Other Questions to Ethics Service re: SMILE October 2010

October 19th 2010

SMILE Questions

re: 10/H0206/32 SMILE – Specialist Medical Intervention & Lightning Evaluation

The most frustrating thing about reading the research documents is that I still do not know the exact status of the LP ‘practitioners’. Are they on the research team or not? Or are they ‘collaborators’ and what does that mean? I have read the research documents and I still don’t know; yet approval has been given for these LP practitioners to use a psychotropic process on the minds of child participants in an NHS RCT.

My second major concern from reading the research documents is that the clinical aspects of this trial are fuzzy, to say the least. Serious ethical questions arise about using child subjects for the first ever clinical research of the LP. Many questions are not addressed or even acknowledged in the protocol or REC documentation (so far as I can see). This clinical aspect of the investigation seems to be treated like a side issue; not just in the research protocol, but also by the REC. Yet it is the clinical aspect that I think should have an REC questioning until there is no room for confusion.

My questions (numbered for reference) are:

Why does the NHS REC Form (section 2) indicate the research is a “Study administering questionnaires/interviews for quantitative analysis, or using mixed quantitative/qualitative methodology” (1)? A major component of SMILE; with 96 participants randomized to 2 arms, one receiving ‘specialist medical care’ and the other with the ‘lightning process’ added; indicates that SMILE includes and should meet all requirements of a clinical trial. It would therefore seem that the NHS REC Form should indicate either “Other clinical trial or clinical investigation” or “Other”. SMILE is not simply a “Study administering questionnaires/interviews”.

The NHS REC Form states: “A47. Will individual researchers receive any personal payment over and above normal salary, or any other benefits or incentives, for taking part in this research?” The reply indicated is ‘No’. The NHS REC Form also states: “In 2009, over 250 children attended groups to access the Lightning process as an intervention for paediatric CFS/ME.” And further states: “Families currently pay approximately Ł620 to attend the Lightning Process course”, and the Phil Parker Lightning Process Prospectus states: “10% of all LP seminar fees + VAT are payable to the LP register”. The same prospectus states: “Annual Licence for practicing in the UK = Ł350 + VAT.” Which suggests that in 2009 LP courses generated approximately Ł155,000 from ‘paediatric CFS/ME’. In the same year the ‘LP register’ (whatever that might be) gained roughly Ł15,500.

Have any of the LP practitioners who are named as “key investigators/collaborators” in the SMILE NHS REC benefited from any of these monies or are they likely to benefit from such monies generated in the future (2)? If the SMILE research data suggests the LP has some efficacy, it would seem likely that LP retailers, licence fee and commission beneficiaries could gain significant financial benefits. Conversely, the same retailers might lose custom and credibility if SMILE shows LP to be ineffective or harmful. Does this constitute a conflict of interests. (3)?

If the LP practitioners are not “investigators/collaborators” but they do have conflicts of interest, what measures have been taken to minimise any possible contamination of the research team (4)? What steps will be taken if one of the LP practitioners makes unsubstantiated claims about themselves or the LP or about CFS/ME; that a doctor or other regulated medical professional would not be allowed to make in a clinical or research setting (5)?

The Protocol says, “After this they will have a telephone call with a Lightning Process practitioner (LPP) (usually approximately 20 minutes). This is used to check that the young person and their parents are happy about attending the course…” This seems to establish the LP practitioners as being on the research team, as they are given the duty: to check if “the young person and their family are happy to continue” – a decision which comes under the umbrella of Informed Consent. Have the LP practitioners received adequate training to understand the principals of Informed Consent including those principals that apply to participants who are deemed incompetent (6)? When and where did this training take place and who paid for it (7)?

The SMILE Protocol says, “An External Advisory Group will also meet: prior to the study starting, by phone conference 6 monthly and at the end of the study. This will be an independent group and will include experts in CFS/ME, including a representative from the Association of Young people with ME (AYME) and the Lightning Process.” Who is in this ‘external advisory group’ (names), why are they needed and what is their function and influence on the research (8)? Who are the “External Advisory Group” accountable to and have they or their intended activities, interests and any conflicts of interest been assessed by the REC (9)? How is this group ‘independent’ and who has set-it-up (10)? Who are the ‘experts in CFS/ME’ and what makes them experts (11)? If this group has no influence they are not needed. If they have influence then they are a potential source of contamination and should be completely transparent and subject to REC review.

The NHS REC form states: “We do not believe there are any risks of being part of this study.” The SMILE Protocol indicates that the research team includes an expert in ethics and provides an impressive CV. If the study has no risks what is the need for an ethics expert (12)? Are they necessary because of ethical difficulties with the project and if so, what are these difficulties and how have they been represented to the REC (13)?

The LP appears to be a type of conditioning process (Pavlov comes to mind). Who will be legally responsible for any undesirable effects of this ‘conditioning’ on participants (14)? If the conditioning has undesirable effects, can the process be reversed and how would this be achieved (15)?

Who is in loco parentis while a child is being processed and how would a request to withdraw be accommodated at this time (16)? If a child indicates a wish to withdraw but their consenting representative wants them to continue (or vice versa), how will this be dealt with (17)? If a child cannot complete any of the 3 processing days because of illness or for other reasons; how will the course be completed for them (18)?

In view of the fact that the subjects for this research are sick children, I think the gaps in the published information show a lack of thoroughness. The protocol for this experiment using a novel and unpredictable psychotropic process on vulnerable children should leave nothing to the imagination.

 

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