The HREA has gone paperless! All applications to the Health Research Ethics Board (HREB) must be submitted electronically through the Researcher Portal as of 2016!
You can go online now to https://rpresources.mun.ca/ to request portal accounts and to register for training sessions.
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The Health Research Ethics Authority (HREA) oversees ethics review of health research by the new Health Research Ethics Board (HREB); all health research that was previously reviewed by the HIC must now be submitted to the HREA.
The Health Research Ethics Authority Act (The Act) came into force on July 1, 2011. The Act can be viewed here. The regulation governing review of clinical trials and genetics research can be found here.
The HREA Act will require that all health research done in the province be reviewed and approved by a local (Newfoundland and Labrador) research ethics review board. The Health Research Ethics Authority (HREA) oversees ethics review of health research by the Health Research Ethics Board (HREB) or an approved health research ethics review body.
The HREA Act, section 2(d) defines “health research involving human subjects” 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 or human biological material.
This includes all research related to health education (e.g. curriculum development in nursing or medicine). Health research does not include tests on non-healthcare equipment or tools to be used by humans, even where the research methods may put humans at risk (e.g. automobile or helicopter safety studies, research to study early childhood learning patterns, human kinetic research to establish parameters of safety for sports equipment).
To note: health research being conducted where the researcher is not affiliated with MUN and participants or data are not about Newfoundland and Labrador or its population does not require local ethics review.
In addition, national health surveys being conducted where the researcher is not affiliated with MUN that include Newfoundlanders and Labradoreans as participants, but do not identify Newfoundland and Labrador as an aggregate and do not report findings specific to Newfoundland and Labrador or to aggregates within Newfoundland and Labrador, does not require local ethics review.
The HREA will
ensure that all health research involving human subjects within the province is conducted in an ethical manner;
enhance public awareness of the ethical dimension of health research involving human subjects;
appoint the members of the provincial Health Research Ethics Board (HREB);
approve other ethics review bodies in the province; and
maintain an inventory of all human health research conducted in the province.
The HREA will consult with the public through an advisory committee of persons from across the province appointed by the Minister of Health and Community Services.
The Health Research Ethics Board appointed by the Authority will
be responsible for the ethical review and approval of applications for health research projects involving human subjects;
review all clinical trials and all genetics research (other health research may be reviewed by other approved ethics review bodies); and
monitor the research activities of persons engaged in health research involving human subjects in the province.
In carrying out their duties the HREA, the HREB and other approved ethics review bodies will apply the Tri-Council Policy Statement (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, 2014) and the Guidelines for Good Clinical Practice of the International Committee on Harmonization.