Скачать или смотреть Basic course in biomedical research-Assignment 7

Ethics
1. 1947, Nuremberg Code  Research risk benefit analysis, competence of investigators and voluntary consent in research; Nuremberg trial and Doctors trial
2. 1964, Helsinki Declaration  Individual rights to make informed decisions, investigators’ duties, research participants’ welfare, vulnerability
3. 1978-79, Belmont report  Autonomy, justice and beneficence, informed consent and review by ethics committee; Tuskegee syphilis study
4. 1992-93, CIOMS guidelines [Council for International organizations on Medical Sciences and WHO]  ADRs and safety of research participants, benefit-risk balance, need and principles of pharmacovigilance, make informed decisions (i.e., informed consent and respect for autonomy), duties and responsibilities of investigators, welfare and protection of vulnerable research participants
5. 1996, ICH [International Council on Harmonization]  Good Clinical practices
6. ICMR guidelines  2000
Ethical principles
1. Autonomy  “self-rule”; respecting human dignity
2. Justice  Fair and impartial
3. Beneficence  Fair and correct; maximizing benefits and minimizing risk/harm
4. Non-maleficence  “First, do no harm”; wrong to waste resources
Genetic research on human subjects requires
1. ‘National Ethical Guidelines for Biomedical and Health Research Involving Human Participants; ICMR, 2017’
2. ‘Genome policy and Genetic research (2000)’.
March 2019 CDSCO Gazette notification under ‘THIRD SCHEDULE (Conducting clinical trial) mentions about audio-video recording of consent as follows: vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity; clinical trial of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process of individual subject.
Novelty of research  Not typically within the scope of ethical review. Novelty pertains more to scientific merit or publication potential, which is the concern of funding bodies or scientific peer reviewers, not ethics committees.
Sponsor of the study  Not typically a stakeholder in the informed consent process
Scientific review committees
1. Novelty, scientific rationality, and importance
2. Soundness of the study design
3. Evaluation of pre-clinical data
AE  Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, does not necessarily have a causal relationship with this treatment.
ADR  Causality present
Serious AE  Serious adverse event means an untoward medical occurrence during clinical trial resulting in death or permanent disability, or hospitalization of the trial subject where the trial subject is an outdoor patient or a healthy person, prolongation of hospitalization where the trial subject is an indoor-patient, persistent or significant disability or incapacity, congenital anomaly, birth defect or life threatening event.
Scopes monkey trial  Teaching of evolution in schools and is unrelated to research ethics.
Review
1. Scientific  ISAC, ICMR (Is research Q sound ?)
2. Ethical  IEC, C/NEC (safety & welfare of research particip. protected ?)
3. Regulatory  DCGI, Genetic Eng. AC, Health Ministry SC (research methods appropriate ?)
IECs protect the rights, safety, dignity, and well-being of human participants involved in research. This includes:
1. Ensuring that adequate provisions are in place for participant safety, care, and support.
2. Reviewing the informed consent process.
3. Evaluating risk-benefit ratios.
4. Safeguarding vulnerable populations.
“Data and Safety monitoring board - DSMB”
Institutions that undertake research will have an Institutional EC.
Independent ECs (Ind EC)  Function outside institutions can be used by researchers who have no institutional attachments.
Scientific Advisory Committee (SAC)  scientific validity, design, feasibility, and methodology. Not typically involved in real-time safety monitoring or AE reporting.
Health Ministry Screening Committee (HMSC) in India is responsible for regulatory oversight of international collaborative research projects, especially those receiving foreign funding.
Reimbursement  Paying back of the actual expenditure direct as well as indirect (time loss) incurred by the subject for participating in the study. given without damages also.
Compensation  Payment for loss or suffering due to adverse event