Listing - Studies other than Clinical Trials of Medicines (includes clinical investigations of medical devices)

This listing is of studies other than clinical trials of medicines and is dated 29 November 2021.

Studies are listed by national and/or local research ethics committee reference number. 196 studies in total. Does not include locally-approved studies listed on the hospital research database after 29 November 2021. Includes NREC COVID-19 studies where notified to the hospital only. Does not include clinical trials of medicines.

Relevant guideline or legislation or process in place at time of study commencement listed for reference.

Declaration of Helsinki (1964), revised '75, '83, '89, '96, '00 Declaration of Tapei (2002)
CIOMS: International Ethical Guidelines for Biomedical Research on Humans (1993), revised 2002
ICH:E6 Guidelines on Good Clinical Practice (1996), revised 2002 (R1)
Data Protection Act 1988
01/30 01/93
Data Protection Amendment Act 2003
04/17 Declaration of Helsinki, revised 2004
Irish Council for Bioethics "Guidance on Operational Procedures for Research Ethics Committees" 2004
05/03 (DL) 05/30 05/49
Irish Council for Bioethics "Human Biological Material: Recommendations for Collection, Use and Storage in Research" 2005
Disability Act 2005
Data Protection Commissioner "Data Protection Guidelines on Research in the Health Sector" 2007
08/62* (DL)08/90 Declaration of Helsinki, revised 2008
CIOMS: International Ethical Guidelines for Epidemiological Studies, 2009
09/77 Research Ethics Committee Standard Application Form, 5.5, 2010
11/31
12/03** 12/58 12/65 12/75 (DL)12/100 HSE National Consent Policy, Part 3 - Research, 2013
13/09 (DL)13/21 13/68 13/74 13/75 13/79 13/81 13/84 Declaration of Helsinki, revised 2013
14/28 14/44 14/50
SLRON
14/52 14/84 Research Ethics Committee Standard Application Form, 5.6, 2014
15/04 15/09* 15/40 15/47 15/62 15/66 15/95 (DL) 15/OTH/51
SLRON
16/12 16/29 16/35 16/45 16/47 16/52 16/55 16/58 SLRON 16/60 16/64 16/72 16/83
16/89
Declaration of Tapei, revised 2016
ICH:E6(R2) Guidelines on Good Clinical Practice, revised 2016 (R2)
CIOMS: International Ethical Guidelines for Health-Related Research on Humans, 2016
17/06 (DL) 17/28 17/37 17/39 17/42 17/50 17/58 17/70 17/75 17/76
18/10* (DL)
GPPR and Data Protection Act 2018 - 25 May 2018
18/21 18/25
Health Research Regulations 2018 - 8 Aug 2018
18/41** 18/43 18/44 18/45 Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont and RCSI, 31 Aug 2018
18/46 18/50 18/52 18/57 18/58 18/60 (DL) 18/63 18/64 18/66 18/68
Radiation Regulations - 8 Jan 2019
HRCDC: April '1919/08 (DL) 19/20 19/23 19/28 19/32 19/33 STAFF19/34 19/36 (DL) 19/46* 19/54
19/55 19/60 19/62 19/68 19/71 (DL) 19/73 19/74 STAFF 19/77 19/78 19/80 19/81 19/82
19/83 19/87 19/91 19/93
20/02 20/07 20/08 20/13 20/17 20/20 20/22 20/23
20-NREC-COV-41
20/29 20/33 STAFF 20/46 20/30
Parallel HRCDC and NREC-COVID19 review Apr - Aug '20 20-NREC-COV-19 20-NREC-COV-26 20-NREC-COV-44 STAFF 20-NREC-COV-47 20-NREC-COV-5620/47 20/48 20/49 20/52 20/53
20/54 20/57 20/63 20/67 STAFF20/68 20/71 20/72 20/78 20/82 RCRS 20/86
21/12 STAFF
Amendments to Health Research Regulations - 21 Jan 21
19/57
20/51 STAFF 20/5820/5920/70 20/76 NDMHS 20/7920/80
21-NREC-MD-002
20/89
21/02 NDMHS21/0421/0621/07 STAFF 21/11 STAFF 21/15 NDMHS21/17 21/20 21/22 NCRI 21/23 NDMHS 21/24 NDMHS
21/2521/26 21/27 21/29 STAFF 21/30 21/32 STAFF 21/31 21/43 anon
Medical Devices Regulations - 26 May 2021
NREC-MD: May '21
20/24 20/55 20/73 20/75 Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont 8.6.21
21/0521/2121/33 (DL)21/34 21/3721/3821/39 NDMHS STAFF21/4121/4621/5021/5221/53
21/5421/55 STAFF21/56 RCRS21/5721/5821/6421/6521/6721/69 STAFF21/70 21/7521/81
21/7621/8021/8521/8621/89

All studies which involve processing of personal data, irrespective of year of commencement, must comply with GDPR and the Health Research Regulations 2018, as amended.

As a result of the Health Research Regulations 2018, a 'consent declaration' was required from a national committee called the 'Health Research Consent Declaration Committee' (HRCDC) in a range of circumstances. Amendments to the HRRs on the 21 January 2021, may result in a some of these declarations no longer being required. 'DL' denotes 'Declaration Live' / 'DNLN' denotes 'Declaration No Longer Needed'

  • Studies involving Staff Members as participants are marked 'STAFF'
  • Studies taking place in the North Dublin Mental Health Services are marked 'NDMHS'
  • Studies predominantly taking place in the St. Luke's Radiation Oncology Network which includes a unit in Beaumont Hospital are marked 'SLRON'
  • Studies analysing anonymised data from the National Office of Clinical Audit are marked 'NOCA'
  • Studies analysing anonymised data from the National Cancer Registry of Ireland are marked 'NCRI'
  • Studies analysing anonymised data from other sources are marked 'anon'
  • Retrospective Chart Review Studies are marked 'RCRS'