Legal Responses to Scientific & Technological Development

Role of Law in Organization of S&T Ent. S&T enterprise is a means for the achievement of a country’s prosperity. Post WW II the USA economy grew on the back of advances in S&T What can Government do to support S&T? Support to be given to small business and not only big business -Small time Kenyan inventors National Machining Complex -Nyayo Car? Should STEM education be encouraged? Ref to the following articles: -“S&T Enterprise: The Right Tools for Prosperity?” -“Would Genetically Modified Salmon get FDA Approval?”

The Need for Self Regulation What is self regulation? Regulation within the profession, industry, by peers, by researchers -Moral turpitude -Create own rules compliance set up Soft law : Non-binding norms produced by law making bodies -Argued that they might serve better the needs & purposes of science than legislative modes of top-down, hierarchical-based authority of the State Soft law preferred because of : -Uncertainties in rapidly developing technological/scientific fields -Social uncertainty & controversy in sensitive areas -Lack of agreement among Governments Argued that combination of soft law and self regulation responds easily to pressure to open up policy making arising from public discomfort with particular scientific & technological developments Lack of a binding force is what distinguishes soft from hard law Hard law required in order to compel compliance Hard law facilitates Government funding and direct support v

Moral, Ethical & Experimental Concerns Experiments often result in pain, or reduction of quality of life on the test subjects -If its morally wrong to cause animals to suffer then experimenting on them leads to severe moral problems -Dr. Jay Vacanti in 1997 grew an ear on the back of a mouse Arguments in favour of animal experiments: -Acceptable if experiments are made as humane as possible -Acceptable if it will lead to significant human benefits? Arguments against such experiments: -Causes suffering -Benefits to humans not proven -Benefits to humans can be produced in other ways! Principal of the thee R’s -Reduction -Refinement -Replacement

Cont… Should oysters, viruses & bacteria be the subject of ethical questions? Consider the article on Animal Testing & Ethics by Claire Andre and Manuel Velasquez.

Clinical Trials & Experimentation Clinical trials are research studies that test how well new medical approaches work in people. Clinical tests in medical research & drug development that generate safety & efficacy of data Conducted only after satisfactory information has been gathered on quality of non-clinical safety & health/ethical approvals granted Cost of trials often met by sponsor (government agency, pharmaceutical, bio-tech or medical device company. Trials often compare at least two or more medications/devices What is the integrity of the clinical research process? What about the safety of those who participate in clinical trials? Public trust in the integrity is critical for funding and participation in trials but more importantly for confidence in treatments resulting from such trials -Ref. Oversight of Clinical Research American Society of Clinical Oncology Policy Statement

Cont… Informed consent in clinical trials to be improved Science should never transform or consider humans as instruments to be merely employed for scientific purposes (US originated informed consent) Participation of patients should be informed and voluntary -Patients consent lies within the context of illness of the doctor/patient relationship -Unlikely that patient’s consent is free from substantial influences, which may be controlling or not depending on the situation -Proposed categories of consent: voluntary, involuntary, coerced, enforced, & partially voluntary