Regulation of research through research governance: within and beyond NSW Health

Geoffrey S Bloom1, Deborah Frew

  • 1Geoffrey Bloom & Associates, Sydney. gbloom@gbloom.com.au

Related Concept Videos

Drug Control Governance: Regulatory Bodies and Their Impact01:03

Drug Control Governance: Regulatory Bodies and Their Impact

Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with a...
Ethics in Research01:56

Ethics in Research

Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
Drug Regulation01:25

Drug Regulation

Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
Accountability and Responsibility of a Nurse I01:30

Accountability and Responsibility of a Nurse I

Accountability in nursing is a fundamental principle that underscores the obligation of nurses to take responsibility for their actions and answer for any errors or omissions in patient care. This principle is grounded in the professional, legal, and ethical frameworks that shape nursing practice. For instance, nurses must adhere to all relevant laws, regulations, and practice standards, including guidelines set forth by nursing boards and professional bodies, to ensure their actions comply...
Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Accountability and Responsibility of a Nurse II01:09

Accountability and Responsibility of a Nurse II

Professional accountability in nursing is a multifaceted concept that encompasses professional ethics, legal standards, and employment expectations. This framework ensures that nurses maintain and elevate the quality of care while upholding the values of their profession. It compels them to treat patients, families, and colleagues with respect, compassion, and integrity.
For example, a nurse demonstrating respect and compassion might listen attentively to a patient's concerns, provide comfort...