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Integrity in research

summer 2016

From triple helix - summer 2016 - Integrity in research [p16-17]

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Frank Wells shares experience of a career in research ethics.

key points

  • Truth telling is foundational for doctors, although at times they will need to judge whether patients can bear hearing completely 'unvarnished' truth about their illness.
  • In medical research, there is no room whatsoever for untruthfulness, but this doesn't always happen so checks are needed.
  • As well as being accountable to their peers, doctors and medical researchers are accountable to God and his standards of truthfulness.

Doctors don't tell lies, do they? Well, maybe a white one just occasionally. After all, not every patient wants to know they have inoperable cancer - at least, not straightaway. But in a research context, which is where I have spent much of my professional life, recording what really happens is a must: there really is no point in doing anything different.

When I was a small boy - decades ago - my parents firmly drilled into me a mantra that I have never forgotten: be polite, do your best and tell the truth. These three principles have stuck with me all my life, but it's the third one I am concentrating on in this article. A lot has happened to me since I was a small boy, of which by far the most important was becoming a born-again Christian in my mid-teens. I qualified as a doctor in 1960 and practised for nearly 20 years as a GP. But, as I now look back and firmly believe, it was God who guided me through seven years working for the BMA (but mainly on ethics and the BNF) and ten years as a pharmaceutical physician, before eventually leading me to a role in research ethics and the maintenance of research integrity.

My advisory role on research integrity means that I'm frequently talking about the importance of telling the truth, especially in the context of clinical research where the accurate reporting of findings and results is essential, including the accurate reporting of negative results.

The practice of integrity is the quality of being honest, and the Bible says a lot about integrity, though sometimes it is not specific. In the Old Testament, for example, integrity can be translated from the Hebrew as 'sincerity, soundness, uprightness or wholeness'. The ninth commandment states, 'You shall not give false testimony against your neighbour' (1) which means always be truthful as far as other people are concerned. More straightforwardly, the psalmist says, referring to the Lord, 'Because of my integrity you uphold me and set me in your presence for ever.' (2) Then in Proverbs, 'The upright will inhabit the land and those with integrity will remain in it'. (3) 'The Lord detests lying lips, but he delights in people who are trustworthy.' (4)

Turning to the New Testament 'integrity' means 'honesty and adherence to a pattern of good works'. For example Paul, writing to Titus, says 'In everything set them an example by doing what is good, In your teaching show integrity and seriousness'. (5) Jesus is the perfect example of a man of integrity: tempted by Satan but never giving in, without blemish and completely truthful. His own statement of his integrity is a fundamental principle of our Christian faith: 'I am the way and the truth and the life. No one comes to the Father except through me'. (6) And, in a colloquial interpretation of the sermon on the mount, Jesus said, 'Don't do anything you don't mean' - and he went on to say a lot more: 'This counsel is embedded deep in our traditions. You only make things worse when you lay down a smoke screen of pious talk saying "I'll pray for you" and never doing it, or saying "God be with you" and not meaning it. You don't make your words true by embellishing them with religious lace. In making your speech sound more religious, it becomes less true. Just say "yes" or "no". When you manipulate words to get your own way, you go wrong'. (7) These are hugely important messages: don't do anything you don't mean; and, yes, always tell the truth.

I have investigated many cases where the researcher has clearly reported material that wasn't true, and not all of my cases involved patients. Indeed, one of my most interesting cases related to a pre-clinical research project for a new treatment of stress-related anxiety. (8) The protocol required treating rats that had been stressed, according to a well-documented model for stressing rats.

The PhD student delegated to do the study could not make the model work - but was told to continue as if it had, so that at the end of the study the rats could be said no longer to be stressed (which they never had been anyway). The student tried to alert the authorities at the university about her concerns, but at first they were not interested. Eventually, however, the university authorities agreed that the model to stress rats did not work, but only after the case had been fully investigated. The implications of not telling the truth about the uselessness of the model for stressing rats could have been far reaching. This was a classic case of a university sweeping the evidence of misconduct under the carpet: lies are told and no action is taken.

What was the first lie ever told? Well, we cannot be absolutely certain, but the first recorded one was in the garden of Eden: 'The serpent said to the woman "You shall not die. For God knows that in the day that you eat [the fruit of the tree in the midst of the garden], then your eyes shall be opened and you shall be as gods, knowing good and evil".' (9) Satan focused on a restriction and used it to blind Eve to all of God's blessings. There was only one tree in the garden that Eve could not enjoy, but there were numerous good trees from which she could enjoy the fruit without restriction. Satan focused only on one perceived negative restriction, and Eve subsequently forgot about God's generosity and grace. Integrity counted for nothing! But it is still so easy for us to forget God's generosity and grace - Satan is still around!

Perhaps Satan got into the mind of the psychiatrist who featured in my first case of fraudbusting. (10) The research project was a clinical trial on a new anti-depressant, which, amongst other things, required biochemistry tests.The clinical trial monitor could not trace any source documents for some of the biochemistry reported results. When challenged, the psychiatrist stated that he had delegated complete responsibility for the study to one of his junior colleagues (whose name he had forgotten!). The junior colleague concerned, once traced, denied any knowledge of the study whatsoever. The psychiatrist was found guilty of serious professional misconduct, for inventing significant data and even including a patient who did not exist. Again the implications of making licensing decisions based on fabricated data are very serious.

Andrew Wakefield is a doctor whose lack of integrity has probably caused dozens of children to die unnecessarily. (11) In 1998 he published a fraudulent research paper claiming a connection between administration of the mumps, measles and rubella vaccine (MMR) and the development of autism and bowel disease. No subsequent researcher was ever able to reproduce these findings and in 2010 he was struck off the Medical Register by the General Medical Council on account of scientific dishonesty and serious professional misconduct. The disease implications of his dishonesty have been enormous. Paul wrote what has become a very well-known passage of scripture, offering spiritual guidance on integrity: 'whatever is true, whatever is noble, whatever is right, whatever is pure, whatever is lovely, whatever is admirable - if anything is excellent or praiseworthy - think about such things.' (12)

So why is integrity valuable? As Christians, we have a responsibility to develop and maintain a reputation for telling the truth. We have a promise from God that he will help us to maintain the trust of others by telling the truth. But he knows we may sometimes fall short and tell lies, and forgives us if we confess that we have done so.

Let's go one stage further and ask why integrity is really valuable. We know that Jesus is coming again. (13) Everyone will have to give account of 'every empty word they have spoken.' (14) Hopefully, we have done our best, been polite and, most of the time, told the truth; for when he comes, that is when we will really appreciate the value of integrity.

Frank Wells was a GP for 20 years and later Under Secretary of the BMA. He founded the Ethical Issues Committee of the Faculty of Pharmaceutical Medicine and is currently Vice Chair of Cambridge South Research Ethics Committee and the Lead Advisor to the Health Research Authority on Integrity, Fraud and Misconduct.

references

1. Exodus 20:16
2. Psalm 41:12
3. Proverbs 2:21 (ESV)
4. Proverbs 12:22
5. Titus 2:7
6. John 14:6
7. Matthew 5:33-37 (The Message)
8. Wells F. The case of the unstressed rats.
Fraud and Misconduct in Biomedical Research, 3rd edition. London: BMJ Books, 2001
9. Genesis 3.1-6
10. Wells F. The case of the Durham psychiatrist. Fraud and Misconduct in Medical Research, 2nd Edition. London: BMJ Books, 1996
11. Deer B. Doctoring the evidence. Sunday Times, 12 August 2012
12. Philippians 4:8
13. Acts 1:10-11
14 . Matthew 12:36



Article written by Frank Wells

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