Accountability and reporting

17.62 The National Statement requires the NHMRC, through AHEC, to audit the activities of HRECs to ensure compliance with the National Statement.^[68] Institutions and HRECs are required to report annually on several matters including:

• membership and membership changes;

• number of meetings;

• confirmation of participation by required categories of members;

• the number of protocols presented, the number approved and rejected;

• monitoring procedures in place and problems encountered; and

• complaints procedures and the number of complaints handled.^[69]

17.63 Institutions and HRECs are also required to provide information from their records to the NHMRC on request.^[70] In the event that annual or other reporting reveals that an institution and its HREC have not complied with the National Statement, NHMRC policy requires that the institution be given an opportunity to explain the non-compliance and to show cause. A proven breach may result in withdrawal of funds, the institution ceasing to be eligible to receive further research funding and the possible naming of the institution in the NHMRC report to Parliament (see Chapter 14).

17.64 The debate about the accountability of the HREC system is on-going. The House of Representatives Standing Committee on Legal and Constitutional Affairs, in its inquiry into human cloning and stem cell research, heard evidence criticising the structure and operation of HRECs including ‘the lack of public accountability in the process and the in-house nature of committees’ and the non-representative nature of their membership.^[71] The Committee recommended in September 2001, that the federal government establish an independent review of the institutional ethics committee system in Australia.

Reporting on human genetic research by HRECs

17.65 Submissions emphasised the importance of reporting mechanisms in ensuring that ethical standards in the National Statement are upheld.^[72] There are additional reporting requirements where HRECs are involved in decision making processes that implement statutory standards, such as the guidelines under s 95 and s 95A of the Privacy Act. All ethics review processes need to be transparent and accountable to both research participants and the public in order to ensure that strict ethical standards are upheld. Reporting requirements are critically important in achieving this goal.

17.66 Privacy NSW criticised existing reporting obligations as inadequate, particularly to protect privacy, and suggested a number of reforms, including the establishment of an independent national ethics review committee, and that records of HREC decisions be provided to research participants, the national committee and the federal Privacy Commissioner.^[73] Other submissions also referred to the need for improved reporting.^[74] The Australian Academy of Science stated that there should be a more comprehensive reporting system for applications that come before HRECs and their outcomes, and that this ‘would allay some concerns over pressures on the system due to commercial arrangements’.^[75] The Department of Human Services South Australia submitted that:

the reporting relationship between HRECs and AHEC/NHMRC should be improved. Requiring a committee to report annually is probably not sufficient. HRECs should become more accountable and transparent, especially given their role in Australia.^[76]

17.67 However, other submissions doubted there was any need for further reporting or opposed its introduction.^[77] The Centre for Law and Genetics expressed the view that, provided that changes were made in relation to reporting of waiver of consent decisions, there was no evidence to support further changes in reporting requirements.^[78]

17.68 Some were concerned that additional reporting obligations may place further stress on the system for ethics review without any significant benefit.^[79] The NHMRC Research Committee considered that it would be ‘counter productive’ to add more reporting requirements.

Pressure on researchers and HRECs has continued to mount over the years, and it would be counterproductive to add more reporting requirements, or other demands at either the researcher or HREC levels. This is not to say that changes might be beneficial, but if so, they should be seen within the global context so that changes at one level lead to a relaxing or facilitation of the regulatory process rather than just adding another layer of bureaucracy.^[80]

17.69 The New South Wales Health Department firmly indicated that additional reporting would not be beneficial—because of its impact on HRECs and AHEC. In responding to a question about whether HRECs should report commercial arrangements in research to AHEC, the Department stated:

Such an option would inundate AHEC with information about which they may not have the resources to action. HRECs currently review the commercial arrangements for a range of research proposals and the National Statement provides some guidance in this matter. However, HRECs would benefit from more thorough guidelines, other than the advice offered in the National Statement, on matters associated with commercial arrangements and potential conflicts of interest.^[81]

17.70 The balance to be struck and the interests at stake were clearly put by the Queensland Government.

Commercial arrangements relating to human genetic research proposals have the potential to substantially increase the risk to the privacy of the genetic information if not managed appropriately. There is also a risk that public perception of research could be tainted if sufficient mechanisms are not put in place to protect privacy where there are commercial interests involved.

Commercialisation of human genetic research is a community concern repeatedly expressed in correspondence received by the Queensland Government. Adequate oversight and reporting mechanisms and safeguards are required. However, as discussed in the Inquiry’s paper, it is necessary to ensure HRECs are not overburdened with reporting requirements that inhibit their core functions.^[82]

17.71 In Chapter 15 the Inquiry recommended that HRECs should be required to report annually to AHEC with respect to human genetic research proposals for which waiver of consent has been granted under the National Statement (see Recommendation 15–1). The Inquiry makes no further specific recommendations concerning reporting to AHEC, but notes that the issue of reporting, including in relation to commercial arrangements, should be addressed by the NHMRC as part of the quality improvement program recommended below.