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Statutes of Newfoundland and Labrador 2006 AN ACT TO ESTABLISH A HEALTH RESEARCH ETHICS AUTHORITY FOR THE PROVINCE (Assented
to Analysis 1. Short title 2. Definitions 3. Authority established 4. By-laws 5. Powers of the authority 6. Authority staff 7. Research ethics board 8. Approval of other research ethics bodies 9. Approval required for research 10. Research project may not be changed 11. Monitoring research projects 12. Final report 13. Application for reconsideration 14. Appeal 15. Appeal panel 16. Commencement of appeal 17. Conduct of an appeal 18. Appeal to Trial Division 19. Constituent committee 20. Annual budget 21. Audit 22. Annual report 23. Meetings of the authority and board 24. Reimbursement of expenses 25. Indemnification 26. Disciplinary proceeding 27. Regulations 28. Act does not apply 29. Offence and penalty 30. Commencement 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. 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 (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. Authority established 3. (1) The
Health Research Ethics Authority for (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. (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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Appeal to Trial
Division 18. An
appeal lies to the Trial Division from a decision of an appeal board under
section 17. 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. 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. Audit 21. The
accounts of the authority shall be audited annually by an auditor appointed by
the authority. 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. 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. 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. 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. 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. Regulations 27. The minister may make regulations necessary to give effect to the purpose of this Act. 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. 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. Commencement 30. This Act comes into force on a day to be proclaimed by the Lieutenant-Governor in Council. ©Earl G. Tucker,
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