“The patients were treated like experimental subjects without any rights… the patients’ welfare was disregarded… the way the testing was done compromised patients’ well-being and safety. Such a procedure of testing on human subjects would not be acceptable in any civilised society.” 12.4. The Panel further concluded that patients were not told clearly about the Levo-Dopa testing: some did not know their doses were being varied or that their neurologists had not been informed. The Panel further concluded that Professor Shorvon knew and approved of the way in which the Levo-Dopa testing was carried out, and approved the accessing of patients’ confidential data and the bypassing of the neurologists. The panel concluded that Professor Shorvon was “responsible for the unethical manner in which the project has been conducted.”
“I refer to your letter dated25th March 2003 . I accept the Report and the conclusions therein.”
“This will enable us to assess if a question arises about Professor Shorvon’s fitness to practise.”
“We feel this information will be very useful to us in considering the matter fully under our own procedures.”
“As you are aware this case raises serious ethical issues in relation to the medical research programme in Singapore. This being the case, [the SMC] would like to be present at the proceedings, through our local counsel who conducted the SMC proceedings in Singapore.”
“Having considered all of the information before it, the Committee was of the view that as lead Principal Investigator Professor Shorvon did have a responsibility over and above that of the other investigators to ensure that the correct procedures were developed and implemented in order that fully informed consent could be obtained from what were vulnerable patients. The Committee was also of the view that there was a real prospect of the facts being proved in this case and that those proved facts could amount to serious professional misconduct….”
“In a sense the facts seem clear cut.”
“As with all big studies, particularly ones that fail, there are clearly things that could or should have been done differently. However at the level of serious professional misconduct I cannot find anything here that should cause serious concern about Professor Simon Shorvon.”
“I do not believe Professor Shorvon fell seriously short of any expected standards at the time.”
“in my opinion any view to be taken of the strength or otherwise of the case and specifically whether the allegations, if proved, amount to serious professional misconduct depends heavily on the evidence of an expert(s) instructed by the Council.”
“10.1. In the light of the report compiled by Professor Williams, the Council is not currently in a position to prove that Professor Shorvon is guilty of serious professional misconduct. The factual evidence cannot be improved on. In normal circumstances, where the Council’s expert evidence is as unequivocal as that provided by Professor Williams, the Council would cancel the inquiry. However, in my view the Council needs to be aware (as I am sure it is) that such a decision will generate a degree of dismay and adverse comment amongst the Singapore medical, and medical regulatory, establishment and the local press. It may also generate press interest here. For these reasons the Council will want to be in a position to justify its decision to all interested parties.”
“In making his decision to cancel Professor Shorvon’s case the Chairman was mindful of various case law and guidance that indicates that the GMC should be wary of cancelling cases that have been referred to it as a result of a determination by another similar regulatory body. However, the Chairman was of the view that even if it were possible to overcome the obvious logistical problems that would arise when trying to have Professor Shorvon’s case re-heard in its entirety, Professor Williams’ report would be a key piece of evidence. If the Panel accepted Professor Williams’ report, and there is no reason to suggest at this time that the Panel should not accept it, then the Panel would in all probability have to conclude that whilst there are aspects of this case that could, in hindsight, have been conducted differently, it could not be said beyond reasonable doubt that Professor Shorvon’s conduct in this case amounted to serious professional misconduct. I should inform you that if further information was to come to light in this case, the GMC may consider whether, in the light of that further information, Professor Shorvon’s case should be reopened.”
“Any indication as to the course you will take in respect of the witnesses or charges etc?”
“We have been working on this recently, although perhaps not in the expected direction. We identified an expert witness to provide a report on the propriety of conducting large scale research programs of this nature, and we managed to instruct a Professor Williams from Birmingham, UK. Professor Williams not only had the right level of experience in conducting such trials, but also was a neurologist and therefore was expert in the relevant area that was being studied by Shorvon in Singapore. We received his report a few weeks ago and it was extremely negative. In short it did not support the case that the conduct of Professor Shorvon in Singapore would amount to “serious professional misconduct”
“I understand this was because of the fact that the IT systems at [the Singapore solicitors] were undergoing upgrading on the 12th August.”
“19. (1) Where, after the Preliminary Proceedings Committee has referred a complaint or information or a conviction to the Committee for inquiry, it appears to the Chairman of the Preliminary Proceedings Committee (having taken into account any observations of any complainant obtained pursuant to paragraph (1A)) that the inquiry should not be held, he may, after consulting a quorum of the Committee, and if they agree, direct that the inquiry shall not be held; and if at the time the direction is given no Notice of inquiry has been sent, rule 17 shall not have effect: (1A) In any case where there is a complaint the Registrar shall, before the Preliminary Proceedings Committee considers the case under paragraph (1), communicate or endeavour to communicate with the complainant with a view to obtaining the observations of the complainant as to whether the inquiry should be held. (2) For the purpose of consultation under paragraph (1) the Preliminary Proceedings Committee shall not be required to meet. (3) Where, after the Registrar has referred a conviction to the Committee for inquiry, it appears to him that the inquiry should not be held, he may direct that the inquiry shall not be held; and if at the time the direction is given no Notice of Inquiry has been sent, rule 17 shall not have effect. (4) The Registrar shall, as soon as may be after any decision to cancel an inquiry, give notice thereof to the practitioner and to the complainant (if any).”
“64. If you are leading a team, you must: • ensure the research plans are clearly explained to the appropriate ethics committee(s), the health care organisations in which the research will take place, and other bodies with supervisory or regulatory responsibilities; • ensure that all members of the team are competent and in a position to carry out their research responsibilities with integrity; • take responsibility for ensuring that the team carries out the research in a manner which is safe, effective and efficient; • do your best to make sure that the whole team understands the need to provide a polite, responsive and accessible service that respects the research participants’ dignity and treats their information as confidential; • ensure that research participants and colleagues understand your role and responsibilities in the team.” • ensure the research plans are clearly explained to the appropriate ethics committee(s), the health care organisations in which the research will take place, and other bodies with supervisory or regulatory responsibilities; • ensure that all members of the team are competent and in a position to carry out their research responsibilities with integrity; • take responsibility for ensuring that the team carries out the research in a manner which is safe, effective and efficient; • do your best to make sure that the whole team understands the need to provide a polite, responsive and accessible service that respects the research participants’ dignity and treats their information as confidential; • ensure that research participants and colleagues understand your role and responsibilities in the team.”
“…that a decision making body should not see relevant material without giving those affected a chance to comment on it and, if they wish, to controvert it, is fundamental to the principle of law (which governs public administration as much as it does adjudication) that to act in good faith and to listen fairly to both sides is a duty lying upon everyone who decides anything…”
“The SMC is dismayed and deeply frustrated by the decision to cancel the hearing in relation to serious professional misconduct by Professor Shorvon. The cancellation of the hearing has had the effect of undermining the authority and integrity of the SMC and its procedures, and has damaged the reputation of Singapore as a centre of clinical excellence in research.”
“They (the patients) knew their own case well and therefore I am sure were given the opportunity to refuse”
“This really is not a very complicated case.”
“It is for Professor Shorvon to explain why the primary facts do not constitute serious professional misconduct.”