skilldevelopment.cpe@lpu.co.in

What you'll learn

Description: This course is designed to: 1) Make the student, researcher and faculty more skill towards conducting ethical research by improving his/ her Knowledge for biomedical research. 2) Improve good documentation practice skills to meet regulatory and industry needs, 3) Research protocol designing and submission process. 4) Understating role and responsibility of key stakeholders involved 5) Understanding of ethical review process and responsible conduct of research Learning Outcome: 1) For better professional research conduct, 2) Better command on ethical procedure help effective communication in the corporate/ professional sphere, 3) Improve good documentation practice skills to meet regulatory and industry needs, 4) Research protocol designing and submission process. 5) Understating role and responsibility of key stakeholders involved 6) Understanding of ethical review process and responsible conduct of research

  • Various historical events and there time line like Nuremberg code, Belmont Report, thalidomide tragedy, Turkish syphilis study etc
  • Overview of ICH :Quality, Safety, Efficacy, Multidisciplinary Guidelines
  • General Principles of Biomedical Research as per ICMR 2017 Guidelines
  • Benefit-risk assessment: Categories of Risk, Informed consent process, Privacy and confidentiality, Payment for participation, Compensation for research-related harm Conflict of interest, Selection of vulnerable and special groups as research participants Community engagement, Post research access and benefit sharing
  • The scientist as a responsible member of society, Contemporary ethical issues in biomedical and health research, Sensitivity to societal and cultural impact of biomedical and health research, mentoring
  • Research study registration with CTRI
  • Ethical considerations in collaborative research Responsibilities of ethics committees, researchers and institutions International collaboration
  • Protocol design and submission process
  • Requirements for EC members: Composition, affiliations, qualifications, member specific roles and responsibilities of an EC Roles and responsibilities of the EC Submission and review procedures: Details of documents to be submitted for EC review Details of documents to be included in the protocol Types of review: Exemption from review, Expedited review, Full committee review Documents to be maintained by EC for record
  • Requisites Essential information for prospective research participants, Responsibility of researchers, Documentation of informed consent process, Electronic consent, Specific issues in Clinical trials: Waiver of consent, Re-consent or fresh consent, Special situations: Gatekeepers, Community consent, Consent from vulnerable groups, Consent for studies using deception

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Dr. Kanav Khera
Professor

Working as Professor, Dept of Pharmacy Practice with more than 17 years of experience in clinical research/biomedical ethics/evidence-based medicine, antibiotic stewardship programs, pharmacovigilance, drug safety, clinical trials, and outcome research. Dr Kanav Khera is also an associate member secretory of the Institutional Ethics Committee at School of Pharmaceutical Sciences, LPU. Dr Kanav Khera had vast experience in providing pharmaceutical care services in Tertiary care hospitals and handling medication errors and related problems. Had published more than 40 research papers in national and international journals and was invited as a guest speaker at various events. Dr Kanav Khera has been honoured with Best teacher and excellence in teaching awards and and also worked as Scientist 1 in a clinical research organization conducting clinical trials