The oxford textbook of clinical research ethics download




















It includes ethical analyses of controversial types of medical experimentation-studies that provoke psychiatric symptoms, induce infections, provide patients with placebos that withhold proven effective treatments or administer fake invasive procedures, test experimental treatments in cancer patients who have exhausted all standard treatment options, and employ the use of deception to generate scientifically valid data.

Part Three offers a systematic critique of "the therapeutic orientation" to clinical trials and the principle of clinical equipoise, which is widely regarded as a fundamental norm for randomized treatment studies. Part Four takes up a range of ethical issues relating to informed consent for research participation, including examination of "the therapeutic misconception" and presentation of a novel approach to the validity of consent: "the fair transaction model.

Bonnie Steinbock presents the authoritative, state-of-the-art guide to current issues in bioethics, covering 30 topics in original essays by some of the world's leading figures in the field, as well as by some newer 'up-and-comers'. Anyone who wants to know how the central debates in bioethics have developed in recent years, and where the debates are going, will want to consult this book. Introduction -- Facing up to paternalism in research ethics -- Preface to a theory of consent transactions in research : beyond valid consent -- Should we worry about money?

Recent research has shown that BRAF inhibitors are effective for a short period of time, but there is little hope that this drugs as single agents will lead to durable benefit in a majority of patients. Among scientists and researchers who work in drug discovery, there is a lot of interest in the development of molecularly targeted cancer agents.

Namely, the identification of a molecular target, the selection of molecules which effectively inhibit this target.

What is starkly different about the development of this class of compounds, however, is that the mechanism of action of these agents are not as straightforward as was once previously assumed and the mechanisms of resistance that tumor cells employ to evade complete destruction are unlike any that have been described before.

These discoveries in addition to utilization of modern molecular biology techniques have led to a series of hypotheses regarding which other types of molecules could be used in combination with BRAF-inhibitors in hopes of revolutionizing the potential of therapeutics in melanoma. This book provides a comprehensive description and ethical analysis of one of the most challenging areas: international health research.

Furthermore, it provides a vivid portrait of the current situation of global governance for health research and its main challenges and suggests a comprehensive and universal ethical framework based on the existing theories and frameworks. This work is a must-read for all the students, scholars, professionals, activists, and policy-makers who are involved or interested in the global health research enterprise and its governance and ethics.

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research.

This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis.

While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.

Cultural aspects of psychiatric diagnosis in DSM-5 in particular and the current status of Cultural Psychiatry in European countries are discussed. Of unique importance to the field of psychosomatics are the reviews on so-called culture-bound syndromes and somatization and culture.

Ethnopsychopharmacology, pharmacogenomics, current and future research perspectives in Cultural Psychiatry and bioethical dimensions of cultural psychosomatics are also reviewed.

Incentives are designed to motivate or encourage people to join a particular study. A list of requirements that must be met by all study participants. Inclusion criteria determine whether or not an individual is eligible to participate. Examples include: participants must be within years of age; participants must be female; participants must have a specific health condition being studied such as asthma or cancer.

The process in which researchers communicate information about a study to potential participants. Information delivered during this process includes, but is not limited to, the purpose of the study, the risks and benefits, and that participation is voluntary and can be discontinued at any time. An independent group of researchers, non-researchers, and community members that reviews, approves, and monitors each research study that is conducted at an institution to ensure that the rights and safety of participants are protected.

The IRB has the right to reject or discontinue any study that does not comply with federal, state, and institutional regulations. A procedure, action, drug, device, or other behavioral or medical process that is being tested in a research trial. A pill, liquid, powder, or other intervention that does not contain any active ingredients. It is made to be indistinguishable from the active intervention. The larger group of people of interest in a particular study.

Examples include: adolescents aged , African American males over 65, adults who suffer from a particular condition or disease. The process by which participants in a research study are assigned to a treatment or intervention by chance.

This is the subset of the population who are asked to participate in the study. An example is: men aged 18 or over, who have diabetes.

In this case, the sample of will represent the overall population of interest, adult men with diabetes. A secondary, or non-intended, effect of a drug or treatment. Side effects are usually negative or bad. Circumstances or situations in which people live that impact their health. These circumstances include, but are not limited to, where people live, work, their educational system, and access to health care.

The idea that all people within a society should equally share in the benefits of that society, and that all people should be able to participate fully in the economic, social, and cultural life of the society. The study of society and human behaviors.

Major areas of social science study include: anthropology, archaeology, sociology, economics, history, linguistics, and geography, among others. A type of research which is used to assess thoughts, attitudes, opinions, and beliefs and involves a set of questions given to a sample of a population.

Media Types. Related Resources. CDC Features: U. Research Terms to Know Below is a glossary of terms that are helpful to know and understand when discussing medical research participation. Blinded Study. Clinical Trial. Control Group. Exclusion Criteria.

Focus Group. Health Disparity.



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