SCHEDULES

SCHEDULE 8Research ethics committees: amendments

Section 113

Ionising Radiation (Medical Exposure) Regulations 2000 (S.I. 2000/1059)

1

In regulation 2(1) of the Ionising Radiation (Medical Exposure) Regulations 2000 (S.I. 2000/1059), in the definition of “ethics committee”—

(a)

omit paragraph (a), and

(b)

for paragraph (c) substitute—

“(c)

a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014, or

(d)

any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers or the Scottish Ministers;”.

Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000 (S.R. 2000/194)

2

In regulation 2(1) of the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2000 (S.R. 2000/194), for the definition of “ethics committee” substitute—

““ethics committee” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Department;”.

Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438)

3

In regulation 1(2) of the Health Service (Control of Patient Information) Regulations 2002 (S.I. 2002/1438), for the definition of “research ethics committee” substitute—

““research ethics committee” means—

(a)

a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014, or

(b)

any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers.”

Nursing Homes Regulations (Northern Ireland) 2005 (S.R. 2005/160)

4

In regulation 2(1) of the Nursing Homes Regulations (Northern Ireland) 2005 (S.R. 2005/160), for the definition of “ethics committee” substitute—

““ethics committee” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Department of Health, Social Services and Public Safety;”.

Residential Care Homes Regulations (Northern Ireland) 2005 (S.R. 2005/161)

5

In regulation 2(1) of the Residential Care Homes Regulations (Northern Ireland) 2005 (S.R. 2005/161), for the definition of “ethics committee” substitute—

““ethics committee” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Department of Health, Social Services and Public Safety;”.

Independent Health Care Regulations (Northern Ireland) 2005 (S.R. 2005/174)

6

In regulation 2(1) of the Independent Health Care Regulations (Northern Ireland) 2005 (S.R. 2005/174), for the definition of “ethics committee” substitute—

““ethics committee” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Department of Health, Social Services and Public Safety;”.

Approval of Research on Organs No Longer Required for Procurator Fiscal Purposes (Specified Purposes) (Scotland) Order 2006 (S.S.I. 2006/310)

7

In article 1(2) of the Approval of Research on Organs No Longer Required for Procurator Fiscal Purposes (Specified Purposes) (Scotland) Order 2006 (S.S.I. 2006/310), for the definition of “appropriate Research Ethics Committee” substitute—

““appropriate Research Ethics Committee” means a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Scottish Ministers;”.

Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 (S.I. 2006/1260)

8

In regulation 1(2) of the Human Tissue Act 2004 (Ethical Approval, Exceptions from Licensing and Supply of Information about Transplants) Regulations 2006 (S.I. 2006/1260), for the definition of “research ethics authority” substitute—

““research ethics authority” means—

(a)

a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014, or

(b)

any other group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers or the Department of Health, Social Services and Public Safety in Northern Ireland.”

Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 (S.I. 2006/2810)

9

In regulation 2 of the Mental Capacity Act 2005 (Appropriate Body) (England) Regulations 2006 (S.I. 2006/2810) (definition of “appropriate body”), for the words from “is a committee” to the end substitute “ is a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014. ”

Mental Capacity Act 2005 (Appropriate Body) (Wales) Regulations 2007 (S.I. 2007/833)

10

In regulation 2 of the Mental Capacity 2005 (Appropriate Body) (Wales) Regulations 2007 (S.I. 2007/833) (definition of “appropriate body”), for the words from “is a committee” to the end substitute “ is a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers. ”

Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 (S.I. 2010/995)

11

In regulation 2(1) of the Human Fertilisation and Embryology (Disclosure of Information for Research Purposes) Regulations 2010 (S.I. 2010/995), for the definition of “research ethics committee” substitute—

““research ethics committee” means a research ethics committee recognised or established by or on behalf of the Health Research Authority under the Care Act 2014;”.

Independent Health Care (Wales) Regulations 2011 (S.I. 2011/734)

12

In regulation 25 of the Independent Health Care (Wales) Regulations 2011 (S.I. 2011/734) (research), in paragraph (2) for the words from “a research ethics committee” to the end substitute “ a group of persons which assesses the ethics of research involving individuals and which is recognised for that purpose by or on behalf of the Welsh Ministers. ”