AUCKLAND DISTRICT HEALTH BOARD RESEARCH REVIEW COMMITTEE
Minutes of the Research Review Committee meeting held on Monday June 26 2006 Room 6, Administration, Level 5, ACH 1pm – 3.25 pm Members: David Sage (Chair), Bridie Kent, David St George, Ivan Bergman, Ralph Stewart (left at 1450 before discussion of 3455), Dianne Rogers, Colin McArthur (arrived 1400), Gayl Humphrey (ex officio) Apologies Christina Birkin, Andrew McCann, Tim Short In Attendance: Richard Frith (A+ Trust) Administrator in Attendance: Frances Hoffmann
The Chair declared the meeting open at 1.00 p.m. ITEM 2: The minutes of the previous meeting of May 22, 2006 were approved in principle. ITEM 3. Terms of Reference The Terms of Reference were discussed and it was resolved to: alter the TOR to keep the membership to nine people and to remove alternates ACTION: DS will ask the Dean, FHMS to nominate a non-ADHB University of Auckland representative with experience in health science and research to become a member of the committee, and ask the ADHB CEO to ratify these changes to the TOR. ITEM 4: Criteria for Approval by RRC Discussion and clarification of the review process and criteria for research project approval took place at various times during the meeting. Applications to the review committee must include: 1) the application form with all signatures 2) a signed budget 3) ethics application & information and consent forms 4) protocol if relevant. All legal documents must be approved; however, if they are not ready by the RRC agenda date the project can still go forward to receive RRC approval, legal approval pending. After review, final RRC approval is dependent on the Review Office receiving the ethics approval. If there are points of clarification requested, depending on the response the RO can either issue final approval or forward the response to the two reviewers for their comment and decision.
Resolved that if scientific rigour of proposal is unclear or complex the committee will seek external expert advice. Documents to Committee for the Review Process GH asked for feedback on what information wanted to accompany projects for review. ACTION: GH to draft a cover check list to accompany all projects which summarises the documents and status of legal documents and ethics approval. Unless specifically requested the protocol will not be circulated automatically but can be requested by reviewers from Gayl. Resolved that from August 1 all applications to the committee will be required to be submitted using an ADHB standard research form incorporating modifications suggested by the committee. Gayl will email prior to meeting and project allocation to find out which members can attend each meeting, reviewers to send their comments to Gayl if they cannot attend meeting. The agenda is determined on the Monday before the meeting, all preparation will occur on the Tuesday and all documents will be sent to the members on the Wednesday. This is the earliest that project information can be distributed to committee members. The option of electronically sending the documents as well as hard copy was also mentioned. Bridie Kent would like this option. Administration Check membership list and ensure time of meeting set at 1pm in all diaries (Colin’s diary was showing 2pm for this meeting.) Research Projects
Project 3511 Reviewer RS CM RS CB* DR BK RRC comments To explain sample size and power given small numbers and pop. sample size No questions No questions Privacy issues 1. Confirm no. from ADHB 2. Describe amount of ADHB nurse time 3. Confirm resource use No questions Not present and no feedback No questions approval pending response and budget and ethics DStG Confirm that sponsor charged PI time despite internal process not charging for this Approve Approve Recommended Decision Approve contingent on response Approve pending budget Approve Approve contingent on Ethics Committee approval re privacy issues Approve, contingent on involvement of realistic numbers of ADHB patients and ADHB nurse time Approve, subject to confirmation re cost allocation
CB* DStG CM
No questions Confirm numbers 1. access to DEXA 2. what is the mix of standard visits and study visits – confirm with budget Not present and no feedback No specific questions Adequacy of sample size for proposed investigation Insufficient info. re proposed statistical method No questions 1) there was a little confusion re numbers in the design 250 in ethics yet in the protocol you talk about 15 patients with mixed valvular heart disease. The 15 is what is confirmed by the NHF grant received 2) Can you inform the committee on whether the echocardiograms at visit 1 and 3 (at one Year) would be standard tests or an extra? 3) Can you confirm who will be undertaking the echo’s i.e. ADHB or elsewhere? 4) if ADHB can you provide evidence of what effect this will have on usual patient access?
Approve subject to further information Approve subject to further information
TS RS CM
Approve subject to further information
Approve subject to further information approval pending budget and ethics
* absent but feedback provided ACTION: GH will feed this information back and pending awaiting documents send approval letters on behalf of RRC. ITEM 5: Draft Drug Savings Policy It was discussed that a sub group would meet to discuss options re a Savings policy and provide a draft working paper to the Committee at the next meeting. Members: David, Colin, Ivan (and Gayl ex officio) will work on this. Process: GH to provide DStG with all documents relating to current remarks on savings. DStG will produce an initial draft (including all matters discussed at last meeting and examples and how each will be dealt with in practice). This draft will be circulated to the sub group and comments and revisions by e-mail and phone. The aim is to have a policy paper formulated for the CFO and the Board. Process for obtaining feedback from researchers and others re this policy will be discussed at the next meeting.
ITEM 6: General Business Gayl tabled a paper describing an Allied Health study. GH summarised issues concerning 3274, which had received GLREF and Physiotherapy funding but still showed a deficit of $23K. The researchers wanted to know their options as study important both operationally and for developing a research ethos within the department. After discussion it was resolved that the committee approve the project, with the following caveat. 1) the study can start despite not having all funds and can operate until funds finish. This will give the researchers the opportunity to continue to seek more funding over the next 15 months. The researchers must also provide a budget which shows how long the study can go until the money currently would run out and to refine the study outcomes a little more clearly for the committee. GH would convey this to the researchers and await their response. It was also recommended that this study could be put forward (approved) to the Grants Committee for agreement of support funding. It was acknowledged that currently there is no support fund but that once monies are transferred this would change and this project could still be looked at in this light. As there was no other general business, the meeting closed at 3.25pm.