Whether the Hospital was justified in refusing to grant the applicant's request for certain information relating to a research study being carried out at the Hospital under sections 36(1)(b) (commercially sensitive information), 37(1) (personal information) and 39(1)(a) (research by or on behalf of an FOI body) of the FOI Act

22 August 2019

Background

On 12 January 2019, the applicant made an FOI request to the Hospital for the following information:

1. The names and purposes of any study, research or other project being carried out at the Hospital involving a particular company, including the names and titles of the principal researchers
2. The date of commencement of the study and the expected duration
3. The number of patients enrolled
4. A copy of the consent form and information issued to any patients enrolled
5. Details of the research ethics approval for the project/research/study
6. Where no relationship exists between the Hospital and/or its staff/researchers and the company, confirmation that this is the case.

The Hospital's decision of 11 February 2019 refused the request under sections 29(1) (deliberative processes), 36(1)(b) (commercially sensitive information), 37(1) (personal information) and 39(1)(a) (research by or on behalf of an FOI body) of the FOI Act. The applicant sought an internal review of the Hospital's decision on 12 February 2019. The Hospital's internal review decision of 4 March 2019 affirmed its decision on the request. On 6 March 2019, the applicant sought a review by this Office of the Hospital's decision.

This Office consulted with the company (the third party) during the review. It said that it did not object to the Hospital's disclosure of the requested information other than that at part 3, which it said was exempt under section 36(1)(b) of the FOI Act. The Hospital then released the records covered by the request except for the information sought at part 3 and details identifying the principal researchers, which the Hospital maintains is personal information.

I have now decided to conclude my review by way of a formal, binding decision. In carrying out my review, I have had regard to the above exchanges and to correspondence between this Office, the Hospital, the third party, and the applicant. I have had regard also to the records considered by the Hospital and to the provisions of the FOI Act.

Scope of Review

This review is confined to whether the Hospital is justified in refusing to grant access to the information sought at part 3 and identifying information concerning the principal researchers. 

Findings

I do not comment on all of the arguments put forward by the parties but have considered all of the relevant submissions.

Section 36(1)(b) - Commercially sensitive information - Number of study participants

Section 36(1)(b) must be applied to certain types of information whose disclosure could reasonably be expected to result in material financial loss or gain to the person to whom the information relates, or could prejudice the competitive position of the person in the conduct of his or her profession or business or otherwise in his or her occupation. The essence of the test in section 36(1)(b) is not the nature of the information but the nature of the harm which might be occasioned by its release.

The harm test in the first part of section 36(1)(b) is that disclosure "could reasonably be expected to result in material loss or gain". The Commissioner takes the view that the test to be applied is not concerned with the question of probabilities or possibilities but with whether the decision maker's expectation is reasonable.

The harm test in the second part of section 36(1)(b) is that disclosure of the information "could prejudice the competitive position" of the person in the conduct of their business or profession. The standard of proof to be met here is considerably lower than the "could reasonably be expected" test in the first part of this exemption. However, the Commissioner considers that, in invoking "prejudice", the damage which could occur must be specified with a reasonable degree of clarity.

In the High Court case of Westwood Club v The Information Commissioner [2014] IEHC 375 Cross J. held that it is not sufficient for a party relying on section 36(1)(b) to merely restate the provisions of the section, list the documents and say that they are commercially sensitive. A party opposing release should explain why disclosure of the particular records could prejudice their financial position. Furthermore, a general prediction without any supporting evidence is not sufficient to satisfy the requirement that access to the record could reasonably be expected to result in the outcome envisaged. In the Supreme Court case of Sheedy v the Information Commissioner ([2005] 2 I.L.R.M. 374, [2005] 2 IR 272, [2005] IESC 35) Mr J. Kearns stated that "[a] mere assertion of an expectation of [prejudice] could never constitute sufficient evidence in this regard”. 

The Hospital made its submission before this Office consulted with the third party. Therefore, its submission concerns its refusal to grant any records covered by the request. It did not seek to make further arguments when this Office told it of the third party's position regarding the release of certain information.

It says that the details are "not fully in the public domain" and contain more in-depth details of research methodology. I do not see how the number of participants of itself reveals anything about research methodologies. Furthermore, while the number may not be in the public domain, this does not of itself mean that it is exempt under section 36 of the FOI Act. One of the Hospital's arguments in relation to section 39(1)(a) is that the recruitment phase of the research is ongoing and, essentially, that the number is subject to change. While it says that harm may result from such disclosure, it does not explain how this harm could arise.

The third party says that disclosure of the number as it currently stands could impact on its ability to secure a “commercialisation partner” for the research. As I understand it, such partners include companies who might develop new drugs or diagnostic tests. The third parry says that knowing whether the number of patients enrolled is higher or lower than anticipated by its competitors that are developing the same or similar therapeutic processes discloses information about the breadth, impact and success of the study and its investment in the area. It says that this could prejudice its ability to commercialise results from the studies and in turn its ability to fund further studies and develop other therapeutic products.

The applicant does not accept that the information is commercially sensitive. She says that the number of patients attending a hospital or clinic, and the number of those who are approached and who ultimately decide to take part in research, is of no particular relevance and cannot have any objective influence on independently conducted research. She says that the number who decide to take part cannot be predicted and may be relative to the number of patients attending a particular doctor or clinic and/or the relative size of the hospital and from the quality and nature of information given to them.

She says that the third party's work in Ireland is to her knowledge unique and without precedent. She says that there is no evidence that its competitors are developing the same or similar therapeutic products because the third party does not develop such products. She says that the third party's publications say that it is carrying out research to help researchers and commercial partners in the future to potentially develop products, and also disclose how many data subjects in Ireland it wishes to sign up for its research.

The grant of access to records under FOI is accepted as generally equivalent to their disclosure to the world at large. As I have said above, the standard of harm required for section 36(1)(b) to apply, on the basis that disclosure could prejudice the third party's competitive position in the conduct of its business, is quite low. It seems to me that there is a difference between knowing how many Irish data subjects the third party may aspire to have participate in the research and the number that have done so at this point in time. Furthermore, it is not necessary to determine whether the third party makes products itself or has or will have competitors in such an area. It is clear that its concerns relate to its ability to secure a commercialisation partner for its research. I accept its position that disclosure to the world at large of the current number of study participants gives certain insights into the project at this point in time that are not otherwise available, which could affect decisions made by potential commercialisation partners. I find that section 36(1)(b) applies to the current number of study participants on the basis that its disclosure could prejudice the third party's competitive position in the conduct of its business.

The public interest

I do not consider any of the exceptions to section 36(1), as provided for in section 36(2), to apply in this case. Section 36(3), however, provides that a record to which section 36(1) applies may be granted if the public interest would, on balance, be better served by granting than refusing to grant the request.

On the matter of where the public interest lies, I have regard to the judgement of the Supreme Court in The Governors and Guardians of the Hospital for the Relief of Poor Lying-In Women v. the Information Commissioner [2011] IESC 26 ("the Rotunda judgment"). It is noted that a public interest is "a true public interest recognised by means of a well known and established policy, adopted by the Oireachtas, or by law". Although these comments were made in relation to another provision of the FOI Act, I consider them to be relevant to consideration of public interest tests generally.

The FOI Act itself recognises a public interest in ensuring that FOI bodies are open about, and can be held accountable for, how they carry out their functions. In this case, there is a public interest in ensuring openness and accountability for the Hospital's involvement in the research study, which reflects the applicant's argument that the hospital has transparency and accountability obligations to patients and the public in relation to its research generally. The material granted by the Hospital to date has served this public interest to a certain extent. It seems to me, however, that it would be further served only minimally by granting access to the current number of study participants, given that this number is subject to change. The applicant also refers to the amount of public money that the Hospital receives. However, the information at issue is not of itself concerned with the expenditure of public monies and I do not attach particular weight to this argument in the circumstances.

The applicant included arguments concerning such matters as the data processing requirements of the General Data Protection Regulation, which I do not consider relevant to whether the record should be released in the public interest.

On the other hand, section 36(1) itself reflects the public interest in the protection of commercially sensitive information. This Office takes the view that the FOI Act was designed to increase openness and transparency in the way in which FOI bodies conduct their operations and, in general terms, it was not designed as a means by which the operations of private enterprises were to be opened up to scrutiny. I do not see any particularly strong public interest in release of this information which would outweigh the public interest in a commercial company being allowed to protect its competitive position. I find that, on balance, the public interest would be better served by the refusal of access to the number of study participants in the record.

Section 37 - personal information

Details identifying the principal researchers are contained in records covered by various parts of the request, including a participant information leaflet and an informed consent form. I understand that one researcher is an employee of the Hospital and that the other is employed by the third party.

Section 37(1), subject to other provisions of section 37, requires the refusal of access to a record containing personal information. Section 2 of the FOI Act contains a two-part definition of the term "personal information", which includes information that "(b) is held by a public body on the understanding that it would be treated by it as confidential". Section 12 also lists 14 non-exhaustive examples of what must be considered to be personal information. It is well settled that where information can be classified as one of the 14 examples of personal information, there is no need for the requirements of the definition to also be met. One such example is (iii), "information relating to the employment or employment history of the individual".

The Hospital says that the identifying information is held on the understanding that it will be treated as confidential and that it relates to the specifics of the individuals' employment and their involvement in specific research. I accept that the identifying information relates to the employment or employment history of the individuals concerned.

However, section 2 of the FOI Act also contains some exclusions to what is personal information where public servants are concerned, which are as follows:

- the name of the individual

- information relating to the office or position or its functions

- the terms upon and subject to which the individual holds/held that office or occupies/occupied that position or

- anything written or recorded in any form by the individual in the course of and for the purpose of the performance of the functions.

The applicant maintains that the identifying information is covered by the exclusions above. The Hospital says that section 37 applies having regard to the exclusions at section 2 but does not explain why it considers this to be the case.

The exclusions to the definition of personal information are quite narrow. They do not deprive public servants of the right to privacy generally. Generally speaking, however, they are intended to prevent FOI bodies from relying on section 37 to refuse to grant access to records created by individual staff members in the course of their work or to details in records that would identify the public servants who dealt with the matters the subject of those records.

The identifying information does not simply reveal that an individual is a member of staff of an FOI body, which is what I consider the first exclusion to be concerned with. The second exclusion seems to me to be concerned with information concerning the general requirements of a public servant's employment by an FOI body, rather than specific tasks that the individual may perform during that employment. I have no reason to consider the third exclusion to apply in this case. Accordingly, I do not consider the identifying information concerning the Hospital's employee in this case to be covered by the exclusions in section 2. I find that it is exempt under section 37(1) of the FOI Act.

While section 2 also contains similar exclusions concerning service providers, I do not consider the arrangement between the Hospital and the third party in this case to amount to a contract for the provision of services. I find that the identifying information regarding the third party's employee is exempt under section 37(1) of the FOI Act.

Exceptions to section 37(1)

A record that is exempt under section 37(1) may still fall to be released under sections 37(2) or (5) of the FOI Act.

Section 37(2) provides for various circumstances in which the exemption at section 37(1) does not apply. One circumstance, at section 37(2)(b), is where the third party has consented to the disclosure of their personal information. Neither of the individuals concerned have given their consent to the release of the information and I do not consider that it would be proportionate or appropriate for this Office to contact them in the context of this review.

The public interest

In considering section 37(5), I consider that only section 37(5)(a) is relevant in this case. This section provides that a request that would fall to be refused under section 37(1) may still be granted where, on balance, the public interest that the request should be granted outweighs the public interest that the right to privacy of the individuals to whom the information relates should be upheld.

The public interest in ensuring openness and accountability for the Hospital's involvement in the research study has been served to some degree by the information already disclosed. It would be further served by disclosing which Hospital employee is a principal researcher in this study. It would also be further served, to a minimal extent, by disclosure of the identity of the third party’s employee.

On the other hand, both the language of section 37 and the Long Title to the FOI Act recognise a very strong public interest in protecting the right to privacy (which has a Constitutional dimension, as one of the un-enumerated personal rights under the Constitution). When considering section 37(5)(a), privacy rights will be set aside only where the public interest served by granting the request (and breaching those rights) is sufficiently strong to outweigh the public interest in protecting privacy.

The applicant states that the Hospital regularly publishes the names of researchers and staff and that similar information is available outside of FOI. I accept that this is the case; however, I do not consider that this is equivalent to a finding under the FOI Act that section 37 does not apply to information defined in the FOI Act as personal information.

Having considered the matter carefully, I find that the public interest in favour of granting the request for the names and titles of the principal researchers does not outweigh the public interest in protecting the right to privacy of the individuals to whom the information relates.

Sections 36(1)(b) and 39(1)(a) (research by or on behalf of an FOI body)

The Hospital's submission says that all of the records covered by the request qualify for exemption under sections 36(1)(b) and 39(1)(a). Given my findings above, there is no need for me to go on to consider whether the identifying information is exempt under those provisions.

Decision

Having carried out a review under section 22(2) of the FOI Act, I hereby affirm the Hospital's decision on the remaining withheld details.

I find that the number of patients enrolled in the study is exempt under section 36(1)(b) and that on balance, in the circumstances, the public interest does not weigh in favour of its disclosure

I find that information identifying the principal researchers is exempt under section 37(1) and that the public interest in upholding the right to privacy outweighs the public interest in granting that part of the request.

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.

 

 

 

Elizabeth Dolan

Senior Investigator