The HREA will be a not-for-profit independent corporation and all industry sponsored clinical trials to be conducted in both institutional and private settings in Newfoundland and Labrador  will be required to have approval of the HREB before it can be conducted in this province.

For industry sponsored clinical trials, all reviews and approvals will be provided by the HREB. There will be a single ethics review and approval for each project and, where relevant, it will be coupled with a site institutional approval to access resources as is the current model for Eastern Health.

The HREA is a voluntary not-for-profit agency. As directed in the HREA Act, members of the Board of the Authority, the Health Research Ethics Board (HREB), the Appeals Panel and the Advisory Committee, shall serve without remuneration but may be reimbursed for their travel and other expenses incurred as members. This reimbursement will be based on the usual government rates.

The chairpersons of the Board of the Authority, the Health Research Ethics Board (HREB) and the Appeals Panel will be compensated based on the usual government rates for carrying out their duties.

The Authority does have salaried staff to maintain the usual operations and functions of the Ethics Office and to provide support to the HREB and to the Board of the Authority.

This act is available on line by going to Statutes of Newfoundland and Labrador (SNL) Chapter H-1.2; An Act To Establish A Health Research Ethics Authority For The Province (Assented to December 12, 2006)
http://www.assembly.nl.ca/legislation/sr/statutes/h01-2.htm

Current ongoing studies will remain under the jurisdiction of the board which had granted approval; that board will remain the REB of record for that study. All future reports and correspondence related to the study will continue to go the board that had granted the approval. Studies that had been approved by HIC will be grandfathered over to the Health Research Ethics Board (HREB) under the HREA.

Under the mandate of the HREA all human health research to be conducted in Newfoundland and Labrador is required to be reviewed and approved by the HREB or an HREA-approved REB to ensure that health research involving human subjects is conducted in an ethical manner. This review will focus on both ethical and scientific issues and will centre on protecting research participants.

This approval does not give researchers permission to access the premises or resources of any institution, organization or aboriginal community nor does it require institutions, organizations or aboriginal communities to participate in research that may not fit with the values of the group or compromise their resources. Researchers will be responsible to contact participating institutions, organizations or aboriginal communities to seek appropriate approvals. It will be left to the discretion of the individual institution, organization or aboriginal communities to define what this approval process will entail.

When the provincial authority is proclaimed all health research involving human subjects will be required to be approved by the Health Research Ethics Board (HREB) or another approved health research ethics body under the HREA. There will be a single research ethics board that reviews all clinical trials and genetics research projects.

There is no minimum number of sites.

All industry sponsored contract research projects submitted to the HREB are subject to a review fee. The invoice for this fee will be sent directly to the sponsor/CRO after the first review by the committee. Payment is due upon review by the committee for services rendered and is not contingent upon securing approval by the HREB or executing a contract with the PI and/or institution.  

The current review fee is $2500. There is a further fee of $1000 for each additional site in a study where there are multiple sites within Newfoundland and Labrador. 

This is a single one-time fee inclusive of amendments and annual renewals and management of safety reports

The following  will be applied as we transition to review of industry sponsored clinical trials under the HREA Act

1. A new project that is not submitted to any ethics board before the date of Proclamation must go to the HREB.
2.  Adding new sites for a project that was submitted to another ethics board, either local or centralized and was approved by that board would continue with the approving board serving as the board of record for that study.
3. A project that has been submitted to another local or central ethics board but is not yet approved would be given a 30 day grace period to obtain full ethics approval.  If the project is approved within the 30 days, the board of approval will remain the board of record. If it does not have a letter of full approval after 30 days then it will need to start the process anew under the HREA.

A multi-site study that is not an industry sponsored  clinical trial and intends to add a new site within the province would apply to the HREB or any HREB-approved REB

ICEHR

Western Health

The HREA Act provides timelines for the HREB in stipulating that notice of receipt of an application must occur within 2 business days and review and response to an application must occur with 30 days.

We are confident that we currently meet these timelines and are planning a review system that will enable us to continue to meet these requirements.  Our current plan includes establishing a subcommittee of the HREB to review clinical trails. This committee will also meet every two weeks .

We are planning to follow a process similar to that of a central board in that the sponsor, their representative or designate can make application for the project and each site would be required to submit a brief site form.

Contract negotiations would remain the responsibility of the institution/ investigator as per current process