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'