Ethical Issues in Global Health Research
Readings
- Potential benefits, limitations, and harms of clinical guidelines
"Over the past
decade, clinical guidelines have increasingly become a familiar part of
clinical practice. Every day, clinical
decisions at the bedside, rules of operation at hospitals and clinics,
and health spending by governments and insurers are being influenced by
guidelines..."
- Multi-center trials and subject eligibility: should local IRBs play a role? (download)
"While its
responsibilities to research subjects require the IRB to satisfy itself
that the trial as proposed is in all ethical and scientific aspects
acceptable, the fact that the multi-center trial has been designed
elsewhere and is offered locally as a package deal severely constrains
the ability of the local IRB to influence its design and management..."
- In loco parentis: minimal risk as an ethical threshold for research upon children (download)
"And within the
broad field of social ethics, bioethics in particular must focus upon
such responsibilities: to the very old and very young, those muted or
rendered incoherent by illness. Yet delineating the nature of that
responsibility has proven to be among the most vexing problems
bioethics has faced..."
- Demarcating research and treatment: a systematic approach for the analysis of the ethics of clinical research
"How should an
IRB understand research protocols that involve the evaluation of
standard therapy? Should all risks to which a research subject will be
exposed in the course of a study be counted as 'research risk,' or
should we only count as 'research risk' those risks which a subject
encounters solely because of research participation?"