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CTSA Institution

Washington University in St. Louis

Disclaimer Please cite the appropriate authors/contacts when using or adapting these materials.
Acknowledgment James M. DuBois, Ph.D., D.Sc.
Hubert Mäder Chair of Health Care Ethics
Department Chair and Bander Center Director
Department of Health Care Ethics, Saint Louis University
Washington University in St. Louis
Contacts James M. DuBois, Ph.D., D.Sc.
Format PDF
URL Download
Materials Provided PDF (34 Pages)
Title Ethical and Regulatory Issues in Clinical Research
Topics Description This detailed course syllabus covers all nine Responsible Conduct of Research (RCR) topics. Some topics are covered in great depth using a total of thirty-seven case reports to address ethics and integrity in conducting research. In addition, there is a reading list and a list of additional reading resources.
Keywords 45 CFR 46 Subpart D; Active Agent; Active-control Trials; Adolescents; Adverse Events; Advertising for Research Studies; Aggressive Behavior; Alzheimer’s Disease; Animal Model; Animals in Research; Announcement; Anthropometry; Authenticity of the Data; Authorship; Bench to Bedside; Biobanking Human Biological Materials; Bipolar Disorder; Blood Samples; Brain; Cell Lines; Centers for Disease Control and Prevention (CDC); Child Abuse; Child Maltreatment; Children; Cognitively Impaired; Collaborative Research; Community Research; Compliance; Conduct of Clinical Research; Confidentiality; Conflicts of Interest; Coping Strategies; Cost Burden to Study Participant; Data Access; Data Management; Decision-Making Capacity; Declaration of Helsinki; De-identified; Dementia; Dissent; DNA Samples; Donors; Drug Side Effects; Dual Responsibilities as Clinician and Investigator; Effective Treatment; Enrollment Fees to Clinical Research for Enrolling Patients; Ethical Decision-Making; Ethical Problem-solving Model in Clinical Research; Ethical Research on Animals; Ethics; Ethics in Epidemiology; Failed all Existing Therapies; FDA; Fetal Tissue; Financial Compensation; Financial Interests; Finder’s Fee; Food and Drug Administration (FDA); For-Profit Company; Free Health Care; Free Physical Exam; Gene Therapy; Genetic Mutation; Ghost Authorship; Gifts to Physicians from Industry; Health Insurance Portability and Accountability Act (HIPAA); High-risk Research; Historical Data; Human Research Protection Office; Human Tissue; Immune Suppression; Improve Parenting Skills; Influenza Vaccine; Informed Consent; Institutional Animal Care and Use Committee (IACUC); Institutional Review Board (IRB); International Team of Investigators; Intervention Programs; Investigation Device; Investigator; Lack of Economic and Psychosocial Factors; Leukemia; Life Expectancy; Limited Education; Lithium Treatment; Maximum Safe Dose; Medicines and Healthcare Products Regulatory Agency (MHRA); Mental Retardation; Mentally Ill; Mentoring; Neglect; Nerve Growth Factor (NGF); Neutral Primary Health Care Nurse; New Antipsychotic Drug; Newspaper; Non-disclosure; Nonfinancial Conflicts of Interest; Not Reporting Negative Data; Omitting Important Data; Oncology Trials; Outpatient Drug Treatment Programs; Parenting Stress Index; Parents; Parkinson’s Disease; Pediatric Research; Personal Identifiers; Phase I Clinical Trials; Placebo-controlled Trials; Poor Environment; Pre-Clinical Primate Studies; Predictors of Risk; Pregnant Women; Primary Care Provider; Primary Family Caregiver; Principal Investigator (PI); Protected Health Information (PHI); Protocol; Psychosis; Psychotropic; Quality Assurance Study; Radio; Randomized Double-blind Clinical Trial; Research Ethics and Compliance; Research in Developing Nations; Research Misconduct; Research Study that Generates a Profit in the R & D Phase; Residential Treatment Facility; Resource Sharing; Rheumatoid Arthritis; Risk-Benefits Ratio; Safeguards; Screening Questionnaires; Seizures; Serious Adverse Events; Sharing Data; Side Effects; Substance Abuse; Surrogates; Test Knowledge of Child Development; Therapeutic Misconception; Therapeutic Obligation; Tissue Bank; Tissue Collection and Storage Company; Two-arm Parallel Group Study; Underreporting Research; Vital Signs; Voluntary; Vulnerable Populations; Wash-out Period; World Health Organization
See Also

Topic Data Acquisition Management Sharing and Ownership, Conflicts of Interest and Commitment, Human Subjects, Animal Welfare, Research Misconduct, Publication Practices and Responsible Authorship, Mentor and Trainee Responsibilities, Peer Review, Collaborative Science, Course Syllabi, Reading List, Other
Topic revision: r3 - 30 Mar 2010 - 19:21:05 - MaryBanach
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