ALRC submission on the review of the National Statement on Ethical Conduct in Research Involving Humans (11 March 2005)
1. The Australian Law Reform Commission (ALRC) makes the following submission to the National Health and Medical Research Council (NHMRC), the Australian Research Council (ARC), and the Australian Vice-Chancellors’ Committee (AVCC) in response to the first consultation draft of the review of the National Statement on Ethical Conduct in Research Involving Humans (National Statement).
Introduction
2. In 2003, the ALRC and the Australian Health Ethics Committee (AHEC) of the NHMRC completed the report Essentially Yours: Protection of Human Genetic Information in Australia (ALRC 96).[1] As well as looking at privacy and discrimination issues involving human genetic information, the Terms of Reference for the Inquiry required the ALRC and AHEC to consider how best to ensure the highest ethical standards in research and practice. This involved consideration of the existing National Statement and the role of Human Research Ethics Committees (HRECs).
3. This submission focuses on the recommendations made in the Essentially Yours report that were aimed at the anticipated review of the National Statement.
Compliance Mechanisms
4. The Inquiry examined the regulatory status of the National Statement and the consequences of non-compliance for researchers and research organisations. It was recognised that the National Statement has played an important role in regulating research, even in the absence of an explicit legal basis. While not supporting any immediate legislative option, the Inquiry came to the conclusion that the requirements for institutions or HRECs to be registered with the NHMRC and to follow the processes set down in the National Statement are incomplete. In particular, there is currently no obligation on private research bodies to adhere to the provisions of the National Statement.
5. Given the existing and likely future extent of private sector research, especially that which is not carried out in conjunction with public sector researchers or research institutions, the Inquiry considered that new mechanisms are required to achieve compliance with the National Statement. It was acknowledged that many issues involved in the design and implementation of an effective regulatory scheme for human genetic research need to be addressed in more detail. The Inquiry thus recommended that the NHMRC look at possible mechanisms as part of its review of the National Statement.[2] Some of the questions that need to be addressed in this process were set out in the Essentially Yours report.[3]
6. The ALRC notes that the draft review National Statement does not have any new mechanisms for ensuring compliance with the National Statement. Paragraph 4.5.6 seems to anticipate that the ARC, AVCC and NHMRC will ‘establish measures to promote and assess compliance by researchers, HRECs, and institutions with this Statement’. The ALRC considers that any new mechanisms under consideration would best be incorporated into the text of the draft review National Statement, thus giving them equal force with existing accountability mechanisms.
Reporting Obligations for Waiver of Consent
7. The concept of consent is fundamental to the legal and ethical regulation of human research. One of the concerns raised during the Inquiry was the waiver of consent provisions in the National Statement. While it was said that the original intention of the provisions was that waiver applications should be ‘exceptional’, there were concerns that the provisions in practice allowed for a much broader use of the waiver, thereby avoiding the primary requirement for participant consent. This might potentially damage public support for medical research.[4]
8. In order to assess better the need for reform of the waiver of consent provisions of the National Statement, the Inquiry undertook a survey of HRECs, requesting information about ethics review of human genetic research proposals considered in 2002.[5] Consultations during the Inquiry identified that circumstances in which HRECs waive consent typically involve the use of archival tissues originally collected for therapeutic or diagnostic purposes. The survey results provided confirmation of this general picture of the circumstances in which waiver of consent is considered by HRECs.
9. Given the limited nature of the survey, and the low response rate of HRECs, the Inquiry concluded that there was insufficient information about the operation of the waiver of consent provisions of the National Statement to justify recommending specific reforms. The Inquiry did, however, recommend augmented reporting requirements in relation to waiver of consent.
10. HRECs are specifically required to report annually to AHEC on decisions made in accordance with guidelines made under s 95 and s 95A of the Privacy Act 1988 (Cth) (s 95 and s 95A Guidelines). However, there is no requirement for HRECs to report waiver of consent under the National Statement itself. Given the limited operation of the s 95 and s 95A Guidelines, the Inquiry concluded that the transparency and accountability of the present system would be better served by requiring HRECs to report specifically on all research proposals for which waiver of consent has been granted, not just those for which waiver has been granted under the s 95 and s 95A Guidelines.[6]
11. Such a reporting mechanism would also allow for better assessment of how waiver of consent provisions operate in practice. At a future time this would place the NHMRC in a better position to review the issue and implement any desirable changes to the waiver of consent provisions.
12. The ALRC notes that the draft review National Statement does not include any specific reporting requirement on HRECs to report to AHEC or the NHMRC where waiver of consent has been approved. The final dot point of paragraph 4.5.4 includes a new catch-all provision providing that HRECs must report to the NHMRC annually on ‘such other matters as the NHMRC and other relevant agencies determine’, and it is possible that this provision could be used to require HRECs to report on waiver of consent matters. However, experience suggests that the NHMRC may be reluctant to request additional information from often under-resourced HRECs. The ALRC considers that the issue of waiver of consent is so critical to public support for research involving humans that reporting requirements should be specifically set out within the National Statement.
Privacy Law and the National Statement
13. The Inquiry noted that the relevant provisions of the National Statement pre-date the enactment of the Privacy Amendment (Private Sector) Act 2000 (Cth) and the approval of the s 95A Guidelines. For this reason the Inquiry recommended that the provisions of the National Statement relating to waiver of consent and reporting of decisions be reviewed to ensure they are consistent with privacy law.[7]
14. The draft review National Statement has changed the way in which privacy is addressed, removing the stand-alone chapter and inserting appropriate references throughout the document. The ALRC notes that the provisions on waiver of consent refer readers to the relevant privacy laws (and guidelines created under those laws). However, the extent of guidance provided to readers about the privacy laws and how they operate in conjunction with the National Statement is almost non-existent, except to note the obligation to comply with these laws. While this approach avoids the need for updates in the event of changes to privacy laws, it leaves readers with very little guidance on how to ensure that their actions are consistent with both the National Statement and privacy laws.
Unspecified Future Consent
15. During the Inquiry there was broad consensus within the medical research community about the need for procedures under which prospective research participants may provide consent for unspecified future research, provided that such research is approved by an HREC. The Inquiry recommended that the National Statement be amended to include specific guidance on obtaining consent to unspecified future research in relation to human genetic research—not only in relation to the operation of human genetic research databases.[8]
16. The ALRC notes that the draft review National Statement includes new provisions (paragraphs 1.2.9–1.2.12) that give effect to this recommendation.
Databases
17. The ALRC notes that the draft review National Statement now includes a section dealing with databases or databanks. The ALRC and AHEC Inquiry identified the need for inclusion of provisions in the National Statement on the establishment, governance and operation of human genetic research databases,[9] and supports the inclusion of these new provisions in the draft review National Statement.
18. The Inquiry also recommended that the new provisions of the National Statement provide guidance on the appropriate use of independent intermediaries (or gene trustees) to hold codes linking genetic samples or information with identifiers.[10] The value in this approach lies in the separation of any identifying information from all sensitive data and material held in a database. No matter who obtains access to this material, they will be unable to identify it without contacting the gene trustee, who will be bound not to release any identifying information without the consent of the individual.
19. It was not the intention of the Inquiry that all databases be required to use an independent intermediary. The system may have greater value where large research databases are established for broad purposes, like UK Biobank or the Estonian database. The system may also be appropriate where commercial organisations develop databases from patient samples and information acquired from hospitals—a practice that is becoming common in the United States . However, the Inquiry concluded that the use of an independent intermediary is an effective method of protecting the privacy of samples and information held in databases. For this reason the Inquiry recommended that the National Statement include guidance on when the use of an independent intermediary would be appropriate.
20. The draft review National Statement (at paragraph 2.3.6) does include mention of the use of an independent custodian in relation to ‘coded data’. However, it merely suggests that a custodian ‘may’ be appointed. The provision does not include any guidance on when it would be appropriate to appoint such a custodian. The ALRC would support inclusion of some further description of the appropriate role of an independent custodian in the National Statement.[11]
21. The Inquiry made a further recommendation on provisions relating to databases and the National Statement. This was for the establishment of a public register of human genetic research databases, and provision that no genetic research under the National Statement be conducted using information from a database unless it is duly registered.[12] The Inquiry concluded that a system for the registration of human genetic research databases is capable of providing greater transparency and accountability to the operation and use of such databases, without subjecting institutions to onerous compliance costs. Such transparency may become increasingly important in allaying public concerns about the privacy, ethical and other implications of the continuing development of research databases. Registration will also provide the information necessary for the NHMRC to provide guidance to HRECs on ethical issues relating to the operation of research databases.[13] The Inquiry specified a number of other requirements that should be applied to databases, including annual reporting on database operations and provision for the audit of the database on request by the institutional HREC or AHEC.[14]
22. Thus, while the ALRC supports the inclusion of the new provisions on databases in the draft review National Statement, it urges that further consideration be given to the provisions and, in particular, that a database registration requirement be inserted into the National Statement.
[1] This report is available online at <www.alrc.gov.au>.
[2] ALRC and AHEC, Essentially Yours: The Protection of Human Genetic Information, ALRC 96 (2003), [14.73]–[14.78] and Rec 14–1.
[3] ALRC and AHEC, Essentially Yours, [14.75].
[4] ALRC and AHEC, Essentially Yours, [15.35]–[15.44].
[5] For a full description of this survey, see ALRC and AHEC, Essentially Yours, [15.45]–[15.50].
[6] ALRC and AHEC, Essentially Yours, [15.51]–[15.60] and Rec 15–1.
[7] ALRC and AHEC, Essentially Yours, Rec 15–2.
[8] ALRC and AHEC, Essentially Yours, Rec 15–4.
[9] ALRC and AHEC, Essentially Yours, Rec 18–1.
[10] ALRC and AHEC, Essentially Yours, Rec 18–3.
[11] See ALRC and AHEC, Essentially Yours, [18.102]–[18.117].
[12] ALRC and AHEC, Essentially Yours, Rec 18–2.
[13] See further ALRC and AHEC, Essentially Yours, [18.79]–[18.91] and [18.96]–[18.101].
[14] ALRC and AHEC, Essentially Yours, [18.99]–[18.100].