Transition to provincial health research ethics board
by SHARON GRAY
Newfoundland and Labrador is leading the way in Canada in the research ethics review process. Within the next year, legislation establishing a new provincial Health Research Ethics Authority (HREA) with the power to ensure that health research involving human subjects is conducted in an ethical manner will be proclaimed.
It will be the first such provincial agency in Canada.
The Human Investigation Committee (HIC), currently the joint health research ethics board for the university and Eastern Health, dates back to the early days of the Faculty of Medicine when it was established to oversee research involving humans. The HIC makes decisions to approve, not approve, suspend or terminate any health research involving human subjects based on whether or not participants are adequately protected.
The functions of the HIC will now come under the new provincial Health Research Ethics Board (HREB) which will be governed by the HREA, a corporation with three partners Eastern Health, the provincial government and Memorial University
The impetus to create a provincial research ethics board stemmed from incidents in which genetics research was done in Newfoundland communities by researchers from outside the province involved in studies not reviewed by a Newfoundland REB. The results of these studies were not communicated to participants. These lapses in investigator responsibility motivated seven years of work culminating in legislation creating the HREA and the HREB. The legislation passed third reading in the House of Assembly in the fall of 2006.
“For the past year a transition team has been working to ensure a seamless transition to a timely and efficient review process which protects research participants and promotes research in this province,” said Linda Purchase, ethics officer of, currently, the HIC and the future HREA/HREB. “The transition team is developing processes, policies, and standard operating procedures to ensure efficient ethics review. The team has representatives from the partner institutions, the current Human Investigation Committee and the private sector.”
The Act requires all health research in the province to be reviewed and approved by the HREB, or an approved duly constituted health research ethics body, before the research can begin. Only the HREB will review clinical trials of drugs and devices and genetics research.
Ms. Purchase explained that the HREA will be an independent, not-for-profit corporation reporting to the minister of Health and Community Services. The board of directors of the HREA has been appointed by the minister on the recommendation of the funding partners. The newly appointed board members are Theresa O’Keefe, Miawpukek First Nation; Joy Maddigan, Department of Health and Community Services; Wayne Miller, Eastern Health; and Penny Moody-Corbett, Faculty of Medicine, MUN.
The HREA will be responsible for appointing members of the HREB and maintaining an inventory of all human health research conducted in the province. It will be supported by Memorial University, Eastern Health, the Government of Newfoundland and Labrador and through fees charged for the review of contract research.
A Constituent Committee, an advisory group from across the province, will be appointed to provide consultation and advice on local issues to the HREA and HREB. For more information on the HREA, to follow its progress or to review the Act, visit www/hrea.ca, email email@example.com or call 709-777-8949.