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HREC General Information

Roles and Responsibilities of the HREC

The documents listed below outline the roles and responsibility of the Human Research Ethics Committee (HREC) and the conditions the Committee operates under. These documents are based on the advice to institutions, human research ethics committees and health care professionals as endorsed by the National Health and Medical Research Council and the Ministry of Health.

NBMLHD HREC Terms of Reference
NBMLHD HREC Standard Operating Procedures
NHMRC Australian Health Ethics Committee (AHEC) Position Statement

Responsibilities of Researchers and Staff

Staff undertaking approved research must follow a strict set of guidelines while conducting their project. The link below is an abbreviated version of the Standard Operating Procedures that research staff must follow. All staff must ensure that:

• No research is conducted which has not received ethics approval by the NBMLHD HREC
• Site authorisation must be received from the relevant Research Governance Officer
• All relevant information has been provided to the HREC
• All relevant guidelines and legal requirements are complied with
• Monitoring requirements are complied with e.g. annual reports
• Proposed protocol modifications and amendments are submitted to the HREC Committee
• Adverse events are promptly notified

Annual and Final Reporting

Annual reporting is a condition of your ethics approval. One of the forms below must be submitted annually to the HREC to maintain ongoing HREC approval. This form must also be submitted on completion of the study.

Full Ethics Annual and Final Progress Report
LNR Annual and Final Report

Amendments and Modifications

Any amendments or modifications to an approved study must receive approval from the HREC Sub Committee. The process for amendment/modification is outlined in the Amendment Submission Requirements document below.

Amendment submission requirements

Request for Amendment or Modification form

Safety Reporting

Safety reporting is a condition of your ethics approval and the guidelines set out in the NBMLHD Memo SAE & SUSAR Reporting below should be strictly adhered to. Information in relation to monitoring and reporting of safety for clinical trials involving therapeutic goods is also available in the NHMRC document below.

Memo SAE & SUSAR Reporting
Safety Reporting Requirements
SUSAR and SAE Report form
Six monthly SUSAR and Annual SAE Summary Report form
NHMRC Position Statement May 2009
Research Proposals Involving the use of Radiation or Radionuclides

Templates for Participant Information Sheets

 The following documents form the basis for all Participant Information and Consent Forms and these should be strictly followed allowing for the details of your particular project. Compliance with the standard templates will assist with the review and approval process:

• Standard wording Participant Information Sheet for research not involving tissue or tissue banking
Standard wording Participant Information Sheet for research involving tissue bank or storage of tissue
• Standard wording Participant Information Sheet for research involving collection of human tissue and genetic testing
Consent form for 14years and Guardian for research involving participants age 14 to 16 years or requiring guardian consent
Pregnant Partner Release of Information form

Complaints

Any person (including participants, researchers, staff, students, administrators etc) can make a complaint about any aspect of a research study. Any other matter of ethical concern can also be brought to the HREC’s attention and will be appropriately investigated.

Complaints by Participants should be made directly to the Patient Representative at the facility where the research is being conducted. (Details can be found on the Participant Information and Consent Form Templates). Further information and contact details can be found on the HREC Complaints page.

Complaints by researchers, staff, students, administrators etc should be made directly to the Executive Officer of the HREC.

 

 

 

Friday, 21 September 2018 1:01:15 PM