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Section 3 (Chapters 3.1 & 3.5), Glossary and Revisions to Section 5 National Statement on Ethical Conduct in Human Research, 2007 submission

ID: 
51
This submission reflects the views of
Organisation Name: 
NHMRC Clinical Trials Centre, Sydney
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

Clinical trials. The proposed revisions to Sections 3.1 and 5 provide adequate guidance for conducting clinical trials (previously covered in Section 3.3) including references to other relevant guidelines and regulatory bodies including the TGA (in proposed section 5.2.6 For relevant research, researchers should show that the research meets the relevant requirements of the CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), ISO 14155 Clinical Investigation of Medical Devices, and the TGA). 

Internet-derived data. We support the inclusion of guidance on the access and use of internet-derived data, reflecting the rise in the use of current electronic media/technologies and emerging platforms (in Chapter 3.1: Research may involve access to and use of internet-derived data relating to individuals, including social media posts, tweets, self-generated ‘lifelogging’ data emitted from mobile phones and other ‘smart’ appliances and data generated through applications such as fitness monitoring devices and web-based games, gambling and dating. Such data may be public (or semi-public), but this does not automatically mean that individuals permit the use of this material for research.)

Identifiability. Regarding terminology relating to identifiability – inconsistent terms and usage between the National Statement and privacy laws should preferably be avoided. We note that the National Statement proposes that researchers establish which of the possible meanings of ‘de-identified data’ is intended if the term is being used in project documentation – which would allow the concurrent use of terminology from both the National Statement and privacy laws yet with the desired clarification of the former.

Storage of records.

(i)               For Section 3.1.55 (Where clinical research involves the use of materials of biological origin, records should be preserved for long enough to enable participants to be traced in the event that evidence emerges of late or long-term health-related effects), for studies involving long-term survivors, this may require retention of records beyond the typical storage period of clinical trial documents of about 15 years after study completion, so potentially challenging and costly to implement this.

(ii)              The National Statement (Element 7: After the project) cross references the Australian Code for the responsible conduct of Research which establishes minimum retention period for data and research materials ie  …’(2.5.3 … at least the minimum period specified in the institutional policy) so there is potential for differing durations set by individual Institutions across multicentre studies.

Return of research findings. Under Element 5: Communication of research finding or results, gives clear and useful guidance as to what an ethically defensible plan relating to disclosure of research findings should contain (3.1.68).

3. Chapter 3.5

Chapter 3.5: Genomic Research

Although return of significant/incidental research findings in genomics research is topical and important, it is a relatively rare occurrence. Overall this revised Chapter provides good and generally clear guidance across many aspects (study design, recruitment and consent of participants, data collection and management, communication of research findings/results and development and an ethically defensible plan for return of findings and individual results) in this field of research.

Breadth and rapidly changing area genomics research. We support the following:

(i)  cross-reference to the NHMRC’s Principles for the translational of ‘-omics’-based tests from discovery to health care for relevant guidance for these fields of studies.

(ii) the need for ongoing review of the guidelines in light of this rapidly changing research area through Section 3.5.3 Methods used in genomic research are not a static set, but are constantly evolving and, as they are developed and applied, may require ethical consideration on an ongoing basis. Therefore, the ethical principles and guidance in this chapter should be considered with reference to the new technologies as they are developed and applied)

(iii) The recognition of the variations in the types of genomic research findings and different circumstances when results must/may be/not returned (section 3.5.30)

(iv) The recognition that “3.5.14 Consent specific to the research may not be required: …(b) if prior consent was provided under the scope of a research program that encompasses the proposed research project”

Wishes of participants regarding receipt of results information. In particular we support the guidance which respects the wishes of participants as described in

section 3.1.68 An ethically defensible plan should: …. (d) if applicable, enable participants to decide whether they wish to receive the findings or results and who else may be given the findings or results; and

section 3.5.39.19 A decision of the participant to not receive information on the research findings should be respected and confirmation of their preference not to receive information should not be routinely sought at a later point in time.,

however still giving guidance that participants have the opportunity to ‘reconsider their decision related to receiving results or findings during the period of the research project (Section 3.5.37).

Obligations of researchers and timeframe. Several sections refer to the duration of obligation of researchers to return results to participants: for the duration of the research project only (section 3.5.37) and that the obligation ceases at the end of the project (section 3.5.38) – however in each case this timeframe may be difficult to define as analysis of clinical trial biospecimens (using different and new techniques) may occur well beyond the end of a clinical trial.

The breadth of the obligations of researchers is clearer ie

3.5.37 Over time there may be a substantive change in the understanding of the significance of the research results or findings. In such cases, researchers have a responsibility to provide the research cohort with the opportunity for each participant to re-consider their decision related to receiving results or findings during the period of the research project.

And 3.5.38 In all other cases, any obligation to return or further analyse or interpret genomic data related to participant information ceases at the end of the project.

Validation

We agree that it is critical that research results are validated prior to return to participants. For greater clarity we propose the insertion of the word ‘first’ and ‘prior to their return’ into section 3.5.32 Participants should be advised that research results or findings that may be returned will ‘first’ need to be validated according to applicable guidelines, e.g. at a NATA-accredited laboratory, ‘prior to their return’.

In section 3.5.39.18 Where feasible, researchers should indicate the timeframe for establishing the validity and potential utility of the relevant information; it may be difficult to indicate the timeframe for the establishing the validity of a test/finding as this may be variable/unknown at the time of discussing the study with the participant.

Decision-tree schema for management of findings. This is a useful schema for return of genomics results in standard clinical care vs research setting.

4. Section 5

Monitoring Approved Research

‘Section 5.5.3  For each clinical trial, institutions and review bodies should ensure that there are appropriate mechanisms for reporting and reviewing serious adverse events, serious adverse drug reactions (ADRs), serious unexpected suspected adverse reactions (SUSARs), and/or serious adverse device events relevant to the scope of their monitoring responsibility.’ should be revised in accordance with the recent updated AHEC guidance on safety reporting

General Comments
Comments: 

We support the proposed changes and congratulate AHEC and the NHMRC. These changes should facilitate the conduct of high quality clinical trials. Comments about specific aspects are in the separate sections of this online response.

The NHMRC Clinical Trials Centre (CTC) is a major Australian academic research organisation (ARO) with a global focus and Australia’s leading clinical trials research centre.  It was established in 1988 with a unit grant from the NHMRC.  It currently employs over 150 staff and has recruited over 65 000 patients into more than 100 trials, working in collaboration with over 800 clinical investigators from around the world.

The NHMRC CTC is affiliated with the Faculty of Medicine, University of Sydney.

The NHMRC Clinical Trials Centre’s mission is to achieve best practice in health care and improve outcomes in Australia and internationally through the better use of clinical trials research.  Our goals are to:

  • generate high quality evidence of the effectiveness of health care interventions through randomised trials
  • be a national resource in design, conduct, analysis and interpretation of randomised trials
  • improve evidence-based health care through the better use of clinical trials and high quality systematic reviews of trials

Page reviewed: 10 July, 2018