SBRI Healthcare - Confidentiality guidance

Confidentiality and disclosure - A guide for applicants, reviewers and commissioning panels*

1. Confidentiality of applications

Applications submitted on this portal are considered confidential; that is, they contain information that is considered critical to an organisation's ongoing operations and could seriously impede them if made public or shared internally. They may also contain material considered personal by the General Data Protection Regulation (GDPR) EU 2016/679 and will therefore be handled in accordance with this Regulation at all times. Our statements regarding privacy and data protection are available on the homepage.

Information contained within applications must necessarily be divulged to third parties in order to make funding decisions. Disclosure of information within applications is tightly controlled as follows:

The Proramme Management Office (PMO) takes all reasonable steps to ensure that the contents of applications are treated as confidential. Application forms and any associated papers are sent to and received by peer and public reviewers (hereafter reviewers) and commissioning panel members, including public members and observers (hereafter panel members) in confidence. Electronic information may be transferred through the secure Research Management System, a secure transfer system, or on encrypted, password-protected removable storage devices by secure carrier. On limited occasions where none of the preceding methods can be used, electronic information is transferred by email. Paper information is sent by secure carrier.

PMO staff do not disclose or discuss the content of any application submitted with any individuals outside the PMO, our customers and partner organisations, except peer and public reviewers, panel members and observers.

By acting as a reviewer or panel member, individuals are agreeing to treat as confidential all applications sent to them by PMO. They must not disclose the fact that the applicant has applied for a research award nor the content of the application to any other person (including work colleagues) without the prior written consent of the applicant, obtained via PMO. Equally, they must not use the information in the application for any purpose other than providing a review of it to PMO or the panel. In addition, any personal information contained within the application must be treated according to the GDPR and therefore must not be disclosed to any third party. For further information, the Information Commissioner's office (ICO) has produced the following comprehensive code of conduct for data sharing: ICO code of conduct for data sharing.

Applications will not be reviewed by individuals where there is a known conflict of interest. Detailed guidance on what constitutes a conflict of interest and how it is handled can be found in the appendix.

Summary meeting minutes may be published after consideration of applications at panel meetings and communication of decisions to applicants. The summary minutes contain the following details relating to application forms: application number (all applications); title (full applications).

*For editorial reasons, the word ‘panel’ has been used throughout; it is interchangeable with board or committee.

2. Data Security

The PMO stores all electronic information in secure premises and any confidential electronic information removed from secure premises by PMO staff is encrypted and password protected. Reviewers and panel members are expected to maintain this level of electronic data security. Cloud-based services such as Dropbox cannot be assumed secure and should not be used for storage of application forms and meeting papers unless there is a contractual guarantee of security from the provider.

All individuals who are sent copies of applications and any associated documents, whether electronic or paper copies, must ensure that these are not retained indefinitely. In general, paper copies collated as panel papers should be left behind for shredding at the end of the meeting. Electronic records may be retained until contract negotiations for successful applications are completed, after which point they must be deleted.

3. Confidentiality of peer and public reviews

Peer and public reviews (hereafter reviews) are considered confidential. Anonymised reviews and scores are shared with panel members (if no conflict of interest). The anonymised reviews are also disclosed to the authors of the application. Review scores will be disclosed to the authors of the application, if requested. Any sections of review forms which are not disclosed to the authors of the application are indicated to the reviewer. After submission, anonymised reviews and scores are made available to other reviewers of the same application.

Receipt of the review form from the PMO, and subsequent completed return, form a 'mutual confidentiality agreement' covering the response. This information will not be released without prior approval unless it is seen to be overwhelmingly in the public interest, i.e. when the benefits of disclosure outweigh the duty of confidentiality.

4. Confidentiality of reviewer identity

Reviewer identity is not disclosed to applicants and anonymous reviews are returned to applicants. It may be disclosed to panel members, except where there is a conflict of interest. It is planned to publish lists of those undertaking review for PMO annually.

5. Confidentiality of panel discussions

Panel discussions are recorded during the meeting and form the basis of the meeting minutes and the feedback/outcome letters to applicants. Comments are not attributed to individual panel members. The full minutes are considered confidential and, in most cases, these are circulated to panel members, PMO and our customers that are involved in the commissioning process. Where there is a conflict of interest, the minutes of discussions of applications are omitted from the copy circulated to the conflicted panel member.

Panel members must not disclose details of discussions or decisions to anyone outside the panel, our customers or the PMO. Individuals assigned to lead discussion (Lead Assessors or Designated Panel Members) are not disclosed to applicants.

When summary meeting minutes are published after consideration of applications at panel meetings and communication of decisions to applicants. The summary minutes contain the following details relating to panel discussions: names of panel members with conflict of interest; outcome of panel discussion for each application (reject/support/conditional support).

6. Confidentiality of written comments

Written comments on applications may be submitted by panel members to contribute to panel discussion, either if they will be absent from the panel meeting, or if they play a particular role in the discussion (Lead Assessor, Designated Panel Member, etc.). These records are used to aid the PMO Secretariat in writing up the meeting minutes and, in some instances, contract negotiation. They are not disclosed to applicants.

7. Confidentiality of panel member identity

Panel member identity is not considered confidential. Names and affiliations of panel members may be published on our websites and in other relevant documents.

Where summary meeting minutes are published after consideration of applications at panel meetings and communication of decisions to applicants. The summary minutes contain the following detail relating to panel members and observers: names of people attending panel meetings (panel members, secretariat and observers); names of panel members with apologies for non-attendance.

8. Confidentiality - for public reviewers and public members of panels

This document applies to members of the public acting as reviewers and panel members. If additional support or advice is needed, please contact the Patient and Public Involvement team: contact details for Patient and Public Involvement Team

9. Freedom of Information Act

The Freedom of Information (FoI) Act (2000) applies to public bodies including NIHR. It gives individuals rights to access information held about them by UK government. Any person can make a request under the Act - no restrictions on age, nationality, or place of residence. Any information can be requested - but some information might be withheld to protect various interests which are allowed for by the Act. Research applications and review reports are considered to be received in confidence and are therefore covered by the exemption in Section 41 (see below). Exemptions under the FoI Act which may be relevant to information contained in applications and related documents, are given below:

Section 12 - the Department reserves the right to refuse a request where the cost of researching, extracting or copying the information is disproportionately high (i.e. >£600 or more than 2.5 days work)
Section 14 - Repeated requests for information or vexatious requests ("vexatious" is undefined in the Act)
Section 21 - Where information is reasonably accessible to the applicant by other means
Section 22 - Information intended for future publication - where release would result in the premature publication of research
Section 23 - Information supplied by, or related to, bodies dealing with security matters
Section 27 - International relations - where disclosure would, or would be likely to, prejudice relations between the UK and any other state or international organisation, or international court, interests of UK abroad etc
Section 36(2)b - Prejudice to effective conduct of public affairs - where disclosure would, or would be likely to, inhibit the free and frank provision of advice, or the free and frank exchange of views for purposes of deliberation, or would otherwise prejudice, or would be likely otherwise to prejudice, the effective conduct of public affairs
Section 38 - Health and Safety - where release might result in the compromising of physical or mental health, or personal security (includes information involving animal data and other sensitive areas of research).
Section 40 - Personal information - involving the disclosure of personal information
Section 41 - Information provided in confidence - by a third party
Section 43 - Commercial interests - where release might result in breach of commercial confidentiality.

Section 21, 23, 36, 40 and 41 exemptions are absolute exemptions i.e. they apply without qualification to information that falls within their scope. The other exemptions listed are qualified exemptions in that they are subject to a public interest test, i.e. they apply only where, on a proper assessment, the balance of the public interest is against disclosure. These cases will be decided by our customer authority.

Appendix: Handling conflicts of interest

It is essential that the personal and institutional interests of those involved in reviewing applications do not influence the decision making process. All those involved share responsibility for ensuring this. Accordingly, it is important that panel members or observers (hereafter panel member), peer reviewers, public reviewers and public members of panels are aware of what constitutes a potential or actual conflict of interest (COI). This is set out in the following document.

EXPERT PANEL MEMBERS

General
The responsibility for disclosing any COI rests with the panel member concerned and should be declared as soon as the conflict is realised. GMG staff will also identify potential COI. Instances of COI are identified below. In addition, in some specialist/niche areas of research it is likely that avoiding any conflict is impossible. In these cases, the secretariat will seek to keep these to a minimum. If a panel member remains in any doubt about a potential COI they should take advice from the chair and the panel at the time. Panel members must decline to act as Lead Assessor/Designated Panel Member where there is a COI. Panel members have a responsibility to return, or to confirm destroyed, any documents they receive related to an application for which they are confirmed as conflicted.

Procedure at meetings
Panel members with COI must leave the room during formal discussion and initial scoring of the application with which they are conflicted. There is no provision for an individual to remain in the room but play no role in the discussion of an application. They must also remain silent if the decision on an application where they have a COI returns to the table and leave the room if asked, or volunteer to do so if the debate appears likely to be reopened. Conflicts of interest will be recorded in the minutes. Where the chair is conflicted, a panel member will be designated as chair for those applications. All declared COI are recorded in the minutes of the meeting.

Instances of conflict

Originators and co-applicants
Originators and co-applicants are always considered conflicted and must follow the procedure above. They may be told the outcome of the discussion at the close of the meeting but must wait for the formal written outcome letter from the PMO Secretariat before sharing this decision with anyone outside the meeting. Assessors' comments (both internal and external) will not be available to the panel member concerned, either within their agenda papers or as tabled papers.
Collaborators
Active collaborators in the proposed research should leave the room while the application is considered. Current collaboration with any applicant in research other than the specific project under consideration or any historical collaboration with the research team should be declared and the decision whether or not this represents a significant COI is guided by discussion with the PMO and/or chair or other programme authority. It is likely that collaboration in the last 5 years will be
considered a COI.
Panel members from the same institution as the prospective researchers
Panel members from the same institution as the research team should leave the room if they are closely associated with the department or unit concerned. In many cases, panel members from the same institution will be asked to leave the room as a matter of course. In some circumstances, where there is no close association, the decision whether or not this represents a significant COI is guided by discussion with the PMO and/or chair or other programme authority. A current or recent past line management relationship is always seen as a COI.
Competitive and commercial interests
Panel members must never derive academic or commercial competitive advantage from knowledge they acquire in the process of reviewing applications. They are considered conflicted if they are involved in or planning to undertake any academic or commercial activity which is similar to that covered by the application. Panel members must declare anything that would be likely to compromise the independence of their opinion. Examples where declarations must be made are
included below:

• personal remuneration from organisations including employment, pensions, consultancies, directorships and honoraria
• shareholdings and other financial interests in companies held by panel members or their close family
• research grants, including major research collaborations, on a competing research topic
• non-financial or unremunerated involvement with organisations, such as directorships of companies or organisations which might benefit from support by the NIHR
• where the panel member has previously acted as a panel member when the application was being considered by another funding body.

This is not an exhaustive list, and panel members are encouraged to declare all potential conflicts. In all cases, the decision whether or not declarations represent a significant COI is guided by discussion with the PMO and/or chair or other programme authority.

Personal relationships
Where panel members have a close personal relationship with an applicant they should declare an interest and leave the room when the application is under consideration.

PEER REVIEWERS

General
Wherever possible, COI are avoided through careful selection of reviewers by PMO staff. However, some relationships may not be apparent and so the guidance below should be followed. In addition, in some specialist/niche areas of research it is likely that avoiding any conflict is impossible. In these cases, the PMO will seek to keep these to a minimum. The responsibility for disclosing any COI rests with the peer reviewer concerned and should be declared as soon as the conflict is realised. If there is any doubt about a potential COI, peer reviewers should take advice from the PMO Programme Manager. Peer reviewers have a responsibility to return, or to confirm destroyed, any documents they receive related to an application for which they are confirmed as conflicted.