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SNL2006 CHAPTER H-1.2

HEALTH RESEARCH ETHICS AUTHORITY ACT

Amended:

2011 c22; 2012 c33 s1

CHAPTER H-1.2

AN ACT TO ESTABLISH A HEALTH RESEARCH ETHICS AUTHORITY FOR THE PROVINCE

(Assented to December 12, 2006 )

Analysis



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 Authority Act .

2006 cH-1.2 s1

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Definitions

        2. In this Act

             (a)  "advisory committee" means the committee appointed under section 19;

             (b)  "appeal board" means an appeal board appointed under section 16;

             (c)  "authority" means the Health Research Ethics Authority for Newfoundland and Labrador established under section 3;

             (d)  "health research involving human subjects" means activities whose primary goal is to generate knowledge in relation to human health, health care and health care systems, and involving human beings as research subjects, health care information respecting human beings and human biological material;

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

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

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

             (h)  "research ethics board" means the Health Research Ethics Board established under section 7; and

              (i)  "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.

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Labrador Inuit rights

      2.1 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.

2011 c22 s1

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Authority established

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

             (2)  The authority shall comprise 4 directors appointed by the minister as follows:

             (a)  a person to represent the Memorial University of Newfoundland appointed following consultation with the president of the university;

             (b)  a person to represent the Eastern Regional Health Authority appointed following consultation with the chief executive officer of that authority;

             (c)  a person employed in the department presided over by the minister; and

             (d)  a person chosen to represent the public of the province.

             (3)  The chairperson of the research ethics board is a member of the authority by virtue of his or her office but shall not vote at meetings of the authority.

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

             (5)  A director shall be appointed for a 3 year term and is eligible to be reappointed for a second term.

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

             (6)  Where a director resigns or ceases to function as a director, whether through incapacity or for another reason, 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.

2006 cH-1.2 s3; 2012 c33 s1

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By-laws

        4. The authority may make by-laws to assist it to carry out its responsibilities and to exercise its powers under this Act.

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Powers of the authority

        5. (1) The authority has power to ensure that health research involving human subjects is conducted in an ethical manner.

             (2)  The authority shall have responsibility to enhance public awareness of the ethical dimension of health research involving human subjects.

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Authority staff

        6. (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 prescribe 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) but they 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.

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Research ethics board

        7. (1) The authority, following consultation with the minister, the president of the Memorial University of Newfoundland and the chief executive officer of the Eastern Regional Health Authority, shall appoint the Health Research Ethics Board comprising not fewer 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)  both men and women to the board;

             (b)  at least 2 persons who have experience in the conduct of health research involving human subjects;

             (c)  at least one person knowledgeable in ethics;

             (d)  at least one person knowledgeable in the law related to health research involving human subjects; and

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

             (3)  The authority shall appoint one of the members of the research ethics board as the chairperson who shall oversee the work of the board.

             (4)  The members of the research ethics board shall be appointed for a term not exceeding 3 years and are eligible to be reappointed.

             (5)  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.

             (6)  Subject to the approval of the authority, the research ethics board may make by-laws to assist it to carry out its duties and to exercise its powers under this Act.

             (7)  The research ethics board may appoint one or more subcommittees composed of its members and those subcommittees have all the powers conferred on the board by this Act.

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Approval of other research ethics bodies

        8. The authority may approve a research ethics body if

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

             (b)  it is established in conformity with the principles respecting the appointment of members to a research ethics board contained in the tri-council policy statement

for the purpose of reviewing applications for approval of health research involving human subjects in accordance with this Act.

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Approval required for research

        9. (1) A person shall not engage in health research involving human subjects without first obtaining approval for the research from the research ethics board or a research ethics body approved by the authority under section 8.

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

             (3)  The authority shall, within 2 business days of its receipt, refer an application made to it under subsection (2) to the research ethics board or a research ethics body approved by the authority under section 8.

             (4)  The research ethics board or a research ethics body approved by the authority under section 8 shall consider the application referred to it under subsection (3) within 30 days of receiving it and may

             (a)  approve the application;

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

             (c)  refuse to approve the application.

             (5)  In exercising its powers under subsection (4), the research ethics board or other 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.

             (6)  Notwithstanding subsection (5), the research ethics board or a research ethics body approved by the authority under section 8, 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 (5) or substitute a standard or rule in its entirety where the board or other body considers it appropriate with respect to a proposed project of health research involving human subjects.

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Research project may not be changed

      10. A person shall not make changes to a project of health research involving human subjects without first submitting the proposed changes to the research ethics board or other research ethics body from which approval for the project was received and obtaining approval for the changes from the board or other body.

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Monitoring research projects

      11. (1) The research ethics board or research ethics body approved by the authority under section 8, whichever gave approval for the health research involving human subjects, shall monitor the research activities of persons engaged in health research involving human subjects.

             (2)  The research ethics board or a research ethics body approved by the authority under section 8, whichever gave approval for the health research project involving human subjects, may conduct a review of record keeping, research methodology, conduct towards human subjects and the research results relating to a project of health research involving human subjects.

             (3)  A principal investigator shall provide the research ethics board or a research ethics body approved by the authority under section 8, whichever gave the approval for the health research project involving human subjects, or a member of it or a person appointed by it to act on its behalf, with access to its records, in whatever form they are kept.

             (4)  A principal investigator shall provide the research ethics board or a research ethics body approved by the authority under section 8, whichever gave the approval for the health research project involving human subjects, or a member of it or a person appointed by it to act on its behalf, with access to the premises where health research involving human subjects is being conducted.

             (5)  Where, as a result of a review conducted under this section, the research ethics board or a research ethics body approved by the authority under section 8, whichever gave approval for the health research project, believes

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

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

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

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

the board or other body may suspend the research project until the deficiencies identified by it have been corrected, or the board or other body may cancel the research project.

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Final report

      12. At the conclusion of a project of health research involving human subjects the principal investigator shall submit a copy of the report respecting the research to

             (a)  the authority; and

             (b)  the research ethics board or a research ethics body approved by the authority under section 8, whichever gave the approval for the health research project involving human subjects.

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Application for reconsideration

      13. (1) A principal investigator who is dissatisfied with a decision of the research ethics board or a research ethics body approved by the authority under section 8 may request that it reconsider its decision and the board or body shall on receipt of the request conduct a review of its decision.

             (2)  In conducting a review of its decision under subsection (1) the research ethics board or a research ethics body approved by the authority under section 8 shall give the principal investigator an opportunity to make a submission to it, which may be in person or in writing, or both, at the discretion of the principal investigator, and at an appearance before it the principal investigator may be represented by a person of his or her choice.

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Appeal

      14. An appeal lies from a decision of the research ethics board or a research ethics body approved by the authority under section 8 or from a decision on reconsideration by it to an appeal board.

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Appeal panel

      15. (1) The authority, following consultation with the minister, the president of the Memorial University of Newfoundland and the chief executive officer of the Eastern Regional Health Authority, shall appoint a panel of persons to act as members of appeal boards.

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

             (3)  Persons appointed to the panel under this section shall not be members of the authority, the research ethics board or a research ethics body approved by the authority under section 8.

             (4)  Members of the panel shall be appointed for a 3 year term and are eligible for reappointment.

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Commencement of appeal

      16. (1) A principal investigator who wishes to appeal from a decision of the research ethics board or a research ethics body approved by the authority under section 8, including a decision on a reconsideration by it, shall apply to the chairperson of the panel appointed under section 15 and the chairperson shall appoint an appeal board consisting of 5 members of the panel.

             (2)  In appointing an appeal board under subsection (1), the chairperson of the panel shall have regard to 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 panel possess it.

2006 cH-1.2 s16

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Conduct of an appeal

      17. (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 approved by the authority under section 8, whichever considered the application for the health research involving human subjects, or its representative.

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

             (3)  The decision of the appeal board is binding on the principal investigator and the research ethics board or a research ethics body approved by the authority under section 8, whichever considered the application for the health research involving human subjects, and shall be given in writing and include the reasons for its decision.

2006 cH-1.2 s17

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Appeal to Trial Division

      18. An appeal lies to the Trial Division from a decision of an appeal board under section 17.

2006 cH-1.2 s18

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Constituent committee

      19. (1) The minister, after consultation with the authority, shall appoint an advisory committee to the authority.

             (2)  The membership of the advisory committee shall, to the extent that it is feasible, include persons from all regions of the province, health care professionals, the aboriginal populations of the province, representatives of health care institutions, persons with experience in the conduct of health research involving human subjects and members of the general public.

             (3)  The advisory committee and 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 appointed by the authority under section 8 and the conduct of health research involving human subjects in general.

2006 cH-1.2 s19

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Annual budget

      20. (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 he or she 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.

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Audit

      21. The accounts of the authority shall be audited annually by an auditor appointed by the authority.

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Annual report

      22. The authority shall, not later than September 30 in a calendar year, prepare and submit to the minister, the president of the Memorial University of Newfoundland and the chief executive officer of the Eastern Regional Health Authority a report on the activities of the authority, the research ethics board and a research ethics body approved by the authority under section 8 in the previous year, including the audited financial statement of the authority.

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Meetings of the authority and board

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

             (4)  Where there is a tie vote on a motion or resolution of the authority or the research ethics board, that motion or resolution shall be considered to be defeated.

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Reimbursement of expenses

      24. (1) With the exception of the chairpersons of the authority, the research ethics board, the appeal panel and an appeal board, members of these bodies, and the advisory committee, shall serve without remuneration but may be reimbursed their travel and other expenses incurred as a member of one of them on a scale approved by the minister.

             (2)  In addition to reimbursement of his or her travel and other expenses, the chairpersons of the bodies referred to in subsection (1) shall be compensated for carrying out their duties in the manner and amount agreed to by the minister and the chairpersons.

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Indemnification

      25. A member of the authority, the research ethics board, a research ethics body approved by the authority under section 8, an appeal board and the advisory committee is not personally liable for anything done or omitted to be done in good faith while carrying out his or her duties as a member of the authority, the research ethics board, a research ethics body approved by the authority under section 8, an appeal board or the advisory committee under this Act.

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Disciplinary proceeding

      26. (1) Where the authority, the research ethics board or a research ethics body approved by the authority under section 8 believes, 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 a determination or direction of the research ethics board, or of a research ethics body approved by the authority under section 8, the authority, board or 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 a determination or direction of the research ethics board, or a research ethics body approved by the authority under section 8, the failure shall be communicated to the person's employer.

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Regulations

      27. The minister may make regulations necessary to give effect to the purpose of this Act.

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Act does not apply

      28. This Act does not apply to health research involving human subjects conducted by a student enrolled in a school to which the Schools Act, 1997 applies as part of his or her curriculum of studies.

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Offence and penalty

      29. A person who fails to comply with this Act is guilty of an offence and liable on summary conviction

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

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

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Commencement

      30. This Act comes into force on a day to be proclaimed by the Lieutenant-Governor in Council. (In force - Jul. 1/11)

2006 cH-1.2 s30