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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

This submission reflects the views of
Organisation Name: 
The University of Sydney
Personal Details
Specific Comments
1. Introduction to Section 3

Section 3 – Introduction

Paragraph 3 – It is up to each researcher and HREC to apply the guidance to their own project, taking account of the four principles of research merit and validity, justice, beneficence and respect.

Our understanding is that the first principle is ‘research merit and integrity’ yet the first principle listed in this paragraph is ‘research merit and validity’. Has there been a change to the first principle? And will this change be reflected throughout the National Statement?


Final sentence – Researchers should also consult the most contemporary version of NHMRC’s Statement on Consumer and Community Participation in Health and Medical Research.

We are concerned that this statement is too specific to health and medical research and may not be relevant to research on, for example, music practices. The NHMRC may consider adding the words ‘where applicable’ to the final sentence.

2. Chapter 3.1

Element 3: Consent (3.1.32)

3.1.32 Researchers should advise participants whether they will be provided with a timely and appropriate summary of the outcomes of the research, whether in the form of a lay summary, a research manuscript or published paper or both.

The University of Sydney HRECs place a high importance on providing feedback to participants and request for researchers to provide a strong justification if they were not to provide this feedback. Researchers should consider the time given by the participants and the principle of respect when making this decision.

When corresponding with participants we request that all documents are written in a language all participants would understand. We ask the NHMRC reconsider the reference to “research manuscript or published papers” and whether these are truly accessible to all participants?


Internet-derived data (3.1.45 – 3.1.48)

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.

3.1.45 For research using internet-derived data, researchers should make study designs readily available to persons to whom the data relates, including information about:

(a)   the form in which the data will be stored (identifiable, re-identifiable, non-identifiable);

(b)   the purposes for which the data will be used.

3.1.46 Unless a waiver of the requirement for consent is obtained, any research use of internet-derived data must be in accordance with the consent obtained from the person to whom the data relates.

3.1.47 Researchers should respect the context in which internet-derived data were posted and the privacy settings that apply.

3.1.48 Researchers should take account of any terms and conditions applicable to social media platforms when using data from these sources (e.g. Twitter) and other web-based communities that do not permit the removal of the name of the author of a post or any changes to the wording of a post.

The University of Sydney has some concerns regarding this section and the workload it imposes on the HRECs. Currently we do not require HREC approval if the information about people used in research is publicly available, e.g. published books/letters, newspaper article, you tube. The statement in 3.1.46 raises concerns that all internet-derived data, even publicly available data, must seek ethical approval and consent from the writer or a waiver for consent (rather than simply citing the public source).

Would the NHMRC consider being more specific regarding the use of internet-derived data and when these are required to be reviewed by an HREC? Is an HREC application required for the use of all internet-derived data?


Data management (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.

The University of Sydney has concerns about the broad nature of this statement. The term “biological origin” captures a wide range of studies, some of which will never result in information that could have “late or long-term health-related effects.” To provide an extreme example, if a study were to be conducted where a finger prick was performed and a blood spot was taken to obtain a sugar level reading in a diabetes study. Would this blood spot along with all records have to be preserved for a prolonged period of time (other than for the standard record keeping times) just in case evidence emerges of late or long-term health related effects?

We request the NHMRC consider changing this clause to be more specific, for example changed to be aimed at specific types of studies?

3. Chapter 3.5

Element 4: Data Collection and Management (3.5.26)

3.5.26 Researchers should not share genomic information unless; (c) the HREC has approved the transfer as set out in any transfer agreement that has been established for this purpose.

The University requests that the NHMRC consider amending the wording in point C, removing any reference to the “transfer agreement.”

Reference to the transfer agreement implies that HRECs must review the legal instrument involved (e.g. Materials Transfer Agreement or MTA) related to genomic information transfers. The requirement of HRECs to review MTAs would be quite onerous and may place further delays on the researcher’s projects commencing. Furthermore, MTAs are usually drafted with legal advice from the University’s Office of General Counsel.

We agree that HRECs should approve the transfer process itself.


Decision tree for the management of findings in genomic research and health care

The University of Sydney see great value of the addition of the decision tree and believe that this is a useful resource for both researchers and HRECs. The decision tree provides clear guidance and we would like to commend the NHMRC for this addition to the National Statement.

4. Section 5

Insurance (5.1.39, 5.1.40)

5.1.39 Institutions must be satisfied that sponsors of trials have made the indemnity or insurance and compensation arrangements required by CPMP/ICH Note for Guidance on Good Clinical Practice (CPMP/ICH-135/95), ISO 14155 Clinical Investigation of Medical Devices and the TGA, as appropriate.

5.1.40 In addition to the requirements in paragraph 5.1.39, institutions must also have arrangements to compensate participants for harm resulting from negligence in research to which the documents listed in 5.1.39 apply.

Our understanding is that there is no applicable regulatory requirements relating to insurance in the ISO 14155 Clinical Investigation of Medical Devices and there is only a brief mention regarding insurance in the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), under clause 5.8 ‘Compensation to Subjects and Investigators’.

Therefore we suggest that the stipulation of insurance requirements be restricted to a statement similar to ‘sponsors of clinical trials should have insurance and compensation arrangements in accordance with applicable regulatory requirements.’ This language reflects that of the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95).


Monitoring approved research (5.5.5 & 5.5.9)

5.5.5 For clinical trials other than those in 5.5.4, there should be (an) identified person/s or committee with suitable expertise to assist and advise the institution and/or review body in carrying out their safety monitoring responsibilities.

Clause 5.5.5 implies that the University requires one identified person/committee. The University and HREC seek expertise from a variety of sources, dependent on the specific discipline, trial design etc. Could this be reworded to state “there should be an identified process to provide suitable expertise to assist and advise the institution and/or review body in carrying out their safety monitoring responsibilities.”


5.5.9 (e) for trials with implantable medical devices, confirm the existence of, or establish, a system for:

(i)             tracking the participant, with consent, for the lifetime of the device; and

(ii)            reporting any device incidents to the TGA.

We recommend that wording of clause 5.5.9(e) should be amended to “of” implantable medical devices rather than “with” implantable medical devices. This will prevent ambiguity in this clause with the vague use of the word “with”.



5. Glossary

Glossary – Clinical Trial

A form of research designed to find out the effects of an intervention, including a treatment or diagnostic procedure.

Recommendation that the Clinical Trial definition should be updated to reflect the World Health Organisation (WHO) definition ‘any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes’.

General Comments

On behalf of the University of Sydney, I would like to thank you for providing the University with the opportunity to take part in the public consultation on the draft Chapters in Section 3 and Section 5 for inclusion in the National Statement on Ethical Conduct in Human Research (2007).

We acknowledge the work which has gone into producing these sections and see it as a vast improvement on the current National Statement. The areas of human genomic research and the use of internet-derived data have been developing at a fast rate. It is very pleasing to see that we will now have a National Statement to assist in guiding the ethics committees, researchers and institutes in reviewing the ethics in these areas.

Page reviewed: 10 July, 2018