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Research for clinical practice becomes robust if appropriate researchers are identified and trained. Utilization of research findings and its ownership can assure the appropriateness and real time research in society. Research on felt need would carry the better applicability than the observed need by external researcher. Thus the structured education program in medical research would be worth to start with.Keywords: Education program; medical research; research gap

Intro -- Preface -- Chapter 1 -- Telehealth Services Proposed for Medicare Part B Reimbursements, 2018: Fact Sheet* -- Introduction -- Five Conditions for Telehealth Services -- Process of Adding Services -- Proposed CY2018 Telehealth Services -- Chapter 2 -- Biologics and Biosimilars: Background and Key Issues* -- Summary -- Introduction -- Events Leading Up to Biosimilars Legislation -- New Regulatory Pathway for Biosimilars -- FDA Approval of Biosimilars -- Zarxio -- Inflectra -- Erelzi -- Amjevita -- Renflexis -- Cyltezo -- Mvasi -- FDA Issues Related to Biosimilars -- Naming -- Labeling -- Transition -- Interchangeability and Substitution -- Reauthorization of the Biosimilar User Fee Act (BsUFA) -- Federal Research and New Drug Development -- Appendix A. Major Laws on Biologics Regulation -- Relevant Laws -- Biologics Control Act of 1902 -- Pure Food and Drugs Act and the Federal Food, Drug, and Cosmetic Act -- The Public Health Service Act -- Regulation of Biologics by Federal Agencies -- Appendix B. Comparison of Biologic Drug Prices -- Appendix C. Top-Selling Drugs -- Appendix D. The Purple Book -- Chapter 3 -- CRISPR Gene Editing Research in Embryos Generates Scientific and Ethics Debate* -- CRISPR Research in Human Embryos -- Ethical Context -- Chapter 4 -- FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development* -- Summary -- Introduction -- History of FDA Drug Regulation -- Early FDA Risk Management Programs -- Risk Evaluation and Mitigation Strategies (REMS) -- Elements of REMS -- Examples of Approved REMS -- Effects of Restricted Distribution Programs on Generic Drug Development -- REMS and Generic Drug Development -- Bioequivalence Testing -- Developing a Single, Shared System of ETASU -- Non-REMS Restricted Distribution Programs -- Issues for Congress -- Legislative Proposals.

In their submission to the government in advance of the white paper on science policy in the United Kingdom the Medical Research Council commends the MRC's own approach to managing directly funded research. But a series of semi-structured interviews with the directors of some of the MRC's units suggests a gap between the MRC's model of managed research and the reality. Although such units are theoretically managed from MRC head office (and units are charged an overhead for this), in practice each unit runs its own affairs. Between major reviews average contact time with the head office contact person is seven hours a year. The first paper argues that a purchaser-provider split would recognise the benefits of decentralisation and allow units to bid for research funds from several sources, the successful ones guaranteeing their survival through a rolling series of research programmes. The second paper criticises the MRC's cumbersome peer review system. Reliance on outside experts atrophies the scientific skills of head office staff and builds delays into decision making. A purchaser-provider model would allow the head office scientific staff to act like commercial research and development managers, commissioning research, and using the outcome, rather than peer review, as a criterion for continued funding.

Intro -- Issues in Medical Research Ethics -- Copyright Page -- Contents -- Contributors -- Introduction -- Chapter 1. On the nature of research -- Chapter 2. Regulation of research -- Chapter 3. Research versus consent -- Chapter 4. Vulnerable groups -- Chapter 5. The extent of the researcher's duties -- Glossary -- References -- Appendices -- List of participants -- List of critical readers -- Index.

That people should only be enrolled in medical research if they have given free and informed consent is now an unquestioned principle of research ethics. It is however a recent innovation. Prior to the prominence given to consent to participation in research in the condemnation of German doctors arraigned at Nuremberg in 1945, informed consent had appeared in American litigation, but only as an issue in clinical malpractice suits. Informed consent as an ethical requirement in medical research had arisen in some earlier European contexts. Despite the Nuremberg judgement, informed consent by participants in research was not widely recognised as ethically mandatory until the early 1970s. This delay seems to have been due in part to scepticism about the practicability of truly informed consent, but medical paternalism and the circumstances surrounding military research during the Cold War period may have contributed.

With the advances of medicine, questions of medical ethics have become more urgent and are now considered of great social and political significance. An innovatively designed, activity-based workbook, this text was prepared using papers and case studies collected from several countries in the European Union. It reflects the issues and concerns that confront clinical practitioners throughout Europe and elsewhere today and presents varying national responses in law and policy to these concerns, as identified by ethicists, lawyers, theologians and practitioners. The problems they examine include the relationship between medical research and medical practice, elementary regulations of medical research, the complexity of informed consent, and the role of the sponsor or scientific community