Report by NRES on Complaint Investigation SMILE trial – March 2011

From National Research Ethics Service, March 2011 –

Complaint investigation – SMILE Study

Complaint Lead – Dr Janet Wisely

March 2011

Key dates and actions

3rdMarch -Correspondence received by email to Joan Kirkbride

4thMarch -Forwarded as formal complaint (previous correspondence had been managed through NRES Standard Operating Procedures) and received by Complaint Lead, Dr Janet Wisely

4thMarch -Initial assessment to consider the scope of the complaint and appropriate policy

7thMarch -Acknowledgement of complaint and copy of NPSA complaint policy sent

22ndMarch -Interviews

25thMarch -Response sent

Background

The complaint received related to correspondence regarding a study given a favourable opinionby an NRES REC. Prior to the formal complaint the matter had been managed by Joan Kirkbride,supported by Hugh Davies and also in consultation with the National Research Ethics Advisors’Panel (NREAP), through NRES Standard Operating Procedures. The matter has been separatelyreviewed by the NREAP during the management of this process. (Please refer to the named list on page 5 for the positions of individuals.)

Nature of the complaint and scope of investigation

The complaint can be summarised into key areas:

Outside NRES remit and NRES / NPSA complaints policy:

o  A complaint against the Lightning Process itself. This complaint is outside of the remitof NRES.

o  A complaint against the SMILE study.  All research falling within the remit described inthe DH Governance Arrangements for Research Ethics Committees requires afavourable opinion from an NRES REC; in this case, it is accepted by all parties that a favourable opinion is in place. There are therefore no issues regarding research governance raised through the correspondence received. Wider issues regarding the study are outside the remit of NRES.

o  A complaint against NRES SOPs in that they do not allow an appeal against a favourable REC decision. This is a policy matter for NRES and the UK Health Departments. The NRES SOPs are prepared by NRES and formally agreed by the UKHealth Departments. The review of such policy is therefore outside of the NRES /NPSA complaints policy. However, given the role of NRES in preparing and seekingapprovals for these SOPs, comment is made on the appropriateness of policy within the context of NRES operation. The commentary and associated recommendations are conducted outside the remit of the formal complaint.

Within NRES remit and NPSA Complaints Policy:

o  A complaint against the REC decision – NRES Standard Operating Procedures (SOPs) do not allow for an appeal against a favourable REC opinion. A REC may review its opinion on a study at any time (as described in SOPs). Under the NPSA Complaints Policy, investigation is required to determine if the standard and quality of services provided in managing the correspondence received on the study were handledappropriately, and to further determine if the matters were managed in line withinagreed procedures, i.e. NRES SOPs and NRES Complaints Policy.

Previous role of NRES Director

As NRES Director, I had previously been briefed on the correspondence received on the study,had supported the decision to review as new information to REC under standard operatingprocedures and had formally requested the NREAP to provide guidance to NRES on the matter.I had no involvement in the decisions made on the study. I concluded that, although I hadprevious knowledge of the matter and some previous involvement, I was still the most appropriate person within the NRES team to complete the complaint investigation. Throughout the investigation previous knowledge of relevant events is declared.

Complaint investigation under NPSA Complaints Policy

In reaching the conclusions detailed below, interviews were held with Joan Kirkbride, HughDavies, Andrew George and Charles Warlow alongside a review of available documentation.The key issue was to determine if matters had been managed appropriately through the available policies – NRES SOPs and NRES Complaints Policy.Appropriate NRES policyThe investigation revealed that the correspondence received had been managed through the NRES SOPs, these allow a REC to review a decision made in light of new information. There was no evidence to support that consideration had been made of the use of the NRES Complaints Policy but, as attached, it is clear in this that it is designed for use by applicants who are unhappy with a REC decision, not a third party. The findings are therefore that the appropriate policy option – NRES SOPs – was taken.

Management through SOPs

The SOPs option was taken and information was referred on to the REC who reconsidered the favourable opinion and confirmed this at a quorate meeting. In this respect all matters were managed through described SOPs. In addition, the views of the NREAP were sought to support the process. This is not described in SOPs but the support of the panel to NRES in such mattersis covered generally within the panel terms of reference, although for concerns of this naturenot specifically stated.

Management of correspondence

Large volumes of correspondence were received and Joan Kirkbride and Hugh Davies undertookto reply in detail to this correspondence. If any criticism is to be made, it could be the extent towhich they undertook to reply in detail to what was becoming increasingly repetitive and potentially vexatious correspondence. This was clearly done with good intention to be supportive and helpful. In hindsight, it may have been helpful to have recognised that the NRES process had reached an end sooner than they did.

The pattern of correspondence overall on the study would suggest that responses to previous correspondence was not being fully considered before further letters were sent, and the letter which prompted the formal complaint suggested that there was no policy through which the process had been handled, which is surprising given the previous correspondence on the matter.

Conclusions

The NRES Complaints Policy does not cover complaint or appeal against a REC decision by a third party. However, the NRES SOPs, whilst not providing an ‘appeal’ by a third party, do allow for the reconsideration of an ethical opinion in light of new information. This route wasfollowed, and followed appropriately as described in SOPs. Additional support was provided bythe NREAP. Although this is not described in SOPs, the support is in line with the agreed terms of reference of the NREAP.

The complaint is not therefore upheld.

Recommendations

1. The NRES Complaints Policy is updated to make it explicit that the policy is not for use for complaint by a third party against a REC decision, i.e. that it is as is currentlydescribed a complaint policy for applicants and study sponsors.

2. The NREAP terms of reference to be reviewed to make availability of the Panel to support NRES on matters relating to complaints and concerns more explicit.

3. NRES to consider development of guidance for operational team on management of correspondence from third parties.

Review of the NRES Standard Operating Procedures and provision for ‘appeal’ against a REC favourable opinion

In reaching the recommendations detailed below, conversations were held in addition to those for the formal complaint investigation, with David Neal and Bill Davidson.

The Governance Arrangements for Research Ethics Committees (GAfREC) are DH policy, as partof the Research Governance Framework for Health and Social Care. GAfREC requires that RECsreview decisions in light of new information, and this information may be information that comes to light after a REC decision or information that is a product of the conduct of the study, such as safety reports. SOPs provide for the implementation of this policy, allowing wide discretion for a REC to review its opinion of a study at any time. GAfREC also allows for furtherreview by a second REC when a REC gives an unfavourable opinion on an application, i.e. anappeal. SOPs set out a formal appeals procedure which implements this policy. There is noprovision in GAfREC for appeal by third parties against REC decisions, and accordingly this is not included in the SOPs.

In considering the appropriateness of this policy, it is worth noting what a favourable ethicalopinion means. It is one part of an approval process within the Research Governance Framework and when all required approvals are in place this gives permission for participants tobe invited to take part in a study. Participants may of course decline. The REC will look carefully at the planned consent process, including information to be provided about the study, opportunity to ask questions, independent sources of advice, time for reflection and also the availability of a complaint process for participants, including those who decline to acceptinvitation to take part in a study. In this context, it is difficult to see the role of an appeal process against a favourable opinion, and concern was expressed by those interviewed on the appropriateness of this option, with one respondent commenting that it would inappropriatelyinterfere with the REC / researcher / participant boundaries and relationships.

Conclusions

NRES SOPs are fully compatible with DH policy as described in Governance Arrangements for Research Ethics Committees. These allow for appeal by applicants or sponsors against unfavourable opinions and for RECs to review decisions in light of new information. No review of SOPs is required to ensure consistency with DH policy and none of those interviewed as part of the review considered changes of DH policy to allow appeal by third parties to be appropriate, and concern was expressed that it would be inappropriate.

Recommendation

No further action is required.

Named individuals

Andrew George   Chair, National Research Ethics Advisors’ Panel

Bill Davidson    Research Governance Manager, Department of Health

Charles Warlow   National Research Ethics Advisors’ Panel – Member

David Neal   NRES, Deputy Director (Policy)

Hugh Davies   NRES, Ethics Advisor

Joan Kirkbride   NRES, Head of Operations

Links

Governance Arrangements for Research Ethics Committees: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4005727NRES

Standard Operating Procedureshttp://www.nres.npsa.nhs.uk/news-and-publications/publications/standard-operating-procedures

Attached

oSMILE investigation interview notes

oNRES Complaints Policy

oNPSA Complaints Policy

National Research Ethics Advisor’s Panel

As described on NRES website

Background

NRES was asked by four UK Health Departments, through the United Kingdom Ethics CommitteeAuthority (UKECA) to establish a central advisory panel. The objective of the panel is to helpwith the strategy, quality assurance and service development of RECs and improve the research environment in the UK. This panel will offer leadership in matters relating to policy, training, ethical arguments anddebates, stakeholder engagement and other allied matters. It is independent but hosted withinNRES and a resource available to all DH funded UK RECs and their appointing authorities.

Membership

A panel of 12 advisors, plus the NRES Ethics Advisor, Dr Hugh Davies, has been appointed. Members have appropriately senior experience and expertise from different and relevant backgrounds, including a past or present REC members and chairs.

Members have one or more of the following expert backgrounds including a past or present RECmember or chair:

Clinical research involving patients

Clinical research involving healthy volunteers

Public health research

Social science

UK Ethics service

Patient and public involvement

The pharmaceutical industry

The panel meet monthly in London or occasionally elsewhere in the UK, as appropriate. Membership and terms of reference of the Panel will be reviewed on an annual basis. The roleof an NREA panel member involves a minimum time commitment of around 1 – 2 days permonth to include some preparation time for the meetings.

Terms of reference of the NREA Advisors’ Panel:

Arbitration on ethical debates and disagreements arising from appeals byapplicants and from within RECs.

Oversight of the ‘shared ethical debate’ external quality assessment program for RECs.

Oversight of NRES training programmes and training delivery as appropriate.

Oversight of personal development programmes for REC chairs.

Advice to NRES or RECs regarding alleged fraud or misconduct in research.

Provision of guidance on governance issues and legal issues.

Support for NRES with business planning and strategy.

Support for NRES with relationships with RECs and support to RECs in their relationships with NRES.

Support for NRES with relationships with other regulators, research funders, universities, professional bodies and industry including AREC.

Support for NRES with patient and public involvement in research.

Support for NRES with media enquiries and response to news items or journal articles about RECs.

Representing NRES at events and conferences.

Facilitating NRES events.

Chairing ad hoc advisory groups and working parties as appropriate.

The National Research Ethics Advisors’ Panel may be contacted via the panel Secretary, Clive Collett (clive.collett@imperial.nhs.uk).

* * * * * * * * * * *

Abstracts from NREAP minutes

The NREAP minutes are routinely published on the NRES website.

Abstracts are included from meetings in December 2010 and February 2011:

December 2010

7. Submissions from the ME Association and others to NRES concerning the ‘SMILE’ study

Received for discussion:

The ME Association and the Young ME Sufferers Trust joint statement

NRES response letter

Notes written by Hugh Davies in early response

IRAS application for the ‘SMILE’ study

The ME Association has raised concerns over a study of ME in young people that was recently approved by a REC. The panel were asked for comments/advice on the broader ethical issues and the actions proposed by NRES:

“…we feel that a fair way forward is to seek the responses of the researchers, sponsor and the ME charities involved in the development of the study before asking the REC to review its favourable opinion. We also note that in this project, subjects will not be deprived of what is current care in this clinic. Research participants will receive this intervention in addition to their standard treatment. We will also be seeking the views of our National Research Ethics Panel.”

The panel were supportive of the proposed NRES action put forward to deal with the concerns raised by the ME Association and others. It agreed that the main REC should be asked to review its favourable opinion in the light of new information (as per current NRES SOPs). The panel were in broad agreement with the preliminary notes written by HughDavies in response to complaints made about the SMILE study. However, the panel feltthat in reviewing its decision the REC involved should limit itself to considering only therelevant new information regarding the study itself and not to consider allegations whichwere outside of its remit or competence to comment upon.

The panel stated that it was important to conduct impartial research into ME and that, where appropriate, it was equally important to ensure the benefits of research are extended to children in line with existing guidelines. It was noted that in the SMILE studyparticipants were not being deprived of current care and the research question was theeffectiveness of the additional tool which the study was designed to evaluate.

Agreed: The panel agreed and endorsed the proposed NRES action

February 20116.

The SMILE Study: Charles Warlow

Received for discussion:

Report for the National Research Advisors’ Panel – Charles Warlow

JW and HD left the room whilst the panel discussed this item.

Following the verbal report from CW, the panel agreed that:

Whilst the panel did not feel that any “material issues” had been raised tocategorically require a second review by the main REC it was felt that NRES had acted appropriately and reasonably in asking the main REC to review its favourable opinionin the light of the ‘new information’ (in line with NRES SOPs). Whilst the panel were not in a position, nor had the remit, to comment upon the initialand subsequent review provided by the main REC, they considered the REC’s opinionsto be entirely appropriate.

If any further studies involving the lightning process are to be reviewed by an NRES REC then the panel felt it would be appropriate for the main REC involved to be appraised of the history of the ethical review of the SMILE study.

The panel supported the NRES operational view that the correspondence receivedafter the REC meeting, in response to the REC decision not to suspend the ethical opinion, does not raise new issues that require a further review by the REC at this time.

DRAFT  March 2011

JW explained that there had been a formal complaint made to the NPSA regarding the handling of the review of the favourable opinion for the study by the main REC followingnew information. JW pointed out that the complaint focused on the review of the “appeal” but that the second review carried out by the main REC was not an “appeal” but rather a review of its favourable opinion in the light of new information as per NRES SOPs:

“9.86 The main REC may review its favourable ethical opinion of a study at any time. Inparticular, this might be prompted by safety reports, progress reports or any other information received about the conduct of the study. The Chief Investigator or sponsormay ask the main REC to review its opinion, or seek advice from the REC on any ethical issue relating to the study.” (Standard Operating Procedures for Research Ethics Committees – Version 4.1, May 2010)

The panel expressed their concern that research into ME was becoming increasingly difficult for researchers and that consequently less research was being undertaken in this important disease area. Given the potentially vexatious nature of correspondence andcomplaints, it was agreed that AG should contact ‘Understanding Animal Research’ to explore areas of common ground in handling correspondence with regard to conductingresearch in contentious areas.

(End)

NRES complaint investigation interview notes are here – https://frownatsmile.wordpress.com/2011/03/25/nres-complaint-investigation-smile-final/

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