ESR 2005 PARITUTU SERUM PROJECT LEADER DR LOUISE GALLAGHER LAID A FORMAL ETHICS COMPLAINT OVER MINISTRY OF HEALTH

INTERFERENCE - IN THE STUDY - BEFORE THE REPORTS MARCH 2005 RELEASE. MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 08 MARCH 2005 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The meeting moved into closed process because further information relating to informed consent and privacy issues for participants is required from the Ministry of Health. Participants and public are scheduled to be informed of results later this week and the Committee needs to be certain the ethical process is maintained. Lou Gallagher from the Institute of Environmental Science and Research (ESR) and her support person Geoff Bertram attended the meeting. The Committee considered the ethical question raised regarding the release of participant information to the Ministry of Health. Copies of information sheets and consent forms relating to phase I and II of the study were circulated. Based on the information provided it appeared that participants had not given specific consent for their results to be released to any other party. The Committee agreed to seek further information from ESR and also from the Ministry of Health who contracted the research to ESR. The Chair to draft a letter and circulate to Committee members for comment.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 12 APRIL 2005 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth A copy of the letter dated 10 March 2005 to ESR and Ministry of Health was circulated to committee members for their information. To date there has been no response to the letter from ESR or Ministry of Health.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 10 MAY 2005 HELD IN THE BOARD ROOM, WHARERATA, MASSEY UNIVERSITY, PALMERSTON NORTH COMMENCING AT 4.30 PM. TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The Committee had received a letter from the Deputy Director General of Health (Public Health) Don Matheson, in response to its letter of 10 March 2005. In this letter he referred to a response which the Committee could anticipate receiving from ESR. As this letter had not yet been received, it was agreed to write to ESR again advising them that the Committee was still awaiting a joint response to its letter of 10 March.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 14 JUNE 2005 HELD IN THE RUSSELL ROOM, WHARERATA, MASSEY UNIVERSITY, PALMERSTON NORTH COMMENCING AT 4.30 PM. MATTERS ARISING FROM THE MAY 2005 MINUTES TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth A letter dated 1 June 2005 had been received from ESR and circulated to the Committee. The Committee felt that the letter did not adequately address all its concerns. It reaffirmed its position that participants must be informed if government departments wish to access study data in the future. It was agreed to provide ESR with copies of the information sheet and consent forms held on file and to invite them to attend either the July or August meeting of the Committee to discuss this matter further.

BEFORE ANY DISCUSION - DR FOWLES - WHO WAS RESPONSIBLE FOR THE DATA - LEFT NEW ZEALAND.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 12 JULY 2005 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. 1. GENERAL BUSINESS

TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The administrator had received a phone call from the principal researcher advising that he was leaving New Zealand and that he had passed all the documents over to the ESR corporate solicitor to reply. No reply had been received to date. It was agreed the Chair should write to the CEO of ESR requesting him to arrange a meeting with members of his organisation and a sub-committee to resolve the outstanding issues which were: Had the second cohort of participants received the same information sheet as the first group?

Was the condition that the Health Advocacy representative be involved in the disclosure of results complied with?

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 09 AUGUST 2005 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. 1. GENERAL BUSINESS

TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The Chair had contacted the lawyer for ESR in an attempt to resolve outstanding issues minuted in July 2005. A reply from him was anticipated shortly.

THE JOINT REPLY TO ISSUE ONE NOTES THE 22 PEOPLE *FROM 1974 TO 1987 PERIODS RESELECTED FOR ESR 2005 TESTING SIGNED CONSENT FORMS. THE STUDIES CONSENT FORM INFORMATION SHEETS - NOTED THE IMPORTANCE AND THAT PRIORITY WOULD BE GIVEN TO TESTING THOSE WITH GREATEST EXPOSURE IN THE 1962 TO 1975 PERIODS. TWENTY-THREE OF 28 ESR 2005 SELECTIONS DID NOT HAVE 1962-1974 EXPOSURES.

THE REPLY NOTES 23 NEW SELECTIONS WERE RECRUITED FROM 377 WHO REPLIED TO QUESTIONNAIRE 1 NOT FROM THE 146 SELECTED AND SENT QUESTIONNAIRE 2 OR THE 61 RANKED IN APPENDIX K. THEY DID NOT HAVE 1962-1974 EXPOSURES- THEY WERE FROM THE ZERO MODELLED 1975-1987 PERIODS AND RESELECTED FROM PERIODS - THAT DELETED TEXT IN ESR 2.7.2004 HAD NOTED WOULD SERVE TO DILUTE. HEALTH OFFICIAL SALLY GILBERT WHO EDITTED THE 2005 ETHICS REPLY HAD EMAILED ESR ON 30.7.2004

ESR EMAILED THE MINISTRY OF HEALTH ON 2.8.2004 OPPOSING FURTHER TESTING AND NOTED THAT

BELOW AND ABOVE TEXT ON THE RESULTS POLITICAL SIGNIFICANCE - EDITTED FROM THE JOINT REPLY. AS A CONSEQUENCE, IN BOTH THE FIRST ROUND OF TESTING AND THE SECOND, THE MINISTRY OF HEALTH TOOK CHARGE OF THE COMMUNICATION STRATEGY FOR RELEASING THE RESULTS TO MEDIA AND PARTICIPANTS. ISSUES AROUND CONFIDENTIALITY OF THE RESULTS BECAME A HIGH PRIORITY. CONFIDENTIALITY OF THE RESULTS BECAME A HIGH PRIORITY BECAUSE PARTICIPANTS RESULTS HAD BEEN REGROUPED AND MISREPRESENTED TO JUSTIFY RETARGETING THE 2005 STUDY AT PERIODS THAT WOULD DILUTE OBSERVED EXPOSURES YET CLAIM THOSE SAME PERIODS WHERE INFLUENTIAL IN ELEVATED TCDD.

THE REPLY DENIED - MINISTRY OF HEALTH CHANGES TO METHODOLGY [AND TEXT] AFTER THE FIRST ESR REPORT WAS RECEIVED - TO STEER THE STUDY AWAY FROM SIGNIFICANT 1960S TCDD EXPOSURES AND BIRTH DEFECT INCREASES. ETHICS CONSENT WAS GRANTED - FOR AN ADD ON YET - THIS WAS DENIED.

DELETED TEXT FROM THE ESR REPLY ON THE TARANAKI ETHICS COMMITTEE CONDITION ADDED TO ESR 2005 CONSENT ON INCLUDING THE LOCAL HEALTH AND DISABILITY ADVOCATE IN PLANNING RESULTS FEEDBACK. SUBJECTS OF THE STUDY FELT IT WAS NEEDED. NEITHER ESR NOR THE MOH WERE COMFORTABLE WITH DISCUSSING THE COMMUNICATION PROCESSES FOR ELEVATED RESULTS WITH HEALTH AND DISABILITY VOLUNTEERS FROM THE TARANAKI AREA ETHICS NOTED THE NEXT STEP AS A FAMILY HEALTH STUDY OF THOSE EXPOSED- THIS WAS ALSO IGNORED. OF 31 ESR 2004 STUDY SUBJECTS THAT THE ESR AND MOH DESCRIBED AS (WELL) TWO WERE UNABLE TO BE CONTACTED TWO WERE NOT GIVEN CONSENT TO PARTICIPATE BY THEIR GP FOR HEALTH REASONS AND FOR THREE OTHERS THEIR HAEMOGLOBIN LEVEL WAS BELOW NEW ZEALAND BLOOD SERVICE GUIDELINES.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 13 SEPTEMBER 2005 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. 1. GENERAL BUSINESS

TRK/03/05/014 - The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth A reply had been received from the lawyer for ESR addressing the two issues raised by the Committee with the principal researcher, as minuted in July 2005. The Committee was satisfied that the consent issue had been satisfactorily clarified. However it was noted that the Health Advocates Trust representative had not been involved in the process of decision making concerning giving the results to participants, as had been specifically requested in the letter to Dr Jeff Fowles from the Taranaki Regional Ethics Committee dated 16 September 2004.

It was agreed to respond to the lawyer at ESR stating that the Committee noted this fact with disappointment and in future would be more vigilant concerning the conduct of research undertaken at ESR. A copy of this letter will be sent to Don Matheson and Karen Poutasi at the Ministry of Health. A final report on this study was still outstanding and this would be requested again via the lawyer.

MINUTES OF MEETING OF THE CENTRAL REGION ETHICS COMMITTEE OF 14 MARCH 2006 HELD IN MEETING ROOM C02, 180 MOLESWORTH STREET WELLINGTON COMMENCING AT 4.30 PM. GENERAL BUSINESS Annual Report December 2004 to December 2005 A copy of the Annual Report for the Central Regional Ethics Committee for the period of December 2004 to December 2005 was presented to the Committee. The Committee approved the report subject to the National Co-ordinator finalising one point in the Complaints section.

MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE OF 10 OCTOBER 2006 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE TERRACE WELLINGTON COMMENCING AT 4.30 PM. TRK/03/05/014 The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The Chair in conjunction with Jane Herschell and John Kleinsman had prepared a submission to the Office of the Ombudsmen regarding a request from the media for the release of Appendix O from the study report. This Appendix contains the individual anonymised test results. The Committees submission had been acknowledged by the Ombudsman who indicated she would ask the Privacy Commissioner to consider the submission. The Chair expressed his thanks to Jane Herschell and John Kleinsman for their considerable input into the submission REMARKABLY THE ETHICS COMMITTEE SUPPORTED THE ESR AND MINISTRY REFUSALS TO RELEASE THE ANONYMISED INDIVIDUAL RESULTS REFUSALS THAT SERVED TO CONCEAL KEY MISREPRESENTATIONS. THE OMBUDSMAN RULED THAT RESULTS AND THEN ANONYMISED SUBJECT ID NUMBERS BE RELEASED.

MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE OF 14 NOVEMBER 2006 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE TERRACE WELLINGTON COMMENCING AT 4.30 PM. GENERAL BUSINESS TRK/03/05/014 The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth The Chair advised the Committee that a letter had been received from the Office of the Ombudsmen outlining the reasons for their decision to override the Committees submission not to release Appendix O of the report to the media. Subsequently another request for information under the Official Information Act was received from ESR for copies of correspondence between ESR and the former Taranaki Ethics Committee. This request had been fulfilled.

MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE OF 12 DECEMBER 2006 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE TERRACE WELLINGTON COMMENCING AT 4.30 PM. Annual Report The Chair advised that prior to publication of the Committees December 2004 December 2005 annual report the Ministry and ESR commented on the Complaints section of the report relating to the study TRK/03/05/014 The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth. ESR had asked that it be revised. The Committee agreed with the Chairs proposal to add the following sentence to the relevant section: However the Committee is pleased to report that ESR has now acknowledged that it has erred and has advised the Committee that it has taken remedial action for the future. The Committee wished it to be minuted that the independence of Ethics Committees needs to be maintained in all activities, including the annual report, while valuing any comments made by the Ministry of Health or other parties. IN 2006 TV 3 BROADCAST CLAIMS THE STUDY WAS FLAWED - THE MINISTRY AND ESR INITIATED REVIEWS AND ALSO LAID BROADCASTING STANDARDS COMPLAINTS AGAINST TV 3. THE MINISTRY OF HEALTH ALSO DELAYED PUBLICATION OF THE ESR ETHICS COMPLAINT AND ESR COMMENTS IN THE ETHICS COMMITTEES 2004-2005 ANNUAL REPORT WHICH WAS STILL BEING CONTESTED AND THEN REWRITTEN IN MARCH 2007. MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE OF 13 FEBRUARY 2007 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE TERRACE WELLINGTON COMMENCING AT 4.30 PM. Annual Report December 2004 to December 2005 The Chair advised that a letter had been received from the Director of Public Health, Ministry of Health addressing points covered in the Committees December 2004 December 2005 Annual Report under the Complaints section of the report relating to the study TRK/03/05/014 The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth. The Chair had replied to this letter. MINUTES OF MEETING OF THE CENTRAL REGIONAL ETHICS COMMITTEE OF 13 MARCH 2007 HELD IN MEETING ROOM C06, LEVEL 2, 1-3 THE TERRACE WELLINGTON COMMENCING AT 4.30 PM. MATTERS ARISING FROM FEBRUARY MINUTES Annual Report December 2004 to December 2005 The Chair advised that he had been contacted by the Manager of Strategic Policy and Ethics Innovation, Sector Policy (MOH), regarding the Committees December 2004 December 2005 Annual Report, Complaints section, relating to the study TRK/03/05/014 The collection and analysis of blood serum in a selected population to investigate serum dioxin levels in residents who live, or have lived, near the former Ivon Watkins Dow chemical factory in Paritutu, New Plymouth. The Ministry maintained it had not been fairly represented in these comments. The Chair suggested to the Committee the addition of another sentence at the end of the statement in question; the sentence to read The Ministry of Health does not agree with the researchers interpretation. The Committee agreed to this addition.