(c) whether a recognised intervention exists that can benefit or reduce the risk of harm to the donor(s), their relatives or their community from any health impact revealed  by this information; Human participation in research is therefore to be understood broadly, to include the  involvement of human beings through: The term ‘participants’ is therefore used very broadly in this National Statement to include those who may not even know they are the subjects of research; for example, where the need for their consent for the use of their tissue or data has been waived by a Human Research Ethics Committee (HREC). The identity, statutory or formal authority to issue such guidelines of each of these agencies is described as is the composition of the committees and approval bodies of each of the issuing agencies. research and its likely outcomes. (b) a risk management plan, including a plan for proposed monitoring and a justification for the proposed monitoring; 5.2.3 To fulfil that responsibility, each member of a review body should: (a) become familiar with this National Statement, and consult other guidelines relevant to the review of specific research proposals; 4.6.6 In research that may foreseeably discover illegal activity but is not designed to expose it, researchers should explain to participants as clearly as possible: (a) the likelihood of such discovery and of any resulting legal obligation of disclosure the researcher may incur; and gametes, embryos and/or participants in assisted reproductive treatments – this research is covered by the. Not disclosing to research participants all of the aims and/or methods of the research. (b) research with findings that may be returned; and embryos excess to the needs of those for whom they were created using assisted reproductive technology – this research is covered by Australian legislation. (c) details of any amendments required by each other review body. 4.2.1 The research and its methods should be appropriate for the children or young people participating in the research. The National Statement is subject to rolling review. shows respect for participants facilitates valid consent. Title. • identifying any risks; 4.7.12 National or multi-centre researchers should take care to gain local level support for research methods that risk not respecting cultural and language protocols. (i) who will take responsibility for any subsequent care requirements. (c) any privacy matters relating to the recruitment of participants; 1995), P. M. McNeill, The Ethics and Politics of Monash Bioethics Review Vol. … Depending on the field of study and complexity of the proposed research, these issues might be addressed in numerous ways. Some methodological approaches require careful boundaries to be maintained between researchers and research participants. For how long will participants be monitored and under what circumstances, if any, would the monitoring plan change? 4.7.3 The researcher should ensure that research methods provide for mutually agreed mechanisms for such matters as: (a) appropriate recruitment techniques; requirements for disclosure of child abuse); and (c) confirm that participants will be advised in advance whether they will be offered the option to receive their findings or results; 3.3.46 Researchers should describe how the validated findings will be assessed for their potential health significance and clinical utility for the participant and/or relatives, including: (a) who will be responsible for making these judgements, including any intention to refer participants to a clinician for this purpose; • the severity of any harm that may occur. The public consultation on the revised draft Section 4 and Section 5 of the National Statement is now open. 3.3.3 Methods used in genomic research are not a static set, but are constantly evolving and, as they are developed and applied, may require ethical consideration on an ongoing basis. However, for some research designs or where recruitment material needs to be ad lib, adapted or tailored to the context (such as some social media, radio or other oral communication) a description of the strategy and broad messages is sufficient. Any research involving humans, or requiring access to personal information, requires approval from a Human Research Ethics Committee (HREC) that is registered with the National Health and Medical Research Council (NHMRC). 5.5.12 In the light of reports received under paragraph 5.5.3 and paragraph 5.5.5, review bodies may require researchers to amend research procedures to protect participants. 3.3.9 The recruitment process should avoid disclosure of genomic information to a potential research participant as an inadvertent consequence of that process. For implications of these factors, see Chapter 4.2: Children and young people, Chapter 4.4: People highly dependent on medical care who may be unable to give consent, and Chapter 4.5: People with a cognitive impairment, an intellectual disability, or a mental illness. 3.3.22 Researchers receiving genomic information should not undertake nor permit attempts to re-identify the material or information or otherwise reduce the protection of the privacy of the participants. 3.3.26 In considering whether to return results of research, researchers should distinguish between individual research results and overall research results. Importation and exportation of human biospecimens for research. The National Statement does not identify State and Territory laws that may be relevant to human research, such as those relating to use of information held by state or territory authorities, use of human tissues, guardianship, and illegal and unprofessional conduct. 13.21 The primary function of an HREC is to protect the welfare and rights of participants in research. Mechanisms for monitoring can include: (a) reports from researchers; 3.4.1 HRECs responsible for approving xenotransplantation research should be satisfied that: (a) all necessary information, as outlined in this chapter, has been received; Limitations may include: (a) the requirement to agree to long‑term monitoring for safety; It does not include non-human biological material such as micro-organisms that live on or in a person. Institutions should consider reviewing appointments to the HREC at least every three years. (b) there are any risk factors or commercial interests that might legitimately delay or restrict the dissemination of the outputs or outcomes; and

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