Legislations and policies related to lab Flashcards

1
Q

What does the Data Protection Act regulate?

A

The collection, processing, storage, use, and sharing of personal information

It encompasses various aspects of personal data management.

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2
Q

What rights does the Data Protection Act protect regarding personal data?

A

Individuals’ rights regarding how their personal data is handled

This includes access, correction, and deletion of personal data.

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3
Q

What does the Data Protection Act ensure about personal data movement?

A

The free and secure movement of personal data within Ireland and the EU

This is crucial for facilitating cross-border data transfers.

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4
Q

What is the right to establish the existence of personal data?

A

Individuals can verify whether an organization holds their data

This right enables individuals to know about their data’s existence.

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5
Q

What is the right of access to data?

A

Individuals can request access to their personal information

This allows individuals to see what data is being held about them.

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6
Q

What may limit access rights under the Data Protection Act?

A

Certain situations, such as legal or public interest

These restrictions are designed to balance individual privacy with other considerations.

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7
Q

What is a concern regarding DNA testing and data protection?

A

Lack of legislations surrounding DNA testing

This poses risks to genetic privacy and data misuse.

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8
Q

What is necessary as direct-to-consumer DNA testing grows?

A

Stronger legislation to protect users’ genetic privacy

Legislative measures must evolve to address new challenges.

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9
Q

What should individuals do before using DNA testing services?

A

Review privacy policies and seek clarification on data ownership, access, and security

This helps to ensure informed consent and understanding of risks.

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10
Q

What does the Freedom of Information Act focus on?

A

Providing public access to certain records

It ensures transparency and accountability in public bodies.

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11
Q

What legal rights does the FOI Act ensure for individuals?

A

The following rights:
* The right to access official records held by Government Departments or other public bodies
* The right to have personal information corrected or updated
* The right to be given reasons for decisions taken by public bodies

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12
Q

What office was established by the FOI Act?

A

The Office of Information Commissioner (OIC)

This office oversees the implementation of the FOI Act.

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13
Q

What is the purpose of the Health and Social Care Professionals Act 2005?

A

To establish CORU, the regulatory body for Health and Social Care Professionals in Ireland.

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14
Q

What are the main functions of CORU?

A

CORU’s functions include:
* Registering qualified professionals
* Setting and enforcing standards of practice
* Investigating complaints and misconduct cases
* Handling fitness-to-practice hearings

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15
Q

What must practitioners do to work legally in their field according to CORU?

A

Practitioners must be registered with CORU.

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16
Q

What can result from failing to meet ethical and professional standards as a medical scientist?

A

Being struck off the register.

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17
Q

What is negligence?

A

Failure to meet the expected professional standard of care, resulting in harm to a patient or client.

Negligence falls under Tort Law and can lead to civil liability.

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18
Q

What are the consequences of negligence?

A

Can lead to a fitness to practice enquiry and may result in a criminal charge if deemed serious enough.

An investigation will be performed into the issue that has arisen.

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19
Q

What is the first element of negligence?

A

Duty of Care

The professional has a legal obligation to the patient.

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20
Q

What is the second element of negligence?

A

Breach of Duty

The standard of care was not met.

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21
Q

What is the third element of negligence?

A

Causation

The breach directly caused harm.

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22
Q

What is the fourth element of negligence?

A

Damages

The patient suffered loss or injury as a result.

23
Q

Fill in the blank: Negligence will result in a _______ enquiry.

A

fitness to practice

24
Q

What is defamation?

A

False statements that harm someone’s reputation.

In the medical profession, this can happen in written or spoken form.

25
What is Libel in the context of defamation?
Written form of defamation, e.g., falsely accusing a colleague of malpractice in an email. ## Footnote Written statements that harm reputation.
26
What is Slander in the context of defamation?
Spoken form of defamation, e.g., making unproven negative claims about another scientist’s competence. ## Footnote Spoken statements that harm reputation.
27
What are the risks associated with making unverified claims in healthcare settings?
Can lead to legal consequences. ## Footnote This includes potential defamation lawsuits.
28
How should social media be used in a healthcare context?
Must be used cautiously—posting about colleagues or patients without evidence or consent could result in a defamation lawsuit. ## Footnote Legal risks associated with unverified claims.
29
What is the Human Tissue Bill?
Legislation in Ireland governing the donation, retention, and use of human organs and tissues for transplantation, research, education, and post-mortem examinations.
30
What recent issue has been highlighted in relation to the Human Tissue Bill?
Unethical retention of human tissue.
31
What does the Human Tissue Bill aim to provide?
A clear legal framework for ethical and respectful handling of human tissues, organ donation, and transplantation.
32
List the main provisions of the Human Tissue Bill.
* Organ Donation & Transplantation * Post-Mortem Examinations & Tissue Retention * Use of Human Tissue in Research & Education * Prohibition of Organ & Tissue Trafficking
33
What must laboratory professionals ensure when handling human samples?
Compliance with legal and ethical standards.
34
What must pathologists and histology labs follow before retaining tissue?
Consent rules.
35
What must researchers obtain when working with human tissues?
Ethical approval and informed consent from donors or families.
36
What must medical educators ensure when using cadavers or tissue samples?
Proper authorization.
37
What is the purpose of the EU In Vitro Diagnostic (IVD) Directive?
Regulates medical diagnostic devices to ensure safety, reliability, and accuracy ## Footnote Examples include blood tests and genetic kits.
38
What does the EU Blood Directive (2002/98/EC) ensure?
Safety and quality of donated blood through strict screening, testing, and traceability ## Footnote Aims to prevent infections.
39
What are the main focuses of the EU Directive on Tissues and Cells (2004/23/EC)?
Sets quality and safety standards for human tissues/cells used in transplants, fertility treatments, and research.
40
What do the European Communities Regulations (2006 & 2007) enhance?
Traceability, safety reporting, and adverse event monitoring for blood, tissues, and cells ## Footnote Ensures compliance with EU standards.
41
What is the role of the Health Products Regulatory Authority (HPRA) in Ireland?
Ensures the safety, quality, and effectiveness of health products, including medicines, medical devices, and human tissues.
42
What type of guide can be found on the HPRA website?
Guide to requirements for the procurement of human tissues and cells intended for human application ## Footnote Based on the EU directive.
43
What is the Irish council for Bioethics?
An independent body established by the Government of Ireland in 2002 to examine and respond to bioethical issues in science and medicine.
44
Why is the Irish council for Bioethics important?
It helps shape ethical policies in healthcare, research, and biotechnology. ## Footnote It advises government, healthcare professionals, and researchers on complex ethical issues and promotes public discussion about bioethical challenges.
45
What does each hospital have regarding bioethics?
Each hospital will have their own ethics committee that will review projects and deem whether the project is acceptable.
46
What is the National Vetting Bureau (Children and Vulnerable Persons) Act 2012-2016?
It provides a legal framework for Garda vetting in Ireland, ensuring background checks for individuals working with children and vulnerable persons.
47
What are the key provisions of the National Vetting Bureau Act?
Mandatory vetting for anyone in a position of trust with children or vulnerable adults, applies to healthcare professionals, students on placement, teachers, sports coaches, and volunteers. ## Footnote Employers must ensure staff and students are cleared before beginning work or placements.
48
What is the responsibility of employers under the National Vetting Bureau Act?
Employers must ensure staff and students are cleared before beginning work or placements.
49
What is Garda Vetting?
It is the hospitals' responsibility to ensure that you do not start your placement without the correct and up-to-date vetting in place.
50
When should Garda Vetting be completed?
Should be done in Year 1.
51
What happens to your vetting when you commence employment?
You will be re-vetted for each and every subsequent employment.
52
Fill in the blank: The Irish council for Bioethics was established in _______.
2002
53
True or False: The National Vetting Bureau Act applies only to healthcare professionals.
False