Benefits of Using Bellberry
Research being conducted on humans can be inherently risky and there is a public responsibility to ensure that any interactions with people during research are ethically acceptable. The provision of review by a Human Research Ethics Committee is one important part of ensuring the appropriateness of any research.
The HREC has responsibility to not only verify that the research is sound but to also confirm the potential benefits of the study justify the potential risks. An institution not only has responsibility for making certain ethical review is provided where appropriate but also has responsibility for the ongoing appropriate governance of research. These responsibilities are outlined in the National Statement. Bellberry both reviews the study and ensures that appropriate governance is in place.
Bellberry’s Committees have reviewed over 1,500* studies since its beginnings in 2004 including approximately a third of all clinical studies registered with the Therapeutic Goods Administration in recent years. Bellberry Committees are able to review all phases of clinical drug trials and social science studies. They currently review on average 32 studies per month (2017/18). With about 100 Committee members throughout Australia and a pool of experts supporting our Committees, we are well placed to provide in depth and robust review of research studies.
Our focus in the HREC review process is on Quality and Timeliness of Review, and our turnaround time is approximately 20 working days from submission of application to the review decision (this does not include the time the application is back with the investigator). Bellberry was recognised by the 2012 McKeon Review as “setting the benchmark” for Australian HREC review services.
- Bellberry operates using an electronic submission process and a dedicated virtual collaboration environment. This enables geographically-disparate Investigators, Sponsors, Institutions and Committee members to interact on each submission, and is used by Bellberry to support swift turnaround. Investigators use the electronic portal not only for initial submission, but for subsequent cycles of questions and answers with the HREC.
- As a specialist service provider, Bellberry provides a dedicated secretariat of 1.8FTE per HREC. User support is available by telephone 0830-1700 5 days per week.
- The Bellberry team undertakes pre-submission triage to ensure applications and supporting documentation are in the best possible shape for review by HREC, and will work with individual Investigators as required to support the review process.
- Submission closing dates occur every Wednesday (except Christmas shutdown). From submission-closing, studies are accommodated at HREC review in two weeks.
- The turnaround time from submission of application to the application being returned with Committee feedback following review is 20 days. This is recognised as setting the standard in the Australian environment, and in conjunction with the CTN scheme provides some of the swiftest start up times in the world.
- Bellberry HREC meetings are constituted according to the National Statement. Using the pool of HREC members, the Bellberry HREC is tailored on a meeting-by-meeting basis specifically to meet the needs of the studies submitted. Skills on the roster ensure that quality reviews can be made of projects ranging from clinical studies of pharmaceuticals, devices and techniques, to social science studies.
- Bellberry provides an independent site monitoring service to audit performance against study approval documentation. This is available on a routine or at-cause basis, and provides support to the geographically-independent HREC.
- Bellberry has recent experience in establishing new HRECs, including the recruitment, selection and induction of members, appointment and mentoring of new HREC chairs. A standardised 12 month HREC initiation plan exists and is available for new HREC locations.
- Bellberry hosts a Policy Forum for the cohort of Bellberry HREC Chairs to ensure consistency for all users, regardless of committee. Bellberry provides policy statements on a number of key and repeatable features of studies, study submissions and review. These policies ensure transparency for users, consistency between committees, and reference documents for all concerned.
- Bellberry provides education and training support as needed, both for the Ethics application process, support for Investigators, and for the electronic ethics system. This can be face-to-face or by webinar.
*Figure correct as at June 2019