eProtocol

HREC

Human Research Ethics Committee’s

Bellberry currently manages eight Human Research Ethics Committees: A, B, C, D, E, F, G and H. We hold eight regular HREC meetings per month and are able to hold extra meetings when required. Meetings are held every Wednesday evening. All study documentation must be submitted via eProtocol 2 weeks prior to a meeting.

The last meeting of 2018 will be 19th December 2018, and the first meeting for 2019 will be 2 January.

We are able to hold extra meetings if and when required. Please contact Bellberry prior to submitting your documents if you have specific time frames.


Role of HRECs

Our Human Research Ethics Committees (HRECs) are designed to review and where appropriate, approve and monitor human research projects. In doing so, each HREC also ensures that “all types of research involving or impacting on humans conform to the highest ethical standards of practice and academic integrity”.

Bellberry not only reviews clinical drug trials, but also provide review for social science and observational studies. We can also assist when there might be disagreement about clearly defining research versus quality assurance activities. The role of the HREC is to ensure participant interests are considered especially where interventions are proposed that may incur risks, suffering or inconvenience. As occurs in clinical research, patients/participants should be provided with relevant information to enable them to determine if they wish to be involved in the quality assurance activity.


HREC Certification & Registration

The NHMRC has granted Bellberry certification of our ethical review processes under the National Approach to Single Ethical Review of Multi-Centre Research (National Approach) for Committees A, B, C, D, E, F, G and H. The current period of certification is valid from 1 January 2017 to 31 December 2018 and the next period of certification is valid from 1 Jan 2019 to 31 December 2019 (certification)

NHMRC HREC code (TGA HREC Code):
Committee A:  EC00372
Committee B:  EC00419
Committee C:  EC00430
Committee D: EC00444
Committee E:  EC00450
Committee F:  EC00455
Committee G: EC00458
Committee H: EC00459
Our HRECs are registered with the Office for Human Research Protections (OHRP) in the USA.  The IRB numbers are:
Committee A: IRB00005845
Committee B: IRB00008609
Committee C: IRB00007608
Committee D: IRB00008610
Committee E: IRB00009875
Committee F: IRB00010616
Committee G: IRB00010975
Committee H: IRB00010976

Standards

Bellberry Committees are registered with the National Health and Medical Research Council (NHMRC) and four of our HRECs are certified under the National Approach to Single Ethical Review of Multi-Centre Research.

Bellberry ensures we abide by and/or the research meets the following guidelines and standards:

  • National Statement on Ethical Conduct in Human Research 2007 (the National Statement)
  • Australian Code for the Responsible Conduct of Research 2007
  • CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95)
  • ISO 14155 Clinical Investigation of Medical Devices
  • Therapeutic Goods Act
  • National Health and Medical Research Council Act 1992

As Bellberry is a national organisation our Committees also consider relevant local legislation when considering health research proposals.

Click here to access the Bellberry HREC Terms of Reference.


For further information on the following please see our HREC Information document. This document contains information on the following:

  • HREC Chairs
  • Committee Members and Orientation
  • Clinical Research Education
  • Committee Management
  • Policy Meetings
  • Research Investigators
  • Insurance and Indemnity
  • Communication between Researchers and Human Research Ethics Committees