#mecfs "Some PACE trial participants were unpleasantly surprised to learn only after the trial of the researchers’ financial and consulting ties to insurance companies..."

http://www.virology.ws/2015/10/22/trial-by-error-ii/

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.ncbi.nlm.nih.gov/pubmed/?term=warlow+sharpe

warlow sharpe
Search results
Items: 1 to 20 of 29

https://pbs.twimg.com/media/CUAOP5nXAAAGFjb.jpg:large

http://web.archive.org/web/20070801080039/http://www.dcn.ed.ac.uk/pages/displayStaff.asp?RecordId=121

MIKE SHARPE

Michael Sharpe studied Psychology, Medicine and Psychiatry in Oxford, Cambridge and London. He directs a Psychological Medicine and Symptom Research Group in the Edinburgh University School of Molecular and Clinical Medicine. He collaborates closely with colleagues in Neurology on a programme of Neuropsychiatry research. The group’s main interest is in medically unexplained neurological symptoms and their management. Other key members of the Neuropsychiatry group are Jon Stone Alan Carson and Charles Warlow.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-05-12_NREAP_Minutes_Final.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 12 May 2010 13:00 – 16:00

Apologies: Sarah Dyer; Charles Warlow

11. Any other business

Withdrawal of Data Following Participation in a Study.

JW asked the panel for their views on how long after consent to take part in a study can a participant ask to have their data withdrawn.

Whilst the panel were not qualified to make any statements regarding the legal aspects of requests to withdraw data already collected in a research study they recognised that there was a tension between
respecting an individual's wish to withdraw their data and the public interest in the validity of research and the integrity of research data.

Whilst respect for autonomy demands that an individual has a right to
withdraw their active participation in a study at any time, their right to withdraw data derived from their participation is clearly more complex and any specific advice will depend upon the details of the individual case.

However, in general the panel noted that it was accepted practice to include in information sheets and consent forms the statement that that whilst participants were free to withdraw their active participation at any time any data collected during the study would still be included in any analysis.

It is not clear whether "participation" could or should be deemed to extend to the later analysis of non-identifiable data collected from an individual, but the panel felt that, in general, the public interest in the integrity of data produced by research trials would normally outweigh the perceived harm that might result from the retention and analysis of an individual's non-identifiable data against their will.

In addition, the panel felt that consideration would need to be given to whether the removal of individual's data would result in insufficient data remaining to produce any meaningful results thereby threatening the integrity of the trial

The issue of "ownership" of the data was also discussed by the panel. A parallel was suggested by AG with discussions regarding property rights in tissue and cell lines derived from tissue.

It has been argued that where the "remover" manipulates and “improves” the tissue he thereby acquires property rights over the tissue 1 .

AG suggested that the processing and analysis of an individual's personal data may be deemed to transfer intellectual property rights over that data to the “processor” thereby removing the right of the individual to request the removal of the data (now owned by the researcher).

However, SWo pointed out that these arguments with regards to property rights in tissue and cell lines were somewhat controversial and may have limited applicability to any case involving data.


Following the meeting the NREAP secretariat found the following guidance related to this issue that broadly support the NREAP position outlined above:

[etc]


The Wellcome Trust would consider it appropriate to retain data and samples within a study if they are anonymised, there is no link back to the participant, the risk to the individual of retaining the data is minimal and the withdrawal of the data threatens the integrity of the study.

http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-06-09_NREAP_Minutes_Final.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date: Time: 09 June 2010 14:00 – 17:00

Present:

Charles Warlow

2. Declarations of Interest
There were none

4. Matters Arising

4.1 Withdrawal of Data Following Participation in a Study.

Janet Wisely explained that following the Panel‟s discussion of this item at the last meeting the Information Commissioner has insisted that the study participant‟s data be removed from any analysis in the study that prompted the initial discussion of this issue.

It was noted by the Panel that this is likely to mean that the study will now not be published.

The Panel noted that the decision taken by the Information Commissioner might have been constrained by the existing date protection law, but strongly indicated that the consequence was that a study might be wrecked and that the autonomy of other participants in the study harmed

Simon Woods (SWo) suggested that NRES might consider providing a template for researchers as it has done in other instances such as the MCA so that researchers have an example of appropriate wording to use when raising the issue of data retention at the time of consent to a study.

The Panel felt that it would be beneficial to seek the views of other interested parties, e.g. the MRC, to mount a coordinated response to this decision.

It was agreed that Andrew George (AG) should contact Professor Janet Darbyshire (Head of the MRC Clinical Trials Unit and Joint Director of NIHR CRN CC) about the Panel's concerns regarding the removal of valuable data from research studies.

Action: AG

http://twitdoc.com/view.asp?id=232720&sid=4ZKG&ext=PDF&lcl=JohnsonPACE.pdf&usr=maxwhd&doc=289226639&key=key-uZS7PDYSUrAiD05o09EN

http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-07-14_NREAP_Minutes_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 14 July 2010 14:00 – 17:00

1. Apologies: Sarah Dyer, Charles Warlow;

4.3 Withdrawal of Data Following Participation in a Study.

Received for Information: email from Andrew George to Professor Janet Darbyshire (Head of the MRC Clinical Trials Unit and Joint Director of NIHR CRN CC) about the Panel's concerns regarding the removal of data from research studies.

JW informed the panel that advice had been reported which referenced the requirements of the EU Clinical Trials Directive to retain integrity of trials data.

There were interpretations to be made but current advice was that integrity of trial data needed to be considered alongside interpretation of data protection issues.


The panel discussed whether NRES or the NREAs should issue advice on the issue of the retention of data following the withdrawal of a participant. The panel agreed that the panel should review the current IRAS form and guidance and this issue should be discussed at a future meeting.

Action: CC

7. Patient Information Sheets – Discussion Document – Andrew George

http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-08-11_NREAP_Minutes_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date: Time: 11 August 2010 14:00 – 17:00

1. Apologies: Sarah Dyer; Charles Warlow..


2. Declarations of Interest
MIST trial – update
Richard Tiner explained that as a non-executive director of MedicoLegal Investigations Ltd he was party to information regarding an investigation conducted by this company into one of the investigators involved in the MIST trial although he did not participate in the investigation itself. The Panel considered that this did not constitute a major conflict of interest and that Richard Tiner should participate fully in the discussion of this item (6. MIST trial – update).


4.2 Withdrawal of Data Following Participation in a Study.

AG informed the panel that he had received further confirmation from Professor Janet Darbyshire (Head of the MRC Clinical Trials Unit and Joint Director of NIHR CRN CC) that they had received a response from the Information Commissioner‟s Office which they have interpreted as meaning that they do not need to withdraw the individual‟s study data from the PACE trial.

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/487271/Online_Responses_CitizenSpace.xls

18/12/2015, 10:51:53

Professor Peter White

Queen Mary University of London


Perhaps most damaging of all have been requests by two trial ex-participants to ""destroy"" all their data collected on them during the trial because of their concern that the data will not be held securely and confidentially, something we promised them to do as part of their giving informed consent.

The first such request was received after we had finished all trial data collection and had started the main analysis.

After some months of trying to obtain advice on what to do, we were advised to destroy this ex-participant's data, which we did (and which took some time to do due to the complexity of the data), but this meant that we had to restart the analysis, which caused several month's delay in publishing the main results paper in 2011.

This paper was important since it showed that there were two treatments for this condition which were safe and moderately effective. It is estimated that some 250,000 people suffer from CFS in the UK.

http://www.twitlonger.com/show/n_1so3l6f

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~


4.3 Patient Information Sheets
Hugh Davies (HD) informed the panel that NRES would be seeking comments next year on the current information sheet guidance and template with a view to issuing updated guidance.


11. Proposed guidance for NREAP to issue to RECs regarding Medical Device Review and CI conflict of interest.

The panel were asked to consider issuing the following NRES document from Joan Kirkbride (Head of Operations) as NREAP guidance:


Discussed: Ethical Review of Medical Device Studies – Financial Interest of Chief Investigator

The panel discussed the draft guidance and agreed that simply having a financial interest in the outcome of the research should not prevent an individual from being an investigator in that research nor result in that application receiving an unfavourable opinion purely for this reason.

It was noted that investigators involved in any research project would have a vested interest in its outcome which may or may not give rise to a significant conflict of interest.

Whilst RECs should always consider the potential for a conflict of interest each case should be considered on an individual basis.

It was considered that the interests of investigators, financial or otherwise, were not restricted simply to medical device studies and


felt that the NREAP guidance document should address the broader issue of conflict of interest in all studies.


Agreed: The panel agreed to issue advice on this subject using the submitted document as a starting point. AG and CC would amend the document accordingly prior to its issue as NREAP guidance
Action: CC & AG

http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-09-08_NREAP_Minutes_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date: Time: 8 September 2010 14:00 – 17:00

5.2 Proposed guidance for NREAP to issue to RECs regarding Medical Device Review and CI Conflict of Interest.

<>

Agreed:
1. The panel endorsed the previous minuted statement on conflict of interest and supported the proposed guidance drafted by NRES regarding medical device review and CI conflict of interest.

2. HD would collate background information on which to base a discussion paper and the panel would consider the wider issue of „conflict of Interest‟ at a future meeting with a view to issuing NREAP guidance on the matter.



http://www.hra.nhs.uk/wp-content/uploads/2013/07/2010-11-10_NREAP_Minutes.pdf

A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date:Time: 10 November 2010 14:00 – 17:00

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 Hugh Davies in response to complaints made about the SMILE study.

However, the panel felt that in reviewing its decision the REC involved should limit itself to considering only the relevant new information regarding the study itself and not to consider allegations which were 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 study participants were not being deprived of current care and the research question was the effectiveness of the additional tool which the study was designed to evaluate.

Agreed: The panel agreed and endorsed the proposed NRES action


http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_Minutes_2010-12-08_FINAL.pdf


A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date:Time: 08 December 2010 14:00 – 17:00

Present:

.... Charles Warlow ....

4. Matters Arising

4.1 The ‘SMILE’ Study

JW informed the panel that the main REC had now reviewed its favourable opinion in the light of new information (as per current NRES SOPs).

The main REC had voted unanimously to confirm the favourable opinion of the application with the following additional conditions:


1. PIS for Teenagers and PIS for Parents: Please add the fact that the Lightening Practitioner is not clinically (medically) qualified (trained).

2. PIS for Teenagers and PIS for Parents: Please include the following text in the „Are there any disadvantages to taking part‟ section:

“Teenagers with CFS/ME can get worse with any intervention offered. There is no data in teenagers, see tables 1 and 2 for data in adults.”

3. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the Parliamentary Inquiry into NHS Service provision for ME/CFS include Data taken from Action for ME (AfME) and Association of Young people with ME (AYME) joint report “M.E. 2008:
What progress” and reference it.

4. PIS for Teenagers and PIS for Parents: Add the figures for GET, CBT and the LP from the 2008 MEA survey and reference this.

The main REC also suggested (not as an additional condition) that in future Dr Crawley should consider using Lightening Practitioners who were additionally clinically qualified.

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_Minutes_2011-01-12_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date: Time: 12 January 2011 14:00 – 17:00

4.2 The ‘SMILE’ study
Received for information only: Letter from Joan Kirkbride


9. NREAP guidance regarding ‘Conflict of Interest’ - Hugh Davies

Following discussion of the SED phase I report the panel are asked to further consider whether they wish to issue NREAP guidance on „conflict of Interest‟.

David Neal expressed the opinion that the NRES paper "Medical Device Review and CI Conflict of Interest” previously considered by the panel, whilst specific to medical devices, was an extremely useful document and hoped that it would eventually be disseminated amongst the REC community.

The panel manager referred DN to the panel‟s previously agreed statement concerning this paper which supported the publication by NRES of this guidance:

“The panel ... supported the proposed guidance drafted by NRES regarding medical device review and CI conflict of interest.” (NREAP Minutes, 8 September 2010)

Agreed: The panel agreed that it might be useful for the panel to consider issuing guidance which might simply identify existing guidelines that may be of use to RECs in considering this issue. Both John Saunders and Hugh Davies would collate relevant guidance for consideration at a future meeting with a view to issuing NREAP guidance.
Action: HD & JS

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-02-09_FINAL.pdf


A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 09 February 2011 14:00 – 17:00

2. Declarations of Interest:
6. The SMILE Study
Janet Wisely (NRES Director) and Hugh Davies (NRES Ethics Advisor) left the room during the discussion of this item.

<>

6. 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 to categorically 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 opinion in 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 initial and subsequent review provided by the main REC they considered the REC‟s opinions to 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 received after 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.

7. Letter from RCP Committee for Ethics in Medicine re Wakefield et al.

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-04-13_-_revised_2012-01-11.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date: Time: 13 April 2011 14:00 – 17:00

4.4 The SMILE Study

AG had contacted „Understanding Animal Research‟ who were happy to explore areas of common ground in handling correspondence with regard to conducting research in contentious areas.

5. NRES Update : Janet Wisely

JW informed the panel that NRES had now received three formal complaints regarding the ethical review of the SMILE study, JW has completed the NRES investigation as per NPSA complaint policy and as per this policy if subsequent complaints are received, and it is deemed they have been fully investigated through the initial investigation, a further investigation is not undertaken, those raising complaints are advised of the investigation that has been completed. Those not satisfied with the response at that stage have options to take their complaint to a further stage, the NPSA Chief Executive, and a third stage to the Parliamentary and Health Service Ombudsman.

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-06-08_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date:Time: 08 June 2011 14:00 – 17:00

4.2. PACE Trial – Text of joint letter calling for more information, 24 May 2011 Received for information only:

PACE Trial – Text of joint letter from the ME Association together with the Young ME Sufferers Trust and the West Midlands ME Groups Consortium to Professor Peter D White (investigator, PACE Trial) calling for more information, 24 May 2011 (http://www.meassociation.org.uk/?p=6171)

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-07-13_FINAL.pdf

A meeting of the National Research Ethics Advisors‟ Panel was held on:
Date: Time: 13 July 2011 11:00 – 12:00

4. Matters Arising
4.1. CFS/ME Research

Richard Tiner drew the panel's attention to a recent article in the BMJ entitled “Living with CFS/ME” 1by Ollie Cornes which he felt would be of interest. CC would circulate the article to the panel by e-mail.

It was also pointed out that the MRC has highlighted Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) as a high priority and will be making available up to £1.5M for new research into the mechanisms of CFS/ME. The MRC has also set up a new group, the CFS/ME Expert Group (chaired by Professor Stephen Holgate, chair of the MRC Population and Systems Medicine Board), to consider how new high-quality research into CFS/ME and partnerships between researchers already working on CFS/ME and those in associated areas might be encouraged. 2

4.2. Disruption of Research

Janet Wisely explained that she had met with Barbara Davies (Communications Director, Understanding Animal Research) to discuss possible ways forward with regards ensuring that medical research may be carried out without fear of harassment. This issue would be discussed further at a future meeting of the panel.

1 BMJ 2011;342:doi:10.1136/bmj.d3836 (Published 22 June 2011)
2 http://www.mrc.ac.uk/Ourresearch/ResearchInitiatives/CFSME/index.htm

<>

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-09-14.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 14 September 2011 14:00 – 17:00

6. Conflict of Interests
The panel were asked to comment on the attached “conflict of interests section from NRES induction material”, particularly regarding how the table “Questions the REC might raise/Preparations and answers from the researcher” might be developed to assist RECs.

Received for discussion/advice:

Conflict of interests section from NRES induction material

In discussion, the panel noted with approval that the latest version of the NRES SOPs states that the following should be considered to be a substantial amendment:
“A change to the payments, benefits or incentives to be received by participants or researchers in connection with taking part in the study, or any other change giving rise to a possible conflict of interest on the part of any investigator/collaborator”

SiWo felt that it would be hard to establish a threshold for when an interest becomes a conflict of interest. Most researchers would all have a strong personal interest in the successful completion of research they were involved in but society did not consider this personal interest to be incompatible with the proper conduct of research.

In addition patient groups could also have a personal interest in the conduct of the research.

Even where a researcher has a financial interest in the outcome of research it would not necessarily represent a conflict of interests incompatible with their being directly involved in that research.

NT felt that the threshold would be reached at the point the research was compromised by the overriding interest.

SD felt that it was important that all parties involved in the research should be aware of the interests of the researchers so that they can make a judgement as to whether these interests would endanger the validity of the trial.

JB agreed and felt that such interests should be more upfront in participant information sheets.

NT commented that the pressures placed on researchers to successfully conduct research studies were increasing.

For example, CLRN funding was dependent upon the number of patients recruited into research studies.

Furthermore, one of the criteria for clinical excellence awards was the number of people recruited into clinical trials.

Whilst these all represented examples of competing interests NT felt that the main issue was that such interests were declared so as to ensure that the legitimate aims of the research were not compromised by interests of the researcher/sponsor.

SiWo agreed that researchers should openly declare what their interests were and that these might be judged to be conflicting where they were incompatible with the aims of the research.

FW propose that any guidance on this issue should state that, as a fundamental principle, that all interests must be declared.

However, the panel felt that this was somewhat onerous given the large number of explicit and implicit interests that all researchers would have.

It was suggested that such a statement might be restricted to „all interests directly associated with the research‟.

It was also pointed out that as interests can change and develop over time that researchers should be asked to declare all foreseeable interests.

This was compatible with the requirement in the NRES SOPs that any change giving rise to a possible conflict of interest on the part of any investigator/collaborator should be submitted as a substantial amendment. Ahere such changes were foreseeable prior to their becoming
an actuality they should be declared at the outset.


CW pointed out that the BMJ has a useful way of looking at whether a non-financial interest is potentially a conflicting interest i.e. individuals seeking publication in the journal should ask themselves whether a competing interest “would embarrass you if it became generally known after publication?” 3

The panel felt that this was a very useful acid test of whether an interest was potentially a conflicting interest.

The panel felt that it would be useful if the IRAS form requested the details of potential conflicts of interests of all investigators involved in research and not just those of the Chief Investigator.

Agreed:

The panel endorsed the tabled “conflicts of interest section from NRES induction material” as suitable guidance on this matter.


http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_Minutes_2011-10-12.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date: Time: 12 October 2011 14:00 – 17:00

CW mentioned a recent article referring to the withdrawal of permission to use their data by participants in a study looking at whether there is a link between CFS and xenotropic murine leukaemia virus related
virus (XMRV).

All six participants withdrew their data with only two deciding to reinstate their consent for the use after the researchers had discussed this with them.

The panel thought that the issue of when participants can legitimately withdraw their data from existing research would be useful to follow up at a future meeting.

NREAP Minutes 12 October 2011
Page 3

http://www.hra.nhs.uk/wp-content/uploads/2013/07/NREAP_MINUTES_2011-11-09_FINAL.pdf


A meeting of the National Research Ethics Advisors’ Panel held on:
Date:Time: 09 November 2011 14:00 – 17:00


7. Conflict of Interests – Draft Guidance

<>

9. Disruption of Research - Caroline Harrison
Unfortunately Caroline Harrison had to give her apologies for this meeting. This item would be discussed at the January NREA Panel meeting.

10. Seeking Consent – Hugh Davies

HD explained that NRES will be revising their existing guidance on information sheets next year.

The NREAs were invited to provide initial advice, ideas, references etc in order to inform this work. Four regional meeting (London, Bristol, Manchester and Edinburgh) will take place to seek the views of stakeholders and HD explained that it would be helpful if as many NREAs as possible could take part in these.

The panel also agreed that stakeholders from outside the REC system should also be invited to attend these meetings.


http://www.hra.nhs.uk/documents/2013/09/nreap-meeting-minutes-11-january-2012.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 11 January 2012 14:00 – 17:00


6. Disruption of Research - Caroline Harrison
Unfortunately Caroline Harrison had not been able to prepare the presentation in time for the meeting. This item would be discussed at the February NREA Panel meeting.

http://www.hra.nhs.uk/documents/2013/09/nreap-meeting-minutes-08-february-2012.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date: Time: 08 February 2012 14:00 – 17:00

7. Disruption of Research - Caroline Harrison
Unfortunately Caroline Harrison had not been able to prepare the presentation in time for the meeting.

This item would be discussed at the March NREA Panel meeting.

8. A consensus statement on research misconduct in the UK - FW
Received for information:
Verbal presentation by Frank Wells regarding the joint BMJ/COPE meeting held on 12
January. The meeting brought together institutions, researchers, and funders to address the problem of research misconduct in the UK.

BMJ News: Scientific misconduct is worryingly prevalent in the UK, shows BMJ survey
BMJ Editorial: Research misconduct in the UK. Time to act
A consensus statement on research misconduct in the UK from the BMJ/COPE high level meeting, London, January 12 2012

The panel noted and welcomed the BMJ/COPE consensus statement on research misconduct in the UK.

It was noted that the HRA should have an interest in research conduct in general and it was suggested that once the HRA business plans have been agreed then it may be appropriate to enter into a dialogue with the UK Research Integrity Office (UKRIO) on this issue.

http://www.hra.nhs.uk/documents/2013/09/nreap-meeting-minutes-14-march-2012.pdf

A meeting of the National Research Ethics Advisors‟ Panel will be held on:Date:Time: 14 March 2012 14:00 – 17:00

10.3 Charles Warlow
Charles Warlow informed the panel that this would be his final meeting and that he was about to sail around the British Isles for the next five months. The panel thanked him for all of his work on the panel over the last 2 1/2 years and wished him well for the future and a bon voyage!

http://www.hra.nhs.uk/documents/2013/09/meeting-minutes-13-june-2012.pdf

A meeting of the National Research Ethics Advisors‟ Panel held on:
Date:Time: 13 June 2012 14:00 – 17:00

8. Disruption of Research – Caroline Harrison
Received for information/discussion:
A verbal presentation by Caroline Harrison regarding legal remedies to counter organised disruption to research
Received for information/discussion:

A verbal presentation by Caroline Harrison regarding legal remedies to counter organised disruption to research

CH started her presentation by indicating that there was no easy answer to the question of whether there were legal remedies available to counter any organised disruption to research.

The fundamental difference was between criminal offences (which may be prosecuted once committed; but where pre-emptive remedies are more difficult and of less „value‟ in terms of protecting researchers) and conduct regulated by the civil law, where pre-emptive remedies to govern future conduct may be obtained.

In criminal law, the offence is committed when all the necessary „elements‟ have occurred.

Those elements are the „actus reus‟ and the „mens rea‟ – i.e. the actions + accompanying mental intent.

Crimes may also be „attempted‟, but only if acts have been done which are „more than merely preparatory‟ to the substantive offence.

Conspiracy to commit crime is also an offence, but proving the requisite degree of
agreement to amount to a conspiracy is difficult.

Hence criminal law has its limitations, in this context.

However, she noted that if the desired objective was to protect researchers and ancillary staff from

NREAP Minutes 13 June 2012
Page 6 of 10

actual violence, or the imminent threat of violence, then this would primarily fall within the domain of criminal law and could be prosecuted once sufficient evidence was available.

Prosecutions may be undertaken privately, or by the police.

However, assaults also amount to a trespass against the person, and so the civil law could be used to restrain people from committing such acts, if there are good grounds for suspecting that this will occur or recur.

Concerted campaigns by groups to disrupt research (where the conduct of the group‟s members falls short of threatening violence) was a much vaguer and more controversial area.

Legal remedies to combat e.g. non-violent or abusive campaigns to dissuade researchers from undertaking certain types research was in practical terms a "nonstarter", because the courts would have to balance the rights of researchers to go about their daily business, with the rights of protesters to free speech and freedom of expression.

Where that balance will be struck in any one case, will be a matter of fact in any situation, and will be difficult to predict in advance.

There were also practical problems, such as identifying
defendant(s) – see below.

There is no specific statutory provision that CH could find, that was designed specifically to protect staff involved in clinical research. CH stated that she could not conceive of legislators or ministers being persuaded that there should be some specific regulation that should be passed, that would apply to researchers, but that did not also apply to the general public.

She noted that within the existing law, there were three statutes that may have the greatest relevance to this area:

1) Protection from Harassment Act 1997;

2) Public Order Act 1986; and the

3) Malicious Communications Act 1988

CH noted that under civil law injunctive relief can be used to limit certain behaviours (e.g. preventing people from going to specified locations, or from contacting the claimant(s) etc., but it cannot require them to do positive acts).

However in order to be able to bring a claim under the civil law, a claimant has to be able to identify an actual defendant that is recognised in law (i.e. something that has legal personality, such as a limited company, or an unincorporated association, or an individual person).

Without this, there is no-one to sue, and no-one upon whom to serve papers, or to punish for breach of any Order made by the Court.

This is likely to cause a real difficulty in the case of research disruption, because the people engaged in such conduct are likely to be part of a loose grouping of like-minded individuals; they may be difficult to identify as individuals, and many will have have no assets or insurance.

Like the Hydra, once you cut off one head, more will spring up in its place

The real problem in both criminal and civil cases is the balance between an individual's right to freedom of expression and the rights of others to carry out their business without harassment.

CH explained that there were two main cases in this area that provided useful parallels:

1) Connolly v. DPP [2007] EWHC 237 (Admin); [2008] 1 W.L.R. 276 4 and

2) Novartis Pharmaceuticals UK Ltd & Ors v Stop Huntingdon Animal Cruelty („SHAC‟) & Ors [2009]
EWHC 2716 (QB) (30 October 2009) 5

Connolly v. DPP concerned a woman who sent graphic images of aborted foetuses to pharmacies.

She was a Roman Catholic who objected to the morning after pill.

She was prosecuted under the Malicious Communications Act 1988.

The court held that all the necessary elements of the offence were made out and so her appeal was rejected, but it also rejected the defendant‟s argument that the prosecution violated her right to freedom of expression under Article 10 of the European Convention on Human Rights.

The court held that the restriction on her Article 10 right to "freedom of expression" was justified because the images were grossly indecent and offensive, and the restriction was justified as being a proportionate limitation on her rights, when balanced against the the rights of others to work without being subjected to grossly offensive material that was plainly intended to shock.

4 http://www.bailii.org/ew/cases/EWHC/Admin/2007/237.html

5 http://www.bailii.org/ew/cases/EWHC/QB/2009/2716.html

NREAP Minutes 13 June 2012
Page 7 of 10

In Novartis Pharmaceuticals UK Ltd & Ors v Stop Huntingdon Animal Cruelty („SHAC‟) & Ors the claimants applied for amendment of the injunction to address concerns about a protest planned for Halloween.

Among other things, the claimants sought orders that the protestors must not: wear clothing or costumes splattered with blood; wear balaclavas, masks or face coverings; use banners to accuse Novartis and/or its employees of murdering, torturing or abusing animals.

Mr Justice Sweeney refused to amend the injunction to prevent the protestors from wearing blood splattered clothing or costumes.

He held that such a restriction was not a proportionate restriction on their freedom of expression, and was unlikely to be practically enforceable.

He also refused to prevent the protestors from wearing masks, but acknowledged that that issue was less „clear cut‟.

In reaching his decision, he balanced the potential for ghoulish masks to cause distress and conceal the identity of people who intend to harass others against:

the practical problems that a ban on masks would cause for the Police; the risk that such a prohibition would heighten tensions; and the rights of people to wear innocuous masks.

CH concluded by stating that she saw no realistic mechanism by which medical research could be singled out as a special category of work, and specifically protected beyond the scope of the general law which already regulates people‟s conduct.

She noted however, that civil law injunctions might be a valid option where the conduct was egregious (indeed, they may be the only realistic option in some cases), and that they did have real "teeth", because breach of such injunctions is a contempt of court, and the ultimate sanction for persistent and deliberate contempt, even in a civil case, is imprisonment.

Thus limited means/the lack of insurance may not be relevant if what you are really seeking to do, is to prevent identifiable individuals from threatening research workers.

http://www.hra.nhs.uk/documents/2013/10/nreap04-guidance-national-research-ethics-advisors-panel-13-february-2012.pdf


Date of document: 13/02/2012
Title of document: Conflict of Interests/Competing Interests.

What proposals could a REC make?

The following steps might be taken in order to mitigate the competing interest (N.B. these measures should be applied in a proportionate manner in accordance with the seriousness of the competing interest):


The investigator's financial interests/other competing interests should be publically declared and described in the participant information sheet

Independent (or shared) management of the research. Responsibility for
participant recruitment and enrolment, the informed-consent process, analysis of the study data, and the subsequent reporting to the sponsor could be devolved to an independent third party

Independent (or shared) monitoring of the research

Encourage researchers to make their research datasets publically available to allow independent validation of results

Where the source of the researcher‘s competing interests derives solely from their relationship with a particular research site then consideration might be given to changing the research site(s) involved the study

Divestiture of significant financial interests

Ending of relationships that create actual or potential conflicts

Disqualification of the researcher from part, or all, of the research project

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

Diagnostically Speaking: How should CFS/ME Be Classified

- and Does it Matter?


Hugh Rickards


"Most prefer the narrative attached to the word ‘physical’, even though prognosis and mortality may be worse.

The same dichotomy is played out in the political arena in relation to disability benefits.

People with CFS/ME, which most doctors would still place in the ‘mental’ camp, are much more likely to be refused benefits than people with ‘physical’ illnesses, such as multiple sclerosis.

Most patient support groups champion the ‘physical’ perspective, and attacks on mental health professionals in the field from the ME activist community are relatively commonplace, especially on social media.

Interestingly, some of these patient support groups are allied with other campaigns against environmental pollutants such as vaccines, organophosphates, and mercury amalgam dental fillings, indicating a preference for the narrative of the ‘toxic agent attacking the patient’.

One interpretation of this narrative preference is that the association between ‘mental disorder’ and ‘not really ill at all’ is so strong, that non-conventional physical explanations are sought when ‘all the tests are negative’.

A different explanation could be that activist groups of all kinds are more attractive to conspiracy theorists".

http://www.palgraveconnect.com/pc/doifinder/10.1057/9781137467324.0009

http://www.commed.vcu.edu/Chronic_Disease/neurologic/2013/medicalorMental.pdf
P D White, H Rickards, and A Z J Zeman

Reply · Report Post