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 27 January 2023.
| 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) | 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) |
16/35 | 16/47
| 16/52 | 16/58
SLRON | 16/60 | 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) |
17/58 | >
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 |
Radiation Regulations - 8 Jan 2019 |
HRCDC: April '19 | 19/08 (DL) | 19/28 | 19/32 | 19/46* | 19/20 | 19/55 |
19/68 | 19/73 | 19/74
STAFF |
19/77 | 19/78 | 19/80 | 19/81 | 19/82 | 19/83 | 19/91 |
20/02 | 20/07 | 20/13 | 20/17 | 20/23
20-NREC-COV-41 | 20/46 | 20/47 | 20/49 | 20/52 | 20/53 | 20/54 |
Parallel HRCDC and NREC-COVID19 review Apr - Aug '20 | 20-NREC-COV-19 | 20-NREC-COV-47 |
20-NREC-COV-56 | 20/63 | 20/68 | 20/71 | 20/72 | 20/78 |
Amendments to Health Research Regulations - 21 Jan 2021 |
19/45 | 19/57 |
20/51 STAFF | 20/58 | 20/59 | 20/76 NDMHS | 20/79 | 20/89 |
21/02 NDMHS | 21/06 | 21/11 STAFF | 21/15 NDMHS | 21/20 | 21/22 NCRI | 21/23 NDMHS | 21/24 NDMHS | 21/30 | 21/32 STAFF |
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 |
21/05 | 21/21 | 21/34 | 21/37 | 21/41 | 21/42 | 21/46 | 21/50 | 21/52 | 21/53 |
21/54 | 21/58 | 21/64 | 21/65 | 21/67 | 21/70 | 21/71 | 21/72
STAFF | 21/75 | 21/76 | 21/77 |
21/79 | 21/80 | 21/81 | 21/82 | 21/83 | 21/84 | 21/85 | 21/86 | 21/89 | 21/92
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 | 21/112 |
Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont 26.11.21 |
22/04 | 22/05 | 22/07 | 22/08 | 22/12 | 22/13
STAFF | 22/14 | 22/17 | 22/19 | 22/21 | 22/23 |
22/24 | 22/25 | 22/28 | 22/30 | 22/31 |
| Research Ethics Committee Standard Application Form 5.6 2014, adapted Beaumont 31.07.22 |
22/34 | 22/39
RCRS | 22/40 | 22/41 | 22/42 | 22/47 | 22/49
STAFF | 22/50
RCRS
NCRI | 22/52 | 22/54 |
Assisted Decision Making Capacity Act - commencement date to be confirmed |
|
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'
