Whether the Hospital was justified in refusing to grant the applicant's request for records relating to a review undertaken by a Hospital consultant in connection with the Surgical Symphysiotomy Ex-gratia Payment Scheme
Case Number: 170398
Background
The Surgical Symphysiotomy Ex-gratia Payment Scheme (the Scheme) was established by the Government on 10 November 2014 to compensate women who had undergone a surgical symphysiotomy procedure. Judge Maureen Harding Clark was appointed independent judicial Assessor to the Scheme. In October 2016, Judge Clark submitted her report on the Scheme to the Minister for Health. The Report was subsequently published on 19 October 2016.
On 7 December 2016, the applicant submitted a request to the Hospital for information relating to a comparative study that, according to a footnote at page 28 of the Report, was being undertaken in the Hospital's Radiology Department at the time.
The applicant specifically sought the following information:
1. Details of the study including terms of reference, methodology, governance, participants, basis of consent, identity of the medical professionals responsible for the study, details of any collaboration with an external entity, etc.
2. The information submitted or intended to be submitted to the research ethics committee or any internal or external body that must provide ethical approval
3. The sources of data for the study
4. Details of the funding for the study
5. Details of the patients who are participants in the study
6. Templates of the consents that have been sent to or received from participants
7. All correspondence or other information exchanged with Maureen Harding Clark or her office concerning the study
It is important to note at this stage that the Hospital has since confirmed that the study referenced in the footnote at page 28 of the Report is the subject of Appendix 1 of the Report, entitled "Symphsiotomy & Pubiotomy Review - An Imaging Perspective", written by Professor L.P. Lawler (the consultant). The applicant also accepts this to be the case. I will refer to this appendix for the remainder of this decision as the consultant review.
As the Hospital failed to issue a decision on the request within the statutory time-frame, the applicant sought an internal review of the deemed refusal of its request on 9 January 2017. As the Hospital also failed to issue an internal review decision within the required time-frame, the applicant sought a review by this Office of the refusal of the request. Following correspondence with this Office, the Hospital wrote to the applicant on 8 February 2017, wherein it refused the request under section 15(1)(d) on the ground that the information sought was already in the public domain and it provided a link to the Scheme Report on the Department of Health's website. It stated that "This study was not a Mater project, although there was a consultant involved as an independent opinion on the judicial review team".
The applicant was not satisfied with the Hospital's position, and on 9 August 2017, it informed this Office that it wished the review to proceed. During the course of the review, Mr Benjamin O'Gorman of this Office informed the applicant of his view that the Hospital was justified in refusing the request on the ground that the records sought were not held by the Hospital. The applicant did not agree with Mr O'Gorman's view and made a submission to this Office on 8 November 2017, along with an additional submission on 6 December 2017.
I have decided to conclude this review by way of a formal binding decision. In conducting the review I have had regard to the correspondence between the Hospital and the applicant and to the correspondence between this Office and both the applicant and the Hospital on the matter.
Scope of Review
The scope of this review is concerned solely with whether the Hospital was justified in refusing to grant the applicant's request on the ground that it does not hold the records sought.
Preliminary Matters
It is important to note that a review by the Commissioner under section 22 of the FOI Act is de novo, which means that it is based on the circumstances and the law as they pertain at the time of his decision. As such, while the Hospital originally refused the request under section 15(1)(d), it became clear during the course of the review that the Hospital's position is that it holds no relevant records and accordingly, section 15(1)(a) is more relevant. The applicant was given an opportunity to make a submission on the applicability of section 15(1)(a) and it did so.
It is also important to note that this review is not concerned with the question of what records the Hospital should hold. If the records sought are not held by the Hospital, that is the end of the matter, regardless of the applicant's views as to what records it believes the Hospital should hold. However, it is incumbent on the Hospital to explain to this Office why it does not hold the records.
Analysis and Findings
Section 15(1)(a)
Section 15(1)(a) of the FOI Act provides that a request for access to a record may be refused if the record does not exist, or cannot be found, after all reasonable steps to ascertain its whereabouts have been taken. The Commissioner's role in such cases is to review the decision of the FOI body and to decide whether that decision was justified. This means that I must have regard to the evidence available to the decision maker and the reasoning used by the decision maker in arriving at his/her decision. The evidence in "search" cases consists of the steps actually taken to search for records, along with miscellaneous other evidence about the record management practices of the FOI body, on the basis of which the FOI body concluded that it has taken all reasonable steps to locate the relevant records.
It appears that the applicant's arguments as to why it considers that the Hospital should hold relevant records are based on its view of the nature of the review undertaken by the consultant. In its submission of 25 August 2017 to this Office, the applicant argued that the number and seniority of Hospital staff who are the authors of the consultant review and the fact that they utilised the Hospital's facilities indicate that the review was a Hospital project. It argued that, based on a reasonable assumption that the Hospital observes minimum international ethical standards, the Hospital should have significant documentation regarding templates and guidelines for health research and should have a minimum set of records on its file documenting the research design and operationalisation of the consultant review. In support of that argument it provided a submission by a lecturer and researcher in sociology who set out her views as to the types of records one might expect to find in relation to what she describes as a "large research project", by referencing a publication by the World Health Organisation, entitled "Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants".
The essence of the Hospital's submission of 22 September 2017, much of the detail of which was provided directly by the relevant consultant, is that the consultant review was not a Hospital project. As Mr O'Gorman of this Office has already provided the applicant with the relevant details of that submission, I do not propose to repeat those details in full here. In summary, the Hospital stated that the consultant review was never a Hospital project, nor was it intended to be. It stated that the consultant review does not constitute a formal research project or hypothesis study. It was simply intended as a summary and guide to the main review. The consultant was not engaged by the Hospital but directly by the judicial review group.
In a subsequent submission of 8 November 2017, the applicant argued that the consultant review goes beyond a simple review of the consultant's input to the Scheme and that it has all the indicia of clinical research. It went on to argue why it believes that certain records should exist in light of its understanding of the nature of the work undertaken. It further argued that the extensive use of the Hospital's resources is inconsistent with the Hospital's claim that it had nothing to do with the consultant review.
Following a request by this Office for further clarifications, the Hospital provided a further submission, much of which was provided by the consultant. The consultant stated that he was approached in his personal capacity and not through his employer. He stated that he does not believe that his institutional affiliation was a matter of consideration and that the Hospital was not approached about the review. The consultant further stated that his role in the Scheme was to review any imaging objectively and form an opinion on any anatomy or pathology present. He stated that for the most part he was sent images on CDs or old radiology films that were from hospitals nationwide, and that the images he received from solicitors and patients were generally not from the Hospital. He stated that they were sent to him personally and not through the Hospital, and that they were usually hand delivered to him to at meetings in Judge Harding Clark's office.
The consultant further stated where images were not available he searched the National Integrated Medical Imaging System (NIMIS) and the Mater Private Archive, and that the NIMIS archive is present in over 90% of public hospitals. He stated that there is archive access in independent Hospitals including the Mater private hospital and that he can also access it from home. He stated that if he ever needed access in the Hospital he did so out of hours and that he did not use any unique Hospital IT systems or imaging archives.
The consultant stated that when he wrote his reports he did so without any administrative input from the Hospital, that all reports were submitted to the Scheme and that he retained no records once the Scheme finished. He stated that at no time did he ever communicate with the Hospital about his personal involvement with the Scheme Review. The consultant stated that he was paid in a private capacity directly by the Department of Health and that he never received any remuneration from the Hospital for the Scheme Review.
The consultant further stated that as he neared the end of the Scheme Review he thought it was necessary to establish some reference values for women who had not undergone symphysiotomy. He stated that this was not a formal, hypothesis driven research study and that he did not make any application to the Hospital's Institution Review Board or Ethics Committee as he was simply trying to establish a range of values as a reference. He stated that to establish these reference values he reviewed an anonymised cohort of x-rays in the NIMIS archive, recorded the results and put them in the review. He stated that he did not save any of the findings on any Hospital system, that no Hospital resources were used in the Scheme Review, nor did the Hospital hold any files on it.
The consultant stated that all imaging and documents received from the Scheme were ultimately returned to the Scheme, and that as he had no further engagement with it, he did not retain any records relating to the Scheme. The consultant stated he hand delivered these records back to the Scheme's office, to either Judge Clark or to one of her assistants.
Having regard to the explanations provided by both the Hospital and the consultant of the nature of the consultant review and of the manner in which it was undertaken, I am satisfied that it was not a Hospital project. While the applicant may hold a different view as to the nature of the work undertaken and as to what records should exist, I have no reason to doubt the Hospital's explanation as to why it holds no relevant records. I find, therefore, that the Hospital was justified in refusing the applicant's request under section 15(1)(a) of the FOI Act on the ground that the records sought do not exist.
I should say for the sake of completeness that in light of the consultant's clarification that he returned all imaging and documents received to the Scheme and that he did not retain any records relating to the Scheme as he had no further engagement with it, I did not deem it necessary to consider whether any relevant records in the possession of the consultant might be deemed to be held by, or under the control of, the Hospital. Even if I had, it seems to me, given my acceptance of the Hospital's argument that the consultant review was not a Hospital project and that the consultant was acting in a private capacity, that any such records, could not be deemed to be held by the Hospital. It is noteworthy that this Office has previously accepted that certain records held by consultants acting in a private capacity are not under the control of the relevant Hospital for whom they also provide services for public patients.
Decision
Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the decision of the Hospital to refuse access to the records sought but vary the grounds upon which that refusal was justified. I find that it was justified in refusing the request under section 15(1)(a) of the FOI Act on the ground that the records sought do not exist.
Right of Appeal
Section 24 of the FOI Act sets out detailed provisions for an appeal to the High Court by a party to a review, or any other person affected by the decision. In summary, such an appeal, normally on a point of law, must be initiated not later than four weeks after notice of the decision was given to the person bringing the appeal.
Stephen Rafferty
Senior Investigator
