Right to Know CLG and Mater Misericordiae Hospital Limited (FOI Act 2014)
Case number: 170397
Issue: Whether the Hospital was justified in refusing access to further records relating to the applicant's request for various types of forms and templates used by the Hospital, and other specified information, in respect of health related research studies on the ground that no further relevant records exist
Review: Conducted in accordance with section 22(2) of the FOI Act by Stephen Rafferty, Senior Investigator, who is authorised by the Information Commissioner to conduct this review
On 7 December 2016, the applicant submitted a two part request to the Hospital for records relating to health related research studies.
At part 1, it sought copies of the templates and forms that are normally used by the Hospital in respect of health related research studies (excluding clinical trials for medicines for human use), to include:
(a) the application form used for ethical approval,
(b) forms or templates to notify other departments within the Mater,
(c) forms or templates to notify external parties (e.g. the HSE or an academic institution)
(d) forms or templates used to communicate with and get the consent of the patients whose information is used in such studies, and
(e) forms and templates used to approve the budget and allocation of resources to such studies.
At part 2, the applicant sought details of how the Mater maintains records of health related research studies (other than clinical trials of medicines for human use) including details of any databases that is uses to record such studies.
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 the request on 9 January 2017. As the Hospital also failed to issue an internal review decision within the required time frame, the applicant subsequently sought a review by this Office of the deemed refusal of the request. Following correspondence with this Office, the Hospital wrote to the applicant on 8 February 2017, wherein it released records relating to parts 1(a) and 1(d). It stated that it held no records relating to parts 1(b), 1(c) or 1(e). In relation to part 2 of the request the Hospital stated that one hard copy file is held for each research study submitted for Institutional Review Board review.
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 the Hospital identified and released to the applicant a further record entitled "Operating Procedure and Policies in relation to Clinical Research", deeming it relevant to part 2 of the request. The Hospital stated it did not hold any further records relevant to the applicant's request.
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 access to any further records coming within the scope of the applicant's request on the ground that no further relevant records exist.
At the outset, I would like to record my disappointment at the Hospital's failure to respond in a timely manner either to the original FOI request or to request by this Office for information during the course of the review. As noted above, the Hospital failed to issue either an original decision or an internal review decision within the time frames set out in the FOI Act. Furthermore, there was a significant delay in the Hospital replying to a request from this Office for details of its relevant records management policy and of the searches undertaken to locate relevant records. This delay necessitated a formal notification being issued to the Chief Executive of the Hospital under section 45 of the FOI Act, requiring the provision of the information sought.
While I fully appreciate that most, if not all, public bodies have recorded significant increases in the number of FOI requests received since the introduction of the 2014 Act, it is important that they make every effort to ensure that the resources afforded to the processing of requests are sufficient to deal with the demand levels.
Analysis and Findings
As outlined above, the Hospital's position is that no further relevant records coming within the scope of the applicant's request exist. Section 15(1)(a) of the FOI Act provides that a request may be refused if the records sought do not exist, or cannot be found, after all reasonable steps to ascertain their 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.
In its submission of 25 August 2017, the applicant argued that the Hospital should have significant documentation regarding templates and guidelines for health research, based on its assumption that the Hospital observes minimum ethical standards. 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". Her submission suggests that one might expect to find records such as an application, the protocol for the proposed research project and supporting documents, a project summary, a description of the ethical considerations involved, background information on previous research etc.
It is important to note that this review is not concerned with what records the Hospital holds or ought to hold in respect of health related research studies, regardless of their nature. Rather, it is concerned with what templates and forms it holds in relation to such studies.
During the course of the review, Mr O'Gorman of this Office provided the applicant with details of the description provided by the Hospital of the role of its Institutional Review Board (IRB) in relation to health related research studies and of the searches it undertook in an effort to locate relevant records. In summary, the Hospital stated that the IRB's remit is to review research studies and clinical trials that are carried out at the Mater Misericordiae University Hospital and/or the Mater Private Hospital and all sites in the case of clinical trials that come under S.I. No. 190 of 2004 (European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004). It stated that the IRB does not have a role in monitoring research studies and clinical trials once their review is complete and refusal or approval to proceed with each study and trial is granted and that it is up to lead investigators (research applicants) of individual clinical trials/research studies to retain documentation for each clinical trial/research study.
The Hospital further stated that while the IRB is the only area within the Hospital that would or could hold these types of records, the IRB does not have a function in creating forms and templates as sought by the applicant. It added that where the IRB communicates with lead investigators, its correspondence is unique to each study trial and it does not hold templates or forms of the type sought, apart from the information already released.
In relation to part 2 of the applicant's request, it appears that the Hospital did not consider that part as a request for records but rather as a request for information relating to how it maintains records of health related research studies. As such it provided a response to the effect that one hard copy file is held for each research study submitted for IRB review. As outlined above, following correspondence with this Office, the Hospital accepted that a procedures document entitled "Operating Procedure and Policies in relation to Clinical Research" was relevant to part 2 and it agreed to release same. While the applicant, in a subsequent submission of 8 December 2017, took issue with the fact that the record in question was not released from the start, it appears to accept that part 2 has been satisfactorily addressed.
However, in that same submission, the applicant suggested that the Hospital's finance department should have forms and templates indicating approval for research studies. In response to a request by this Office for clarification of that point, the Hospital stated that its finance department does not hold forms or templates to approve the budget and allocation of resources to health related research studies and that all research assistants who deal with clinical and non-clinical research studies devise and deal with their own budget templates.
Having regard to the explanations provided by the Hospital and to the details of the searches undertaken, I am satisfied that the Hospital was justified in deciding that no further relevant records exist. 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 no further relevant records exist.
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 further relevant records under section 15(1)(a) on the ground that no such records 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.