New Zealand Association of Clinical Research

Fisher & Paykel Healthcare Clinical Education Centre, Level 5, Auckland City Hospital, Thursday 11th December 2008

As my term as President draws to a close, I have taken time to review the highlights, decisions and even some of the challenges of this year and table this report as a summary.

The Annual Conference is the highlight of the NZACRes year for me and not only because I love to meet people and put faces to names. There will be a full report of the 2008 conference, but I would note that this year’s conference offered a fantastic programme and flowed smoothly under the guidance of the excellent organising team and the dedicated staff of the Conference Company. It was beneficial for the Exec to have a stand at the conference to promote the association and likewise having the Ethics Committees on site to answer questions offered a great opportunity. Having said this, I would note that as the conference did not quite break even this year and perhaps we should consider increasing the ‘09 registration fee.

The Conference Organising Committee did a fantastic job and as I mentioned at the close of the conference some of them have made themselves available for the ‘09 team. I believe the key to keeping our conference vibrant and growing is to draw on the vast array of our combined ideas, networks and experiences. I hope that the conference organising team will grow after this meeting and that the new team combined with the growth in our association will produce an even bigger and better conference next year.

The New Zealand Wide Constituency of NZACRes has required the Exec to wrestle with several issues through the year such as the election of the Executive in keeping with the Rules of the Organisation, as well as convening meetings over teleconference from various sites through the country. All of these are challenges which we as an organisation will need to overcome.

Administrative Support from Amanda Henson-Molloy aka info@nzacres.org.nz has been essential to the functioning of the organisation over the past year. During the year Amanda notified us of her families intention to move to Dunedin. It was agreed that there was no reason why the service could not be offered from Dunedin and we would strongly recommend that this arrangement be continued.

Advertising on the NZACRes Website is an ongoing matter. There are regular approaches from people seeking to advertise on the Association’s website. Faced with these requests and being unsure whether, as a charity, we are allowed to charge for advertising a policy was created to handle these issues where by, if the advertisement supports the NZ Clinical Research Environment then we would allow no-cost advertising, otherwise we would decline the request.

Developing Networks is a stated role of NZACRes. To support our relationship with our ‘sister’ organisation in Australia, ARCS, we have submitted articles for their bi-monthly newsletter and promoted their offer of discounted membership fees for our members. The incoming Exec will need to explore whether reciprocating this membership arrangement could benefit our members. Beyond ARCS there are other organisations supporting research in Australasia with whom developing relationships could be beneficial. For example the Australasian Research Management Society (ARMS) and Association of Clinical Research Professionals (ACRP)

Regional Meetings have been hosted in Auckland (3) Wellington (1) & Christchurch (1). Attendance has been fantastic on all occasions with the feedback noting the excellent topics and good presenters. Ahead of each occasion we discussed whether these meetings should be open to non-members. Somehow the incoming Exec will need to firm up a policy on this matter, considering both the maintenance of benefits for members as well as the fact that certainly in regions outside of Auckland the number of members is too low to justify such an exclusive meeting.

The Ethics Committee have in the past year drafted new guidelines and an application form for Interventional Studies. This draft was circulated broadly through our network and we negotiated an extended feedback period for our members. This is yet to make its final appearance but 2009 will undoubtedly be the year. When they are launched the circulation could be facilitated via our network.

NZACRes Registration with Charities Commission was completed earlier this year. This included submission of ‘Rules’ and specifying the Certified Officers and income streams. The Charities Commission will need to be notified of any change to these aspects and may impose some limitations on our dealings particularly in regard to income streams.

I am pleased and proud of what we have managed to do this year, but we have discussed and identified other exciting ideas that we have unfortunately been unable to see through. Valuable ideas like offering a training grants scheme, co-ordinating training courses and offering an award recognising excellent service to research, some of which may come to the fore in the future.

The NZ Association of Clinical Research is an organisation with a great deal of potential for good within our industry and it is my earnest desire is that this potential is increasingly realised.

I wish the incoming executive all the very best and look forward to 2009 with you all.

Auditor
At the 2007 meeting there was discussion to see if an auditor should be appointed and there was a majority vote against appointing one for 2008. It was requested that this question be put to the vote at next year’s AGM and subsequent AGMs as NZACRes grows in size.
There was an overwhelming majority vote not to appoint an auditor for 2009.

Membership
Proposed: Will need to review the current membership fee ($49.50, early bird $44.40) and look at increasing this. It might be too late to increase this for 2009 as this will need to be reviewed properly, perhaps look at increasing this for 2010.

Election of Officers for 2009
Nominee’s names have been circulated by email. NZACRes members are spread throughout NZ and as the AGM was to be held in Auckland, the Executive committee decided to ask members to vote by email for their choice of management committee members for 2009.
It has been noted that the NZACRes rules of incorporation indicate that voting must be done by those attending the AGM in person or by nominee. A motion was passed at the AGM to allow for a change in the constitution to enable email voting for the 2009 committee and for subsequent voting in the future.

A call for nominees to be made for at least a month prior to the AGM.
List of all nominees (with bio sketches) indicating which would be willing to stand as President are to be circulated at least 14 days ahead of AGM,
E-voting must be for a notified timeframe and be closed ahead of the AGM to allow for scrutiny.
Votes will be for up to 5 individuals noting among their number the preferred president.
Votes will be scrutinized to ensure maximum of one vote per financial member

At 2008 AGM, members present were asked if they agreed for the motion to be passed. The vote was unanimous (10 votes) for passing the motion and allowing for e-voting for the 2009 committee members. Constitution changes drafted will be submitted to Charities Commission for amendment.

Nominees for 2009
Annette Reinheimer (Ch-ch)
Gina Baker (Auck)
Marina Dzhelali (Wgtn)
Karin Gruber (Auck)
Joline Ong (Auck)
Fiona MacKay (Auck)
Gunther Kothen (Auck)

Voting will elect five committee members. The five elected members can select to extend the numbers from five to seven members in the committee.

The 5 elected members for the 2009 Executive Committee, as accounted for by our voting scrutinizer Taina Von Blaramberg are as follows:

The handover meeting from 2008 committee members to new 2009 committee will be held as soon as possible and arrangements for banking access and signatories will be arranged.

Conference update
The 2009 conference committee consists of:
Tim Sato
Tracey Schuuman
Michael Gibson
Helen Mason

The 2009 Executive Committee will work closely with the 2009 Conference Committee. This year there will be more overlap between the two committees to ensure a smoother running of the finance and also to ensure we have enough support for the Conference Committee.

Update from the last Auckland meeting on Informed consent
This was a productive meeting and the Chair of the Northern X committee attended and she took some of the issues to the last Chairs meeting. The meeting concluded with the EC chairs agreeing that NZACRes should put forward a formal letter addressing the issues that were discussed at the last Auckland Regional Meeting regarding Informed Consent. Before putting a formal letter forward, it would be beneficial for a wider group consultation to see who is affected by these issues and what solutions we can offer. It is important to have a wide group review with representatives from sponsor, CRO, DHB and other concerned parties to be present at this review.
The following issues to be reviewed:

Ongoing participant access to clearly beneficial drugs after the completion of a study – Are there a lot of studies that do not provide compassionate supplies? What support can ethics committees offer to researchers who are trying to ensure patients will have access?
Lengthy Participant Information Sheets - can this be simplified? What support can ethics committees offer to researchers to achieve this?
In the case of research conducted involving acutely ill people, could a different informed consent process be used? Realistic process that takes into account short time frames for consenting and treatment initiation, patient’s reduced ability to comprehend information and no appropriate proxies available to seek consent.

It was suggested by Stuart Ryan that there is a subcommittee who follows this up with representation from Pharma, PI’s amd CRO’s.

Outcome of the Training Survey
59 people responded during the conference.
The results showed that there is definitely a role for NZACRes to continue to foster and promote local and international training / education opportunities.
The incoming committee will look at ways to meet the needs of the members in relation to this.
Stuart Ryan mentioned that Counties Manukau DHB is working collaboratively with a number of Education partners to develop a Center for Health innovation which will have a strong research component. There may be opportunities to partner and provide the education required in the future.

Charity status – check our constitution and Charitable Trust can run like a business that can sustain the charity. eg. if we are allowed to charge for advertising to allow for income to come in to pay for admin support in our association. More advertising will also attract more traffic to our website. Perhaps look at updating this in the constitution if it is not stated while we are updating the e-voting option so we only need to update the constitution once.
Excellence Service Award – if we want to implement this, maybe look at providing travel grants for out of town members so income re-directed back into the service.
Feedback from sponsors and from previous sponsors who did not sponsor this year (why they did not want to sponsor again). Keep momentum going, follow-up on currently available sponsors. Stands/booths not enough funding this is almost equivalent to cost of venue. Speaker funding should come from major sponsors. There is another conference (ARMS?) in Christchurch that is competing for our sponsors. We need to secure sponsorship urgently or companies will have their budget sent out with no allocation to our conference.
Budget for 2009 – it will be good practice to have some structure in having budget set or drafted. This could be something that the outgoing committee can draft for the incoming committee before handover. Eg. Increase in membership, budget for grants, travel, etc.
Identify and drive the membership benefits. Need to stress this to members to entice new membership and to keep current memberships. Be mindful that benefits apply to all members and not just a grant for one member.
Education and/or Training courses. Can work with other groups that are already offering or working toward these courses so we are not delivering these but facilitating.
Add Marina and Annette in as Regional Representatives for NZACRes to keep networks outside of Auckland active. Also to allow Marina and Annette not to be burdened with the monthly meetings for the Exec. Committee. But will have regular contact to keep with them to keep up to date with what is happening in our Regional networks and vice versa.
A wider group review from NZACRes before putting forward a formal letter to the Ethics Committee regarding issues about the Patient Information Sheet and Informed Consent.

We are pleased to invite you to attend the New Zealand Clinical Research Conference 2009.

Hosted by the New Zealand Association of Clinical Research, the 2009 Conference offers a unique opportunity to exchange experience, share expertise and network within the scientific, healthcare and clinical research community.

The opportunities for putting forward your views and opinions to industry leaders and your peers, as well as collaboration and networking will be invaluable.

Click here to register your interest in sponsorship and exhibition opportunities.

Conference Managers:       The Conference Company
Telephone:                            +64 9 360 1240
Facsimile:                              +64 9 360 1242

The Nursing Research Section (NZNO) has contracted Research New Zealand to undertake a major update of the Index of Nursing Research. The Index is a free database accessible through the Nursing Research Section (NRS) of the NZNO website www.nursingresearch.co.nz

In an attempt to locate potential research for the Index, the NRS is inviting nursing researchers to advise it of New Zealand research on the practice of nursing, nursing education, nursing policy or nursing management.

Attached is a notice (klick here to download) from the NRS describing in more detail the scope of the Index and how researchers can contribute their own completed research, or research they have supervised.

The ARCS Board has moved to better define the membership categories, and Full Membership will be only available to those based in Australia and working primarily in or for the industry in therapeutic development roles. ARCS have established a new Class of membership called Overseas Associates to encourage membership from all the various countries with an interest in the Australian research environment and ARCS services. Their goal is to be able to meet the needs of this group more effectively in the future through e-learning and the development of co-operative agreements with organizations in their country.

To this end ARCS have agreed to allow members of NZACRes to join ARCS at a discounted rate of $98 AUD. As a special Overseas Associate Member of ARCS,NZACRes members will be eligible for all member benefits (member-only areas of the website, information services, discounted attendance at ARCS events etc), including the DIA e-membership. The new ARCS Constitution will apply to applications and renewals and at renewal members will be asked to confirm their status and any change will only be implemented then. Click here to download the application form and apply today!

To bring together researchers, clinicians, health care professionals and consumers with an interest in melanoma clinical trials to foster collaboration and the exchange of ideas.
To develop and support large-scale, multi-centre melanoma studies of clinical relevance and importance which would be difficult for any single centre to complete.
To provide a single point of contact for sponsors and investigators wishing to undertake melanoma trials in Australia and New Zealand.

ANZMTG membership is free and open to all researchers, industry representatives and consumers.

The group is growing at a rapid pace and are about to publish their first newsletter (which will provide a good update of recent activities).

The ANZMTG clinical trial portfolio currently includes 4 active studies and 3 proposed protocols. More study specific information is available on their website: www.anzmtg.org

ANZMTG also encourages new research and is able to facilitate new protocol development. A study synopsis application form will be posted online soon.

Application forms are available online and also attached please find a membership form.

Australian & New Zealand Clinical Trials & Research Providers Directory to facilitate access to Australian and New Zealand service providers engaged in Pharma, Biotech and Device Development.

The Directory will:

The Clinical Trials & Research Providers Directory is a joint initiative by the Australia - New Zealand Biotechnology Alliance (ANZBA), Invest Australia and New Zealand Trade & Enterprise. Coordination and compilation of data is being managed by ANZBA.

NZACRes establishes communication channel with Multi-regional Ethics Committee

In June the NZACRes committee had the great opportunity to meet with members of the Multi-regional Ethics Committee (MEC) and the Northern X and Y committees in Auckland - to discuss some questions on the new multi-regional Ethics process and learn more about the committees` work. It was an open and constructive exchange and NZACRes could establish a channel of communication between the Ethics committee and members of the research community.

The MEC made the following recommendations how researchers can assist the ethical review process:

Furthermore, some areas for training were identified and the NZACRes committee is looking at adequate training sources for researchers which can help to improve the quality of research applications. This will focus on two key aspects:

Following this meeting, a Safety Discussion Group formed to look at possible improvements of the safety reporting process. We were also informed that NEAC (the National Ethics Advisory Committee) is looking at the possibility of expedited review for low-risk observational studies; this is currently worked through by the ministry of Health. A review of the application forms will be carried out, and this will include the feasibility of electronic submissions

The Royal Society of New Zealand maintains a list of all science and technology awards available to New Zealanders. The list is at www.rsnz.org/awards/other.php