Third Parties and Contracts
Studies approved by External Ethics Committees
All research studies and clinical trials taking place in Beaumont Hospital which have been approved by an external recognised research ethics committee, including a national research ethics committee, are required to follow the site sign off process.
Studies approved by Local Ethics Committee in Beaumont Hospital
All clinical trials of medicines (CTIMPs) taking place in Beaumont Hospital which have been approved locally by the Beaumont Hospital Ethics (Medical Research) Committee are required to follow the site sign off process (The site sign off-process takes place after research ethics committee approval.)
A percentage of other research studies taking place in Beaumont Hospital which have been approved locally also follow this process. This typically occurs in respect of:
- studies involving third parties which warrant contracts being entered into with the hospital
Examples of Third Party Involvement
Examples of third party involvement include a third party sponsor, a third party funder, a third party data controller, or a third party data processor.
[A reminder that it is possible for a university to be a third party sponsor, funder, data controller or processor.]
Examples of Contracts or Agreements entered into with Third Parties
Examples of contracts or agreements which are entered into with third parties include clinical trial / study agreements, memorandums of understanding, material transfer agreements, data controller-to-data controller agreements, and data controller-to- data processor agreements.
Such agreements are typically drafted by the third party and delineate the responsibilities of the third party and of the hospital. This is expected to change once either template contracts or minimum contract requirements are finalised, and released by the HSE Research and Development Department.
The hospital arranges for legal review prior to CEO signature as part of the site sign off process.
There has been an increase in the number of research-related contracts being entered into by the hospital in general, and this can be attributed to GDPR requirements. Data controller-to-data controller agreements and data controller-to-processor agreements, for example, are required by GDPR.
Assessing when contracts are required
Assessing when contracts are required and which contracts need to be entered in to between which parties is not easy. Some questions to consider with a view to starting to make this assessment are available here