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.]

  A number of buildings on the campus of Beaumont Hospital are operated by third parties e.g. - the Aislin Centre is operated by the HSE, the Smurfit Building is operated by the Royal College of Surgeons in Ireland etc.

  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 National Office for Research and Development.

  The hospital arranges for legal review prior to signature of contracts by the CEO, Cancer Research Executive Committee Chair or Co-Chair - legal review forms 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. For some questions to consider with a view to starting to make this assessment, see Are you entering into research contracts? (drafted BH Ethics)

  Are template contracts available?

  Yes - To speed up the review process the IPHA Model Template Clinical Trial Agreements (link to the IPHA website) should be used for all new clinical trials.

  No other template contracts are available at this time.