Third

Session, 45th General Assembly

Elizabeth II, 2006

BILL 23

AN ACT TO ESTABLISH A

HEALTH RESEARCH ETHICS AUTHORITY FOR THE PROVINCE

Received and Read the First Time ................................................................ November

20, 2006

Second Reading .............................................................................................. November

20, 2006

Committee ................................................................................. Amendment

November 23, 2006

Third Reading .................................................................................................. November

23, 2006

Royal Assent ......................................................................................................................................

HONOURABLE

TOM

OSBORNE

Minister

of Health and Community Services

Ordered

to be printed by the Honourable House of Assembly

EXPLANATORY

NOTE

This Bill

would provide for the creation of the Health Research Ethics Authority for Newfoundland and Labrador . The authority would be charged with the

general supervision of all health research involving human subjects conducted

in the province.

A BILL

AN ACT TO ESTABLISH A HEALTH RESEARCH

ETHICS AUTHORITY FOR THE PROVINCE

Analysis

Short title

Definitions

Authority established

By-laws

Powers of the authority

Authority staff

Research ethics board

Approval of other research ethics bodies

Approval required for research

Research project may not be changed

Monitoring research projects

Final report

Application for reconsideration

Appeal

Appeal panel

Commencement of appeal

Conduct of an appeal

Appeal to Trial Division

Constituent committee

Annual budget

Audit

Annual report

Meetings of the authority and board

Reimbursement of expenses

Indemnification

Disciplinary proceeding

Regulations

Act does not apply

Offence and penalty

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 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.

Authority established

(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.

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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

(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,

Queen's Printer