This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. Alternative approaches can be used if the approach satisfies the requirements of the applicable statutes and regulations. Discussions of an alternative approaches can be scheduled by contacting the FDA staff responsible for implementing this guidance. If the appropriate FDA staff cannot be located, contact can be made using the telephone number listed on the title page of this guidance.

The Public Population Project in Genomics and Society (P³G) is an international not-for-profit consortium dedicated to the development and management of multi-disciplinary policy infrastructures and research consortia. Through its tools and services, P³G helps the international research community prepare and propose more effective health care strategies aimed at disease prevention, tailoring treatments, and, promoting the health of individuals, families and communities.

This Information Paper draws on the international and Australian literature to discuss best practice in biobanks across six broad areas: establishment (including discontinuation); consent; data management; governance; access; and commercialisation and benefit sharing. 

Through the Carlton Connect Initiatives Fund (CCIF), the Centre for Epidemiology and Biostatistics at the Melbourne School of Population and Global Health developed the Guidelines for the Ethical Use of Digital Data in Human Research.

The International Council for Science (ICSU) is an international non-governmental organization devoted to international cooperation in the advancement of science. Its members are national scientific bodies and international scientific unions. TWAS is a Scientific Associate of ICSU.

This is a chapter from National Health and Medical Research Council's (AU) National Statement on Ethical Conduct in Human Research (2007) (Updated in May 2018).

This document clarifies the responsibilities of those involved in clinical trials to monitor and report adverse events and other safety issues. Supplementary guidance on other clinical trial safety monitoring and reporting issues is also available.

This book contains key statistics on the outcomes of the 2014 application rounds for NHMRC’s research funding, as well as historical information relating to research funding and activity over the last ten years. 

This paper provides information on the establishment, management and governance of biobanks in Australia. A biobank is a collection of human biological material held for health and medical research. Biobanks facilitate this research, while protecting participants’ interests and privacy.

NHMRC is pleased to be able to publish the Good Practice Process for Site Assessment and Authorisation Phases of Clinical Trial Research Governance (the Good Practice Process). The Good Practice Process was developed and finalised, following stakeholder consultation, by the NHMRC’s Research Governance Working Group. This group has broad representation from clinical trials sites, clinical trial sponsors and State/Territory health departments. The Good Practice Process aims to streamline the site assessment and site authorisation of clinical trials by: • Outlining a set of principles and critical success factors for site assessment and site authorisation; • Detailing a set of planning and preparation activities that can made a site more responsive to commencing clinical trials; and • Proposing a streamlined workflow for site assessment and authorisation.