Performing a background review

Justify the importance of your research question

• Has your research question been answered by previous studies?
• If yes, how can your research add further value?
• Do potential subjects, medical colleagues and the public think that your research is important?

Justify your methodology

• What are the methods used by similar studies?
• Are these methods suitable for your own research, considering your resources and target population?
• Were there issues that limited the scientific validity and reliability of previous studies?
• Could your research question be answered using other methods that are less risky, intrusive or burdensome to subjects?

Identify as many potential hazards and ethical issues as possible

• Have previous studies identified adverse events from any research procedures, drugs or devices that are identical or similar to what you plan to use?
• Have similar studies been rejected, investigated or terminated due to safety or ethical concerns?
• Do potential subjects, medical colleagues and the public have any worries about this research (for example, regarding stigma or exploitation)?
• If yes to any of the above, how can you manage each of these issues?

NOTE: The fact that you could not find any safety information is not necessarily evidence that a procedure or intervention is safe – in some instances, it could mean that no pre-clinical / clinical studies have ever been done to test its safety.

Identify any extra help or advice that you would need.

You may need to consult or involve the following individuals in your research:

• Experts in your own field
• Experts from other departments (e.g. pathologists, social workers, engineers, etc.)
• Patients, potential subjects, community representatives
• Research sponsors / manufacturers of any investigational products
• Regulatory bodies (e.g. Drug Control Authority)
• Ethics or legal advisors