Legal Guidance

Question 1

What is the human tissue act?

Answer 1

The Human Tissue Act came into force on 1st September 2006 establishing Informed consent as the fundamental principle underpinning the lawful removal, storage and use of human tissue and organs.

The Act sets up an overarching Authority (the Human Tissue Authority) to regulate relevant activities through a system of licensing and the production and provision of directions and guidance.

It applies to ‘relevant material’ from living persons. This is defined as “material, other than gametes which consists of or includes human cells.” Hair and nail are excluded but blood is included.

Non-compliance with the Act can lead to severe penalties, ranging from fines through to imprisonment of up to three years.

Question 2

What are the 8 principles of the 1998 data protection act?

Answer 2

The act protects individual rights regarding the use of, and access to, their personal data.
The 8 core principles are:

1, Information must be processed fairly and lawfully.
2, Information collected must be processed for limited purposes.
3, Information collected must be adequate, relevant and not excessive.
4, Information collected must be accurate and up to date.
5, Information must not be held for longer than is necessary.
6, Information must be processed in accordance with the individual’s rights.
7, Information must be kept secure
8, Information should not be transferred outside the European Economic Area unless adequate levels of protection exist.

Question 3

What is ‘Duty of Candour’

Answer 3

Every healthcare professional must be open and honest with patients. Healthcare professionals must:

• Tell the patient (or, where appropriate, the patient’s advocate, carer or family) when something has gone wrong.
• Apologise to the patient (or, where appropriate, the patient’s advocate, carer or family)
• Offer an appropriate remedy or support to put matters right (if possible)
• Explain fully to the patient (or, where appropriate, the patient’s advocate, carer or family) the short and long term effects of what has happened.

Question 4

What is ACCE?

Answer 4

Developed the first publicly-available analytical process for evaluating scientific data on emerging genetic tests.

It is a model process that includes collecting, evaluating, interpreting, and reporting data about DNA (and related) testing for disorders with a genetic component in a format that allows policy makers to have access to up-to-date and reliable information for decision making.

Question 5

What does ACCE stand for?

Answer 5

1. Analytic validity (i.e. how accurately and reliably the test measures the genotype of interest),
2. Clinical validity (i.e. how consistently and accurately the test detects or predicts the intermediate or final outcomes of interest),
3. Clinical utility (i.e. how likely the test is to significantly improve patient outcomes),
4. Ethical, legal and social implications
   (I.e. ethical, legal, and social implications that may arise in the context of using the test)

Question 6

What is the main role of NICE?

Answer 6

Producing evidence based guidance and advice for health, public health and social care practitioners.

Developing quality standards and performance metrics for those providing and commissioning health, public health and social care services.

Providing a range of informational services for commissioners, practitioners and managers across the spectrum of health and social care.

Question 7

What does NICE stand for?

Answer 7

National Institute for Health and Care Excellence