The HREA Corporate Statement
The Health Research Ethics Authority (HREA) of Newfoundland & Labrador, a non-profit agency, was established by the Health Research Ethics Authority Act (The Act) and came into effect on July 1, 2011. It is charged with the general supervision of all health research involving human subjects conducted in this province.
The powers of the HREA
To ensure that health research involving human subjects is conducted in an ethical manner.To be responsible for enhancing public awareness of the ethical dimension of health research involving human subjects.
Definition of human health research
The Act defines human health research as “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.[…] Human beings as research subjects include human remains, cadavers, tissues, biological fluids, embryos and fetuses, and records pertaining to them.”
The basis for research ethics review
The HREA will ensure that research ethics reviews conducted by the Health Research Ethics Board (HREB) and other approved research ethics bodies will be conducted according to the principles and guidelines of the Tri-Council Policy Statement (TCPS2). It will also adhere to the principles and guidelines of ICH-GCP (E-6 Guidelines for Good Clinical Practice of the International Committee on Harmonization) and other guidelines or standards approved by the HREA for the purpose.
Governance:
The HREA is established as a corporation with a Memorandum of Understanding between the HREA, Memorial University, Eastern Health, and the Department of Health and Community Services. The MOU sets out the contributions by each party with respect to the processes and policies governing the operations and funding of the HREA.
The HREA Board will comprise four directors appointed by the Minister of Health as follows:
- a person to represent Memorial University of Newfoundland appointed following consultation with the President of the University;
- a person to represent the Eastern Regional Health Authority appointed following consultation with the Chief Executive Officer of that Authority;
- a person employed in the Department of Health and Community Services appointed by the Minister;
- a person chosen to represent the public of the province.
The chairperson of the HREB is a member of the HREA by virtue of his or her office but shall not vote at meetings of the HREA. The minister will appoint one of the directors as the chairperson. The current HREA board members are:
- Ms. Regina Coady, Director (Public), Chairperson
- Ms. Gillian Sweeney, Director (Government Representative)
- Ms. Kelli O’Brien, Director (Newfoundland and Labrador Health Services)
- Dr. Tana Allen, Director (Memorial University Representative)
- Dr. Fern Brunger, Ex-officio, HREB Chairperson
- Ms. Barbara Mason, Ex-officio, Ethics Director
Appointment of the Health Research Ethics Board and other research ethics bodies
The HREA Board appoints the HREB comprising not fewer than 10 members. The HREA may approve other research ethics bodies if they are a not-for-profit body and established in conformity with the principles respecting the appointment of members to a research ethics board contained in the TCPS2.
Accountability
The HREA will 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 HREA, the HREB and any research ethics body approved by the HREA in the previous year, including in the report an audited financial statement of the HREA.