OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
INTRODUCTION
The Office for Health and Medical Research (OHMR) has developed a draft Policy Directive on
Consistent State-wide 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).
OHMR is seeking feedback from researchers, clinicians, ethicists, participants and other stakeholders affected by the policy prior to finalising. The main aims of the draft Policy Directive are to:

streamline Biobank consent into a consistent state-wide form 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.
A copy of the draft Policy Directive is available at www.health.nsw.gov.au/ohmr .
BACKGROUND
The ten-year strategic plan for health and medical research aims for NSW to possess an internationally collaborative Biobanking framework built upon cutting-edge quality management, diverse biological samples and enhanced health data-linkage that enables innovation in healthcare and utilises Biobanking as an essential public health asset. During consultation on the plan, and in subsequent discussions since, a consistent theme from Biobanks was that a standardised and streamlined approvals system can optimise ethical, legal and secure access to biospecimens and linked data.
The 2009 Cancer Institute NSW (CINSW) Review of Biobanking had previously identified streamlining administration as a significant issue for Biobanks being used effectively as research assets. The cancer biobanks who are members of the CINSW Biobanking Stakeholder Network
(BSN) have also been undertaking significant work to develop a consistent state-wide consent form for their biobanks. In 2014, OHMR agreed to develop a consent form and Policy Directive to assist with this process, and that will apply to all biobanks collecting specimens in NSW Health facilities.

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
Currently there is no standard participant consent process for obtaining samples from patients in
NSW Health facilities for use in Biobanking. The Policy Directive: PD2005_406 ‘Consent to
Medical Treatment
– Patient Information’
does contain a standard form that includes research consent, but this policy is not targeted at research Biobanking and treats research consent as incidental to the medical procedure consent. It also does not contain consent for medical record linkage.
By streamlining consent into a consistent state-wide form (that will be used separately to the medical procedures consent form in PD-2005-406) it is anticipated that researchers will more efficiently access samples from multiple Biobanks and across multiple collection points, and be assured that consistent ethical consent has occurred in terms that are endorsed by NSW Health.
This aims to reduce administration costs, potentially increase the number of samples able to be used in research projects, and facilitate research collaboration and information and sample sharing.
How to Provide Feedback
Feedback is sought from researchers, participants, clinicians, biobank managers, ethicists and any other stakeholder affected by the Policy Directive.
A copy of the Draft Policy Directive can be obtained from www.health.nsw.gov.au/ohmr or by emailing biobankconsent@doh.health.nsw.gov.au
.
Feedback should be provided on the Form in the Appendix.
Submissions close on 29 January 2016 and should be emailed to biobankconsent@doh.health.nsw.gov.au.
Next Steps
The next steps in finalising the Policy Directive are:

Consultation across NSW Health – closes on 29 January 2016

Review of feedback received – February/March 2016

Publication of Policy Directive – April 2016

Proposed phase-in period ends – April 2017
For more information see www.health.nsw.gov.au/ohmr or call OHMR on (02) 9391 9228.

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
FEEDBACK ON DRAFT POLICY DIRECTIVE ON CONSENT FOR BIOBANKING
NAME: ____________________________ DATE : _____________
INSTITUTION : _______________________ BIOBANK NAME: _________________________
Instructions: Please provide comments in the box below that relate to each section of the draft
Policy Directive. Where feedback is sought on a specific issue outlined in a Consultation Box in the Policy Directive, please include in the relevant section. Expand the boxes below if more space is required.
SECTION 2 APPLICATION OF POLICY
SECTION 3 OBTAINING CONSENT
See Consultation Points 3.2.1, 3.2.2, 3.3.1, 3.3.2 & 3.4.1

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
SECTION 4 RECONTACTING PARTICIPANTS
See Consultation Points 4.1 and 4.2
SECTION 5 PRIVACY, INFORMATION SHARING AND DATA LINKAGE

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
APPENDIX 1 CHECKLIST
APPENDIX 2 CONSENT FORM

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
APPENDIX 3 PARTICIPANT INFORMATION SHEET
APPENDIX 4 THE RETURN OF RESEARCH/ INCIDENTAL FINDINGS
See Consultation Points Appendix 4.3, 4.4, 4.5, 4.6

OFFICE FOR HEALTH AND MEDICAL RESEARCH (OHMR)
OTHER COMMENTS
DOES THIS POLICY IMPACT YOUR CURRENT BIOBANK PROCEDURES IN A SIGNIFICANT
WAY? IF SO, HOW?