HREB Readiness Assessment

$1500

This service provides expert guidance on ethical issues that may be hidden within your healthcare or biotech research. According to the Health Research Ethics Authority Act, any research involving human subjects that takes place within the province of Newfoundland & Labrador must gain the approval of the Health Research Ethics Board. Getting approval requires submitting a proposal for review by the Board. Submitting the proposal without any guarantee of approval costs $3500. While the Board must examine your proposal within 30 days of submission, the actual approval process could take much longer depending on whether your proposal is approved on the initial submission. When you purchase a readiness assessment, a PhD qualified ethicist and member of the NL HREB reviews your proposal prior to initial submission. By having this expert understanding of the HREB involved in the drafting of your proposal you are greatly increasing the likelihood of your proposal being approved on initial submission. This saves your organization time on reviewing, redrafting, and resubmitting the document as well as waiting for the proposal to be reviewed by the Board again. As with the initial submission, this second submission has no guarantee of approval.

Deliverables:

• A submission-ready copy of your proposal that has been audited for any ethics or compliance violations.

• If needed, one additional review of the same proposal within 6-months of initial contract signing.

NOTES: This service does not review for clinical or medical errors and is responsible only for the ethics of the proposal and its compliance with standard PHIA and TCPS 2 standards as well as proper NL HREB document standards. To avoid conflicts of interest, the consultant will not participate in the HREB evaluation of your organization’s proposal.