This course aims to sensitize members of ethics committees, researchers, students on the ethical principles of research ethics in humans, essentially in the context of public health research and implementation trials. Real time videos will provide situations and examples of challenging situations which are common in every day research and practice. Much of the course will be taught using a case method approach and participants will have an opportunity to work through a number of ethical dilemmas in a variety of situations. The focus would be more related to public health research and implementation research. New ! - “Covid related ICMR ethics guidelines; ICMR _SOPs for Ethics review during Covid Pandemic, WHOs- Ethics acceptability of Covid-19 human challenge studies, and CDSCO New drugs and clinical trials regulations 2019.
New ! - “Covid related ICMR ethics guidelines; ICMR _SOPs for Ethics review during Covid Pandemic, WHOs- Ethics acceptability of Covid-19 human challenge studies, and CDSCO New drugs and clinical trials regulations 2019.COURSE DESIGN & DURATION
The course is designed as a three month computer based eLearning program, largely self-taught, complimented with online lectures, video films and online study material. English would be the language of instruction.
ELIGIBILITY The course is open to the following candidates:
Members of ethics committees, investigators, doctors, and public health researchers; graduates from medicine or other health sciences (dentists, physiotherapists, nurses, pharmacists etc.), who would be getting into research with humans; Medical doctors desirous to do their dissertation for their MD, MS, McH, DNB, DM. Even doctors, nurses, dentists, physiotherapists who intend to get only into clinical practice would benefit from it as they would be able to assess the ethics of any research article which they read. The course is suggested for all MBBS graduates, those doing post graduation in any medical field (DNB, MD, MS, DM, McH, MDS) and also young researchers embarking into research, research associates, research fellows, project directors, research officers, field workers, and research coordinators. All personnel indulging in research would benefit.
Eligible candidates would be screened based on their application and statement of purpose by the selection committee.Decision made by the selection committee would be final
The course contents includes an introduction and sensitization to the following : Principles of research ethics in humans and the history of ethics, ethics of placebo trials and clinical equipoise, privacy and confidentiality, informed consent, conflict of interest, ethical issues in community based research, standards of care, ethics in qualitative research, publication ethics, Institutional Review Boards (IRBs) also known as Institutional Ethics Committees (IECs) - objectives, constitution, roles, responsibilities, review process, sensitization to government of India regulations, GCP and IC-GCP, safety reporting time lines, compensation and post-trial access, audits, regulatory requirements of clinical trials research; and sensitization to some of the ethical issues involving marginalized populations. We have added ICMR guidelines related to the Covid pandemic, Covid related studies and WHO guidelines 2020.
TEACHING & COURSE DELIVERY METHODOLOGY
The course will be delivered in the hybrid / blended eLearning mode i.e. through a combination of online lectures, live interactive sessions, interactive discussion board and recommended readings from journal articles/ links.
EVALUATION Students will be evaluated through online exam in the form of MCQs and participation in live interactive session.
- Duration: 3 Months
- Brochure: Download
- Program Fee: Indian: 9000 INR , South Asian Candidates : SAARC states "Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan and Sri Lanka".150 USD , Other International Candidates: 330 USD
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