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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: 
27
This submission reflects the views of
Organisation Name: 
Australian National Data Service
Personal Details
Specific Comments
Comments: 
2. Chapter 3.1

Because appropriate consent is such a crucial part of ethical data sharing during and after the project (and referred to often in subsequent sections), we suggest that a specific new numbered paragraph be added in the Consent section (page 13-14) providing some guidance to the key questions raised in the Consent Key Questions box (page 13).

Such a numbered paragraph might be something along these lines:

If researchers are planning to add the data to an open access repository or make the data or materials available for reuse, this information should be supplied to the participants in the consent process. The use of ‘extended consent’ or ‘unspecified consent’ (see 2.2.14-2.2.16) would be appropriate for this purpose.

 

2. Chapter 3.1

We agree with the more comprehensive list of research materials that may contain personal information on page 15 (page 27 in the previous version).


2. Chapter 3.1

Under the “Data Identifiability” section (3.1.38 to 3.1.44, pages 16-17) the following point could be added (might fit best after 3.1.42):

It should not be assumed that identifiable or re-identifiable data cannot be shared for re-use. These data can be shared through mediated access requirements and/or ethics committee approval for re-use.


2. Chapter 3.1

"3.1.49 Researchers should reach mutual agreements with collaborators regarding the ownership, storage location, right to access, right to analyse/use and right to produce research outputs based upon stored data/ biospecimens. Such an agreement need not necessarily be a contractual document, but should facilitate a clear resolution of these issues.”

Issues such as right to access, right to analyse/use and right to produce research outputs based upon stored data are covered by the use of licences, such as under the creative commons suite. We suggest that the word ‘"licensing" could also be included in the list in the first sentence.

Custodianship of data, beyond the life-span of a project, is also an important issue for collaborators to agree upon. We suggest that the word "custodianship" could also be included in the list in the first sentence.

2. Chapter 3.1

3.1.60 In the absence of justifiable ethical reasons (such as respect for cultural ownership or risks to the privacy of research participants) and to promote access to the benefits of research, researchers should collect and store data generated by research projects in such a way that they can be used in future research projects. Where a researcher believes there are valid reasons for not making data accessible, this must be justified.

We suggest inserting the word “reasonable” in front of the words “risks to the privacy of research participants”.

We suggest adding “(including for example using appropriate national or international data and information standards)” after the words “..in future research projects.”

2. Chapter 3.1

Banking and sharing of data

While some data may be collected, aggregated and stored for a single purpose or activity, permission may sometimes be sought from participants to ‘bank’ their data for possible use in future research projects or to otherwise share it with other researchers.

To this end, data may be deposited in an open access repository or data warehouse, similar to an archive or library, and aggregated over time. Archived data can be made available for later analysis, unless access is constrained by restrictions imposed by the depositor/s.

The custodian of data may be the individual researcher or agency who collected the information, or an intermediary that manages data coming from a number of sources. In some cases, an independent custodian may be necessary to enable access by researchers or participants to the data while maintaining it in a coded form.“ (pages 18-19)

We suggest changing “open access repository” to “open or mediated access repository”.

We suggest adding “Such data can grow in value over time, for example longitudinal surveys.” in between the first and second sentences in the second paragraph (i.e. after “and aggregated over time.”)


2. Chapter 3.1

3.1.61 When data are being collected with the intention of sharing the data with other researchers (such as by adding them to an open access repository) or by adding them to a databank, researchers should clearly describe to reviewers how the collection of their research data will conform to the requirements for consent set out in paragraphs 2.2.14 to 2.2.18.“

We suggest changing “open access repository” to “open or mediated access repository”.

2. Chapter 3.1

Element 6: Dissemination of project outputs and outcomes (page 22)
We recommend that, similar to the excellent list of examples of data on page 15, a list of  research outcomes could be provided here. Suggested wording is below:

Research outputs and outcomes can take many forms, for example:

Scholarly publications (peer-reviewed journals or books)

Reports to funding bodies

Commissioned reviews for public bodies

Reports to research participants

Data

Non-positive results

Protocols

Code

Software

Algorithms

Presentations, posters, conference materials

Creative works and performances

2. Chapter 3.1

The Australian Code for the Responsible Conduct of Research establishes minimum retention periods for data and research materials. In accordance with this provision, institutions must establish guidelines with regard to the appropriate retention of data and materials for research conducted under the auspices of that institution. One of the important reasons for these requirements is to enable researchers to substantiate reported findings of research if they are challenged.” Page 23

We note that in the revised edition of the Australian Code for the Responsible Conduct of Research that has been released for public consultation there is no longer a minimum retention period for data and research materials.

2. Chapter 3.1

“3.1.77 There may be sound ethical reasons supporting the banking of data for future use by either the original research team or for sharing the data with other researchers. Increasingly, researchers have been urged to make their data available through an open access arrangement. Any banking or sharing of data (e.g. via open access arrangements) must be anticipated in the research plan and in the processes and documentation used to obtain consent.”

We suggest replace last sentence with “Any banking or sharing of data (e.g. via open or mediated access arrangements) should be anticipated in the research plan and in the processes and documentation used to obtain consent. Where explicit consent was not obtained or when re-using legacy data, data banking may still proceed (e.g. by re-contacting participants, or where it is not possible to re-contact and if consent did not preclude data banking, through an assessment of the data to ensure there is no risk of harm or discrimination to the participants).”

General Comments
Comments: 

ANDS thanks NHMRC and the Australian Health Ethics Committee, for the opportunity to comment on the revision of the National Statement on Ethical Conduct in Human Research, 2007.


The redesign of Chapters 3.1, 3.2 and 3.3 into ‘Chapter 3.1 The elements of research’ gives a consistent message across all fields of human research.


Particularly commendable in the re-casting of Chapter 3 is the effective and sensible reconciling of three (potentially conflicting) objectives:

  1. protecting the privacy of research subjects;

  2. maintaining good records of research; and

  3. enabling new research to be built on old.  

We feel this has been done laudably by establishing the importance of all three principles and explaining what practical steps can be taken to maintain the first principle while achieving the other two.


The outcomes of this document will be a further streamlining for researchers during the process of ethics application due to an improved clarity, and, through the introduction of numerous considerations around data sharing, an opening of further research collaborations, opportunities and discoveries.

Page reviewed: 10 July, 2018