the planning period, it is important to establish what, if any, form of ethical approval is required for the proposed IPD meta‐analysis project. This matters not just in ensuring that the project itself is adhering to ethical standards and good research practice, but is also information that those supplying IPD may need in order to gain their own clearance to release data. Host institutions may take different approaches; although some will grant a waiver from requirement for formal ethical review, others may decide that this approval is required. If formal ethical review is needed, this should be factored into the project timelines, especially as it may take some time to complete. Research funders will often require that either a waiver is in place or approval has been granted before they will release funds.
Key points that may be made when applying for exemption or making an application for ethical approval include:
IPD meta‐analyses use existing data and do not involve recruitment of participants (although see Section 3.12 regarding prospective IPD meta‐analysis).
The IPD obtained and used will not contain any direct identifiers for participants, such as names or identifying numbers that are known to anyone outside of the immediate trial management team.
The IPD will be held securely at the central research team’s host institution with access restricted to members of the team.
The IPD will be held, managed and used according to a binding data‐sharing agreement or contract, including commitment that the recipient project team will make no attempt to re‐identify trial participants.
The research questions to be addressed in the IPD meta‐analysis project are the same as or close to those to which the trial participants originally consented.
It is also worth highlighting these points in the IPD meta‐analysis protocol, and in data‐sharing agreements, as they may help IPD providers gain permission to release their data.
Discussions around ethical approval might draw on evidence that patients are generally supportive of their clinical trial data being re‐used in further research activity provided that there are appropriate safeguards around confidentiality. A consultation exercise undertaken in 2008 by the National Cancer Research Institute (NCRI) demonstrated that most respondents believed that material and data collected from patients with cancer should be used, without identifiable information, as broadly as possible and that retrospectively seeking consent was inappropriate.82 A systematic review of quantitative and qualitative research studies found widespread, although conditional, support among patients and the public for data sharing for health research.83 Although participants recognised actual or potential benefits, they expressed concerns about breaches of confidentiality and potential abuses of the data.
In our experience, trial investigators do not generally require formal ethical approval to share their trial IPD, and sharing may even be a pre‐condition of the original funding for their trial. They may, however, need to apply to an institutional review board or a central legal department for formal approval. Requirements will vary internationally, institutionally and according to the design of the study from which they are sought, and are subject to change. Those providing data will need to comply with legal and ethical requirements accordingly. In an IPD meta‐analysis project that developed a risk prediction model for infection in children being treated for cancer presenting with febrile neutropenia (a fever indicating possible infection and risk of complications),84 we collected de‐identified IPD from both clinical trials and audit, and ascertained which data providers required ethics, institutional or other approval and authorisation before they could share IPD with the project. Table 3.1 shows those that did and did not require formal approval.
Table 3.1 Consent sought to collaborate in an IPD analysis of predictive factors for infection in children being treated for cancer presenting with febrile neutropenia
Source: Adapted from Phillips et al.,85 with permission from BMJ Publishing Group Ltd.
| Country | Study type(s) | Review body approached | Review body | Answer |
|---|---|---|---|---|
| Belgium | Prospective | Yes | University Hospital Review Boards | Agreed |
| Bulgaria | Prospective | No1 | – | – |
| Canada | Prospective | No1 | – | – |
| Canada | Institutional Review Board | Agreed | ||
| Chile | Prospective | No1 | – | |
| Germany | Prospective | No1 | – | – |
| Italy | Prospective | No1 | – | – |
| Netherlands | Prospective | No1 | – | – |
| Slovenia | Prospective | Medical Ethics Committee | Agreed | |
| Switzerland | Prospective and retrospective | Hospital Review Board | Agreed | |
| Turkey | Audit | No2 | – | – |
| UK | Audit | NHS Ethics Committee | Agreed | |
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