Clinical Trials and Its Regulation
Clinical Trials are experiments or observations done in clinical research. They are prospective studies on human participants concerning new treatments. They generate data on safety and efficacy. They need approval. Phases Phase 0: pharmacodynamics and pharmacokinetics in humans (animal study) Phase 1: screening for safety (first in humans) Phase 2: efficacy against a placebo (in patients testing for efficacy) Phase 3: final confirmation of safety and efficacy (larger number
Risk and Regulation: Food and Risk
Good News: usually are of low risk Bad News: most are due to food mishandling (microbial problems) Rules for controlling the food risks: 1. Keep your prepared foods either very cold (under 40 degree Fahrenheit) or very hot (over 140 degree Fahrenheit). Do not hold between 40-140 degree Fahrenheit for more than 2 hours. The reason behind is that microorganisms multiply rapidly at warm temperatures. A single organism can increase to 2,097,152 organisms within 7 hours. So, don't
Criticisms of Health Research Regulation in UK
Here are some of the criticisms: 1. Insufficient funding. 2. Confusion about the confidentiality and consent requirements of clinicians working in areas where research is conduted and on whom recruitment processes often rely. 3. Insufficient transparency. 4. It is unethical to request the GP to disclose patient details under the Health and Social Care Act 2012. 5. Data sharing that is legally, ethically and professionally acceptable may nonetheless be considered unacceptable
Risk and Regulation: Food and Risk
Food Risks: 1. Hormones: - Bovine Growth Hormones (BGH) (in all cattles, regulates milk production) - Does not affect humans - Concerns are over the use of BGH in the economics of increasing the milk supply rather than human safety 2. Pesticides: - Low risk, the pesticide must be safe at 100 times the legal level for extra security - Often due to the pesticide not approved for that type of products 3. Carcinogens: - Less than 1% of cancer deaths can be attributed to food addi
British Courts (Civil)
England and Wales 1. Supreme Court (House of Lord) (above 5 judges) 2. Court of Appeal (3 judges) 3. Divisions: High Court (only judge) - Chancery including "Court of Protection" (Mental Capacity Act 2005) - Family - Queen's Bench (legacy) 4. County Courts (only judge) 5. Magistrates' Courts (only judge) Scotland 1. Supreme Court (House of Lord) (above 5 judges) 2. House of Session: - Inner House of Court of Session (3-5 judges) - Outer House of Court of Session (only in Edin
