Disclaimer  

Rare Voices Australia and the RARE Portal team don't endorse any researcher or research group. This information aims to help you make decisions about engaging in research or sharing personal data with researchers. Talk to your doctor about any research project you are thinking about being part of. 

Medical research involves studying, analysing and collecting data. Information is used to better understand, diagnose, treat and manage health conditions. Research is especially important in rare diseases, where knowledge and treatments are limited. People living with a rare disease are often asked to take part in research.  

Types of research and data collection include:  

• Basic science research to understand the biology of diseases.  
• Health services research to improve the effectiveness, quality and safety of health care.   
• Clinical trials to test the safety, quality and effectiveness of new treatments. This includes diagnostic tools and other medical technologies.  

A sign that research is being done safely and fairly is that it has been approved by a research ethics approval group. These groups include independent experts in research, ethics and community perspectives. They check whether a research study is safe, respectful and ethical before it can begin. They make sure participants are protected and that the research follows the laws and ethical standards of the country where it is being done. 

Research is essential for improving care in rare diseases. Participation in research and sharing your information is always voluntary. It is important that you feel informed and comfortable before agreeing to be part of a research project. Speak with the researcher and/or your medical professional to fully understand: 

• The type of study. 
• What the study involves. 
• Whether the study is being conducted by a trusted organisation. 
• The impact of taking part in the study for you and your family. 
• Whether it has the appropriate approvals.  

These questions can help guide your decision:  

• Has your medical professional identified any possible risks, side effects or concerns related to the study?  

• Is the researcher or research team linked with a reputable organisation, such as an Australian hospital or university?  

• Has the study been approved by a recognised Human Research Ethics Committee?  

• Are you eligible for the study, and do you understand all the eligibility criteria?  

• What are the possible benefits, if any, of taking part?  

• Will clinical care be provided, and will participation affect your usual care or treatments?  

• Can you stop taking part in the research at any time? 

• What happens to your data or samples if you decide to stop taking part? In some studies, your data may already be de-identified, which means your name has been removed. Once this happens, it may not be possible to take your data out of the study. 

• How much time will you and/or your family need to give up to take part in the study, including for travel, preparation or extra appointments? Are there any out-of-pocket costs?  

• What is expected of you, and does this fit with your personal and family circumstances?  

• Can you easily contact the researcher or team with questions? Are supports available if needed, including social or mental health support?  

• How will your samples and/or data be stored? Will they be identifiable, who can access them, how might they be shared, and how long will they be kept? Researchers may collect contact details, medical history and genetic information (including information about family members).  

• What are the implications of sharing your data with researchers?  

• Can you access the research results if you want to, and when will they be available?  

Research conducted overseas may be subject to different laws and ethical standards. Ask your medical professional to help you consider the following:  

• Is the international research being run by a reputable hospital or university?  

• How will your personal data or samples will be used and stored overseas? What laws will protect them? Will they be shared with other countries?  

• Has the study been approved by a recognised Human Research Ethics Committee?  

• What costs might you or your family need to cover (travel, accommodation, testing, insurance)?  

• Where relevant, who will be responsible for your clinical care?  

• If you are travelling overseas to participate, who will be responsible for your care?  

• Could your participation impact on your access to services or treatments in Australia?  

• Who can you contact in Australia or overseas, if you have any questions or concerns?  

You can ask your medical professional to help you recognise red flags before taking part in research. For example: 

• Research that is not linked to a trusted health service, university, government agency or other recognised research institution. 
• Exaggerated claims – beware of unrealistic promises, including quick fixes or cures.   
• Conflicts of interest – ask whether the researcher has financial or political ties to the research outcomes (e.g. market research). 
• Pressure to be involved. This could include any financial incentives other than reimbursement of your costs.

Beware of any undue influence that causes you to:  

• Take risks you wouldn't usually take. 
• Underestimate potential risks.  
• Withhold or misrepresent information required to assess your eligibility.  

Information about the ways Australian researchers should work with you is available in the National Health and Medical Research Council's National Statement on Ethical Conduct in Human Research 2025.  

Talk to your medical professional about your concerns.  

Ask for more information from the researcher. Request copies of:  

• Participant information sheets.  
• Consent forms. 
• Proof of ethics approval.  
• Study contact details.  

Seek advice from a relevant community support organisation.  

Remember: 

• Your participation in research is voluntary. 
• Deciding not to take part in research will not affect your care in any way. 
• You can stop participating at any time. 
• In some cases, after your information or samples have been de-identified, it may not be possible to have them removed or deleted from the study. 

The Australian Government’s Australian Clinical Trials website includes information about what you should know about taking part in a clinical trial.  

To learn more about clinical trials, visit Healthdirect Australia: Clinical Trials.  

The National Statement on Ethical Conduct in Human Research 2025 provides information on how your data must be protected. 

Ethical guidelines for research with Aboriginal and Torres Strait Islander peoples.  

The Privacy Act 1988 covers the legal requirements for data privacy.