Department of Research and Innovation
HREC - Information for patients
What is a Human Research Ethics Committee?
Research proposals involving human participants must be reviewed and approved by a Human Research Ethics Committee (HREC) before the research can commence. The HREC is established by and advises an institution or organisation, in this case CDD, regarding ethical approval for research projects.
What is the role of a Human Research Ethics Committee?
"To protect the welfare and rights of the participants in research and the primary responsibility of each member is to decide, independently, whether in his or her opinion, the conduct of each research proposal submitted to the HREC will protect participants." (NHMRC - National Statement on Ethical Conduct in Research Involving Humans), whilst considering the principles of ethical conduct:
- Integrity - honest and ethical conduct of research
- Regard for welfare, rights, beliefs, perceptions etc
- Responsibility to minimise risks of harm or discomfort
- Respect for dignity and wellbeing
- Consent MUST be obtained before patient participation
- Research merit and safety must be demonstrated
Therefore,
- by providing objective and informed opinions about new research protocols, the HREC aims to protect the rights and welfare of participants in clinical trials;
- in ensuring the safety of patients in clinical trials, the HREC also facilitates research that will benefit the worldwide community;
- the HREC protects the integrity of research and development into gastroenterological disorders at CDD and safeguards the wellbeing of patients participating in clinical trials.
Who are members of an HREC?
The members of an HREC must be representative of the community. As such a minimum composition is required. There must be at least one of each:
- Chairperson
- Layman
- Laywoman
- 2 Persons with knowledge of and current experience in areas of research regularly considered (e.g. health, medical, social, psychological etc)
- Person with knowledge of and current experience in the professional care, counseling or treatment of people (e.g. doctor, nurse, social worker etc)
- Minister of Religion (can be of any religion)
- Lawyer
No maximum number is set by the NHMRC, however, for logistical reasons at CDD generally no more than 2 members per category will be on the committee at any one time. If you have been involved in a clinical trial at CDD and wish to make a complaint regarding the ethical conduct of the staff please email chair_hrec@cdd.com.au.
INTERESTED IN BEING A MEMBER?
How much time will it take?
- Dependant upon number of projects submitted (can be limited).
- Generally meet every 8 weeks. Can be increased to monthly if number of projects significantly increases.
- Each meeting lasts approximately 1.5-2 hrs.
- Time needed to read documents and prepare for each meeting is approx 1-2 hrs (depending at what capacity the member is acting).
- If you are the Chairperson…it will take a bit more time!
Is it compulsory attendance?
- All members need to give their comments on each project to give a recommendation.
- Members must endeavor to attend all meetings - the date and time of which is set as a routine scheduled event.
Examples of issues raised by an HREC - Protocol/Investigator Brochure
- Number and necessity of invasive procedures
- Nature and severity of side effect profile
- Inclusion and Exclusion criteria
- Adherence to international guidelines and standards, e.g. GCP - Good Clinical Practice
- Privacy and confidentiality of patients and data collected
- Scientific Merit (this is NOT the primary capacity of the HREC)
Examples of issues raised by an HREC - Patient Information and Informed Consent form
A good HREC will be especially critical of this document as this is often the total written information that the patient will receive for the study.
- Complexity and accuracy of language
- Explanation of drug regimen
- Side effects
- Alternative treatments
- Unexpected injury and compensation
Available positions for new members will be posted on this website. If you are over 18 years of age you are welcome to apply.
