8: Ethics in human research

What are the 3 laws/regulations on human research

Declaration of helsinki

National Regulatory Authorities

Institutional Review Board

World Medical Association Declaration of Helsinki

statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data

General principles of WMA DoH

health and well being of patient is first consideration

physician must commit to primacy of patient health and offer care in their best interest

medical research is subject to ethical standards that ensure respect for all participants and protect their health

primary purpose of medical research is to understand the causes, development and effects of diseases; improve preventive, diagnostic and therapeutic interventions

Risks, burdens and benefits

research only conducted if importance of objective outweighs risk and burdens

physicians must be confident that risks and burdens are adequately assessed and can be satisfactorily managed

Individual, group and community vulnerability

those with health needs should be researched on

participants should receive specifically considered support and protections

Scientific requirements and research protocols

have scientifically sound and rigorous design to produce reliable knowledge and avoid research waste

welfare of animals used must be respected

protocol should contain statement of ethical considerations and should indicate how principles in this declaration have been addressed

this should include aims, method, benefits, risks and burdens, qualifications of researcher, sources of funding, conflicts of interest, etcc

Research ethics committees

protocol must be submitted and approved to concerned EC

if research is collaborated internationally, protocol must be approved by EC in both sponsoring and host countries

Privacy and confidentiality

every precaution must be taken to protect privacy of research participants and confidentiality of their personal information

Free and informed consent

component of respect for individual autonomy

participants must be voluntary

participants have right to refure or withdraw at any time without reprisal

National Regulatory Authorities

National Research Council of Thailand

NRCT

IRB

items for review and rank by appropriate, inappropriate and not applicable

protocols like research validity, research value, inclusion criteria, risk, benefits, vulnerability

IRB informed consent

treating health care provider discloses appropriate information to a competent patient so that the patient may make a voluntary choice to accept or refuse treatment

What is clinical study?

research under human volunteers intended to add to medical knowledge

either for treatment, diagnosis or prevention of diseases

Types of clinical study

clinical trials/interventional studies

observational studies

Common drug development timeline

research and development, 3-6 years, target identification, compound screening, lead identification

preclinical studies, 1 year, in vitro studies, pharmacological, kinetic and toxicity testing, mechanistic evidence

clinical trials, 4-7 years, phase 1; small group, phase 2; larger group, phase 3; wide demographic and assess long term affects

review and approval, 1-2 years, safety evalutaion, applications, post release monitory, phase 4; additional risk-benefit analysis

market and sales

What is pre clinical study

exploratory study involving very limited human exposure to the drug, with no therapeutic or diagnostic goals

screening studies, microdose studies

What is clinical trials

may compare a new medical approach to; standard one already available, placebo with no active ingredients, no intervention

trials used in drug development are called phase defined by FDA

Phase 1 of clinical trials

conducted with healthy volunteers and emphasize on safety

goal to find out what the drug’s most serious events, metabolized, excreted

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Phase 2 of clinical trials

gather preliminary data on effectiveness (whether drug works on those with certain diseases)

participants who received drug compared to similar participants receiving different treatment (usually placebo or different drug)

safety is evaluated and short term adverse events

Phase 3 of clinical trials

gather more information on safety and effectiveness

study with different populations and different dosages and by using drugs with other drugs

phase 4 of clinical trials

studies continue after FDA approved a drug for marketing

gather more information about drugs safety, efficacy and optimal use