Listing - Unregulated Studies (excludes regulated clinical trials)

This listing excludes clinical trials of medicines and clinical investigations of medical devices (regulated clinical trials) and is dated 31 October 2022.

19/74 STAFF
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)
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**12/65 12/75 (DL)12/100 HSE National Consent Policy, Part 3 - Research, 2013
13/09 (DL)13/21 13/68 13/74 13/79 13/81 13/84 Declaration of Helsinki, revised 2013
14/28 14/44 14/50
SLRON
14/52
Research Ethics Committee Standard Application Form, 5.6, 2014
15/04 15/40 15/66 15/OTH/51
SLRON
15/95 (DL)
16/29 16/35 16/47 16/52 16/58 SLRON 16/60 16/64 16/83
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) 17/37 17/42 17/58 17/76
18/10* (DNLN)
GPPR and Data Protection Act 2018 - 25 May 2018
18/21 18/25
Health Research Regulations 2018 - 8 Aug 2018
18/43 18/44 18/45
Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont and RCSI, 31 Aug 2018
18/46 18/52 18/60 (DL) 18/63 18/66
Radiation Regulations - 8 Jan 2019
HRCDC: April '1919/08 (DL) 19/23 19/28 19/32 19/36 (DL) 19/46* 19/20 19/55 19/68 19/71 (DL)
19/73 19/77 19/78 19/80 19/81 19/82
19/83 19/87 19/91
20/02 20/07 20/08 20/13 20/17 20/23
20-NREC-COV-41
20/4620/47 20/49 20/52 20/53 20/54
Parallel HRCDC and NREC-COVID19 review Apr - Aug '20 20-NREC-COV-19 20-NREC-COV-26 20-NREC-COV-47 20-NREC-COV-56 20/63 20/68 20/71 20/72 20/78 20/86
Amendments to Health Research Regulations - 21 Jan 2021
19/45 19/57
20/51 STAFF 20/5820/5920/70 20/76 NDMHS 20/7920/89
21/02 NDMHS21/0621/11 STAFF 21/15 NDMHS21/20 21/22 NCRI 21/23 NDMHS 21/24 NDMHS 21/26 21/30 21/32 STAFF 21/33
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 21/3721/39 NDMHS STAFF21/4121/4221/4621/5021/5221/53
21/5421/5721/5821/6421/6521/6721/7021/7121/72
STAFF
21/7521/7621/77
21/7921/8021/8121/8221/8321/8521/8621/8921/92
RCRS
21/93 21/94 21/96
21/98* 21/99 21/100
RCRS
21/101 21/102 21/103
RCRS
21/105 21/107 21/110 21/108
STUDENTS
21/112
Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont 26.11.21
22/0422/0522/0722/09 22/13
STAFF
22/14 22/1722/21 22/22 22/25 22/28 22/30
22/31
Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont 31.07.22
22/39
RCRS
22/49
STAFF
22/50
RCRS
NCRI
Assisted Decision Making Capacity Act - 21 Nov 2022

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 involving Students as participants are marked 'STUDENTS'
  • 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'