the framework do and what does it mean for charities?

As with most things in research, there isn’t a one-size fits all rule. Research by its nature is very varied and each study has its own nuances and complexities. Therefore, deciding how to handle health related findings will vary depending on the study design. This framework recognises but suggests that researchers should have a clear, well-reasoned policy in place specific to their particular investigation. It also emphasises that researchers need to explain this policy to patients during the consent process and specify how feedback will be given. This should hopefully help to alleviate some of the ‘surprise’ element in telling a participant that they may have other health or reproductive problems.

The framework has had a lot of input from external organisations including AMRC, the British Heart Foundation, Cancer Research UK, the Economic and Social Research Council, and the Health & Social Care R&D Division, Public Health Agency, Northern Ireland.

Dr Jeremy Farrar, Director of the Wellcome Trust, said:

As we involve more and more people in medical research and our ability to identify disease markers increases significantly, it is inevitable that we will often see cases where findings could have potential health implications for individuals. We need a public discussion about where and how it is appropriate to feed this information back to participants.

The future

It’s hoped that this framework will be a really useful tool for researchers, prompting them to think more widely about issues surrounding feedback of health related findings. But this isn’t a closed book – as more evidence comes out to inform the best practice, our thinking might also need to change. While it’s important that we all remain aware of this, hopefully this framework is an encouraging start.