RCSI Sponsorship Office - 'Beaumont Hospital specific' Institutional Review - SOP (updated 20 December 2023)

The Royal College of Surgeons in Ireland (RCSI) Sponsorship Office released an updated RCSI Sponsorship Office 'Beaumont Hospital specific' Institutional Review SOP on the 20 December 2023.

It requires investigators to contact the RCSI Sponsorship Officer early on when planning any research study proposed to place in Beaumont Hospital which will involve RCSI.

Examples of Studies proposed to take place in Beaumont Hospital which involve RCSI include:

  • interventional studies or clinical trials sponsored by RCSI
  • research studies which involve sending data or samples to RCSI (including the RCSI Smurfit Building)
  • research studies being conducted for the purposes of obtaining an academic qualification from RCSI - MCh, MD, MSc or PhD
  • research studies in receipt of funding which is being managed via RCSI


Contact with the RCSI Sponsorship Officer occurs in advance of applying for research ethics approval. This is irrespective of whether one is planning to submit to Beaumont Ethics Committee, or to one of the national research ethics committees.

The RCSI Sponsorship Officer will assess whether the study is interventional or observational.

If the study is deemed to be interventional, you will be asked to complete a RCSI Sponsorship Office Clinical Research Study Registration Form (CSRF)(last updated 20 December 2023)

If the study is deemed to be observational, you will be asked to complete a RCSI Material Data Information Form (MDIF)(last updated 5 December2023)

Please do not complete a CSRF or MDIF unless the RCSI Sponsorship Officer directs you to do so.

 

The RCSI Sponsorship Officer can be contacted at: - mauricedowling@rcsi.ie

The RCSI Sponsorship Office can be contacted at: - sponsorship@rcsi.ie

The RCSI Sponsorship Officer may refer to you the following departments within RCSI.

RCSI Contracts Office (Clincial Research): - clinrescont@rcsi.ie

RCSI Data Protection Office - dataprotection@rcsi.ie

Please initiate contact with the RCSI Sponsorship Officer well in advance of applying for research ethics approval

Audit of Active Research Studies taking place in Beaumont Hospital which involve RCSI.

The RCSI Contracts Office is conducting an audit of active research studies taking place in Beaumont Hospital which involve RCSI with a view to ensuring the correct assignment of data protection responsibilities and that necessary contracts are put in place.

As part of this audit, researchers conducting active studies may be asked for a copy of the ethics application form, the data protection impact assessment, any information leaflets, consent forms in use, and any correspondence from the Health Research Consent Declaration Committee. They may also be asked to complete the RCSI Sponsorship Office Clinical Research Study Registration Form (last updated 20 December 2023) or the RCSI Material Data Transfer Form (last updated 5 December2023).

At the present time, the focus of this audit is on biobanks and other long and medium term studies.