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					                        OPEN MINUTES




           Multi – region Ethics Committee




                         15 June 2010




VENUE:
Standards New Zealand
155 The Terrace
Wellington




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Meeting of the Multi-Region Ethics Committee open to the public held on
                             15 June 2010
        at Standards New Zealand, 155 The Terrace, Wellington




                              PRESENT:

                    Mr Richman Wee (Chairperson)
                      A/Prof Margaret Horsburgh
                          Dr Russell Franklin
                         Mr Hector Matthews
                         Mrs Carolyn Weston
                           Dr Paul Copland
                          Mrs Maliaga Erick
                        A/Prof Sheila Williams
                            Dr John Baker
                           Dr Chris Wynne
                          Dr Helen Moriarty


                             APOLOGIES :

                         Mrs Georgina Johnson


                         ADMINISTRATORS:

                          Annisha Vasutavan
                            Claire Lindsay




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                               NEW PROTOCOLS

   1. A randomised controlled trial of paracetamol versus placebo on
      airways resistance in asthma (Protocol No. PA02

             Lead Investigator: Prof. Richard Beasley
             MEC Reference: MEC/10/06/050

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Russell Franklin and Ms Carolyn Weston will review
the researcher’s response prior to final ethical approval under delegated
authority.

Requirements:


General                        Part 2: A5 – Please provide more information on the power
                                calculations for the study and describe how the
                                randomisation will be done.
                               Would it be appropriate to conduct liver function tests on
                                participants as part of pre-screening?
                               Part 2: B12, Compensation – if participants become ill due
                                to participating in the study and need to see their GP, will
                                the researcher reimburse the participant for this cost? And
                                in particular please specify who will carry the cost of
                                consultations for breakthrough pain
                               Please ensure that one of the study investigators is
                                available 24 hours a day to participants
                               Please insert contact details of study investigator in the
                                Patient Card

Participant                    Please include all the propriety names of paracetamol in
Information Sheet and           parenthesis, to make it clear to participants.
Consent Form                   Please make it clear to participants that they must not take
                                any over-the-counter drugs without consulting with the
                                study investigators.
                               Please remove reference made to the Central Region
                                Ethics Committee and replace with Multi-region Ethics
                                Committee.

Documentation                  Please ensure any outstanding documentation (Part IV,
                                evidence of Maori consultation and Locality Assessments)
                                is submitted.




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2. Is Beta-Defensin-1 a Diagnostic Biomaker for Diabetic Nephropathy

              Lead Investigator: Associate Professor Rachel Page
              MEC Reference:     MEC/10/06/051

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Russell Franklin and the Chairperson will review the
response prior to final ethical approval being given under delegated authority.

Requirements:

National Application         Part 2: A2.2 – The sample size is very small. Is the
Form                          study adequately powered to get meaningful results?
                              Please comment
                             Part 2: A6.3 – Please clarify how participants will be
                              informed of their positive result occurs

Participant                  Please make it clear to participants the benefits of
Information Sheet             participating in the study
                             Please remove reference made to the Central Region
                              Ethics Committee and replace with Multi-region
                              Ethics Committee

Suggestion                   Please consider consulting interest groups such as
                              Diabetes New Zealand and the New Zealand Kidney
                              Foundation

Documentation                Please ensure any outstanding documentation (Part
                              IV, evidence of Maori consultation and Locality
                              Assessments) is submitted




3. A pilot study of Snus and Zonnic in smoking patients with smoking
related diseases

              Lead Investigator: Dr Julian Crane
              MEC Reference: MEC/10/06/052


The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr John Baker and Mr Hector Matthews will review the
response prior to final ethical approval being given under delegated authority.




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Requirements:

General                   Please submit a study protocol

National Application      Part 2: A5.3 – Please consult a statistician about the
Form                       statistical methods
                          Part 2: B8 – Please be more specific in defining the
                           exclusion criteria (i.e. what serious underlying health
                           conditions apply?)
                          Part 2: B8 – Please confirm with SCOTT that approval
                           is not required for the administration of these medicines
                          Part 2: B9 – How do the study investigators aim to
                           remain in contact with the participants for 12 months?
                           Please comment

Participant               Please ensure Participant Information Sheets and
Information Sheet          Consent Forms are presented in standard form as per
and Consent Form           the Guidance document, and are printed on institutional
                           letterhead
                          Under the third section “Who can take part in this
                           study?” the investigators should be more specific in
                           respect of exclusions. For example “People with a
                           serious medical condition such as congestive heart
                           failure, peripheral vascular disease, high blood pressure,
                           fast or irregular heart rhythm, angina, recent heart attack
                           or stroke, stomach ulcer, over-active thyroid, or diabetes
                           mellitus”.
                          Please remove reference made to the Central Region
                           Ethics Committee and replace with Multi-region Ethics
                           Committee

Suggestion                Part 2: E9 – Please consider providing vouchers instead
                           of money as compensation, as it may have tax
                           implications for certain participants

Documentation             Please ensure any outstanding documentation (Part IV,
                           evidence of Maori consultation and Locality
                           Assessments) is submitted




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4. Comparison of early range-of-motion vs rigid casting for non-
operative management of acute Achilles tendon ruptures presenting
within 48hours of injury – A randomised controlled prospective study

             Lead Investigator: Vimalan Selvaratnam
             MEC Reference: MEC/10/06/053

The Multi-region Ethics Committee deferred the above study because of the
following concerns. Dr Chris Wynne will contact the Principal Investigator to
discuss these concerns with him and assist with the resubmission.

Requirements:


 General                      Please submit a study protocol
                              The Committee is concerned about the feasibility of
                               recruiting 283 patients; please comment on the
                               feasibility of this recruitment target within the 9 month
                               time-frame.
                              Funding – Please clarify the funding for this study
                              Please consider increasing the amount of time the
                               participants have to decide whether they would like be
                               enrolled in the study. There is a concern that 30
                               minutes is not sufficient.
                              Please clarify whether Wellington Hospital will be the
                               only site

 National Application         Part 1: 8.2.2 – Please ensure that the supervisor signs
 Form                          the Application Form.
                              Part 2: D – Please clarify how participant confidentiality
                               will be maintained.

 Participation                Please read the Committee Guidelines detailing how to
 Information Sheet             prepare Participant Information Sheets and Consent
 and Consent Form              Forms.
                              Please remove the participant instructions from the
                               Participant Information Sheet.
                              Please state that this study was approved by the Multi-
                               region Ethics Committee
                              Please remove the section detailing the side effects of
                               medication, as there is no medication involved in this
                               study.

 Documentation                Please ensure any outstanding documentation (Part IV,
                               evidence of Maori consultation and Locality
                               Assessments) is submitted.




                                                                               6
5. Pzifer Study A3921024: A Long-term Open-label Follow-up Study of
Tasocitinib (CP-690,550) for Treatment of Rheumatoid Arthritis

              Lead Investigator: Dr Nigel Gilchrist
              MEC Reference: MEC/10/06/054

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Helen Moriarty and Margaret Horsburgh will review
the researcher’s response prior to ethical approval being given under
delegated authority.

Requirements:

 National Application            Compensation – please clarify who is paying for the
 Form                             cost of participant’s X-rays.

 Participant                     Please ensure the Participant Information Sheet is
 Information Sheet and            written in lay terms so it is accessible to all participants.
 Consent Form                    Please remove all abbreviations and write out the terms
                                  in full, to ensure participants understand.


 Documentation                   Please ensure any outstanding documentation (Part IV,
                                  evidence of Maori consultation and Locality
                                  Assessments) is submitted.

 Suggestion                      Please reconsider what benefit prior non-responders
                                  might expect from recruitment in this trial



6. Simvastatin and rhabdomyolysis

              Lead Investigator: Dr Lianne Parkin
              MEC Reference: MEC/10/06/055

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Russell Franklin and Dr Helen Moriarty will review the
researcher’s response prior to ethical approval being given under delegated
authority.

Requirements:

General                          Please list the Christchurch investigator’s that are
                                  involved in this study and clarify Michael Tatley’s role

Suggestion                       Please consider linking the lab data CK levels, as per
                                  HRC reviewer 2 recommendation, to identify less



                                                                                  7
                                extreme rhabdomyolysis

Documentation                  Please ensure any outstanding documentation (Part
                                IV, evidence of Maori consultation and Locality
                                Assessments) is submitted



7. HRCI Dual Anti Platelet Therapy STUDY IDE # G080186 – “A
prospectivem multi-centre, randomised, double-blind trial to assess the
effectiveness and safety of 12 versus 30 months of dual antiplatelet
therapy (DAPT) in subjects undergoing percutaneous coronary
intervention (PCI) with either drug-eluting stent (DES) or bare metal
stent (BMS) placement for the treatment of coronary artery lesions

             Lead Investigator: Dr John Ormiston
             MEC Reference: MEC/10/06/056

The Multi-region Ethics Committee approved the above study subject to the
following conditions. The Chairperson will review the researcher’s response
prior to ethical approval being given under delegated authority.

Requirements:

Participant Information        Page 3 of 7 – Please clarify the risks associated with
Sheet                           participating in this study compared to the risks of six
                                months standard care
                               Page 4 of 7, last paragraph – Please ensure this
                                paragraph is appropriately contextualized to New
                                Zealand
Documentation                  Please ensure any outstanding documentation (Part
                                IV, evidence of Maori consultation and Locality
                                Assessments) is submitted.



8. Prospective, Multicentre, Randomised, Double-Blind Placebo-
Controlled Trial Comparing REMICADE® (infliximab) and Placebo in the
Prevention of Recurrence in Chron’s Disease Patients Undergoing
Surgical Research Who are at an Increased Risk of Recurrence

             Lead Investigator: Associate Professor Richard Gearry
             MEC Reference: MEC/10/06/057

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Paul Copland and Mrs Maliaga Erick will review the
researcher’s response prior to ethical approval being given under delegated
authority.




                                                                              8
Requirements:

National Application         Part 2: F7 – It is misleading to state that the
Form                          drug/treatment will be available to participants after
                              the study ends. The drug is not covered by
                              Pharmaceutical Schedule for this indication and the
                              cost would be prohibitive to an individual. Please
                              comment
                             Part 2: B10 – The protocol acknowledges an
                              incidence of adverse reactions to infliximab infusion.
                              Please explain what provisions the private research
                              centers, Shakespeare Specialist Group and P3
                              Research Ltd. (i.e. non-hospital centres) will make for
                              adverse reactions which might occur outside normal
                              business hours
                             Part 2: C5.3 – Please provide details of personal
                              indemnity insurance for all investigators (i.e. Current
                              MPS certificates) and indemnity insurance for the two
                              private institutions (i.e. Shakespeare Specialist Group
                              and P3 Research Ltd)
                             Part 5: 1.9 and 1.10 – The statements that “samples
                              will be stored until the end of the study and will only
                              be used for study purposes” and “when the study has
                              been completed, remaining samples will be destroyed
                              by burning and autoclaving” conflict with the
                              Participant Information Sheet and Consent Form
                              which refers (page 10 of 26) “your samples will be
                              stored to allow for future research”. Please explain
Participant Information      Page 2 of 26 – the questions in the third paragraph
Sheet                         “Do we have your permission to contact your
                              doctors…” should be moved to the Consent Form
                             Page 10 of 26 – the statements addressing “What
                              happens to my samples after they are no longer
                              needed for this study”, contradict what is said in the
                              Part 5 document. Please reconcile
                             Page 12 of 26 – the statements referring to risk of
                              reactivation of tuberculosis should be presented in
                              bold type (i.e. “Some patients have had severe
                              infections…” through to ”if you come in contact with
                              anyone who has tuberculosis you should tell your
                              study doctor”
                             Page 20 of 26, final paragraph – the statements
                              concerning healthcare environment do not apply in
                              New Zealand. The words “Centocor Research and
                              Development…” through to “not covered by your
                              government’s health plan or private insurance” should
                              be deleted
                             Page 21 of 26 – the statements concerning
                              healthcare environment do not apply in New Zealand.



                                                                          9
                                The sentence “However, if your study doctor arranges
                                for you to have additional medical tests…” through to
                                “not covered by your government’s health plan or
                                your private insurance” should be deleted
                               Page 21 of 26, paragraph 5, line 5 – The word
                                “Consent” should be inserted before “…form…”
                               Please remove the check boxes and insert these into
                                a separate Consent Form

Participant Information        Please insert the following parameters:
Summary Page                        - How the drug is to be administered
                                    - How frequently the drug will be administered
Documentation                  Please ensure any outstanding documentation (Part
                                IV, evidence of Maori consultation and Locality
                                Assessments) is submitted



9. Fetal middle cerebral artery Doppler velocimetry to determine the
timing of second and subsequent fetal blood transfusions in the
treatment of fetal anaemia secondary to red cell alloimmunisation – a
randomised controlled trial

             Lead Investigator: Dr Emma Parry
             MEC Reference: MEC/10/06/058

The Multi-region Ethics Committee approved the above study subject to the
following conditions. The Chairperson will review the researcher’s response
prior to ethical approval being given under delegated authority.


Requirements:

General                        Please supply a study protocol

National Application           Part 2: A3.1 – Study design needs to be adequately
Form                            documented. There is no indication of two-parallel-
                                group study design, the study interventions (i.e.
                                measures) and a description of the primary outcome
                                measure. What is standard care?
                               Part 2: A4.2 – Please explain how the “best estimate
                                of the incidence of the primary outcome (i.e. 46.8%)”
                                is derived
                               Part 2: A.8 – It seems unlikely that the study fee of
                                AUD$150 will cover study costs. Please provide
                                Locality Assessments signed by General managers at
                                the respective sites indicating that they are prepared
                                to cover any outstanding costs of conducting this
                                study



                                                                          10
                                Part 2:F – This is a multi-national study and it is
                                 accepted that there is has been no Māori consultation
                                 in the study design. Nevertheless, Māori consultation
                                 is required for the local (i.e. New Zealand)
                                 implementation of the protocol. Please provide
                                 evidence of consultation with local Māori communities

Participant Information         Page 3 of 4 – “Risks” refers to possible risks
Sheet and Consent                associated with intra-uterine blood transfusion
Form                             procedure which is an entry criterion for the study and
                                 not a consequence. The section including “Common
                                 complications” and “Rare complications” should be
                                 deleted
                                Page 3 of 4 – Please clarify and explain the chart that
                                 is referred in to the 1st paragraph
                                Page 4 of 4 – Under compensation, standard wording
                                 from the Guidance document should apply. The
                                 investigators should state that the project has been
                                 approved by the Multi-region Ethics Committee and
                                 quote the approval numbers

Documentation                   Please ensure any outstanding documentation (Part
                                 IV, evidence of Maori consultation and Locality
                                 Assessments) is submitted



10. An evaluation of the relationship between the intestinal Crohn’s
disease and oral Crohn’s Disease

             Lead Investigator: Anita Nolan
             MEC Reference: MEC/10/06/059

The Multi-region Ethics Committee approved the above study subject to the
following conditions. Dr Russell Franklin and Dr Paul Copland will review the
researcher’s response prior to ethical approval being given under delegated
authority.


Requirements:

National Application            Part 5 – Please submit the memorandum that is
Form                             referred to when available

Participant Information         Please reflect Part 6: 9 in the Participant Information
Sheet                            Sheet
                                Under the title “Compensation Arrangements” –
                                 Please explain how the study investigators aim to
                                 cover the cost of compensation if ACC does not



                                                                             11
Documentation                   Please ensure any outstanding documentation (Part
                                 IV, evidence of Maori consultation and Locality
                                 Assessments) is submitted
                                Please submit Maori consultation for the Dunedin site
                                 that is specifically concerned with this study.


11. Implementing performance improvement in New Zealand Emergency
Departments: The six hour time target policy

              Lead Investigator: Dr Peter Jones
              MEC Reference: MEC/10/06/060

Dr Peter Jones attended the meeting and participated in the discussion of the
application.

The Multi-region Ethics Committee approved the above study subject to one
condition.

Documentation                   Please ensure any outstanding locality assessments
                                 are submitted for the four localities where interviewing
                                 is to take place.




                           GENERAL BUSINESS

Minutes

The Minutes of the Open Meeting held on 18th of May 2010 were confirmed as
a true and accurate record of proceedings. (Mrs. Mailiaga Erick and Dr John
Baker)

Submissions to the Health Select Committee

Dr Russell Franklin reviewed the submissions that were made to the Health
Select Committee on the current inquiry into improving New Zealand's
environment to support innovation through clinical trial and informed the
committee of the nature of the submissions.


                             ADMINISTRATION

Claim forms

Meeting closed at 1.30pm




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