The Office for Health and Medical Research (OHMR) previously released for consultation a draft policy directive on consistent statewide consent form for research biobanking (draft policy directive) that outlines requirements for participant consent when collecting human tissue for storage prior to use in research (i.e. biobanking).

Following feedback a further draft was prepared and consultation occurred with experts in biobanking and ethics during 2016, and a revised draft was prepared.
The OHMR is now releasing this revised version for consultation prior to finalisation. 

Please see the draft policy directive.

OHMR is seeking feedback from biobanks, researchers, clinicians, ethicists, participants and other stakeholders affected by the policy prior to finalising.

Submissions close on Monday, 20 February 2017 and should be emailed to: biobankconsent@doh.health.nsw.gov.au

Background

The main aims of the draft policy directive are to:
  • promote the use of consistent state-wide patient consent forms across NSW
  • ensure consistent ethical consent has occurred in terms that are endorsed by NSW Health
  • enable data linkage to participant health information held by NSW Health, Medicare (MBS) and Pharmaceutical Benefits Scheme (PBS) (subject to any Commonwealth approval) by acquiring consent at the time of sample collection
  • enable and facilitate the return of research and/or incidental findings that have serious health implications to participants
In drafting the policy, consideration was given to the National Health and Medical Research Council's (NHMRC) National Statement on Ethical Conduct in Research Involving Humans along with information gathered from preliminary consultations with over 20 experts and biobanks (both cancer and other diseases) on current consent requirements, principles and procedures.
The principles and procedures outlined in the draft policy directive are designed to guide those involved in obtaining consent to ensure ethical and valid consent is obtained from every participant.
For any further information, or to provide preliminary feedback, please contact Brett Reed, Principal Policy Officer at brett.reed@moh.health.nsw.gov.au or on (02) 9391 9362.
Page Updated: Wednesday 11 January 2017