Complaint investigation by NRES – Interview Notes – 22nd March 2011

Complaint investigation – SMILE Study

SMILE investigation – interview notes

All interviews held by telephone on 22ndMarch 20111.

Bill Davidson (BD)

JW explained briefly the background to the study and the formal complaint that had beenreceived. BD confirmed he was aware of the study because of correspondence that had also beensent to the DH. It was agreed that as BD had had no involvement in the NRES handling of the study and associated correspondence there was no role for BD in terms of the specific complaint and specific study. The purpose of the interview with BD was to explore, in principle, the issues raised regarding SOPs as they are written, not to make judgements about whether they had been followed.

JW asked if BD considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

BD confirmed SOPs and GAfREC were compatible. GAfREC allows that new information can be any information from any source – safety reports for example or other information received as aproduct of the ongoing research, as well as information from any route that may have beenavailable at the outset but was not disclosed, for example fraudulently or inadvertently.

JW asked BD his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, SOPs allow for consideration of new information as described and BD did not support concept of ‘appeal’ but agreed that NRES need to consider how SOPs work in practice and in light of experience may wish to reflect on guidance and process for reviewing new information afteroriginal decision.

JW explained that in the SMILE case NRES had used the NREAP as a further support to this processand asked if BD would agree that this additional assurance process should be formally capturedfor any such future cases?

Would urge caution of describing in SOPs but agreed with suggestion that NREAP Terms ofReference (ToR) could expand on current wording to make it clearer that advice may be provided in such cases, both NRES management and RECs.JW asked if there was anything else BD would like to add?BD had nothing to add and the meeting was closed. The notes have been agreed by BD.

2. Hugh Davies (HD)

JW explained that a formal complaint had been received on the SMILE study and that this was being managed through the NPSA Complaints Policy. JW explained the remit of the ComplaintsPolicy, which could not judge ethical decisions or management decisions. Similarly, any complaint about the actual intervention was not within the remit of NRES. But an investigation was requiredto determine if the standard and quality of services provided in managing the correspondence received on the study were handled appropriately, and to further determine if the matters weremanaged in line within agreed procedures, i.e. NRES SOPs and NRES Complaints Policy. JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review; even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked HD to summarise his role in the process and asked if there was anything else that hadnot been documented in his report and correspondence that he would want noted or taken intoconsideration?

HD explained that as Ethics Advisor he had supported Joan and the committee in managing the issues that had been raised, that he had not been particularly mindful of the process as he saw this as Joan’s role but he had been anxious that issues raised had proper consideration and review. He and Joan worked together in preparing responses to correspondence. HD reflected the comment from the committee as he had left when they thanked him for not telling them how to think, theyhad been able to make their own decisions and judgments. He felt he had usefully been able to support the committee by summarising issues and pointing them to relevant guidance.

JW asked HD his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, not sure what this would add.

JW asked HD if he considered the current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

HD felt current SOPs had allowed for the issues to be considered, and had given the issues a fairreview. He added that SOPs even allowed them to go the ‘extra mile’ in acknowledgement of the volume of correspondence that had been received.

JW referenced that in the SMILE case NRES had used the NREAP as a further support to this process and asked if HD would agree that this additional assurance process should be formallycaptured for any such future cases?

Think this would blur boundaries to include in SOPs, agreed with the suggestion that NREAP ToR could be updated though to make the role clearer in supporting both NRES staff and RECs in such difficult cases.

JW and HD acknowledged that JW had herself suggested the referral to NREAP.

JW asked if there was anything else HD would like to add?

Just to acknowledge the amount of time, huge volume of information and correspondence and had tried to reply as rapidly as possible, but it had been very difficult with the volume received.Also needed to note that had worked with investigator and sponsor as well in dealing with the issues and providing responses.

The meeting was closed. The notes have been agreed by HD.

3. David Neal (DN)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. DN confirmed he was aware of the study because of briefings that had been made at NMG (NRES Management Group) and the consideration by NREAP. It was agreed that as DN had had no involvement in the NRES handlingof the study and associated correspondence there was no role for DN in terms of the specific complaint and specific study. The purpose of the interview with DN was to explore, in principle, the issues raised regarding SOPs as they are written, not to make judgements about whether theyhad been followed.

JW asked if DN considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

Yes, SOPs are designed to implement GAfREC and go beyond GAfREC with respect to otherlegislation such as clinical trials regulations. For the purpose of review of opinion they allow appeal by applicants against an unfavourable opinion and review of a favourable opinion at any time in light of reports received by the REC, reflecting the policy set out in GAfREC.

JW asked DN his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, issues are covered through existing GAfREC and SOPs. Need to note that participants are free to decline to take part in a study. The REC will review the informed consent procedure and will consider information given, opportunity to ask questions and time to reflect on decision as part of that consent process. A complaints procedure will also be in place for participants that are concerned with the consent process or with ongoing involvement within the study.

JW asked DN if he considered the current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

No not specifically, although generally SOPs are kept under review.

JW explained that in the SMILE case NRES had used the NREAP as a  further support to this processand asked if DN would agree that this additional assurance process should be formally captured in SOPs for any such future cases?

Not a specific role, we have maintained the appropriate boundaries between RECs and NREAP which is not an ethics committee and this is important. NREAP is just one source of possible advice to RECs and others may be better placed to provide expert support or advice in different circumstances. However, a general statement in the introduction to SOPs describing the NREAPand referring to the terms of reference for the Panel in more detail may be helpful. It may also be worth consideration in the NREAP ToR giving a role to respond to public concerns.

JW asked if there was anything else DN would like to add?

None

The meeting was closed. The notes have been agreed by DN.

4. Andrew George (AG)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. AG confirmed that heagreed with the NREAP assessment that SOPs had been followed. He accepted, though, that there was a requirement for JW, through NPSA Complaint Policy, to review if the standard andquality of services provided in managing the correspondence received on the study were handledappropriately, and to further determine if the matters were managed in line within agreedprocedures, i.e. NRES SOPS and NRES complaints policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked AG if there was anything in addition to the NREAP noted comments which he wouldwish to add in terms of the NRES management of the issue from his perspective, and the role of the NREAP?

No

JW asked if AG considered the current SOPs were compliant with GAfREC – current and the updated version that is scheduled for release.

Yes

JW asked AG his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

Consider, yes, but not required as current process allows appropriate review and a change to an‘appeal’ process could be problematic for potential vexatious approaches and a third party accessto appeal would interfere inappropriately with the REC / researcher / participant relationship.

JW asked AG if he considered current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

No, pleased that the current process allowed enough flexibility for the matter to be reviewed,when really the new information was more a weight of opinion.

JW said that NRES had found the access to NREAP for support in the SMILE case had beeninvaluable and asked if AG would agree that this additional assurance process should be formallycaptured for any such future cases?

NREAP is not a judicial body, any described role needs to be kept as advisory and Terms of Reference is the appropriate place not SOPs. Need to be clear that NREAP is not constituted as a REC and does not have a role to supersede decisions made by RECs.

JW and AG acknowledged that JW herself had made the referral of the matter to NREAP.

JW asked if there was anything else AG would like to add?

No

The meeting was closed. The notes have been agreed by AG.

5. Charles Warlow (CW)

JW explained briefly the background to the study and the formal complaint that had beenreceived which was being managed through NPSA Complaints Policy. CW confirmed that onrequest from NRES he had undertaken a comprehensive review of the issues raised and presented these to the NREAP, and that he agreed with the NREAP assessment that SOPs had been followedand also that he thought it important that the study should proceed.

JW and CW acknowledged that JW herself had asked CW to undertake this review for the panel, but that she (and HD) had left the room for the panel discussion.

CW accepted, though, that there was a requirement for JW through NPSA Complaints Policy toreview if the standard and quality of services provided in managing the correspondence received about the study were handled appropriately, and to further determine if the matters were managed in line within agreed procedures, i.e. NRES SOPS and NRES Complaints Policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they had been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked CW if there was anything in addition to the NREAP noted comments which he wouldwish to add in terms of the NRES management of the issue from his perspective, and the role of the NREAP?

No

JW asked CW his views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, really cannot see how it can be appropriate for a third party to have access to appeal againsta favourable REC decision. Need to be able to review new information as we did, but not appeal. Concerned that this would be inappropriate and could be used to be vexatious.

JW said that NRES had found the access to NREAP for support in the SMILE case had been invaluable and asked if CW would agree that this additional assurance process should be formallycaptured for any such future cases?

As an advisory role in ToR, yes, could be more specifically described.

JW asked if there was anything else CW would like to add?

No

The meeting was closed. The notes have been agreed by CW.

6. Joan Kirkbride (JK)

JW explained that a formal complaint had been received on the SMILE study and that this was being managed through the NPSA Complaint Policy. JW explained the remit of the complaint policy, which could not judge ethical decisions or management decisions. Similarly, any complaint about the actual intervention was not within the remit of NRES. However, an investigation wasrequired to determine if the standard and quality of services provided in managing the correspondence received on the study were handled appropriately, and to further determine ifthe matters were managed in line within agreed procedures, i.e. NRES SOPS and NRES Complaints Policy. JK accepted that as Head of Operations she was responsible for ensuring the matter hadbeen managed through SOPs. She said it had been a difficult issue to manage, with huge volumes of correspondence which had also been quoted and put into the public domain. JK said it was acampaign against a study the like of which she had not had to manage before.

JW and JK acknowledged that JW had provided advice during the process, and had reviewed some correspondence but that JK had prepared all responses, liaised with all parties herself and JW hadnot been directly involved until JK referred the matter to her as a formal complaint, as required inNPSA Complaints Policy.

JW explained that the key element of the complaint was the SOPs themselves, regardless of whether or not they have been followed and she was therefore exploring this issue as part of her review, even though she would make quite clear this was a policy issue that sat outside of the complaint process itself.

JW asked JK to summarise her role in the process and asked if there was anything else that hadnot been documented previously that she would want noted or taken into consideration?

JK confirmed she had managed the issue through SOPs and had nothing further to add at that stage.

JW and JK acknowledged that it had been JW who had suggested that the NREAP also beconsulted. JW asked JK if she had considered managing the issue through the NRES Complaints Policy?

No, she considered the issue as a concern from a number of quarters about a REC decision and as such managed this as information for the REC to consider – as per SOPs. She added that in this respect it did not occur to her to manage it in any other way.

JW asked if JK felt the NRES Complaints Policy should cover such issues?

No, the policy is correct in being for applicants.

JW asked JK if she felt the matter could have been referred through the NPSA Complaints Policy sooner, accepting that JW herself could have provided this advice?

It was difficult because at each step you could not appreciate what was coming next. The initial request had come in through FOI but even in hindsight the SOP route was the appropriate one. It was only when a letter challenged my own actions, rather than the thoughts and assumptions of the REC, that I immediately referred through the complaints procedure.

JW asked JK her views on whether NRES should consider revision to SOPs to allow an appeal against a favourable opinion?

No, I don’t think so. It would seriously undermine the REC position and the new information route is there to be used. Even if we had had concerns with process in light of new information, we haveoptions available if required to co-opt members or give further advice to the REC, potentially with support of NREAP so think SOPs allow us to manage appropriately.

JW asked JK if she considered current SOPs required any revision to the process presentlydescribed which allow for a REC to reconsider an opinion in light of new information?

SOPs worked fine, could maybe look at detail of wording in a general review but nothing fundamental needs changing.

JW asked if the use of NREAP as a further support to this process had been helpful and asked if JKwould agree that this additional assurance process should be formally captured for any suchfuture cases?

The support was helpful, a role in SOPs would be a step too far for an advisory panel, but more detail in ToR about role in supporting NRES managing concerns could be helpful.

JW asked if there was anything else JK would like to add?

A considerable amount of work and on reflection we could have been more organised as an operations team in dealing with the volume of correspondence if we could have predicted howmuch the issue was going to grow. We perhaps need some operational guidance to ensure thingsare pulled into a central response sooner in such cases. We kept the SHA informed as theappointing authority, operational guidance would ensure this link in.

The meeting was closed. The notes have been agreed by JK.

Janet Wisely

Director, National Research Ethics Service

22nd March 2011

(End)

NRES full response / report on their investigation of complaint is here – https://frownatsmile.wordpress.com/2011/03/25/nres-complaint-investigation-smile-final/ 

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