HFEA

Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964 and amended by the:29th WMA General Assembly, Tokyo, Japan, October 197535th WMA General Assembly, Venice, Italy, October 198341st WMA General Assembly, Hong Kong, September 198948th WMA General Assembly, Somerset West, Republic of South Africa, October 199652nd WMA General Assembly, Edinburgh, Scotland, October 2000 53rd WMA General Assembly, Washington DC, USA, October 2002 (Note of Clarification added)55th WMA General Assembly, Tokyo, Japan, October 2004 (Note of Clarification added)59th WMA General Assembly, Seoul, Republic of Korea, October 200864th WMA General Assembly, Fortaleza, Brazil, October 2013 Preamble 1. The Declaration is intended to be read as a whole and each of its constituent paragraphs should be applied with consideration of all other relevant paragraphs. 2. General Principles 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. Risks, Burdens and Benefits 16. 17. 18. Vulnerable Groups and Individuals 19.

Tuskegee syphilis experiment A doctor draws blood from one of the Tuskegee test subjects. The Tuskegee syphilis experiment (/tʌsˈkiːɡiː/)[1] was an infamous clinical study conducted between 1932 and 1972 by the U.S. Public Health Service to study the natural progression of untreated syphilis in rural African American men who thought they were receiving free health care from the U.S. government.[1] The Public Health Service started working with the Tuskegee Institute in 1932. The 40-year study was controversial for reasons related to ethical standards, primarily because researchers knowingly failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for the disease they were studying. By 1947, penicillin had become the standard treatment for syphilis. History[edit] Study clinicians[edit] Taliaferro Clark Oliver Wenger The venereal disease section of the U.S. Wenger and his staff played a critical role in developing early study protocols. Raymond A. Raymond A. Study details[edit]

Declaration of Helsinki The Declaration of Helsinki[1] is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics.[2][3][4] It is not a legally binding instrument under the international law, but instead draws its authority from the degree to which it has been codified in, or influenced, national or regional legislation and regulations.[5] Its role was described by a Brazilian forum in 2000 in these words "Even though the Declaration of Helsinki is the responsibility of the World Medical Association, the document should be considered the property of all humanity".[5] History[edit] The Declaration was originally adopted on June 1964 in Helsinki, Finland, and has since undergone seven revisions (the most recent at the General Assembly in October 2013) and two clarifications, growing considerably in length from 11 paragraphs in 1964 to 37 in the 2013 version.

Research ethics The academic research enterprise is built on a foundation of trust. Researchers trust that the results reported by others are sound. Society trusts that the results of research reflect an honest attempt by scientists and other researchers to describe the world accurately and without bias. But this trust will endure only if the scientific community devotes itself to exemplifying and transmitting the values associated with ethical research conduct.[1] There are many ethical issues to be taken into serious consideration for research. Research ethics in a medical context is dominated by principlism, an approach that has been criticised as being decontextualised.[2] Research ethics is different throughout different types of educational communities. Research informants participating in individual or group interviews as well as ethnographic fieldwork are often required to sign an informed consent form which outlines the nature of the project. Key issues[edit] Honesty. See also[edit]

Trolley problem The trolley problem is a thought experiment in ethics, first introduced by Philippa Foot in 1967, but also extensively analysed by Judith Jarvis Thomson,[2][3] Peter Unger,[4] and Frances Kamm as recently as 1996.[5] Outside of the domain of traditional philosophical discussion, the trolley problem has been a significant feature in the fields of cognitive science and, more recently, of neuroethics. It has also been a topic on various TV shows dealing with human psychology.[citation needed] The general form of the problem is this: There is a runaway trolley barrelling down the railway tracks. Overview[edit] Foot's original formulation of the problem ran as follows: Suppose that a judge or magistrate is faced with rioters demanding that a culprit be found for a certain crime and threatening otherwise to take their own bloody revenge on a particular section of the community. Related problems[edit] The fat man[edit] One such is that offered by Judith Jarvis Thomson: Act utilitarians deny this.

Ethics The three major areas of study within ethics are:[1] Meta-ethics, concerning the theoretical meaning and reference of moral propositions, and how their truth values (if any) can be determinedNormative ethics, concerning the practical means of determining a moral course of actionApplied ethics, concerning what a person is obligated (or permitted) to do in a specific situation or a particular domain of action[1] Defining ethics[edit] The word "ethics" in English refers to several things.[6] It can refer to philosophical ethics—a project that attempts to use reason in order to answer various kinds of ethical questions. [edit] Main article: Meta-ethics Meta-ethics asks how we understand, know about, and what we mean when we talk about what is right and what is wrong.[8] An ethical question fixed on some particular practical question—such as, "Should I eat this particular piece of chocolate cake?" Meta-ethics has always accompanied philosophical ethics. Normative ethics[edit] Virtue ethics[edit]

Participation Participation may refer to: Participant redirects here. Participant Productions Data Protection Act 1998 The Data Protection Act 1998 (DPA) is a United Kingdom Act of Parliament which defines UK law on the processing of data on identifiable living people. It is the main piece of legislation that governs the protection of personal data in the UK. Although the Act itself does not mention privacy, it was enacted to bring UK law into line with the EU data protection directive of 1995 which required Member States to protect people's fundamental rights and freedoms and in particular their right to privacy with respect to the processing of personal data. In practice it provides a way for individuals to control information about themselves. Most of the Act does not apply to domestic use,[1] for example keeping a personal address book. History[edit] Personal data[edit] The Act's definition of "personal data" covers any data that can be used to identify a living individual. Subject rights[edit] View the data an organisation holds on them. Data protection principles[edit] Consent[edit] Exceptions[edit]

Randomized controlled trial Flowchart of four phases (enrollment, intervention allocation, follow-up, and data analysis) of a parallel randomized trial of two groups, modified from the CONSORT (Consolidated Standards of Reporting Trials) 2010 Statement[1] The key distinguishing feature of the usual RCT is that study subjects, after assessment of eligibility and recruitment, but before the intervention to be studied begins, are randomly allocated to receive one or other of the alternative treatments under study. Random allocation in real trials is complex, but conceptually, the process is like tossing a coin. After randomization, the two (or more) groups of subjects are followed in exactly the same way, and the only differences between the care they receive, for example, in terms of procedures, tests, outpatient visits, and follow-up calls, should be those intrinsic to the treatments being compared. History[edit] Ethics[edit] Trial registration[edit] Classifications of RCTs[edit] By study design[edit] Adaptive[edit]

Disclosure it can mean different things. heres 2. Definition: Disclosure is an intellectual property term that means one of two things. 1.A disclosure is any public distribution of information about an invention, by print, demonstrations, or other means. 2.Disclosure also refers to any part of a patent application process where the inventor discloses details about his invention. An adequate disclosure would let a person skilled in the area of your invention reproduce or use your invention. 1.The act or process of revealing or uncovering. 2.Something uncovered; a revelation. ------------this would an actual written statement Real Estate: A written statement, presented to a potential buyer, that lists information relevant to a piece of property, whether positive or negative Read more:

Small studies: strengths and limitations A. Hackshaw + Author Affiliations A. A large number of clinical research studies are conducted, including audits of patient data, observational studies, clinical trials and those based on laboratory analyses. The definition of “small” depends on the main study objective. When comparing characteristics between two or more groups of subjects (e.g. examining risk factors or treatments for disease), the size of the study depends on the magnitude of the expected effect size, which is usually quantified by a relative risk, odds ratio, absolute risk difference, hazard ratio, or difference between two means or medians. Fig. 1— Schematic diagram showing how study size can influence conclusions. Studies with a small number of subjects can be quick to conduct with regard to enrolling patients, reviewing patient records, performing biochemical analyses or asking subjects to complete study questionnaires. It is often better to test a new research hypothesis in a small number of subjects first.

Ethics Deontological ethics Deontological ethics or deontology is the normative ethical position that judges the morality of an action based on the action's adherence to a rule or rules.[1] It is sometimes described as "duty" or "obligation" or "rule"-based ethics, because rules "bind you to your duty".[2] Deontological ethics is commonly contrasted to consequentialism[3] and virtue ethics. Deontological ethics is also contrasted to pragmatic ethics. Deontological philosophies[edit] There are numerous formulations of deontological ethics. Kantianism[edit] Immanuel Kant's theory of ethics is considered deontological for several different reasons.[4][5] First, Kant argues that to act in the morally right way, people must act from duty (deon).[6] Second, Kant argued that it was not the consequences of actions that make them right or wrong but the motives of the person who carries out the action. Kant's three significant formulations of the categorical imperative are: Moral absolutism[edit] Divine command theory[edit]