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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: 
Cerebral Palsy Alliance
Personal Details
Specific Comments
2. Chapter 3.1

Section 3.1 - Element 4: Data collection and management in the introductory passage it is stated that: Data are pieces of information, for example:Information derived from human biospecimens such as blood, bone, muscle and urine.

This should also state: “and their derivatives” as biospecimens are regularly cultured or specific cells derived from the original source.

2. Chapter 3.1

Section 3.1 – Element 4: Data identifiability

Language throughout the National Statement should be consistent to ensure that researchers are clear as to whether their data is identifiable, re-identifiable or non-identifiable. This will also help HREC committees if language is consistent.

3. Chapter 3.5

Section 3.5.5 – The recruitment process should avoid disclosure of information to a potential research participant as an inadvertent consequence of that process.

Disclosure of what information? Participants need to be informed to adequately consent; the term information here is unclear. 

3. Chapter 3.5 – If the participant has agreed to be notified of the existence of potentially relevant information and the option to receive this information, they should only be notified after the test validity and the potential utility of the information have been established.

What happens if a participant changes their mind between the recruitment process and research findings but has not relayed this to the researchers? Where feasible, participants should be reminded of their right to refuse genomic results prior to receiving them, even when they initially stated that they wanted to receive them.

3. Chapter 3.5 – 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.

Similarly, a participant may have changed their mind regarding not receiving information regarding their results.

In an effort to consider both these points – and a continuum to – participants should be notified that their results are now available, if they choose to receive them, while also reminding them of their right to refuse their genomic results if they wish to do so, and the possible implications their results may have on their wider family.

General Comments

The CPA considers the approaches to revise Chapter 3.1 – The Elements of Research, and 3.5 – Genomic Research, as a significant improvement as these sections now contain much more comprehensive guidelines. However, we would recommend that the AHEC consider the following points in relation to Chapter 3.1 and 3.5.

Supporting attachments

Page reviewed: 10 July, 2018