Ethical conduct

Question 1

What should the lab have in place in relation to ethical conduct?

Answer 1

a) There is no involvement in any activities that would diminish confidence in the laboratory competence, impartiality, judgement or operational integrity.
b) Management and personnel are free from any undue commercial, financial or other pressures and influences that may adversely affect the quality of their work.
c) Where potential conflicts in competing interests may exist, they shall be openly and appropriately declared
d) There are appropriate procedures to ensure that staff treat human samples, tissues or remains according to relevant legal requirements.
e) Confidentiality of information is maintained.

Question 2

If a patient phoned the lab, can you give them a result and why?

Answer 2

Results should not be communicated to the patient without the opportunity for adequate genetic counselling. All results are confidential unless disclosure is authorised wherein the results may be reported to other parties with the patient’s consent or as required by law.

Question 3

What does ISO stipulate about data protection?

Answer 3

The laboratory should ensure that all information is stored safely and that there are reasonable safeguards against loss, unauthorised access, tampering and other misuse.

Question 4

What does ISO stipulate about informed consent?

Answer 4

ISO states that all procedures should be carried out with the informed consent of the patient. The standards also state that using patient samples for purposes other than those requested should only occur if the samples are rendered anonymous or have been pooled.

Question 5

What are the different types of incidental findings?

Answer 5

1) actionable (whether immediately or remotely)
2) clinically relevant, but not actionable
3) of uncertain significance.

Question 6

What considerations should be made when reporting and incidental finding?

Answer 6

• Is it clinically relevant
• Is the disease or risk clearly proven
• Would reporting the finding lead to a better clinical outcome (e.g. are treatments available)
• Has the patient given informed consented for this test
• Patient autonomy- Is there an option for the patient to opt-out for receiving feedback from incidental findings
• Would withholding the information open the department to litigation
• Is it ethical to withhold the information