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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: 
45
This submission reflects the views of
Organisation Name: 
Curtin University
Personal Details
Specific Comments
Comments: 
1. Introduction to Section 3

A notable change in Section 3 is the integration of some of the material in current Chapter 3.3: Interventions and therapies, including clinical and non-clinical trials, and innovations into the new Chapter 3.1 and the relocation of other material from Chapter 3.3 into Section 5. You may wish to consider whether the guidance related to interventional research, particularly clinical trials of unapproved therapeutic substances, devices or biologicals, is sufficient.  Clinical trials of unapproved therapeutic goods are regulated by the TGA; the National Statement may refer to the TGA regulations but should not attempt to replicate them.

2. Chapter 3.1

3.1 Introduction, Paragraph 2

“… interventional, experimental or observational in nature …” Interventional and experimental research are listed as though they are separate types of research, however, these two terms refer to the same thing and are interchangeable.

 

3.1.2 and 3.1.3

More specific definitions regarding clinical trials, clinical research, health care etc., need to be incorporated into the National Statement in order to determine the scope of these guidelines and apply them in a consistent manner (suggested additions to the glossary appear later in this table).

 

3.1.2 (d)

“…either justify to an HREC…” implies that this type of research must be reviewed by an HREC.

 

3.1.2 (f), 3.1.3, 3.1.17 (and 5.5.3, 5.5.4, 5.5.5, 5.5.9, 5.5.12)

Given there are clauses that refer specifically to clinical trials, you need to clarify how a clinical trial is different to other types of clinical interventional research.  Alternatively, dispense with the term ‘clinical trial’ altogether. 

 

3.1.17-3.1.19

These sections appear to be related to consent rather than recruitment.

 

Element 3

This section, which attempting to incorporate humanities based research, has not included autoethnographic research which has implications for the consent process.

 

3.1.27

This paragraph is slightly confusing in the way it is written. It appears to say that potential participants should receive information on “who has been selected from the participant pool, and which individuals have chosen to participate” when I think it means to say the consent strategy should be clearly presented to potential participants.

 

3.1.29

This would be better placed in section 2.2.6

 

3.1.46

It would be helpful to explain in more detail the meaning of 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, when such data are often posted without formal consent for use by researchers.

 

3.1.52

“… authorized …” should be changed to British spelling to be consistent with the remainder of the document

 

Element 4

It has also been noted that the language used in Element 4: Data Collection and Management of Chapter 3.1 related to data identifiability, specifically, the terms ‘individually identifiable data’, ‘re-identifiable data’ and ‘non-identifiable data’, although consistent with Chapter 3.2 of the current National Statement, contrast with the categories of information used in privacy legislation, i.e. ‘identified data’, ‘potentially identifiable data’ and ‘de-identified data’. You may wish to consider whether it is advisable for the National Statement to use language that is consistent with privacy legislation.

 

Element 7

“The Australian Code for the Responsible Conduct of Research establishes minimum retention periods for data and research materials.”

4. Section 5

 5.1.6

The removal of chapter 3.3 from HREC review is understandable, however there are other sections hidden within the National Statement that require ethical review by the HREC which are not clearly outlined here (i.e. research that involves active concealment or planned deception, what used to be section 3.4.4, illegal activities etc.). This makes it ambiguous and difficult to find when deciding what research must be reviewed by a HREC and what does not, particularly when these assessments are not risk based and no clear definitions are given.

 

5.5.2

This sentence repeats itself.  Suggest to you delete the first half of the sentence (“The frequency and type of monitoring should reflect the degree of risk to research participants and”)

 

5.5.3-5.5.5

Remove these clauses and refer to the recently revised AHEC Position Statement on Safety Monitoring and Reporting in Clinical Trials Involving Therapeutic Goods (Medicinal Products and Medical Devices) & The Reporting of Serious Breaches of the Protocol/Good Clinical Practice.  Many institutions and HRECs lack the requisite expertise to review raw safety data.  The revised AHEC Position Statement has rightly been updated to reflect the fact that Sponsors are responsible for gathering safety data, interpreting it (whether via a DSMB or through a different process), deciding on a course of action, and then reporting this information to the relevant parties.  These parties are then at liberty to decide whether a trial can continue at their site, or whether ethics approval needs to be reassessed. 

 

5.5.12

You may wish to add ‘unanticipated problems’ as a reason for a study no longer being ethically acceptable. 

 

5.5.12 (b)

Replace “side-effects” with ‘adverse effects’.  The term ‘side effect’ is often misused.

 

5.5.12 (c)

Stopping a trial before all the data are collected is fraught with risk.  Results showing futility or efficacy at interim data cuts are often the result of random error that will later be rectified as more data become available.  For this reason, interim data analyses should always correct for multiplicity.  A trial that is stopped early may not answer the question it set out to answer and, as a result, the participants will have been exposed to risk without any possibility of benefit.  The trial may then need to be repeated, thus exposing a new set of participants to risk. 

 

Stopping rules should be clearly defined in the protocol /Statistical Analysis Plan created by the Sponsor.  It should specify when, how, and by whom interim analyses for futility and efficacy will be performed, and who will decide whether a trial should be stopped early (this is usually one of the functions given to a Data Safety and Monitoring Board, which is independent from the study team).  The institution/review body can decide whether this plan is acceptable when they review the study. 

 

Stopping a trial early may be less ethically acceptable than letting it go to completion.  We recommend against using language in the National Statement that implies that a review body can stop a trial on a whim, or that stopping a trial for futility/efficacy is something that happens regularly.

5. Glossary

Glossary

Clinical trial

The definition of a clinical trial should reflect the purpose of clinical trials, which is to inform clinical practice.  It should also clarify how a clinical trial is different to other types of clinical interventional research.  The World Health Organisation definition of a clinical trial (‘any research study that prospectively assigns human participants or groups of humans to one or more health related intervention to evaluate the effects on health outcomes’) is too broad as it encompasses, for example, low-risk student research whose only benefit is to increase the skill/expertise of the student, with very little contribution to knowledge or understanding (i.e. it is highly unlikely to inform clinical practice and, therefore, should not be referred to as a clinical trial).   

 

A clinical trial may, perhaps, be defined as a large-scale clinical interventional study [where ‘clinical research’ is defined] that is intended to inform clinical practice.  Alternatively, it may be sufficient for the National Statement to refer to clinical interventional research and omit the term ‘clinical trial’ altogether.

 

Glossary

Health care/health intervention/health research/health outcome 

The definition of ‘health research’ will dictate when and how some of these guidelines are applied i.e. does ‘health’ simply mean physical health, or does it also encompass mental health, behavioural improvements, quality of life etc.

 

The U.S. National Institute of Health uses the following definition: [A] Health-related biomedical or behavioural outcome is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioural status or quality of life. Examples include: positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); positive or negative changes to psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and /or information retention); positive or negative changes to disease processes; positive or negative changes to health-related behaviours; and, positive or negative changes to quality of life.

 

Glossary, Suggested additions

Clinical research

Is ‘clinical research’ the same as ‘health research’ or is it more narrowly defined (e.g. research that may only be conducted in a clinical setting such as a hospital, or research that contains procedures that may only be conducted by a registered health professional).  If the latter, then the scope of what is meant by the term ‘clinical research’ should be clearly defined. 

 

It may be worth looking at the type of research that is covered under clinical trial insurance policies.  For example, Unimutual’s criteria for determining whether research is covered by its General Clinical Trial Protection cover is as follows:

 

1. Is the study or research to test:

  • a drug; or
  • a surgical procedure or device; or
  • a therapeutic procedure or device; or
  • a preventative procedure or device; or
  • a diagnostic procedure or device;

where the nature of the study or research is such that it requires the investigator or an assistant to be a registered medical practitioner or other registered qualified health service provider?

 

2. Does the study or research require any:

  • penetration of the skin (other than taking of blood samples); or
  • biopsy or any taking of or extraction of tissue samples; or
  • penetration of the bodily orifices (other than ears or mouth); or
  • insertion of diagnostic or other device within the bodily orifices (other than ears or mouth);

to be undertaken by a registered medical practitioner or other registered qualified health service provider?

 

If the answer is “Yes” to either 1 or 2 above, the study or research is a clinical trial for the purpose of Unimutual’s protections.

 

However, please note that if the study or research:

  • involves evaluating outcomes of established health care management or treatment relating to the condition or illness from which the participants are suffering; or
  • only involves the participants completing questionnaires or interviews;

then the study/research is not a clinical trial for the purpose of Unimutual protections.

General Comments
Comments: 

Thank you for the opportunity to participate and respond to proposed changes to Section 3 (Chapters 3.1 &3.5), Glossary and Revisions to Section 5 of the National Statement on Ethical Conduct in Human Research, 2007.

 

In principle Curtin University welcomes continued review of the National Statement on Ethical Conduct in Human Research to enable institutions, human research ethics committees and researchers better understand their obligations and responsibilities in the ethical conduct of research conducted in humans.

 

The National Statement is a long and complicated document which at times is ambiguous and conflicting, and is difficult to interpret. Curtin University, as an institution, endorses a principles based approach to the National Statement (for example, the current draft update of Code of Responsible Conduct of Research and GERAIS guidelines) and assessment of human research based on risk, and does not support a prescriptive approach. The redrafted sections of the National Statement encompass a combination of these approaches.

 

In general terms the proposed changes are endorsed by Curtin University, however there is a concern that there appears to be a significant overlap with the Australian Code for the Responsible Conduct of Research and current guidelines regarding clinical trials produced by the Therapeutic Goods Administration. The focus of the National Statement should rest with ethical conduct in human research, however the proposed changes seem to stray into responsible research practices.

Page reviewed: 10 July, 2018