To: Chief Executive of NPSA
Date: 3rd May 2011
Ref. 10/H0206/32 submission date 24.05.2010
Assessing the feasibility and acceptability of comparing the Lightning Process with specialist medical care for Chronic Fatigue Syndrome or Myalgic Encephalopathy (CFS/ME) pilot Randomized Controlled Trial. (SMILE)
I wish to submit a formal complaint about the conduct of the SW 2 Regional Ethics Committee and the National Research Ethics Service in their handling of the above study application. I would like to make it clear that my complaint is not intended as an appeal against an REC decision – I am aware that there is no appeal process for third parties against REC decisions. Please also note that my complaint is in no way vexatious in intention. I have no personal or professional relationship with the researchers and no vested interest in this study. The purpose of my correspondence with the REC – which commenced in October 2010, after ethics approval had been granted – has been with a view to bringing to the REC’s attention new information that I believe warrants a review of their favourable opinion. I was pleased that the REC did conduct a review, but they failed to address the fundamental issues raised by that new information, and they have subsequently failed to take into account further new information, which seriously compromises the validity of the study and more importantly, compromises the rights and welfare of the research participants and their parents. I use “parents” to indicate the adults with personal responsibility for the patients. My concerns relate to the rights, safety, dignity and well-being of the paediatric patient participants and their parents and to the professional conduct of the National Patient Safety Agency, which I believe has breached its stated remit in the context of this study application. I believe I also have both a right and a duty to report concerns that criminal offences may have been committed and that the spirit of the law and regulations may not have been upheld. Please be aware that my complaint and any response received may be placed in the public domain in the public interest.
Areas of complaint
. Conduct of the Chief Investigator (CI), which I believe the REC did not use Standard Operating Procedures (SOPs) to deal with, and which may amount to research-related fraud and misconduct.
. Conduct of the REC in handling the original study application and the review of its opinion.
. Conduct of the NRES once the matter had been referred on.
Summary of specific concerns
- Failure to declare or treat this as an application for approval of a clinical trial.
- Failure to disclose risks and material information to the REC and study participants.
- The REC relied too heavily on the views and opinions of the CI, which are in contradiction of medical and scientific evidence provided to the REC by concerned parties.
- The REC failed to take sufficient account of the lack of impartiality of the care organisation supporting the study and of the External Advisory Group.
- The reasons given by the CI why children should be used as test subjects for this intervention before first testing it on adults are unsubstantiated and contradicted by existing scientific evidence.
- The reasons given by the CI to justify this research were not evidence-based.
- Reasons why the research could not be justified were evidence-based yet were dismissed as largely matters of opinion.
Patients’/parents’ right to give informed consent to participate in the study has been undermined by the following:
8.1 The study participants are the patients of the CI, recruited by her at her specialist NHS clinic at the point of initial diagnosis, which is likely to positively and prejudicially influence the primary outcome of the study – recruitment and retention.
8.2 Non-disclosure of risk to participants in the study proposal.
8.3 Non-evidence-based declaration of risk as slight following ethics review.
8.4 Non-disclosure that the information regarding the success rate of the intervention and regarding the underlying causes of ME/CFS (and other diseases) in the advertising of the intervention cannot be relied on as it is unsubstantiated, and given that patients’/parents are specifically advised in the study protocol to read such information – this inevitably makes promise of therapeutic gain even if therapeutic gain is not promised directly in the patient information leaflets. Therefore, participants are subject to coercion in breach of the Declaration of Helsinki and their human and civil rights.
8.5 Financial incentive to participate given that the LP costs upwards of £620. With no risk declared initially, and then only “slight” risk declared after ethical review, and with claims of such high success rates in the advertising material that they have been directed to read, incentive to patients/parents to try a product that is already on the market, in addition to the standard care they would normally receive, is inevitably high, particularly for less wealthy families.
8.6 Non-disclosure that practitioners administering the intervention are currently breaking the law by breaching Consumer Regulations and are under surveillance by the Trading Standards Service and the Advertising Standards Authority.
9. Given that the Phil Parker Group is in beach of consumer regulations and under surveillance by Trading Standards for false and misleading claims, aggressive selling and illegal marketingpractices, the effect of exposure to advertising of the product under evaluation on the study outcomes. If the intervention were a drug in a blinded trial, exposure to such aggressive sales techniques in the product’s advertising would be likely to increase the placebo effect in the control group. As a psychotropic intervention in a non-blinded trial, such expectations of recovery as promised from the advertising are likely to influence the paediatric patient’s belief that they are recovered, and their inclination to say they feel better when they may not. No biomedical tests are being used to assess the impact of the intervention – only subjective measurements using questionnaires focussing on the patients’ moods and feelings – even though it is claimed that the intervention affects the patient’s physiology and is being tested as a treatment. This not only compromises the scientific value of the study but increases the risks of psychological and physical harm to the participants.
10. The dignity, safety and well-being of a vulnerable group of minors are being put at an indefensible degree of risk by the DH/NHS/NPSA by entrusting their care to practitioners who are not medically or clinically qualified and are breaking the law.
11. As a result of the above, criminal offences may have been and may be currently being committed.
Full NPSA Complaint in pdf