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Settling down after dinner in front of your black and white television set some 45 years ago you were in for some troubling viewing. On the late evening news a young mother, with her two year old on her lap, was being interviewed by an ITN journalist.

“This happened entirely without my consent or any knowledge on my part or any of the other patients’ part that this was going on.”

“What happened was…” she began, as she told how she had been unwittingly involved in a research project where repeat cervical biopsies had been taken.

“…they were using us to find out about cancer of the neck of the womb and what they did was to take a small piece of skin about the size of my little fingernail from the neck of the womb.  This was done about three times in the first six weeks after the birth of the baby and as a result of this, the third time it was done to me, I haemorrhaged and I was ill for about a fortnight.”

“Now, you complained to the authorities at the hospital,” said the interviewer.  “What was their reaction?”

Her face changes and her head lifts slightly, aping the arrogance of the doctors who answered her. “Well, their reaction very much was that I ought to be grateful for having been included in their programme at all.”

The language is interesting and revealing: “without my consent”,  “they were using us”, “done to me”,  “ought to be grateful”.  Although this happened a generation ago the woman’s feelings still resonate just as strongly today and should remind us of how far we have come in a relatively short time.

She was clearly surprised and angry that this could happen to her.  Perhaps she even felt betrayed.  She was certainly left feeling disappointed and used by a medical profession that saw her as nothing more than a piece of convenient research material and certainly not as an equal, perhaps not even as a person. In short, she had been shown no respect.

The reason for the interview and the news item was the publication the following day of a ground-breaking book called Human Guinea Pigs by Maurice Pappworth.  The book would cause a sensation both in the professional and public worlds.  The author would be vilified by his colleagues for washing the dirty linen of the medical profession in public, and the public would be horrified at just how dirty that linen was.  In his book, Pappworth targeted published studies from the UK and the US conducted on vulnerable groups, such as children, adults suffering from mental illness and prisoners.  The common feature he identified in these experiments, and his main complaint, was deception.  The patients were rarely told of their participation, and their valid informed consent was never sought.  Some patients found themselves being used merely as convenient subjects to evaluate new treatments or tests, none of which would be of any personal benefit.   Pappworth believed that trust was a sacred covenant between doctor and patient and that such research, built on deception, breached that covenant.

The book and the furore that it created, including discussions in the press, questions in parliament and of course the kind of human stories presented on the evening news that we began with, all served to shape a new climate for transparency and control.  No longer could healthcare professionals expect to work behind close doors on projects that no one knew about or understood.

But, did we need all this to change us as professionals?  Should not our very professionalism and basic human decency have been enough?  Perhaps, but maybe when people become involved in the excitement of discovery they simply forget that those who are helping them towards that discovery are people too.

But, we must never forget this and I have a simple rule that might help, which I used to tell all my new research staff.   When you work in clinical care you are there to help the patient, but when you cross the threshold of a research facility everything changes and that relationship reverses; now the patient is there to help you.  Forgetting the nature of this relationship leads to failure on many levels.  Without the willing participation of people in clinical research there would be no research and, of course, no need for all the rules, regulations and laws that surround us.  And, incidentally, no need for us, as research professionals, either.

All researchers should be taught the principles of Good Clinical Practice or GCP.  These principles have their origins in the pharmaceutical industry, but are now widely applied as an internationally accepted quality standard for the conduct of clinical research in humans. These principles are designed to ensure the safety of research participants and the quality of the data collected.  But, they also go further.

If I had to distill everything we teach in GCP down into a single word it would be this: respect.  If researchers respect their participants and remember this in everything they do then all those rules and regulations, and even the principles of GCP themselves, follow naturally.  How could we deceive someone we respect, or coerce them, or be careless with their confidential personal data? How could we contemplate conducting a poorly designed experiment on them?  How could we expose them to undue risks?  How could we harm them?   If respect is the foundation upon which we build, our house will be strong and lasting.

The business then of those who teach GCP, is ensuring not only that their colleagues understand the intricacies of research regulation, but also the very essence of what it is all about:  safeguarding our patients by treating them first and always with respect.

© Allan Gaw

If you would like to view the video clip of the news item entitled Human Guinea Pigs from May 17,1967 discussed here, you can find it at the following website:

http://jiscmediahub.ac.uk/record/display/039-00046573 but you may need an institutional login to see it.

If you would like to read more about Maurice Pappworth and his work you can do so in our book On Moral Grounds: Lessons from the History of Research Ethics.

My books available on kindle:

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