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NEWFOUNDLAND AND LABRADOR

REGULATION 51/25

Health Research Ethics Regulations

under the

Health Research Ethics Act

(Filed June 20, 2025)

Under the authority of

section 29 of the Health Research Ethics Act,

I make the following regulations.

Dated at St. Johns, June 13, 2025.

Krista Lynn Howell

Minister of Health and Community Services

REGULATIONS

Analysis

Short title

Definition

Applications

Committees

Cancellation of health research project

Repeal

Commencement

Short title

These regulations may be cited as the Health Research Ethics Regulations .

51/25 s1

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Definition

In these regulations, "Act" means the Health Research Ethics Act .

51/25 s2

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Applications

(1)The authority shall refer all applications for approval to engage in health research involving human beings as research participants that contain proposals for genetics and genomics research to the research ethics board.

(2) The authority may refer applications for approval to engage in health research involving human beings as research participants that do not contain proposals for genetics or genomics research to the research ethics board or a research ethics body.

51/25 s3

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Committees

(1) The research ethics board may appoint the following committees:

(

a) Clinical Trials Committee which shall be responsible for reviewing applications to conduct health research involving clinical trials;

(

b) Non-Clinical Trials Committee which shall be responsible for reviewing applications to conduct health research other than clinical trials and genetics and geonomics research; and

(

c) Genetics and Genomics Committee which shall be responsible for reviewing applications to conduct health research involving genetics and geonomics.

(2) Each committee shall consist of the following persons appointed by the research ethics board from the members of the research ethics board:

(

a) at least 2 persons who have experience in the conduct of health research;

(

b) at least one person knowledgeable in ethics;

(

c) at least one person knowledgeable in the law related to health research;

(

d) at least one person to represent the general public ; and

(

e) at least one person knowledgeable in privacy.

(3) The research ethics board may appoint a member of the research ethics board to replace a member of a committee in relation to an application referred to the committee where

(

a) the research ethics board is of the opinion that the application referred to the committee would place a member of the committee in a conflict of interest; and

(

b) replacement of the member who is in a conflict of interest is necessary to satisfy the requirements prescribed in subsection (2).

51/25 s4

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Cancellation of health research project

In addition to the reasons prescribed in paragraph 13(4)(

a) of the Act, the research ethics board or research ethics body, whichever approved the health research project, may cancel a health research project where, as a result of a review conducted under

section 13 of the Act,

the research ethics board or research ethics body, whichever approved the health research project, is of the opinion that the person engaged in the health research

(

a) failed to comply with conditions placed on the health research project by the research ethics board, a research ethics body, a sponsor or regulatory agencies responsible for clinical trial approvals, oversight and inspections;

(

b) failed to obtain the written approval from the research ethics board or research ethics body that approved the health research project for substantive changes to the health research project; or

(

c) submitted false records associated with the health research project.

51/25 s5

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Repeal

The Health Research Ethics Authority Regulations

, Newfoundland and Labrador Regulation 57/11, are repealed.

51/25 s6

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Commencement

These regulations come into force on July 1, 2025.

51/25 s7

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