Statutes of Newfoundland and Labrador 2024 Chapter H-1.03

Be it enacted by the Lieutenant-Governor and House of Assembly in Legislative Session convened, as follows:

Short title

1. This Act may be cited as the Health Research Ethics Act.

Definitions

2. In this Act

(a) "advisory committee" means the committee appointed under section 21;

(b) "appeal board" means an appeal board appointed under section 18;

(d) "authority" means the Health Research Ethics Authority for Newfoundland and Labrador continued under section 4;

(e) "business day" means a day that is not a Saturday or a holiday;

(f) "competent Canadian research ethics body" means a body that

(i) is constituted in a Canadian jurisdiction,

(ii) is affiliated with a university, hospital, government or government agency,

(iii) is a not-for-profit body,

(iv) adheres to the requirements of the tri-council policy statement, and

(v) consists of at least 5 members, of whom at least

(A) 2 persons have expertise in relevant research disciplines, fields, and methodologies covered by the body,

(B) one person is knowledgeable in ethics,

(C) one person is knowledgeable in the law and is not the legal counsel or risk manager of the university, hospital, government or government agency with which the body is affiliated, and

(D) one person has no affiliation with the university, hospital, government or government agency with which the body is affiliated;

(g) "director" means a director appointed under section 4;

(h) "health research" means research activities in relation to human health, health care and health care systems involving

(i) human beings as research participants,

(ii) health care information respecting human beings, and

(iii) human biological material;

(i) "human beings as research participants" includes human remains, cadavers, tissues, biological fluids, embryos and foetuses, and records pertaining to them;

(j) "minimal risk health research" means health research in which the probability and magnitude of possible harms implied by participation in the research are no greater than those encountered by human participants involved in the health research in those aspects of their everyday life that relate to the research;

(k) "minister" means the minister appointed under the Executive Council Act to administer this Act;

(l) "principal investigator" means the person who has the principal responsibility for initiating and overseeing the conduct of a health research project;

(m) "research activities" means activities the primary goal of which are to generate or extend knowledge through a disciplined inquiry or systematic investigation;

(n) "research ethics board" means the board established under section 8;

(o) "research ethics body" means a body approved by the authority under section 9; and

(p) "tri-council policy statement" means the Tri-Council Policy Statement "Ethical Conduct for Research Involving Humans" adopted in August, 1998 by the Medical Research Council of Canada, the Natural Sciences and Engineering Research Council of Canada and the Social Sciences and Humanities Research Council of Canada, and includes amendments to the statement and another statement of principles and guidelines respecting ethical conduct for research involving humans adopted by those councils in substitution for the tri-council policy statement.

Labrador Inuit rights

3. This Act and regulations made under this Act shall be read and applied in conjunction with the Labrador Inuit Land Claims Agreement Act and, where a provision of this Act or regulations made under this Act is inconsistent or conflicts with a provision, term or condition of the Labrador Inuit Land Claims Agreement Act, the provision, term or condition of the Labrador Inuit Land Claims Agreement Act shall have precedence over the provision of this Act or a regulation made under this Act.

Authority continued

4. (1) The Health Research Ethics Authority for Newfoundland and Labrador is continued as a corporation.

(2) The authority shall consist of 7 directors comprised of

(a) the following persons appointed by the minister:

(i) a person employed by Memorial University of Newfoundland appointed following consultation with the president of the university,

(ii) a person employed by the Provincial Health Authority appointed following consultation with the chief executive officer of the Provincial Health Authority,

(iii) a person employed in the department presided over by the minister, and

(iv) 3 persons chosen to represent the public of the province; and

(b) the chairperson of the research ethics board, who shall be a non-voting director.

(3) The minister, following consultation with the president of Memorial University of Newfoundland and the chief executive officer of the Provincial Health Authority, shall appoint one of the directors as the chairperson of the authority.

(4) A director appointed under subparagraph (2)(a)(iv) shall be appointed for a term of 3 years and is eligible to be reappointed but shall not serve for a period longer than 9 consecutive years.

(5) Where the term of a director expires, the director continues to be a director until reappointed or replaced.

(6) Where a director resigns, dies or becomes incapable of performing the duties of a director, the minister shall appoint, in accordance with subsection (2), a person as a replacement director to serve for the remainder of the term of the director being replaced.

By-laws

5. The authority may make by-laws regarding its responsibilities and powers under this Act.

Objects of the authority

6. The authority shall

(a) provide oversight of the ethics review process to ensure that health research is conducted in an ethical manner; and

(b) be responsible for enhancing awareness of the ethical dimension of health research.

Authority staff

7. (1) The authority may employ those persons necessary to enable it to exercise its powers under this Act, including the provision of administrative and other support to the research ethics board, and may determine their duties and the conditions of their employment.

(2) The authority may establish the salary and other benefits of a person employed under subsection (1).

(3) Notwithstanding subsection (2), the salary and other benefits of a person employed under subsection (1) shall be consistent with the salaries and benefits applicable to persons performing similar duties and having similar responsibilities in the public service of the province.

Research ethics board

8. (1) The authority, following consultation with the minister, the president of Memorial University of Newfoundland and the chief executive officer of the Provincial Health Authority, shall appoint a research ethics board comprising of not less than 10 members.

(2) In making the appointments under subsection (1) the authority shall be guided by the principles respecting the appointment of members to a research ethics board contained in the tri-council policy statement and, in particular, shall appoint

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

(b) at least one person knowledgeable in ethics;

(d) at least one person knowledgeable in privacy; and

(e) at least one person to represent the general public.

(3) The authority shall consider gender diversity when appointing members to the research ethics board under subsection (2).

(4) The chairperson of the research ethics board shall be selected by a majority vote by all members of the research ethics board.

(5) The members of the research ethics board shall be appointed for a term not exceeding 3 years and are eligible to be reappointed but shall not serve for a period longer than 9 consecutive years.

(6) Where a member of the research ethics board resigns or ceases to function as a member of the board, whether through incapacity or for another reason, the authority shall appoint a person as a replacement member to serve for the remainder of the term of the person being replaced.

(7) Where the term of a member of the research ethics board expires, the member continues to be a member until reappointed or replaced.

(8) Subject to the approval of the authority, the research ethics board may make by-laws regarding its duties and powers under this Act.

(9) The research ethics board may, in accordance with the regulations, appoint one or more committees composed of its members and those committees have all the powers conferred on the research ethics board by this Act.

Approval of other research ethics bodies

9. The authority may approve a research ethics body for the purpose of reviewing applications for approval of health research in accordance with this Act where the research ethics body

(a) is a not-for-profit body; and

(b) satisfies the criteria established by the authority.

Approval required for research

10. (1) A person shall not engage in health research without first obtaining approval for the research from the research ethics board or a research ethics body.

(2) A person shall submit an application for approval to engage in health research to the authority.

(3) An application under subsection (2) shall include the application fee set by the authority.

(4) The authority shall, in accordance with the regulations and within 2 business days of its receipt, refer a completed application to the research ethics board or a research ethics body.

(5) The research ethics board or a research ethics body shall consider the application referred to it under subsection (4) within 30 days of receiving it and may

(a) approve the application;

(b) approve the application subject to the changes the research ethics board or research ethics body may require; or

(6) In exercising its powers under subsection (5), the research ethics board or research ethics body shall apply

(a) one or both of

(i) the tri-council policy statement, and

(ii) the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use Guidance E6: Good Clinical Practice: Consolidated Guideline; and

(b) other guidelines or standards approved by the authority for the purpose.

(7) Notwithstanding subsection (6), the research ethics board or a research ethics body, subject to the approval of the authority, may vary a standard or rule contained in the tri-council policy statement or other document referred to in or approved under subsection (6) or substitute a standard or rule in its entirety where the research ethics board or other research ethics body considers it appropriate with respect to a proposed health research project.

(8) Notwithstanding subsections (6) and (7), the research ethics board or a research ethics body may, in accordance with criteria established by the authority, approve or conduct a summary review of an application where the proposed health research project has been approved by a not-for-profit research ethics body in another jurisdiction.

Minimal risk health research

11. (1) Notwithstanding section 10, a person is not required to obtain approval under section 10 to engage in minimal risk health research where the person received approval to engage in minimal risk health research from

(a) a competent Canadian research ethics body; or

(b) a body prescribed in the regulations.

(2) A person referred to in subsection (1) shall

(a) in the form and manner determined by the authority, notify the authority of the health research in which it is engaged; and

(b) pay the fee set by the authority.

(3) The minister shall consult with the authority before making regulations referred to in paragraph (1)(b).

(4) Sections 13 to 20 apply, with the necessary changes, to minimal risk health research and for that purpose a reference in those sections to

(a) "research ethics board or research ethics body”, “research ethics board or research ethics body that approved the health research project” or “research ethics board or research ethics body, whichever approved, the health research project” shall be read as a reference to the “research ethics board”; and

(b) a reference in those sections to “health research” shall be read as “minimal risk health research”.

Health research project may not be changed

12. (1) A person shall not make substantive changes to a health research project without the written approval of the research ethics board or research ethics body that approved the health research project.

(2) Where a person makes substantive changes to a minimal risk health research project, the person shall, in the form and manner determined by the authority, notify the authority.

Monitoring research projects

13. (1) The research ethics board or research ethics body that approved the health research project,

(a) shall monitor the research activities of persons engaged in health research; and

(b) may conduct a review of

(i) record keeping,

(ii) research methodology,

(iii) conduct towards human participants involved in the health research, and

(iv) the research results relating to a health research project.

(2) A person shall provide the health research ethics board or research ethics body that approved the health research project, or a member of it or a person appointed by it to act on its behalf, with access to

(a) its records, in whatever form they are kept; and

(b) the premises where health research is being conducted.

(3) Where, as a result of a review conducted under this section, the research ethics board or a research ethics body, whichever approved the health research project, is of the opinion that

(a) the health research being conducted does not conform to the approved health research project;

(b) record keeping associated with the health research project is inadequate;

(c) the research methodology being applied is not in keeping with the methodology approved for the health research project; or

(d) conduct towards human participants involved in the health research project is improper,

the research ethics board or research ethics body may suspend the health research project until the deficiencies identified by it have been corrected.

(4) The research ethics board or research ethics body, whichever approved the health research project, may cancel a health research project for one or more of the following reasons:

(a) as a result of a review conducted under this section, the research ethics board or a research ethics body, whichever approved the health research project, is of the opinion that

(i) the health research being conducted does not conform to the approved health research project,

(ii) record keeping associated with the health research project is inadequate,

(iii) the research methodology being applied is not in keeping with the methodology approved for the health research project, or

(iv) conduct towards human participants involved in the health research project is improper; or

(b) another reason prescribed in the regulations.

Close-out report

14. (1) At the conclusion of a health research project the principal investigator shall submit a copy of a close-out report respecting the health research to

(a) the authority; and

(b) the research ethics board or a research ethics body, whichever approved the health research project.

(2) The close-out report referred to in subsection (1) shall be prepared in accordance with the requirements established by the authority.

Application for reconsideration

15. (1) A principal investigator who is dissatisfied with a decision of the research ethics board or a research ethics body may request that it reconsider its decision and the research ethics board or research ethics body shall on receipt of the request conduct a review of its decision.

(2) In conducting a review under subsection (1) the research ethics board or research ethics body shall give the principal investigator an opportunity to make submissions respecting the review and a principal investigator may appear in person or be represented by another person chosen by the principal investigator.

(3) A submission referred to in subsection (2) may be made orally or in writing, or both, at the discretion of the principal investigator.

Appeal

16. Where the research ethics board or a research ethics body conducts a review under section 15, a principal investigator who is dissatisfied with the decision of the research ethics board or research ethics body regarding that review may appeal the decision to an appeal board by applying to the chairperson of the appeal panel.

Appeal panel

17. (1) The authority shall appoint a panel of persons to act as members of appeal boards.

(2) One of the persons appointed to the appeal panel shall be appointed by the authority as chairperson of the appeal panel.

(3) Persons appointed to the appeal panel under this section shall not be directors of the authority or members of the research ethics board or a research ethics body.

(4) Members of the appeal panel shall be appointed for a term of 3 years and are eligible to be reappointed but shall not serve for a period longer than 9 consecutive years.

(5) Where the term of a member expires, the member continues to be a member until reappointed or replaced.

Appeal board

18. (1) Where the chairperson receives an application under section 16, the chairperson shall appoint an appeal board consisting of 5 members of the appeal panel.

(2) In appointing an appeal board under subsection (1), the chairperson of the appeal panel shall consider the subject matter of the appeal and the need for expertise in the area of the subject matter to the extent that the members of the appeal panel possess it.

Conduct of appeal

19. (1) An appeal board shall consider the matter of the appeal and give full opportunity to be heard to the principal investigator and the research ethics board or a research ethics body, whichever considered the application for the health research, or its representative.

(2) The appeal board may substitute the decision it considers appropriate or dismiss the appeal.

(3) The decision of the appeal board shall

(a) be in writing; and

(b) include reasons for the decision.

(4) The decision of the appeal board is binding on the principal investigator and the research ethics board or the research ethics body that considered the application for the health research.

Appeal to Supreme Court

20. A decision of an appeal board under section 19 may be appealed to the Supreme Court within 30 days of the decision of the appeal board.

Advisory committee

21. (1) The minister, after consultation with the authority, may appoint an advisory committee to provide advice to the authority.

(2) The membership of the advisory committee shall, to the extent that it is feasible, include

(a) persons from all regions of the province;

(b) health care professionals;

(d) representatives of health care institutions;

(e) persons with experience in the conduct of health research; and

(f) members of the general public.

(3) Where the minister appoints an advisory committee under subsection (1), the advisory committee, the authority and the research ethics board shall meet at least once a year to discuss matters related to the activities of the authority, the research ethics board and a research ethics body and the conduct of health research in general.

Annual budget

22. (1) The authority shall annually, not later than January 31, prepare and submit to the minister a budget containing estimates of amounts required during the next financial year for the purpose of defraying the expenses of administering this Act.

(2) The minister may approve the budget submitted or may make the changes the minister considers appropriate.

(3) The authority shall not incur, enter upon or contract for, or become liable for, an expenditure in excess of the estimated amount of expenditure set out in the budget approved by the minister.

(4) The financial year of the authority begins on April 1 in a year and ends on March 31 in the following year.

Audit

23. The auditor general shall, in accordance with section 19 of the Auditor General Act, 2021, annually, audit the records, accounts and financial transactions of the authority.

Annual report

24. The authority shall, not later than September 30 in a calendar year, prepare and submit to the minister, the president of Memorial University of Newfoundland and the chief executive officer of the Provincial Health Authority a report on the activities of the authority, the research ethics board and a research ethics body in the previous year, including the audited financial statements of the authority.

Meetings of the authority and research ethics board

25. (1) The authority and the research ethics board may conduct their meetings in person or by video conference or teleconference so long as, at a meeting, all participants may communicate simultaneously and instantaneously.

(2) A quorum of the authority or the research ethics board shall be constituted in accordance with the conditions for constituting a quorum contained in the tri-council policy statement.

(3) A director of the authority or a member of the research ethics board participating in a meeting by videoconference or teleconference shall be counted as present at the meeting for the purpose of establishing a quorum under subsection (2).

(4) A motion or resolution of the authority or the research ethics board shall be decided by a majority vote of directors or members in attendance at the meeting.

Reimbursement of expenses

26. (1) A chairperson of the authority, the research ethics board, the appeal panel or an appeal board

(a) shall be compensated for carrying out the chairperson's duties in the manner and amount agreed to by the minister and the chairperson; and

(b) may be reimbursed travel and other expenses incurred as a chairperson on a scale approved by the minister.

(2) Directors of the authority and members of the research ethics board, the appeal panel or an appeal board shall serve without remuneration but may be reimbursed for their travel and other expenses incurred as a director or member on a scale approved by the minister.

Indemnification

27. A director or employee of the authority and a member or employee of the research ethics board, a research ethics body, an appeal board and the advisory committee, or a person advising the authority, research ethics board or research ethics body, is not personally liable for anything done or omitted to be done in good faith while carrying out their duties as a director or employee of the authority or a member or employee of the research ethics board, a research ethics body, an appeal board or the advisory committee, or as a person advising the authority, research ethics board or research ethics body, under this Act.

Disciplinary proceeding

28. (1) Where the authority, the research ethics board or a research ethics body is of the opinion, on reasonable grounds, that a person, licensed by a body authorized under an Act to regulate a health care or other profession of which the person is a member, has failed to comply with this Act, the regulations or a determination or direction of the research ethics board, or of a research ethics body, the authority, the research ethics board or research ethics body shall refer the matter to the appropriate official of the licensing body of the profession of which the person is a member who shall deal with it as an allegation.

(2) Where a person, who is not a person licensed under an Act to regulate a health care or other profession, has failed to comply with this Act, the regulations or a determination or direction of the research ethics board, or a research ethics body, the failure shall be communicated to the person's employer.

Regulations

29. The minister may make regulations

(a) respecting the referral of applications under subsection 10(4);

(b) respecting the appointment of committees of the research ethics board, including the composition and terms of reference of those committees;

(d) prescribing additional reasons for cancelling a health research project;

(e) defining any word or phrase used but not defined in this Act; and

(f) generally to give effect to this Act.

Act does not apply

30. This Act does not apply to health research conducted by a student enrolled in a school to which the Schools Act, 1997 applies as part of the student's curriculum of studies.

Offence and penalty

31. A person who fails to comply with this Act, the regulations or a determination or direction of the research ethics board, or of a research ethics body is guilty of an offence and liable on summary conviction to a penalty of

(a) not less than $5,000 and not more than $50,000 for a first conviction; and

(b) not less than $10,000 and not more than $100,000 for a second or subsequent conviction.

Transitional

32. (1) A person who is a director of the authority at the time of the coming into force of this Act shall continue to be a director until the expiry of the person's term.

(2) A person who is a member of the research ethics board, the appeal panel or the advisory committee at the time of the coming into force of this Act shall continue to be a member until the expiry of the person's term.

(3) A research ethics body approved at the time of the coming into force on this Act continues to be approved.

(4) Health research approved at the time of the coming into force of this Act continues to be approved.

(5) Where an appeal or reconsideration was commenced before the coming into force of this Act, the appeal or reconsideration shall continue under this Act.

SNL2008 c.P-7.01 Amdt.

33. (1) Paragraph 2(1)(w) of the Personal Health Information Act is amended by deleting the reference "Health Research Ethics Authority Act" and substituting the reference "Health Research Ethics Act".

(2) Paragraph 2(1)(x) of the Act is amended by deleting the reference "Health Research Ethics Authority Act" and substituting the reference "Health Research Ethics Act".

(3) Section 44 of the Act is amended by deleting the reference "Health Research Ethics Authority Act" and substituting the reference "Health Research Ethics Act".

RSNL1990 c.P-43 Amdt.

34. Schedule C of the Public Service Commission Act is amended by deleting the reference "Health Research Ethics Authority Act, paragraph 3(2)(d)" and substituting the reference "Health Research Ethics Act, subparagraph 4(2)(a)(iv)".

Repeal

35. The Health Research Ethics Authority Act is repealed.

Commencement

36. This Act comes into force on July 1, 2025.