Second

Session, 50th General Assembly

Charles III, 2024

BILL 64

AN ACT RESPECTING

HEALTH RESEARCH ETHICS

Received

and Read the First Time ................................................................

Second

Reading ............................................................................................

Committee .....................................................................................................

Third

Reading ...............................................................................................

Royal

Assent .................................................................................................

HONOURABLE JOHN

HOGAN, KC

Minister of Health

and Community Services and Attorney General

Ordered to be printed by

the Honourable House of Assembly

EXPLANATORY NOTES

This Bill would repeal the Health Research Ethics Authority Act and enact the Health Research Ethics Act .

The Bill would

increase the number of

directors of the Health Research Ethics Authority;

require the Health Research

Ethics Authority to change the composition of the research ethics board by

requiring the Health Research Ethics Authority to appoint at least one person

who is knowledgeable in privacy and to consider gender diversity when

appointing members to the research ethics board;

increase the independence of

the research ethics board;

clarify the responsibilities of

the Health Research Ethics Authority by redefining its objects;

allow the research ethics board

or a research ethics body to approve or conduct a

summary review of an

application to engage in health research, in accordance with criteria

established by the Health Research Ethics Authority, where the proposed health research

has been approved by a not-for-profit research ethics body in another jurisdiction;

allow minimal risk health

research to be conducted in the province without obtaining the approval of the Health

Research Ethics Authority or a research ethics board where the research has

been approved by a body that is prescribed in the regulations or that satisfies

the criteria prescribed in the Act or the regulations;

amend the reconsideration and

appeal process to be consistent with the Tri-Council Policy Statement

"Ethical Conduct for Research Involving Humans"; and

incorporate gender-neutral

language.

A BILL

AN ACT RESPECTING HEALTH RESEARCH ETHICS

Analysis

Short title

Definitions

Labrador Inuit rights

Authority continued

By-laws

Objects of the authority

Authority staff

Research ethics board

Approval of other research ethics bodies

Approval required for research

Minimal risk health research

Health research project may not be

changed

Monitoring research projects

Close-out report

Application for reconsideration

Appeal

Appeal panel

Appeal board

Conduct of appeal

Appeal to Supreme Court

Advisory committee

Annual budget

Audit

Annual report

Meetings of the authority and research

ethics board

Reimbursement of expenses

Indemnification

Disciplinary proceeding

Regulations

Act does not apply

Offence and penalty

Transitional

SNL2008 c.P-7.01 Amdt .

RSNL1990 c.P-43 Amdt .

Repeal

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 Act.

Definitions

2. In

this Act

(a) "advisory committee" means t he committee appointed under

section 21;

(b) "appeal board" means a n appeal board appointed under

section 18;

(c) "appeal panel" means a panel of

persons appointed under

section 17 to act as members of appeal boards;

(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

(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 pe rson 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

(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

(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;

(

c) at least one person

knowledgeable in the law related to health research;

(

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

(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

(

c) refuse to approve

the application.

(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 p roposed health research project

has been approved by a not-for-profit research ethics body in another

jurisdiction.

Minimal risk

health research

(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

(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

(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

(

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) r ecord 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

(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

(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

(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

(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

(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) T he 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

(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;

(

c) persons from the Indigenous

populations of the province;

(

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), t he 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

(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

(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

(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

(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;

(

c) prescribing bodies for the purposes of

paragraph 11(1)(b );

(

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

(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 .

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.

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