Our ethics policy

The SMILE Foundation provides funding for research into rare childhood diseases. In anticipation of the sensitive ethical issues that are associated with this research SMILE has adopted an ethical position statement that will underpin all research funding decisions.

Effective ethical control involves legislation as well as industry and community codes of best practice. These arise out of public concern and discussion and are a result of political and social consensus – they put in place the enforcement procedures for which non-compliance has a legal consequence and the voluntary procedures for which non-compliance has a social and professional consequence.

SMILE recognises that biomedical research within Australia is rigorously controlled by state and federal legislation and by voluntary guidelines. These controls rely heavily on a system of self regulation that has achieved international recognition and acclaim. Key to the review, management and monitoring of research are the human and animal ethics committees whose members include relevant scientific and community representatives. All research projects are reviewed by the appropriate ethics committee prior to commencing and the progress and completion of the projects is similarly monitored.

SMILE funded research must fulfil all prescribed requirements for ethical and legal compliance and release of the funds will be dependent on provision of evidence that this has been achieved.

Because much of the funded research will involve children and in order to better recognise and meet specific community expectations, SMILE reserves the right to make release of funds conditional on the satisfactory compliance with additional or more stringent ethical control measures than may reasonably and generally be applied by local ethics committees and other regulatory bodies.

Some examples of areas of particular sensitivity that may incur additional controls include:

• acquisition of voluntary consent – guarantees to be applied that consent be obtained from all research participants and/or parents or guardians and that provision of waiver of consent by the HREC to be precluded, particularly when it relates to clinical studies or research as part of therapeutics
• monitoring of research conduct – procedures to be implemented that require independent (eg HREC) interviews with research participants and staff and inspection of research laboratories and hospital wards where research occurs
• dissemination of research outcomes - strategies to be determined and approved prior to allocation of funds to ensure that research data is shared and disseminated appropriately in order to facilitate ongoing research in the funded area of investigation
• use of stem cells and cloning techniques - procedures to be implemented to manage any potential conflict of interest where research could involve stem cells derived from embryos cloned for specific therapeutic use in unwell relatives or friends
• use of animals – additional monitoring and research conduct reports required where procedures are highly invasive or where transgenic or similar techniques can manifest with phenotype with severe impact on animal well being beyond that generally acceptable.
• research involving Aboriginal and Torres Strait islander peoples – ensure procedures developed and implemented to engage the indigenous community in all aspects of research from design to conduct, outcomes to benefits.
• genetic research – ensure that strategies are in place to preserve the genetic, tissue and information privacy of research participants, their families and extended communities now and into the future.
• gene therapy – ensure that the project has received approval from GTRAP, OGTR as well as local HREC particularly in circumstances where life threatening illness may put pressure on researchers and clinicians to treat immediately at all costs
• fetal research – ensure that any potential for conflict of interest related to the clinician and woman associated with abortion and release of fetal tissue for research has been addressed.