Ethical conduct in clinical research

https://www.nhmrc.gov.au/guidelines-publications/e72

The National Statement on Ethical Conduct in Human Research.

This is a set of guidelines for any researcher in Australia conducting research with human participants. The guidelines are also relevant to those involved in ethical review, research governance, or study participants. The National Statement promotes ethical human research that involves participants being accorded respect and protection. The National Statement clarifies the roles and responsibilities of institutions and researchers (in the design, conduct and dissemination of results of human research), and review bodies (i.e. the Human Research Ethics Committee). The National Statement should be used when designing, reviewing and conducting research that involves human participants in Australia.

http://www.ich.org/about/mission.html

ICH-GCP The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has a set of guidelines called Good Clinical Practice (GCP). ICH-GCP is a harmonised international standard for the design, conduct, monitoring, auditing, recording, analysing, and reporting of clinical trials that involve human participants. It is based on the principle that clinical trials should be conducted ethically. These ethical principles have their origin in the Declaration of Helsinki. Good Clinical Practice (GCP) is: “A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.” Study staff must complete and maintain up-to-date appropriate and accredited ICH-GCP training.

https://www.nhmrc.gov.au/_files_nhmrc/publications/attachments/r39.pdf

The Australian Code for the Responsible Conduct of Research

A code to guide institutions and researchers in responsible research practices. This Code is a reference for people outside the research community who require information on the standards expected in the responsible conduct of research within Australia; and was developed for universities and other public sector research institutions.  

Developing a Research Protocol and Participant Information Sheet and Consent Form

https://www.nhmrc.gov.au/health-ethics/national-approach-single-ethical-review/standardised-participant-information-and

Standardised Participant Information and Consent Forms

If you are developing a clinical research project, you will need to have a Participant Information Sheet and Consent Form. In Australia, The National Health and Medical Research Council (NHMRC) has developed basic templates that can provide an initial framework for researchers when writing the patient information sheet and consent form. For definitions of Informed Consent, refer to the ICH-GCP guidelines or The National Statement.

http://www.spirit-statement.org/

The SPIRIT Statement

When developing your clinical trial protocol in line with The National Statement and ICH-GCP, the SPIRIT statement can be used as a guide for what to include. SPIRIT stands for Standard Protocol Items: Recommendations for Interventional Trials. The SPIRIT statement provides recommendations for a minimum set of scientific, ethical and administrative elements that should be addressed in a clinical trial protocol.

http://www.equator-network.org/

The Enhancing the QUAlity and Transparency Of health Research (EQUATOR) Network

Guidance for writing a protocol for non-clinical trial research (e.g. a qualitative or case-control study) as well as additional links to reporting guidelines.

Trial Registries

Clinical Trials should be registered, and without registration peer-reviewed journals can refuse to publish the study results. For example, the International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial. Studies are required to be publicly registered prior to enrolling any participants. In Australia, trials can be registered with the Australian and New Zealand Clinical Trials Registry, the United States National Library of Medicine, or both.  

http://www.anzctr.org.au/

Australian and New Zealand Clinical Trials Registry

The Australian and New Zealand Clinical Trials Registry (ANZCTR) is an online registry of research being undertaken in Australia, New Zealand and elsewhere. It is a free trial registry recognised by the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) as a primary registry (see the WHO ICTRP here: http://apps.who.int/trialsearch/)

https://clinicaltrials.gov/

The US National Library of Medicine ClinicalTrials.gov Trial Registry An online registry and global database of clinical trials. It is a free trial registry recognised by the World Health Organisation (WHO) International Clinical Trials Registry Platform (ICTRP) as a primary registry (see the WHO ICTRP here: http://apps.who.int/trialsearch/)

Legal and Regulatory considerations

Depending on the study design, legal and regulatory requirements may need to be considered. Below are some useful links.

https://www.tga.gov.au/clinical-trials

The Clinical Trial Notification (CTN) scheme is a notification process whereby an Australian clinical trial sponsor is required to notify the Therapeutic Goods Administration (TGA) that the research involves an ‘unapproved’ medicine or device, or a medicine or device is being used outside of its ‘approved’ indication.

https://medicinesaustralia.com.au/policy/clinical-trials/clinical-trials-research-agreements/

Clinical Trial Research Agreements

A Clinical Trial Research Agreement (CTRA) may be required between the sponsor and the site, or between collaborative or cooperative research groups. Medicines Australia has developed templates (which in many cases have been pre-approved by research organisations).

Insurance and Indemnity

https://medicinesaustralia.com.au/policy/clinical-trials/indemity-and-compensation-guidelines/

Provision of insurance and indemnity is required for almost all clinical research. The mechanism for insurance and indemnity depends on the type of study sponsor (e.g. pharmaceutical company, Contract Research Organisation, or investigator-initiated whereby a public institution acts as sponsor). The Medicines Australia templates are recommended for use and are widely accepted. However, in some instances, sponsors whose circumstances do not fit these scenarios will need to arrange their own clinical trials insurance. Further information is available on the Medicines Australia website (for commercially sponsored research), or through State government insurance schemes. Researchers and / or sponsors of research are encouraged to contact the applicable HREC for insurance and indemnity information specific to the project needs.

Reporting Study Results

When reporting Clinical Research (i.e. preparing a manuscript for a peer-reviewed journal), there are specific guidelines to follow when analysing and writing up your results. Some journals will explicitly state which guidelines authors should follow. Well recognised reporting guidelines for Randomised Controlled Trials (RCTs), Observational Studies, and Systematic Reviews / Meta-analyses are listed below.

http://www.consort-statement.org/

CONSORT

The CONSORT (CONsolidated Standard of Reporting Trials) guideline for RCTs was developed by the CONSORT group and contains a checklist and flow-diagram for authors and reviewers.

https://www.strobe-statement.org/index.php?id=strobe-home

STROBE The STrengthening the Reporting of OBservational Studies in Epidemiology (STROBE) Statement is a guideline for reporting cohort, case-control, and cross-sectional studies. A checklist and flow-diagram is available for authors and reviewers.

http://www.prisma-statement.org/

PRISMA Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) is a minimum set of items for reporting systematic reviews or meta-analyses. A check-list and flow diagram is available for authors and reviewers.

If you are a person who is interested in taking part in a clinical trial

https://www.australianclinicaltrials.gov.au/

Australian Clinical Trials The Australian Government provides information for people who are considering or who have been invited to take part as a participant in a clinical trial. Information and resources are provided to consumers as well as health care providers, researchers and industry.