The academic medicine handbook : a guide to achievement and fulfillment for academic faculty
https://libcat.nshealth.ca/en/permalink/provcat32568
Laura Weiss Roberts, editor.
--New York, NY:
Springer
, c2013.
- Available Online
- View e-Book
- Location
- Online
Attaining professional success and finding personal happiness in academic medicine is not an easy path, yet both are critical if the future is to be brighter through better science, better clinical care, better training, better responsiveness to communities, and better stewardship and leadership in the health professions. This concise, easy to read title consists of 'mini' chapters intended as a resource to assist early- and middle-career physicians, clinicians, and scientists in understanding …
- Available Online
- View e-Book
- Other Authors
- Roberts, Laura Weiss
- Responsibility
- Laura Weiss Roberts, editor
- Place of Publication
- New York, NY
- Publisher
- Springer
- Date of Publication
- c2013
- Physical Description
- 1 online resource (xxi, 486 p. : 19 ill., 11 ill. in color)
- ISBN
- 9781461456933
- Subjects (MeSH)
- Clinical Medicine
- Education, Medical
- Subjects (LCSH)
- Medicine
- Internal medicine
- Neurology
- Psychiatry
- Abstract
- Attaining professional success and finding personal happiness in academic medicine is not an easy path, yet both are critical if the future is to be brighter through better science, better clinical care, better training, better responsiveness to communities, and better stewardship and leadership in the health professions. This concise, easy to read title consists of 'mini' chapters intended as a resource to assist early- and middle-career physicians, clinicians, and scientists in understanding the unique mission of academic medicine and building creative, effective, and inspiring careers in academic health organizations. Organized in eight sections, the Guide covers such areas as finding your path in academic medicine, getting established at an institution, approaching work with colleagues, writing and reviewing manuscripts, conducting empirical research, developing administrative skills, advancing your academic career, and balancing your professional and personal life. Each chapter includes pointers and valuable career and 'best practices' strategies in relation to the topic area. An exciting addition to the professional development literature, Achievement and Fulfillment in Academic Medicine: A Comprehensive Guide is an indispensable resource for anyone seeking to achieve a fulfilling career in academic medicine.
- Contents
- Approaching the Profession of Academic Medicine -- How To Find Your Path in Academic Medicine -- How to Build the Foundation for a Successful Career in Academia -- How to Be Organized and Manage Time -- How to Align Individual Goals with Institutional Goals -- How to Prepare the Best Possible Curriculum Vitae -- How to Interview -- EVALUATING A LETTER OF OFFER OR CONTRACT -- How to Give a Lecture -- How to Build Assessments -- How to Supervise Trainees in Clinical Settings -- HOW TO EVALUATE AND GIVE FEEDBACK -- How to Teach in Clinical Settings -- WRITING EFFECTIVE LETTERS OF RECOMMENDATION -- Creative Teaching -- Educational Innovation Using Technology -- Maintaining Excellent Clinical Documentation -- How to avoid medicolegal problems -- How to Network and Be a Good Colleague -- Best practices in interprofessional collaboration in academic settings -- FROM LESSONS LEARNED: MENTEE PERSPECTIVE ON MENTORSHIP -- How to Be a Good Mentor -- How to Participate in Institutional Review Board Activities -- How to Participate in Ethics Committees -- 24 Intervening With Unethical and Unprofessional Colleagues -- How to Write and Publish an Empirical Report -- How to Write a Case Report -- How to Review a Manuscript -- How to Evaluate Biomedical Research Publications Rigorously -- How to Understand Flaws in Clinical Research -- How to conceptualize a research project -- How to Conduct a First Small Project -- How to Prepare an IRB Application -- HOW TO ENGAGE COMMUNITIES IN RESEARCH -- How to Approach a First Grant Application -- Funding Your Research While Maintaining Your Curiosity -- How to Review Grant Applications -- How to Prepare a Poster -- How to Prepare and Give a Scholarly Oral Presentation -- How to Be an Effective Team Leader and Committee Member of Chair -- The Art of Principled Negotiation in Academic Medicine -- How to think about money in academic settings -- Departmental Strategic Planning -- How to Read a Basic Budget -- How to Strengthen Your Own and Others' Morale -- HOW TO CREATE YOUR PACKAGE FOR PROMOTION -- How to understand promotion criteria for 'traditional' & 'research' tracks -- How to Understand Promotion Criteria for 'Clinician Educator' and 'Teaching' Tracks -- How to Develop an Educator's Portfolio -- How to Build a National Reputation for Academic Medicine Promotion -- How to Recognize and Address Unconscious Bias -- IMGs in Academic Medicine: Challenges and Opportunities -- How to 'Pitch' a Non-traditional Career Path -- How to Approach a Healthy Life Balance -- How to Care for the Basics – Sleep, Nutrition, Exercise, Health -- How to Manage Personal Finances -- PROFESSIONAL RELATIONSHIPS AND FIVE KEY ELEMENTS ESSENTIAL FOR OPTIMAL CAREER SUCCESS -- How to Recognize and Avoid Burnout -- How to Manage Personal Finances -- How to Develop Professional Reationships -- Index.
- Format
- e-Book
- Location
- Online
The art of applying to Canadian medical schools
https://libcat.nshealth.ca/en/permalink/provcat26343
Rosemary Marchant.
--Toronto, ON:
Worksafe Incorporated
, c2012.
- Call Number
- WB 290 M315 2012
- Location
- Halifax Infirmary
This is a book on how to apply to Canadian medical schools. The approach coaches the student through the process of choosing the most appropriate schools to apply to. It also helps the applicant to present themselves effectively.
- Call Number
- WB 290 M315 2012
- Author
- Marchant, Rosemary
- Responsibility
- Rosemary Marchant
- Alternate Title
- Applying to Canadian medical schools
- Place of Publication
- Toronto, ON
- Publisher
- Worksafe Incorporated
- Date of Publication
- c2012
- Physical Description
- 234 p.
- Subjects (MeSH)
- Medical colleges - Canada
- Schools, Medical - Canada
- Interviews as Topic - Canada
- Job Application - Canada
- Abstract
- This is a book on how to apply to Canadian medical schools. The approach coaches the student through the process of choosing the most appropriate schools to apply to. It also helps the applicant to present themselves effectively.
- Contents
- Introduction -- Who are Medical Schools Seeking? -- What particular abilities are the admission committees seeking? Cognitive abilities: Non-cognitive abilities; Physical abilities; Selection process -- What is the success rate? -- When to apply? -- What if I was rejected last year, should I reapply? -- How to apply -- Considerations in the choice of medical schools -- Essays and long answers: Essay application requirements; General rules for writing essays; Constructing a paragraph; General approach to the long essay -- McMaster University’s CASPer -- The interview: Traditional interview: Multiple mini interviews; Interview preparation; At the interview; Sound advice -- Referees and verifiers -- Peak Performance: Using our thoughts to create success -- Will I get in? -- Integrity -- Appendices -- Biography.
- Format
- Book
- Location
- Halifax Infirmary
- Copies
- 1
- Loan Period
- 3 weeks
Bioethics Across the Globe : Rebirthing Bioethics
https://libcat.nshealth.ca/en/permalink/provcat45140
Akira Akabayashi.
--Singapore:
SpringerOpen
, c2020.
- Available Online
- View e-Book
- Access
- Open access
- Location
- Online
- Available Online
- View e-Book
- Author
- Akabayashi, Akira
- Responsibility
- Akira Akabayashi
- Place of Publication
- Singapore
- Publisher
- SpringerOpen
- Date of Publication
- c2020
- Physical Description
- 1 online resource (xviii, 146 p.)
- ISBN
- 9783030382810
- 9783030382803 (print ed.)
- Subjects (MeSH)
- Bioethical Issues
- Specialty
- Ethics
- Contents
- 1. A Brief History of Bioethics in Japan -- 2. Brain-Death and Organ Transplantation: The First Japanese Path -- 3. Informed Consent, Familism, and the Nature of Autonomy -- 4. End-of-Life Care, Advance Directives, Withholding and Withdrawing Life-Sustaining Treatment, and the Goals of Medicine -- 5. The Moral Status of the Embryo: The Second Japanese Path -- 6. The Great East Japan Earthquake and the Fukushima Daiichi Nuclear Power Plant Accident -- 7. Outcome Egalitarianism and Opportunity Egalitarianism -- 8. Research Regulations, Ethics Committees, and Confronting Global Standards -- 9. Modern Medical Professionalism -- 10. What Does It Means to be Truly “Interdisciplinary”? -- 11. Rebirthing Bioethics: Going Global.
- Access
- Open access
- Format
- e-Book
- Location
- Online
Biomedical Research : An Insider's Guide
https://libcat.nshealth.ca/en/permalink/provcat39724
Seward B. Rutkove.
--New York, NY:
Springer
, c2016.
- Available Online
- View e-Book
- Location
- Online
This comprehensive yet concise book introduces people at all levels of training--undergraduate, graduate, and medical students, residents, fellows, and junior faculty--to the basic joys and challenges of biomedical research. By discussing many key research issues, would-be and early-stage academics will not only be better informed about the world of biomedical research, but will learn a basic set of instructions to help jumpstart their careers. Biomedical Research: An Insider's Guide is divided…
- Available Online
- View e-Book
- Author
- Rutkove, Seward B
- Responsibility
- Seward B. Rutkove
- Place of Publication
- New York, NY
- Publisher
- Springer
- Date of Publication
- c2016
- Physical Description
- 1 online resource (xvii, 299 p.)
- ISBN
- 9781493936557
- 9781493936533 (print ed.)
- Subjects (MeSH)
- Biomedical Research - methods
- Research Design
- Abstract
- This comprehensive yet concise book introduces people at all levels of training--undergraduate, graduate, and medical students, residents, fellows, and junior faculty--to the basic joys and challenges of biomedical research. By discussing many key research issues, would-be and early-stage academics will not only be better informed about the world of biomedical research, but will learn a basic set of instructions to help jumpstart their careers. Biomedical Research: An Insider's Guide is divided into five sections. The first focuses on decision points regarding whether or not to enter research and if so what type: basic, clinical, or translational. The second section focuses on the practicalities of pursuing medical research, including institutional review boards and animal care committees as well general suggestions regarding idea generation and collaboration. The third section covers a core aspect of research: writing--detailing the evolution of both grants and papers. The fourth section addresses a range of issues, including conferencing to patents to working with industry to obtaining philanthropic support. The final section deals with all-important broader life issues from job choices to being a mentor to thoughts on how to keep the big picture front and center. An invaluable resource that offers insightful, practical advice, Biomedical Research: An Insider's Guide reveals how biomedical research can be both challenging and truly rewarding.
- Contents
- Part 1: Basic considerations -- 1. So do you really want to pursue research? -- 2. What's in store: The brighter side of medical research -- 3. What's in store: The darker side of medical research -- 4. One degree of separation -- 5. Choosing and working with a mentor -- 6. Identifying a research niche you can call your own -- 7. Useful Definitions -- Part 2: Research Foundations and Structures -- 8. The Institutional Review Board: Do's, Don'ts, and Nevers -- 9. Animal Care and Use Committees -- 10. Research beyond humans and vertebrates -- 11. Hiring Research Staff -- 12. Strategy and Tactics: Running a Successful Laboratory -- 13. Everything you ever wanted to know about collaboration -- Part 3: Successful Paper and Grant Writing -- 14. Writing a successful research paper. I. Up to the point of submission -- 15. Writing a successful research paper. II Revising, resubmitting, and post-acceptance tasks -- 16. Funding: An overview -- 17. Where to apply for funding: making the right choices -- 18. Writing a winning grant application -- 19. Grant budgeting -- 20. Grant writing: Pearls and lumps of coal -- 21. Research Training, Fellowship, and Career grants -- 22. Grant review from the inside -- 23. Interpreting your reviews -- 24. To resubmit or not resubmit and how to do it -- Part 4: Good presentations, conferencing, networking, and other useful tools -- 25. The art of good presentation -- 26. Effective conferencing -- 27. Networking in the 21st century -- 28. Conflicts of interest -- 29. Scientific conduct and misconduct: what is right and proper, what is not, and what is somewhere in the middle -- 30. Article review and reading: being efficient and as thorough as you need to be -- 31. Patents -- 32. Working with industry -- Part 5: Career choices and life lessons -- 33. Jobs in biomedical science: seeking, landing, and changing -- 34. Academic Promotion and Titles -- 35. On being a mentor -- 36. Yardsticks of success -- 37. Research Life Lesson #1: Everything takes longer than you think, so plan for it -- 38. Research life lesson #2: A person's research is endlessly important to them -- 39. Research Life lesson #3: Balance, timing, cycles and seeing the big picture -- 40. Research Life Lesson #4: Your career is an ultramarathon, not a sprint -- 41. Conclusion: Nothing satisfies like meaningful work.
- Format
- e-Book
- Location
- Online
Cancer of the Oral Cavity, Pharynx and Larynx : Evidence-Based Decision Making
https://libcat.nshealth.ca/en/permalink/provcat39795
Jesus E. Medina, Nilesh R. Vasan, editors.
--Cham:
Springer
, c2016.
- Available Online
- View e-Book
- Location
- Online
Written for residents and practitioners of otolaryngology, medical oncology, radiation oncology, and maxiollofacial surgery, this book provides the reader with a comprehensive, concise discussion of the best evidence available on which to base clinical decisions needed when managing patients with squamous cell carcinomas of the oral cavity, pharynx and larynx. Because of its accessible and practical format, this book is considerably different than other related titles on the market. Formatted w…
- Available Online
- View e-Book
- Other Authors
- Medina, Jesus E
- Vasan, Nilesh R
- Responsibility
- Jesus E. Medina, Nilesh R. Vasan, editors
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- c2016
- Physical Description
- 1 online resource (ix, 116 p. : 22 illus., 14 illus. in color)
- ISBN
- 9783319186306
- 9783319186290 (print ed.)
- Abstract
- Written for residents and practitioners of otolaryngology, medical oncology, radiation oncology, and maxiollofacial surgery, this book provides the reader with a comprehensive, concise discussion of the best evidence available on which to base clinical decisions needed when managing patients with squamous cell carcinomas of the oral cavity, pharynx and larynx. Because of its accessible and practical format, this book is considerably different than other related titles on the market. Formatted with questions at the beginning of each chapter that are then answered with evidence and best practices available for each case, each chapter addresses situations the clinician is likely to face in the diagnostic evaluation and treatment of a patient with cancer of the head and neck. Most clinical decisions in the management of cancers of the head and neck region are based on the results of a few controlled, randomized clinical trial trials (Evidence Level I). However, most decision-making is based on the results of case-control studies (Evidence Level II), descriptive studies, reports of expert committees, or opinions of respected authorities (Evidence Level III). This information is scattered throughout the literature and often comingled with information about other topics. Therefore, there is a need for a publication in which the evidence pertinent to making decisions regarding a particular clinical problem is distilled from the literature and presented in a single concise, clinical, situation-driven source. Cancer of the Oral Cavity, Pharynx and Larynx: Evidence-Based Decision Making is just such a resource.
- Contents
- Preface -- 1. Evidence-Based Medicine -- 2. Oral Cavity Cancer -- 3. Oropharynx Cancer -- 4. Cancer of the Nasopharynx -- 5. Cancer of the Hypopharynx -- 6. Larynx Cancer.
- Format
- e-Book
- Location
- Online
Care in Healthcare : Reflections on Theory and Practice
https://libcat.nshealth.ca/en/permalink/provcat43976
Franziska Krause, Joachim Boldt, editors.
--Cham:
Palgrave Macmillan
, 2018.
- Available Online
- View e-Book
- Access
- Open access
- Location
- Online
This book is open access under a CC BY 4.0 license. ; This book examines the concept of care and care practices in healthcare from the interdisciplinary perspectives of continental philosophy, care ethics, the social sciences, and anthropology. Areas addressed include dementia care, midwifery, diabetes care, psychiatry, and reproductive medicine. Special attention is paid to ambivalences and tensions within both the concept of care and care practices. Contributions in the first section of the b…
- Available Online
- View e-Book
- Other Authors
- Krause, Franziska
- Boldt, Joachim
- Responsibility
- Franziska Krause, Joachim Boldt, editors
- Place of Publication
- Cham
- Publisher
- Palgrave Macmillan
- Date of Publication
- 2018
- Physical Description
- 1 online resource (xi, 298 p.)
- ISBN
- 9783319612911
- 9783319612904 (Print ed.)
- 9783319612928 (Print ed.)
- 9783319870434 (Print ed.)
- Subjects (MeSH)
- Ethics, Clinical - history
- Patient Care - ethics
- Philosophy, Medical
- Specialty
- Ethics
- Health Services Research
- Abstract
- This book is open access under a CC BY 4.0 license.
- This book examines the concept of care and care practices in healthcare from the interdisciplinary perspectives of continental philosophy, care ethics, the social sciences, and anthropology. Areas addressed include dementia care, midwifery, diabetes care, psychiatry, and reproductive medicine. Special attention is paid to ambivalences and tensions within both the concept of care and care practices. Contributions in the first section of the book explore phenomenological and hermeneutic approaches to care and reveal historical precursors to care ethics. Empirical case studies and reflections on care in institutionalised and standardised settings form the second section of the book. The concluding chapter, jointly written by many of the contributors, points at recurring challenges of understanding and practicing care that open up the field for further research and discussion. This collection will be of great value to scholars and practitioners of medicine, ethics, philosophy, social science and history.
- Contents
- Understanding Care: Introductory Remarks -- Framing Care -- Forgotten Approaches to Care: The Human Being as Neighbour in the German-Jewish Tradition of the Nineteenth Century -- Nursing as Accommodated Care: A Contribution to the Phenomenology of Care. Appeal, Concern, Volition, Practice -- Fundamentals of an Ethics of Care -- The Interdependence of Care and Autonomy Caring Relationships: Commercial Surrogacy and the Ethical Relevance of the Other -- Situated Care -- Sociomaterial Will-Work: Aligning Daily Wanting in Dutch Dementia Care -- The Dementia Village: Between Community and Society -- Regulation as an Obstacle to Care? A Care-Ethical Evaluation of the Regulation on the Use of Seclusion Cells in Psychiatric Care in Flanders (Belgium) -- Witnessing as an Embodied Practice in German Midwifery Care - Tensions in Diabetes Care Practice: Ethical Challenges with a Focus on Nurses in a Home-Based Care Team -- Caring About Care in the Hospital Arena and Nurses’ Voices in Hospital Ethics Committees: Three Decades of Experiences -- Towards a Three-Dimensional Perspective of Space for Humanizing Hospital Care -- Conclusion: Asking the Right Questions.
- Access
- Open access
- Format
- e-Book
- Location
- Online
Clinical bioethics : a search for the foundations
https://libcat.nshealth.ca/en/permalink/provcat40962
edited by Corrado Viafora.
--Dordrecht:
Springer
, c2005.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Other Authors
- Viafora, Corrado, 1950-
- Responsibility
- edited by Corrado Viafora
- Place of Publication
- Dordrecht
- Publisher
- Springer
- Date of Publication
- c2005
- Physical Description
- 1 online resource (xix, 206 p.)
- Series Vol.
- v. 26
- ISBN
- 9781402035937
- 9781402035920 (print ed.)
- Subjects (MeSH)
- Ethics, Clinical
- Philosophy, Medical
- Contents
- PART 1. CLINICAL BIOETHICS: COMPARING THEORETICAL MODELS -- Clinical Bioethics in a Post Modern Age -- The "Telos" of Medicine and the Good of the Patient -- The Foundation of Medical Ethics in the Democratic Evolution of Modern Society -- A Communitarian Approach to Clinical Bioethics -- A Hermeneutical Approach to Clinical Bioethics -- A Deliberative Approach to Clinical Bioethics -- PART 2. TOWARD CLINICAL BIOETHICS INTEGRATING "INTERNAL MORALITY" AND "EXTERNAL MORALITY" -- "A Helping and Caring Profession": Medicine as a Normative Practice -- PART 2.1. THE GOALS OF MEDICINE IN RELATION TO THE SUBJECTIVISATION OF HEALTH AND RATIONALISATION OF HEALTH CARE INSTITUTIONS -- Medicine as a Practice and the Ethics of Illness -- The Right to Choose One's Health -- The Tension between Ethics and Evidence-based Medicine -- Maintaining Integrity in Times of Scarse Resources -- PART 2.2. BIOETHICAL JUDGMENT: EPISTEMOLOGICAL STATUTE AND INSTITUTIONAL CONTEXT -- For an Ethical Function in Hospitals -- The Ethical Function in the Health Care Institutions: Clinical Ethics Committees.
- Format
- e-Book
- Location
- Online
Clinical Medical Ethics : Landmark Works of Mark Siegler, MD
https://libcat.nshealth.ca/en/permalink/provcat41735
Laura Weiss Roberts, Mark Siegler, editors.
--Cham:
Springer
, 2017.
- Available Online
- View e-Book
- Location
- Online
This instant gold standard title is a major contribution to the field of clinical medical ethics and will be used widely for reference and teaching purposes for years to come. Throughout his career, Mark Siegler, MD, has written on topics ranging from the teaching of clinical medical ethics to end-of-life decision-making and the ethics of advances in technology. With more than 200 journal publications and 60 book chapters published in this area over the course of his illustrious career, Dr. Sie…
- Available Online
- View e-Book
- Other Authors
- Roberts, Laura Weiss
- Siegler, Mark
- Responsibility
- Laura Weiss Roberts, Mark Siegler, editors
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- 2017
- Physical Description
- 1 online resource (xvii, 419 pages) : 17 illus., 8 illus. in color
- ISBN
- 9783319538754
- 9783319538730 (print ed.)
- Subjects (MeSH)
- Ethics, Medical
- Ethics, Clinical
- Abstract
- This instant gold standard title is a major contribution to the field of clinical medical ethics and will be used widely for reference and teaching purposes for years to come. Throughout his career, Mark Siegler, MD, has written on topics ranging from the teaching of clinical medical ethics to end-of-life decision-making and the ethics of advances in technology. With more than 200 journal publications and 60 book chapters published in this area over the course of his illustrious career, Dr. Siegler has become the pre-eminent scholar and teacher in the field. Indeed his work has had a profound impact on a range of therapeutic areas, especially internal medicine, pediatrics, surgery, oncology, and medical education. Having grown steadily in importance the last 30 years, clinical ethics examines the practical, everyday ethical issues that arise in encounters among patients, doctors, nurses, allied health workers, and health care institutions. The goal of clinical ethics is to improve patient care and patient outcomes, and almost every large hospital now has an ethics committee or ethics consultation service to help resolve clinical ethical problems; and almost every medical organization now has an ethics committee and code of ethics. Most significantly, clinical ethics discussions have become a part of the routine clinical discourse that occurs in outpatient and inpatient clinical settings across the country. This seminal collection of 46 landmark works written by Dr. Siegler with colleagues throughout his career was edited by Dr. Laura Weiss Roberts and by Dr. Siegler. Dr. Roberts is a prominent psychiatric ethicist and physician-scientist as well as a mentee and longtime collaborator of Dr. Siegler. The text is organized around five themes of foundational scholarship: restoring and transforming the ethical basis of modern clinical medicine, the doctor-patient relationship, education and professionalism, end-of-life care, and clinical innovation.With introductory perspectives by a group of renowned scholars in medicine, Clinical Medical Ethics: Landmark Works of Mark Siegler, MD explains the field authoritatively and comprehensively and will be of invaluable assistance to all clinicians and scholars concerned with clinical ethics. .
- Contents
- Part I -- Restoring and Transforming the Ethical Basis of Modern Clinical Medicine -- 1. An Introduction from Laura Weiss Roberts, M.D., M.A. -- 2. A Perspective from Mark Siegler, M.D. -- 3. A Perspective from Daniel P. Sulmasy, M.D., Ph.D. -- 4. A Perspective from Dana Levinson, M.P.H., Holly J. Humphrey, M.D., and Kenneth S. Polonsky, M.D. -- 5. A Perspective from Jordan J. Cohen, M.D. -- 6. A Perspective from Peter A. Singer, M.D. -- Part II Landmark Works on Clinical Medical Ethics by Mark Siegler, M.D. -- 7. Foundational Scholarship -- 7.1 Clinical ethics and clinical medicine (1979) -- 7.2 Decision-making strategy for clinical ethical problems in medicine (1982) -- 7.3 An ethics consultation service in a teaching hospital. Utilization and evaluation (1988) -- 7.4 Clinical medical ethics (1990) -- 7.5 Ethics committees and consultants (1990) -- 7.6 Future directions in clinical ethics (1991) -- 7.7 Clinical ethics (1991) -- 7.8 Clinical ethics in the practice of medicine (1996) -- 7.9 Five major themes in bioethics (1997) -- 7.10 The contributions of clinical ethics to patient care (1997) -- 8. The Doctor-Patient Relationship -- 8.1 Searching for moral certainty in medicine: a proposal for a new model of the doctor-patient encounter 1981) -- 8.2 Clinical intuition: a procedure for balancing the rights of patients and the responsibilities of physicians (1981) -- 8.3 The doctor-patient encounter and its relationship to theories of health and disease (1981) -- 8.4 The physician-patient accommodation: a central event in clinical medicine (1982) -- 8.5 Confidentiality in medicine: a decrepit concept (1982) -- 8.6 Medical consultations in the context of the physician-patient relationship (1982) -- 8.7 Metaphors and models of doctor-patient relationships: their implications for autonomy (1984) -- 8.8 The progression of medicine: from physician paternalism to patient autonomy to bureaucratic parsimony (1985) -- 8.9 Learning from our patients: one participants impact on clinical trial research and informed consent (1997) -- 8.10 The physician-surrogate relationship (2007) -- 9. Education and Professionalism -- 9.1 A legacy of Osler: teaching clinical ethics at the bedside (1978) -- 9.2 Basic curricular goals in medical ethics: the DeCamp conference on the teaching of medical ethics (1985) -- 9.3 Fellowship training programs in clinical ethics (1988) -- 9.4 Development of a teaching program in clinical medical ethics at the University of Chicago (1989) -- 9.5 Internal medicine residents' preferences regarding medical ethics education (1989) -- 9.6 Caring for medical students as patients (1990) -- 9.7 Teaching clinical ethics (1990) -- 9.8 Medical students as patients: a pilot study of their health care needs, practices, and concerns (1996) -- 9.9 What and how psychiatry residents at ten training programs wish to learn about ethics (1996) -- 9.10 Clinical ethics teaching in psychiatric supervision (1996) -- 9.11 Training doctors for professionalism: some lessons from teaching clinical medical ethics (2002) -- 10. End-of-Life Care -- 10.1 Pascal's wager and the hanging of crepe (1975) -- 10.2 Critical illness: the limits of autonomy (1977) -- 10.3 Brain death and live birth (1982) -- 10.4 Against the emerging stream: should fluids and nutritional support be discontinued? (1985) -- 10.5 Euthanasia: a critique (1990) -- 10.6 Elective use of life-sustaining treatments in internal medicine (1991) -- 10.7 Intimacy and caring: the legacy of Karen Ann Quinlan (1993) -- 10.8 The rise and fall of the futility movement (2000) -- 11. Clinical Innovation 11.1 Ethical issues in growth hormone therapy (1989) -- 11.2 Orthopedic surgeons' attitudes and practices concerning the treatment of patients with human immunosuppressive virus infection (1989) -- 11.3 Ethics of liver transplantation with living donors (1989) -- 11.4 Bone marrow transplantation for sickle cell disease; a study of parentsÇÖ decisions (1991) -- 11.5 Ethical justification for living liver donation (1992) -- 11.6 Transplantation of liver grafts from living donors into adults: too much, too soon (2001) -- 11.7 Elective surgical patients as living organ donors: a clinical and ethical innovation (2009) -- Appendix.
- Format
- e-Book
- Location
- Online
Clinical trials and human research : a practical guide to regulatory compliance
https://libcat.nshealth.ca/en/permalink/provcat22768
Rozovsky, Fay A.
--San Francisco, CA:
Jossey-Bass
, 2003.
- Call Number
- W 32.5 R893c 2003
- Location
- Dickson Building
- Call Number
- W 32.5 R893c 2003
- Author
- Rozovsky, Fay A.
- Other Authors
- Adams, Rodney K.
- Place of Publication
- San Francisco, CA
- Publisher
- Jossey-Bass
- Date of Publication
- 2003
- Physical Description
- 639 p.
- ISBN
- 0787965707
- Subjects (MeSH)
- Clinical Trials as Topic - legislation & jurisprudence
- Clinical Trials as Topic - standards
- Ethics Committees, Research
- Ethics, Research
- Human Experimentation - legislation & jurisprudence
- Human Experimentation - standards
- Other Subjects
- United States
- Format
- Book
- Location
- Dickson Building
- Loan Period
- 3 weeks
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
https://libcat.nshealth.ca/en/permalink/provcat31841
by Tom Brody.
(2nd ed.)
--Amsterdam, Netherlands:
Elsevier
, c2016.
- Available Online
- View e-Book
- Access
- Registration required for PDF access.
- Location
- Online
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous…
- Available Online
- View e-Book
- Author
- Brody, Tom
- Responsibility
- by Tom Brody
- Edition
- 2nd ed.
- Place of Publication
- Amsterdam, Netherlands
- Publisher
- Elsevier
- Date of Publication
- c2016
- Physical Description
- 1 online resource,
- ISBN
- 9780128042175
- Subjects (MeSH)
- Clinical Trials as Topic
- Clinical Trials Data Monitoring Committees
- Drug Approval
- Research Design
- Abstract
- Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
- Access
- Registration required for PDF access.
- Format
- e-Book
- Location
- Online
Clinical trials : study design, endpoints and biomarkers, drug safety, and FDA and ICH guidelines
https://libcat.nshealth.ca/en/permalink/provcat50526
Brody, Tom.
(2nd ed.)
--Philadelphia, PA:
Elsevier
, 2016.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Author
- Brody, Tom
- Edition
- 2nd ed.
- Place of Publication
- Philadelphia, PA
- Publisher
- Elsevier
- Date of Publication
- 2016
- ISBN
- 9780128042175
- Subjects (MeSH)
- Clinical Trials as Topic
- Clinical Trials Data Monitoring Committees
- Drug Approval
- Research Design
- Notes
- Access to this online resource is restricted to IWK Health Centre employees working from inside the hospital network.
- Format
- e-Book
- Location
- Online
The CRA's guide to monitoring clinical research
https://libcat.nshealth.ca/en/permalink/provcat22643
Woodin, Karen E.
--Boston, MA:
Thomson CenterWatch
, 2003.
- Call Number
- W 20.5 W891c 2003
- Location
- Halifax Infirmary
- Dickson Building
- Call Number
- W 20.5 W891c 2003
- Author
- Woodin, Karen E.
- Other Authors
- Schneider, John C.
- Place of Publication
- Boston, MA
- Publisher
- Thomson CenterWatch
- Date of Publication
- 2003
- Physical Description
- 448 p.
- ISBN
- 1930624379
- Subjects (MeSH)
- Clinical Trials as Topic - standards
- Clinical Trials Data Monitoring Committees
- Drug Approval - organization & administration
- Ethics, Research
- Guideline Adherence
- Research Design
- Research Support as Topic - organization & administration
- Format
- Book
- Location
- Halifax Infirmary
- Dickson Building
- Copies
- 2
- Loan Period
- 3 weeks
Data monitoring in clinical trials : a case studies approach
https://libcat.nshealth.ca/en/permalink/provcat22357
DeMets, David L.
--New York, NY:
Springer
, 2006.
- Call Number
- W 20.5 D232 2006
- Location
- Halifax Infirmary
- Call Number
- W 20.5 D232 2006
- Author
- DeMets, David L.
- Other Authors
- Furberg, Curt D.
- Friedman, Lawrence M.
- Place of Publication
- New York, NY
- Publisher
- Springer
- Date of Publication
- 2006
- Physical Description
- 374 p.
- ISBN
- 0387203303
- 9780387203300
- Subjects (MeSH)
- Biomedical Research - standards
- Clinical Trials Data Monitoring Committees
- Randomized Controlled Trials as Topic
- Format
- Book
- Location
- Halifax Infirmary
- Loan Period
- 3 weeks
Diagnostic and statistical manual of mental disorders
https://libcat.nshealth.ca/en/permalink/provcat53200
Prepared by the Task Force on DSM-IV and other committees and work groups of the American Psychiatric Association.
(4th ed. Text Revision)
--Washington, DC:
American Psychiatric Association
, 2000.
- Call Number
- WM 100 D536 2000
- Location
- IWK Health Sciences Library
- Call Number
- WM 100 D536 2000
- Corporate Author
- American Psychiatric Association
- Responsibility
- Prepared by the Task Force on DSM-IV and other committees and work groups of the American Psychiatric Association
- Edition
- 4th ed. Text Revision
- Alternate Title
- DSM-IV-TR
- Place of Publication
- Washington, DC
- Publisher
- American Psychiatric Association
- Date of Publication
- 2000
- Physical Description
- 943 p.
- ISBN
- 890420254
- Subjects (MeSH)
- Mental Disorders - classification
- Mental Disorders - diagnosis
- Psychiatry
- Format
- Book
- Publication Type
- Terminology
- Location
- IWK Health Sciences Library
- Copies
- 1
- Loan Period
- 2 weeks
Equitable Access to Human Biological Resources in Developing Countries : Benefit Sharing Without Undue Inducement
https://libcat.nshealth.ca/en/permalink/provcat39811
Roger Scarlin Chennells.
--Cham:
Springer
, c2016.
- Available Online
- View e-Book
- Location
- Online
The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biolo…
- Available Online
- View e-Book
- Author
- Chennells, Roger Scarlin
- Responsibility
- Roger Scarlin Chennells
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- c2016
- Physical Description
- 1 online resource (xix, 197 p.)
- ISBN
- 9783319197258
- 9783319197241 (print ed.)
- Subjects (MeSH)
- Bioethics
- Developing Countries
- Genetic Research - ethics
- Global Health - ethics
- Health Equity
- Healthcare Disparities
- Abstract
- The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research; With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials); Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement.
- Contents
- Introduction -- Exploitation -- Common Heritage of Humankind -- The Altruism Argument -- The "No Value Added" Argument -- Justice and Exploitation in Bilateral Exchanges -- Undue Inducement and Coercion -- Risks to Indigenous Peoples as Vulnerable Population -- Closing Chapter -- List of Legal Cases.
- Format
- e-Book
- Location
- Online
Ethics in health services management
https://libcat.nshealth.ca/en/permalink/provcat53315
Darr, Kurt.
(3rd ed.)
--Baltimore, MD:
Health Professions Press
, 1997.
- Call Number
- W 84.1 D225E 1997
- Location
- IWK Health Sciences Library
- Call Number
- W 84.1 D225E 1997
- Author
- Darr, Kurt
- Edition
- 3rd ed.
- Place of Publication
- Baltimore, MD
- Publisher
- Health Professions Press
- Date of Publication
- 1997
- Physical Description
- 310 p.
- ISBN
- 187881236X
- Format
- Book
- Location
- IWK Health Sciences Library
- Copies
- 1
- Loan Period
- 2 weeks
Ethics in psychiatry : European contributions
https://libcat.nshealth.ca/en/permalink/provcat40976
Hanfried Helmchen, Norman Sartorius, editors.
--Dordrecht:
Springer
, c2010.
- Available Online
- View e-Book
- Location
- Online
- Available Online
- View e-Book
- Other Authors
- Helmchen, H (Hanfried)
- Sartorius, N
- Responsibility
- Hanfried Helmchen, Norman Sartorius, editors
- Place of Publication
- Dordrecht
- Publisher
- Springer
- Date of Publication
- c2010
- Physical Description
- 1 online resource (xviii, 573 p.)
- Series Vol.
- 45
- ISBN
- 9789048187218
- 9789048187201 (print ed.)
- Subjects (MeSH)
- Bioethical Issues
- Patient Rights
- Psychiatry - ethics
- Contents
- Part I. The Context -- 1. Societal Framework of Psychiatry -- 2. Stigmatisation of People with Mental Illness and of Psychiatric Institutions -- 3. Economical Framework of Psychiatric Care -- 4. Conflicts of Interest -- 5. Between Legislation and Bioethics: The European Convention on Human Rights and Biomedicine -- 6. Ethics Committees for Clinical Research – The West-European Paradigm -- 7. Clinical Ethics Committees and Ethics Consultation in Psychiatry -- Part II. Principles of Ethics in Psychiatry -- 8. Ethical Principles in Psychiatry: The Declarations of Hawaii and Madrid -- 9. Informed Consent in Psychiatric Practice -- 10. Advance Directives: Balancing Patient’s Self-Determination with Professional Paternalism -- 11. Confidentiality -- 12. Justice in Access to and Distribution of Resources in Psychiatry and Mental Health Care -- Part III. The Applications of the Ethical Principles in Psychiatric Practice and Research -- 13. Ethics of Diagnosis and Classification in Psychiatry -- 14. Competence Assessment -- 15. General Overview of Ethical Issues in Psychiatric Treatment -- 16. Prevention and Early Treatment -- 17. Ethical Implications of Psychopharmacotherapy -- 18. Ethical Problems in Psychotherapy -- 19. Neuromodulation – ECT, rTMS, DBS -- 20. ‘Coercive’ Measures -- 21. Ethics of Deinstitutionalization -- 22. Ethical Issues in Forensic and Prison Psychiatry -- 23. Treatment of Substance Dependence -- 24. Dementia and End-of-Life Decisions: Ethical Issues – A Perspective from The Netherlands -- 25. Ethics of Research with Decisionally Impaired Patients -- 26. Ethical Concerns in Carrying Out Surveys of Psychiatric Morbidity -- 27. Genetics – Ethical Implications of Research, Diagnostics and Counseling -- Part IV. Non-medical Uses of Psychiatry -- 28. Political Abuse of Psychiatry -- 29. Abuse of Psychiatry for Political Purposes in the USSR: A Case-Study and Personal Account of the Efforts to Bring Them to an End -- 30. (Neuro-)Enhancement -- Part V. Teaching Ethics in Psychiatry -- 31. Teaching Ethics in Psychiatry -- Part VI. Conclusions and Summary -- 32. Summary and Conclusions.
- Format
- e-Book
- Location
- Online
Ethics, Law and Governance of Biobanking : National, European and International Approaches
https://libcat.nshealth.ca/en/permalink/provcat39547
Deborah Mascalzoni, editor.
--Dordrecht:
Springer Netherlands
, c2015.
- Available Online
- View e-Book
- Location
- Online
Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate,…
- Available Online
- View e-Book
- Other Authors
- Mascalzoni, Deborah
- Responsibility
- Deborah Mascalzoni, editor
- Place of Publication
- Dordrecht
- Publisher
- Springer Netherlands
- Date of Publication
- c2015
- Physical Description
- 1 online resource (viii, 277 p.)
- Series Vol.
- 14
- ISBN
- 9789401795739
- 9789401795722 (print ed.)
- ISSN
- 1875-0044
- Subjects (MeSH)
- Biological Specimen Banks - ethics
- Biological Specimen Banks - legislation & jurisprudence
- Genetic Privacy - standards
- Genetic Research - ethics
- Health Policy
- Internationality
- Abstract
- Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks.Then how do we regulate it? This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent? An underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn't only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.
- Contents
- Ethics Law and Governance of Biobanking: A Very Complex Normative Puzzle -- Biobanks: A Definition -- A Participatory Space Beyond the “Autonomy Versus Property” Dichotomy -- Intellectual Property and Biobanks -- Consent, Privacy and Property in the Italian Biobanks Regulation: A Hybrid Model Within EU? -- Data Protection Principles and Research in the Biobanks Age -- The New General Data Protection Regulation—Where Are We and Where Might We Be Heading? -- The Tension Between Data Sharing and the Protection of Privacy in Genomics Research -- Incidental Findings: The Time Is not yet Ripe for a Policy for Biobanks -- Biobanking Across Borders: The Challenges of Harmonisation -- Governing Biobanks Through a European Infrastructure -- EU Governance for Research and Ethics in Biobanks -- A Bold Experiment: Iceland’s Genomic Venture -- The Estonian Genome Center, University of Tartu -- Management of the Ethical Aspects of a Local Mental Diseases Biobank for Research Purposes: The Italian Experience -- Biobank Governance in Spain: From the Autonomy of Research Ethics Committees to the Autonomy of Lay People -- Public Deliberation and the Role of Stakeholders as a New Frontier in the Governance of Science: The British Columbia Biobank Deliberation and the DePGx Project -- Making Researchers Moral.
- Format
- e-Book
- Location
- Online
Ethics of Innovation in Neurosurgery
https://libcat.nshealth.ca/en/permalink/provcat44164
Marike L. D. Broekman, editor.
--Cham:
Springer
, 2019.
- Available Online
- View e-Book
- Location
- Online
This book covers all ethical aspects of introducing novel implants and procedures in neurosurgery in a structured way, addressing the current knowledge gap concerning ethical innovations in neurosurgery. Initially it explores the difficulties involved in defining when a procedure should be considered innovation, research, or care. To this end, it presents not only an overview of current literature, but also data from a recent survey among neurosurgeons in Europe. The book subsequently discusses…
- Available Online
- View e-Book
- Other Authors
- Broekman, Marike L. D.
- Responsibility
- Marike L. D. Broekman, editor
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- 2019
- Physical Description
- 1 online resource (xviii, 167 p.) : 1 illus.
- ISBN
- 9783030055028
- 9783030055011 (Print ed.)
- 9783030055035 (Print ed.)
- Subjects (MeSH)
- Ethics, Clinical
- Neurosurgery - ethics
- Neurosurgical Procedures - ethics
- Specialty
- Neurosurgery
- Abstract
- This book covers all ethical aspects of introducing novel implants and procedures in neurosurgery in a structured way, addressing the current knowledge gap concerning ethical innovations in neurosurgery. Initially it explores the difficulties involved in defining when a procedure should be considered innovation, research, or care. To this end, it presents not only an overview of current literature, but also data from a recent survey among neurosurgeons in Europe. The book subsequently discusses the ethical issues related to innovation. These include: informed consent (what should a surgeon tell the patient and how should he/she do so), oversight (can any surgeon simply implant a novel spinal device?), the learning curve (when should a surgeon be allowed to perform a novel procedure?), vulnerable patients (how to innovate in the pediatric population or in an emergency setting), and conflicts of interest, as well as the ethics of paying for innovative treatments. In turn, the closing chapters focus on the evaluation of neurosurgical research and innovation. Are cultural changes necessary and how could innovation benefit from (international) collaborations? Given the range of topics addressed, the book offers neurosurgeons, residents, scientists, companies and hospital administrations a valuable guide to introducing novel implants and techniques in neurosurgery.
- Contents
- Part I. Innovation in Neurosurgery: Key Ethical Challenges -- 1. Defining Innovation in Neurosurgery: Challenges and Implications -- 2. Informed Consent for Neurosurgical Innovation -- 3. Ethical Challenges of Current Oversight and Regulation of Novel Medical Devices in Neurosurgery -- 4. Ethics of Neurosurgical Innovation: Oversight and Regulation -- 5. The Ethics of the Learning Curve in Innovative Neurosurgery -- 6. Innovation in Pediatric Neurosurgery: The Ethical Agenda -- 7. Conflict of Interest in Neurosurgical Innovation -- Part II. Payment for and Right to Innovation in Neurosurgery -- 8. The Ethics of Funding Innovation: Who Should Pay? -- 9. Public Pressure for Neurosurgical Innovation -- 10. Surgical Innovation for Terminal Illnesses: Do Patients have a Right to Access Innovative Treatments? -- 11. Ethics Committees, Innovative Surgery, and Organizational Ethics -- Part III. Evaluation of Innovations in Neurosurgery -- 12. Evaluating Awake Craniotomies in Glioma Patients: Meeting the Challenge -- 13. Ethical Considerations of Neuro-Oncology Trial Design in the Era of Precision Medicine -- 14. The Ethics of Passive Data and Digital Phenotyping in Neurosurgery -- 15. Research Ethics: When Innovation is Clearly Research -- Part IV. Innovation in Neurosurgery: Required Culture and Team Collaboration. 16. Innovation and Team Collaboration in Neurosurgery -- 17. Culture and Attitudes Supporting Ethical Innovation in Neurosurgery -- 18. Perspective: Future of Innovation in Neurosurgery.
- Format
- e-Book
- Location
- Online
The FDA for Doctors
https://libcat.nshealth.ca/en/permalink/provcat39622
William H. Eaglstein.
--Cham:
Springer
, c2014.
- Available Online
- View e-Book
- Location
- Online
This book explains the Food and Drug Administration (FDA) as an institution and provides understanding of its nomenclature, societal role, policies, goals and challenges. While many readers will have some knowledge of the FDA, few have an appreciation of the many specific areas of FDA authority. For example, how many realize that the US is one of only two countries which allow direct-to-consumer drug advertising, which is regulated by FDA? Or that FDA itself advertises to try to prevent young p…
- Available Online
- View e-Book
- Author
- Eaglstein, William H
- Responsibility
- William H. Eaglstein
- Place of Publication
- Cham
- Publisher
- Springer
- Date of Publication
- c2014
- Physical Description
- 1 online resource (xi, 97 p. : 1 illus. in color)
- ISBN
- 9783319083629
- 9783319083612 (print ed.)
- Subjects (MeSH)
- Biological Products - standards
- Device Approval
- Drug Approval
- Government Regulation
- United States Government Agencies
- Other Subjects
- United States. Food and Drug Administration
- Other Subjects
- United States
- Abstract
- This book explains the Food and Drug Administration (FDA) as an institution and provides understanding of its nomenclature, societal role, policies, goals and challenges. While many readers will have some knowledge of the FDA, few have an appreciation of the many specific areas of FDA authority. For example, how many realize that the US is one of only two countries which allow direct-to-consumer drug advertising, which is regulated by FDA? Or that FDA itself advertises to try to prevent young people from smoking cigarettes, and that all proprietary drug names must be approved by FDA? How many doctors or other readers are familiar with the formal definition distinguishing drugs from devices and the importance this has for development costs and for our knowledge about the ultimate products? How many know how much nutritional supplements are regulated by FDA? The FDA for Doctors is not for those looking for detailed instruction on dealing with the FDA or its operations. Rather, it is written by a doctor with doctors in mind, with the hope that the information in this book will make physicians, and other readers, more thoughtful and insightful, especially with regards to therapeutics and the many broad societal issues underlying FDA's activities. With over 40 years of experience as a clinical investigator in many trials done for FDA registration, the author has been a member of and chaired an FDA advisory committee, and has been a consultant to several divisions of the FDA. He has also had the opportunity to serve on the U.S. Senate Labor Committee, helping with its FDA oversight activities. In addition to a long academic medical career the author has been a consultant to and a full time employee of drug and device companies.
- Contents
- 1. Doctors and the FDA -- 2. What Are Drugs? -- 3. What Are Devices? -- 4. What Are Biologics, Biological Products and Biological Drugs? -- 5. What Are Combination Products -- 6. What Are Dietary Supplements and Nutraceuticals? -- 7. What Are Cosmetics and Cosmeceuticals? -- 8. What Is the FDA and What Does It Do? -- 9. Foods, Doctors and the FDA -- 10. The FDA Approval Process and Drug Development -- 11. The New Drug Application (NDA), the Investigative New Drug Exemption (IND) and the General Drug Approval Pathway -- 12. FDA and Tobacco Products -- 13. FDA Advisory Committees -- 14. FDA, Labels and Labeling for Medical Products -- 15. FDA and Product Names -- 16. FDA and Promotion and Advertising -- 17. Off-Label Use -- 18. Additional Drug Approval Pathways and Expanded Access (Treatment INDs); and Personal Importation of Unapproved Drugs -- 1.9 FDA Exclusivity and Patents -- 20. Adverse Event Reporting, Pharmacovigilance and FDA -- 21. FDA Rule Making and Guidances -- 22. Enforcement and Warning Letters -- 23. The FDA, Politics and Criticism -- 24. Brief History of the FDA.
- Format
- e-Book
- Location
- Online
