Human Tissue Act 2004 Overview

The Human Tissue Act 2004 created the Human Tissue Authority (HTA) to oversee the ethical use of human tissue in the UK.

The HTA licenses organizations that store and use human tissue for various purposes, including research, treatment, post-mortem examinations, teaching, and public exhibitions.

The HTA aims to establish clear and reasonable standards for using human tissue, ensuring both public and professional confidence.

The HTA issues licenses to organizations that carry out various activities involving human tissue from both the deceased and living individuals. These activities include anatomical examinations, post-mortem examinations, removal and storage of human tissue, and public display of human remains.

The HTA oversees organizations that work with relevant material from human donors. These organizations are required to adhere to ethical guidelines and maintain a safe and ethical environment.

The HTA licenses organizations that store human tissue for research purposes, but only for projects that have been ethically approved.

The HTA makes sure that organizations involved in human tissue applications are licensed and comply with regulations for quality and safety.

Each research licence issued by the HTA requires a designated individual (DI) who is responsible for ensuring compliance with the regulations.

The Human Tissue Act 2004 (HTA) was created to address concerns about the ethical use of human tissue in research after the Alder Hey organ retention scandal.

It aims to ensure that human tissue is used ethically and that individuals have a right to choose whether their tissue is used for research.

The HTA regulates the use of human tissue for research, donation, and transplantation. It sets out requirements for consent, storage, and disposal of tissue.

The HTA ensures that individuals understand the implications of donating or using their tissue and can make informed decisions.

The Act emphasizes the importance of respecting individuals' dignity and autonomy in relation to their tissue.

It requires researchers to obtain informed consent for the use of human tissue. They must also comply with specific regulations regarding storage, handling, and disposal.

The Redfern report, commissioned in response to the Alder Hey scandal, recommended a new law on informed consent and other measures to ensure ethical use of human tissue.

The HTA focuses on the use of deceased individuals' tissue in Scotland, while other countries have similar legislation.

A systematic examination of processes and practices to ensure they comply with regulations and standards.

Ensuring that all necessary paperwork and documentation regarding human tissue are properly maintained by the responsible department.

Following established procedures and guidelines during the handling and processing of human tissue.

Tracking the movement of human tissue from the moment it's received until its disposal.

Confirming that all employees involved in handling human tissue are adequately trained and experienced.

Any tissue or sample that contains human cells. This includes things like blood samples, biopsies, and organ tissue.

Material that came from a human body and contains cells. This includes relevant material, embryos, and hair and nails.

A license needed to store and use relevant material for research purposes in the UK.

A license needed to store and use human anatomical material for research and educational purposes in the UK.

Permission from the donor is necessary to hold and use relevant material for research or anatomical study.

Cells that have been grown in a lab and have divided many times, creating a stable cell line.

Primary human cells are those taken directly from the body. They are considered relevant material and need a license.

An established cell line is a cell line that has been expanded and is no longer considered relevant material. It does not require a license for storage.

An individual responsible for overseeing all activities related to a human tissue license, ensuring compliance with regulations and conditions.

A team of individuals appointed to support the Designated Individual (DI) in their responsibilities, assisting with compliance and related tasks.

An official document issued by the Human Tissue Authority permitting the storage and use of human tissue for research purposes, subject to specific conditions.

A formal authorization granted by an ethics committee, typically within an NHS organization, approving a research study involving human tissue.

Human tissue that has been processed or treated to remove all cellular components, rendering it no longer subject to the Human Tissue Act.

Human tissue samples obtained from donors who passed away more than 100 years ago.

The act of moving human tissue samples from one location to another, usually for research purposes.

A central database where all relevant samples, including NHS samples, are recorded.

A process, not just a signature on a form, that ensures individuals understand and agree to the uses of their bodily material or data.

The process of making it impossible to identify an individual from their data or tissue samples.

All research involving human participants, their data, or tissues, conducted by Brunel University staff or students must undergo ethical review and approval.

An ethical committee within a College that reviews research involving human participants, data, or tissue.

The University Research Ethics Committee, responsible for reviewing and approving all research involving human tissue.

All Human Tissue Act (HTA) related activities must be governed by clear policies, procedures, and standard operating procedures.

The permission granted by the HTA to Brunel University to work with human tissue.

Detailed protocols outlining the methods, storage, record keeping, and disposal of human tissue samples.