Clinical and Research Ethics Flashcards
Why is the concept of “scientific validity” important in research ethics?
Scientific validity ensures that the research question is important and relevant. It is essential for the research to address significant issues in a meaningful way. If the research lacks scientific validity, it can waste resources and fail to contribute valuable knowledge.
What are the responsibilities of a Research Ethics Committee (REC) when reviewing research proposals?
RECs are responsible for ensuring that the research meets ethical standards, such as protecting participants’ rights and welfare, ensuring informed consent, assessing risk vs. benefit, and ensuring that the research is scientifically valid. They do not provide legal advice but ensure ethical compliance.
What are the potential problems with industry-funded trials, and how do they relate to publication bias?
Industry-funded trials may not be published, or they may present results that are more likely to be positive due to the interests of the pharmaceutical company. This can contribute to publication bias, where negative outcomes are underrepresented, distorting the overall body of evidence.
How do ethical guidelines in animal research promote the welfare of animals used in experiments?
Ethical guidelines in animal research, such as the 3Rs (Reduce, Replace, Refine), aim to minimize animal use, seek alternatives to animal testing, and reduce pain and distress. They ensure that the use of animals is justified by significant scientific or medical benefits, with stringent welfare protections in place.
What role do Research Ethics Committees (RECs) play in ensuring informed consent in research?
RECs ensure that researchers provide participants with clear, understandable, and sufficient information about the study, including its purpose, risks, and benefits. They review consent procedures to ensure that consent is voluntary, informed, and given by capacitous individuals or their legal representatives when necessary.
What are the key characteristics of good science?
Good science is:
Well-communicated without misrepresentation
Used well in research
Well-designed research
Trustworthy
Advances knowledge and understanding
Respects participant autonomy
Rewarding to do
Responsive to people’s needs
Benefits people and society
Can be boring but necessary and useful
Exciting and cutting-edge
What is research ethics?
Research ethics is the study of the principles, regulations, and practices that govern how research should be conducted. These principles apply to all researchers, whether they are untrained undergraduates or internationally recognized specialists.
What are the key ethical issues in research?
The key ethical issues include:
Scientific Validity: Whether the research question is important and relevant.
Consent: Must be voluntary, informed, and from a capacitous individual.
Confidentiality: Protection of participants’ confidentiality.
Balance of Risks vs. Benefits: Ensuring that benefits outweigh risks.
Equipoise: Ethical balance in trials.
Placebo: Use of placebo-controlled trials when necessary.
Reciprocity: Moral duty to volunteer for research.
What does the Data Protection Act 2018 require regarding confidentiality in research?
The Data Protection Act 2018 requires that all research data, particularly sensitive data, be adequately protected to ensure participants’ confidentiality is maintained.
What are some key responsibilities of RECs?
RECs:
Review research proposals
Ensure ethical standards are met
Have 12-18 members, including lay people
Provide an ethical review of research
Do not give legal advice
What is salami slicing in research publication?
Salami slicing, or segmented publication, is the practice of dividing a single research study into several smaller papers. This practice is considered professionally unacceptable but still occurs in scientific publishing.
What are the authorship criteria defined by the International Committee of Medical Journal Editors (ICMJE)?
The ICMJE authorship criteria include:
Conception, design, or analysis contribution
Drafting or revising the article critically for intellectual content
Final approval of the version to be published
Accountability for the accuracy and integrity of any part of the work
How many animals are used in research worldwide, and what are the primary purposes?
Approximately 100 million animals are used in research worldwide. In the UK, 2.66 million animals are used annually, with 52% used for medical or veterinary research, 34% for fundamental science, and 6% for cosmetics. Rodents are the most commonly used animals in research.
What are the 3Rs of ethical animal experimentation?
The 3Rs are:
Reduce: Minimize the number of animals used in experiments.
Replace: Use non-animal methods when possible.
Refine: Minimize pain and distress to animals, ensuring justifiable purposes for their use.
What is the purpose of animal research in medicine?
Animal research is used to understand how the body functions and how diseases affect it. It allows researchers to conduct studies that would not be ethical to perform on humans, due to similarities in anatomy and biology between humans and non-human animals.
What historical events led to animal protection activism?
Animal protection activism began with the Martin’s Act in 1882, the first legislation in the UK aimed at protecting animals, particularly cattle and horses. The act was amended in 1835 to include domestic animals like dogs and cats, marking the beginning of animal welfare activism.
What legislation regulates the use of animals in scientific research in the UK?
The Animals (Scientific Procedures) Act 1986 regulates the use of animals in research that might cause pain, suffering, or lasting harm. It requires ethics committees in institutions and provides special protection for certain species such as primates, cats, dogs, and horses.
