• Risks to subjects are minimised.

• Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result.

• Selection of subjects is equitable.

• Informed consent will be sought from each prospective subject or the subject's legally authorised representative.

• Informed consent will be appropriately documented.

• When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

• When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.