A voice for women's health

AWHC Submission Draft SOPs for Health & Disability Ethics Committees - February 2012

AWHC Submission on the Draft Standard Operating Procedures for Health & Disability Ethics Committees

 
Introduction

The Auckland Women’s Health Council (AWHC) is an umbrella organisation for individual women and women’s groups in the Auckland region who have a commitment to and an interest in women’s health issues. The focus of the Council is broad and spans many issues that are of interest to women, particularly those that impact on their health and the health of their families.

The AWHC was formed in 1988 and Council members took an active role in ensuring that the recommendations of the Cartwright Report were implemented. Since then the Council has made many submissions on matters related to research, teaching, the establishing and functioning of ethics committees, ethics committee guidelines, consumer representation on ethics committees, etc.

The AWHC begins this submission with general comments on the draft SOPs document before providing comments on specific issues raised in the document.

General Comments

Since 1995 the AWHC has consistently proposed that ethics committees should be part of the Office of the Health and Disability Commissioner with a Director of Ethics Committees taking responsibility for the administration, monitoring and reporting functions in a similar manner as the Director of Advocacy oversees the advocacy service.1

The Council continues to promote this recommendation as the changes introduced by the Ministry of Health over the past decade have seen the purpose of ethics committees move from that of ensuring the protection of the rights, health and welfare of research participants to becoming more focused on the agendas of researchers and the vested interests and requirements of the pharmaceutical industry. The lessons that led to the establishment of new patient-centred ethics committees in the early 1990s have been forgotten as a series of changes have been implemented that have served to undermine the main functions of ethics committees.

The “Draft standard operating procedures for health and disability ethics committees” continues this unfortunate trend and weakens the concept of independent ethics committees which focus on the rights, health and welfare of research participants. The AWHC is opposed to the reduction in the number of ethics committees from seven to four, and the reduction in the number of ethics committee members. The Council is also concerned that the current document does not state that the chairperson of each ethics committee will continue to be a lay person, in keeping with the recommendations of the Cartwright Report.

The AWHC has major concerns about medical devices that have not been approved by either international agencies such as the US Food and Drug Administration or any New Zealand agency. Recent examples of the damage and trauma done to New Zealanders by the ASR hip joints, the gynaecological mesh, and breast implants provide strong evidence of the need for serious scrutiny of all new devices that are being used in New Zealand patients. All medical devices must be required to undergo clinical trials and to obtain ethics committee approval prior to such trials going ahead.

The AWHC has similar concerns about tissue banks and we address the issue of tissue banks on pages 6 and 7 of this submission.

Section 1: Purpose and application

The AWHC does not support the emphasis and focus of standard operating procedures being on streamlining ethics committee procedures to meet the requirements of the research and pharmaceutical industries. It is essential to the purpose of ethics committees that they are independent from the Ministry of Health and safe from the relentless cost cutting exercises of various governments. Like the National Cervical Screening Programme which was also established in the wake of the Cartwright Inquiry, ethics committees have fallen victim to Ministry of Health restructurings carried out by those with little understanding of the history of and reason for these significant programmes.

It is totally inappropriate to abrogate the important roles and functions of ethics committees, to drastically reduce the types of research considered by full ethics committee review, and place an inordinate amount of power in the hands of Minister of Health appointed chairpersons. 

In a submission written in 2001 the AWHC wrote:
“The AWHC is strongly opposed to the proposal listed in 133 on page 33 that the Director-General of Health should have the power to alter the number of HDECs or their corresponding designation regions of authority.”2

Our objections were ignored and the number of ethics committees was subsequently reduced at a considerable cost to their ability to adequately fulfill their duties. This undermining of the role, independence and authority of ethics committees by successive governments and the Ministry of Health has thus proceeded relentlessly over the past decade.    

Section 2: The role of HDECs

The list on page 4 revealing what the Ministry of Health has now decided that ethics committees will not do is further evidence of the serious erosion of the primary focus of ethics committees.

While the AWHC agrees that an ethics committee review does not constitute consultation with relevant population groups, the proposed list of what ethics committees do will not do confirms the rubber-stamping exercise that ethics committee reviews will now be limited to. 
 
Paragraph 5 (page 5). The AWHC does not support the restriction preventing ethics committees from requiring specific changes to research protocols on the grounds of lack of scientific validity, as it is important that research participants give their time, and bodies to well-designed studies that are going to yield trustworthy findings.

One AWHC member commented in regard to locality-specific governance issues that locality assessments need to be made consistent and transparent, especially when, as in the Auckland region, more than one DHB may be involved.

It is also essential that ethics committees are able to ensure that a research study is legal, and that such advice has been sought and the study amended as advised. The same applies to scientific advice. Council members noted that having lawyers and ethicists as well as others enrich the quality of the review, and we are concerned at the proposed changes which will diminish the value of the review process.

Section 3: Scope of HDEC review

The fact that the Minister of Health “requires updated SOPs for HDECs to clarify and reduce the scope of HDEC review” is precisely why the AWHC has argued for 17 years for the responsibility for independent ethics committees to be transferred to the Office of the Health and Disability Commissioner.

The Ministry of Health lacks sufficient independence to clarify and define what is health and disability research and what is not. It will lead to the creation of a dangerous situation if the definition of when a study requires an HDEC review is reduced to the limits described on pages 7 and 8 of the draft document. Such a change is not in the best interests of research participants.

 

Section 4: Applying for HDEC review

The AWHC supports the move to all applications for HDEC review being submitted electronically and that researchers be able to ask that their application be reviewed by the HDEC nearest to them.
 

Section 5: The full review pathway

The AWHC does not support the large amount of research that will now be reviewed by the expedited review pathway, which means by the chairperson of the ethics committee. This path risks personal bias, or the lack of specialist knowledge, leading to faulty and ill-advised decisions.

As noted already the document fails to mention that the chairperson of each ethics committee must be a lay person. This is a serious omission and the requirement for lay Chairs must be clearly stated.

The imposition of a 35-day time limit and the adoption of the 35-day review clock are indefensible in the context of limited resources being provided for the adequate and ethical functioning of ethics committees; especially with the consequent reduction in the number of ethics committees from seven to four, and the reduced membership numbers of each ethics committee.

All decisions made by an ethics committee, whether they be made by the chairperson, or the chairperson and two other committee members, or by an expedited or a full review pathway must be recorded, minuted and submitted to the next meeting of the full ethics committee. There must be a clear and concise summary of all discussions, and the rationale for the decisions that were made.

The AWHC is concerned these SOPs reflect the determined cost cutting that provides further indication that the Minister of Health underestimates the importance of independent ethics committees focused on the need to protect participants in research trials. Nor can the public have any confidence in such short-sighted measures that are tailored the needs of the research industry and on cost-savings at the expense of the safety of research participants. 

 

Section 6: The expedited review pathway

The AWHC is totally opposed to the vast amount of research that will now be reviewed by the Chairs of the ethics committees under the expedited review pathways outlined in this section. The expedited review process places too much power and responsibility in the hands of the four Chairs and it does not meet the need for independent, robust, transparent and accountable ethical reviews. As noted above the risks involved are considerable.

Chairs must be required to consult with at least two other members of the ethics committee, and should the chair reject their advice, the research proposal should then be required to go to a full review.

 

Section 7: Decisions open to HDECs

The limiting of decisions open to Ministry of Health controlled ethics committees provides further evidence as to the need for ethics committees to be placed within the protection of the office of the Health and Disability Commissioner. 
 

Section 8: HDECs and the Accident Compensation Act 2001

The elephant in the ethics committee room emerges in this section – the problems associated with what the document disingenuously refers to as “commercially sponsored” studies.

Paragraph 138 raises some serious issues about the nature of research that is conducted on behalf of pharmaceutical companies but fails to adequately address the lack of independence that investigators have when taking part in drug company sponsored research. Hundreds of articles and many books detail what happens when the pharmaceutical industry conducts and controls the research into the products they produce.3, 4, 5, 6, 7, 8 Their own interests always take priority over those of researchers and research participants. It also the drug company that decides what is published and when.

The AWHC notes that concerns about compensation arrangements in drug company sponsored research have frequently been raised during meetings of the Northern X Ethics Committee, but without satisfactory resolution. It is also not always made clear to participants that they may not be covered under the current accident compensation legislation.

There is now a large body of evidence that demonstrates that the pharmaceutical industry and researchers cannot be relied on to put the safety of research participants or those who subsequently consume their drugs or use their devices above financial considerations. Research participants become vulnerable when investigators and sponsors assume responsibility for ensuring that adequate and fair compensation arrangements are in place. “Assurances from the sponsor” is not a credible or reliable guarantee.

It is also an unacceptable risk to leave localities “responsible for checking that they and relevant members of the local research team are appropriately indemnified and insured.” The issues around compensation, indemnity and insurance are those best dealt with by an independent agency – such as the Office of the Health and Disability Commissioner – which can bring important experience and expertise to these complex issues. Leaving such problems with localities is akin to burying one’s head in the sand. 

 

Section 9: Challenging HDEC decisions

The AWHC supports the appeal options outlined in this section with the provision that it is inappropriate for the secretariat to advise the Chair of their views (paragraph 151). The ethics committee is responsible for all decisions that are made, not the secretariat. 
 

Section 10: Locality review

The transfer of locality reviews to district health boards raises the issue of monitoring.

Given the ethics committees’ proposed shift of focus from protecting research participants to accommodating the desires of the pharmaceutical and research industries, it is absolutely essential that a robust system of monitoring the changes put in place to ensure that the new guidelines are followed and that the responsibilities of all localities, DHBs, investigators, and the sponsors are properly carried out. 

 

Section 11: Amendments to approved studies

The guidelines providing for substantial amendments and non-substantial amendments to approved studies are open to a wide and varied interpretation of the listed definitions as to what is substantial and what is not. This is risky and dangerous. Given the context in which “sponsored research” is being undertaken in New Zealand it is inadvisable to permit such discretion in regard to whether amendments submitted for HDEC review meet the vaguely defined test of substantiality.

All amendments must to be sent to the HDEC chairperson who should be required to consult with at least two other EC committee members when reaching a decision as to the status of an amendment.


Section 12: Post-approval processes

While the AWHC supports the concept that responsibility for proactively monitoring a study remains with the investigator and sponsor of that study, it is absolutely essential that HDECs keep all approvals under review.

If an annual report is not received by the ethics committee, and there is no response to the reminders sent to the investigator, the study file must remain open until the HDEC has received documented proof that the study did not actually go ahead.

This section of the document fails to address the requirement for ethics committees to ensure there is an annual report for all studies disclosing:

  • whether they are completed or not.

  • if a study is subsequently abandoned because it did not produce the expected results,

  • or if it produced negative outcomes for research participants.

It must be made mandatory for a full report to be submitted to the ethics committee. Negative and adverse outcomes must be notified in the interests of public safety and public accountability.    


Section 13: HDEC review of tissue banks

The AWHC strongly recommends that all applications relating to the establishment and management of tissue banks must be referred to the Office of the Health and Disability Commissioner prior to a review being sought from an ethics committee. It must be made mandatory that all proposals to establish a tissue bank be reviewed by an ethics committee.

Standard policies must be developed for all tissue banks that detail the reason for and purpose of the tissue bank, how it will be governed, the processes for obtaining and storing tissue, where it will be stored, informed consent policies and forms, the process for withdrawing consent, who will have access to tissue samples, the return or disposal of tissue samples, public accountability for the use of tissue samples, etc. There must be no provision for tissues to be removed without the consent of the patient or research participant.

The importance of and need for such requirements are clearly documented in chapter 7 “A Traffic in Tissues” in Deadly Monopolies.8

In conclusion the AWHC has serious concerns about the health and safety of research participants in clinical trials given the changes to ethics committees that have been made and those that are being proposed in this document. We note that our concerns are shared by academics at both Auckland and Otago universities.9

Auckland Women’s Health Council
9 February 2012

 

References
  1. Auckland Women’s Health Council. Submission on the Review of the Ethical Review Structure in New Zealand. 29 October 1997.
  2. Auckland Women’s Health Council. Submission on The Draft Operational Standard for Health and Disability Ethics Committees. 15 August 2001.
  3. Merrill Goozner. The $800 Million Pill. University of California Press. 2004.
  4. Marcia Angell. The Truth about the Drug Companies. Random House. 2005.
  5. Ray Moyhihan & Alan Cassels. Selling Sickness: How Drug Companies are Turning Us All Into Patients Allen & Unwin. 2005.
  6. Jacky Law. Big Pharma: How the world’s biggest drug companies control illness. Constable. 2006.
  7. Ray Moynihan & Barbara Mintzes. Sex, Lies and Pharmaceuticals. Grey Stone Books. 2010. 
  8. Harriet Washington. Deadly Monopolies. Doubleday. 2011.
  9. Martin Johnston. Changes may be threat to patients, say critics. NZ Herald. 6 February 2012.


The New Zealand Law Society also wrote a submission documenting their concerns with the changes to ethics committees being pushed through by the current government and Minister of Health, Tony Ryall.

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