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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: 
Medical Technology Association of Australia
Personal Details
Specific Comments
2. Chapter 3.1

Element 4:

Data Collection and Management(p15)

More clarity is required on options for use of information not explicitly collected for research but subsequently used for research purposes.  Consideration of a ‘patient opt out’ system for use of data for research purposes, where data was initially collected as standard of care. 

Data Identifiability (p16)

Language should be consistent with Privacy Legislation.  This will also allow alignment within the Patient Informed Consent Form language. 

Internet derived data (p17)

Consideration should be given to data generated/collected by wearable and implanted medical devices.

Section 3.1.45 "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; (b) the purposes for which the data will be used" and Section 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"

  • We are of opinion that,a consideration should be given to an ‘opt out’ option for patients for use of data collected for research purposes, where the original data was obtained as standard of care in a health and medical setting. Because a requirement to inform and collect consent is not practicable.
4. Section 5

Section 5.5.9 (p52) (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) report any device incidents to the TGA"

  • We are of opinion that, more clarification is required on the requirement to track the participant for the lifetime of the device, if the requirement extends beyond a system that associates a patient identifier with device identifier and having a product complaints reporting process in place
  • And please provide reference to TGA reporting requirements for device ‘incidents’

Page reviewed: 10 July, 2018