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 outweigh 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 the appropriate governance is in place.
Bellberry’s Committees have reviewed well over 1,000 trials since its beginnings in 2004 including more than 40% of new clinical studies registered with the Therapeutic Goods Administration in 2010. Bellberry Committees are able to review all phases of clinical drug trials and they currently review on average 22 trials per month (2010/2011). With more than 50 Committee members and a pool of experts supporting our Committees, we are well placed to provide in depth and robust review of research studies. One of our unique capabilities is the review of multicentre research. Since 2005, Bellberry has been providing review of multicentre research, which enables the one study to receive one review only. For example, in 2009, we reviewed 67 multicentre research projects conducted at 191 sites. This reduction in duplication is recognised as an important aspect of supporting clinical trials in Australia. To ensure we provide robust review, Bellberry Committees will only review six to seven new studies at any meeting (pending complexity). This limit was set by Committee members who believe in order to provide a thorough review each meeting should be limited to six studies. Each study is presented to the Committee by a primary reviewer and a second review is given by a secondary reviewer. This model works very well and provides each study with an extremely rigorous review.
The ministerial Clinical Trials Action Group Report (March 2011) cites recommendations to boost the business of clinical trials in Australia including support for a 60 calendar day timeframe for both ethics and governance review of clinical trials. Bellberry Committees fall well within national benchmarks for timeliness and we remain committed to further reductions in our turnaround times. Timeliness is critical to our operations as we are aware that delays in providing review of clinical trials and in providing feedback can be extremely costly for the study sponsor. An internal quality review was conducted in March 2011 which showed that the mean time Bellberry takes to approve a study is 12 working days. An investigator can expect to receive comments detailing the Committee’s deliberations 2 days following the committee meeting. A previous analysis performed in 2009 highlighted that a study was taking 15 business days to be reviewed by the Committee, that is, the study was lodged with Bellberry 15 days prior to being reviewed. The introduction of Bellberry’s new online submissions system – eProtocol – has enabled this timeframe to be reduced to 11 days, representing a saving of four days from the total review. eProtocol has also provided the opportunity to improve some of our other processes such as the review of amendments. All amendments are now usually reviewed within a 48 hour timeframe.
The Australian Council on Healthcare Standards EQuIP 4 standards- The ACHS EQuIP 4 Guide July 2006 section 4.3.6 states that ‘One of the ways in which it is possible for an organisation to demonstrate Extensive Achievement (EA) in a criterion is to undertake research’. Research fuels the advancement of further knowledge. It can lead to patients being treated with the most contemporary and advanced treatments and ensure they receive the highest level of healthcare possible. Utilising Bellberry HRECs will assist an organisation in meeting standard 2.5 of the ACHS EQuIP 4 Guide.
Quality Assurance Activities
Bellberry not only reviews clinical drug trials but 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.