Mr John Peters johnpetpub@gmail.com Skipton House 80 London Road London SE1 6LH Email: hilary.tulloch@nhs.net 11 July 2019 Dear Mr Peters, RE: REC reference: 02/7/089 – release of PACE Trial data Thank you for your letter dated 06 June 2019 appealing the advice given to the research team by the Edgbaston Research Ethics Committee (REC), notably that the data from the PACE trial, even in an anonymised form, should not be put into the public domain. This advice from the REC was made to the researcher on 28 March 2017 and reconfirmed to you on 20 May this year. You have requested Chief Executive’s review of this advice, as allowed under the HRA’s Complaints Policy and Procedure, based on the advice being unfair, unreasonable and not in the public interest. I have now had chance to review your appeal, the contents of which have been discussed further with the REC Chair and another member of the REC. In reviewing your appeal letter, the REC Chair highlighted some of the principles used by the REC when giving advice such as in this instance. The Chair flagged the training REC’s receive teaches members to consider the risk of deductive disclosure of identity, especially where qualitative data are concerned. In the case of the PACE trial, the REC decided to take a conservative position on the risk, particularly as the original request to make data available came from a member of the concerned community. The REC has advised it is normally happy for researchers to seek consent from participants to make their data available to other bona fide researchers on the understanding that they are bound by codes of ethics set by their professional body, employer or funder. The REC also advised in qualitative studies, it is important that the analysis be carried out according to one of the recognised theoretical frameworks, partly in order to guard against the risk of the analysis being over-influenced by the viewpoint of the analyst. Again, the REC took the view that this would be easier to achieve within a university or other research institute with a code of practice on these matters. Upon reviewing the documentation, I note the advice made by the REC in March 2017 was from an ethical point of view and the Chair recommended further advice, on governance related legalities, be sought from the researcher’s organisation. I am satisfied the REC did not act improperly in issuing its original advice as this was based on the information provided to the REC at the time and was clear it was from an ethical standpoint. I am satisfied the REC gave the advice in an attempt to appropriately balance the confidentiality of participants with the public interest in transparency. Having reviewed the First-Tier Tribunal (FTT) and discussed this with the REC Chair, the REC accepts that this provides more detailed guidance on how the balance between participant confidentiality and the public interest in transparency should be struck. The REC has therefore reconsidered its initial advice and accepted the majority decision finding from the FTT which supported the Information Commissioner’s ruling requiring the disclosure of the data. The REC has informed the researcher of this change of advice. This reconsideration is based on the information you have brought to our attention and the change of advice does not in any way suggest that either the REC or the researcher acted improperly or in bad faith previously. Your appeal has therefore been upheld. Please accept my thanks for bringing this to our attention. As you may be aware, the HRA is consulting on transparency and openness in health and social care research and would be keen to hear your views on the development of the final transparency strategy. Please see the Make It Public section of our website for more details and how to respond. Finally, if you still remain dissatisfied with our response and handling of the complaint and appeal you may wish to write to the Parliamentary and Health Service Ombudsman. Contact details: The Parliamentary and Health Service Ombudsman Millbank Tower Millbank London SW1P 4QP Tel: 0345 015 4033 Website: www.ombudsman.org.uk Yours sincerely, Teresa Allen Chief Executive Health Research Authority