**As of April 1, 2012 HREB'S Review Fees for industry-sponsored clinical trials will increase**
Review Fee of $2500 INCREASED to $3000
Additional Site Fee of $1000 INCREASED to
$1500

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 For Application Guidelines & Templates
Click Here

2012 Deadline & Meeting Dates
Click Here
 

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.

 

Welcome to the Health Research Ethics Authority (HREA) Website


The Health Research Ethics Authority Act (The Act) came into force on July 1, 2011. The Act can be viewed at http://www.assembly.nl.ca/legislation/sr/statutes/h01-2.htm.  The regulation governing review of clinical trials and genetics research can be found at http://www.assembly.nl.ca/legislation/sr/regulations/rc110057.htm
The 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 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, December 2010 http://www.pre.ethics.gc.ca/) and the Guidelines for Good Clinical Practice of the International Committee on Harmonization (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ich/efficac/e6-eng.php).  

Transition Policy - Click here to see our transition policy, approved at the HREA Board Meeting of August 17, 2011.

Thank you for your continued support. This site will continue to be updated as new content becomes available.