title: The role of consent in medical research: breaking or building walls? A call for legislative reform.
abstract: Research has been integral to the practice of medicine for almost as long as the discipline has existed. Until fairly recently research used to be conducted on human subjects without mandatory requirement for their consent. However, over time medical research became associated with significant cruelty resulting in an outcry for regulation of research actives. This resulted in significant legislation in place for monitoring. Today it is mandatory to obtain consent from subjects before embarking on medical research, and indeed treatment. Its significant regulatory role notwithstanding, the issue of consent at times becomes a hindrance to research. This paper examines the issue of consent in relation to medical research in the context of present legislation. It lays out the background to medical research with respect to purpose, scope, standard protocol and related issues; it then addresses the issue of consent in various scenarios, highlighting problems and the need for legislative reform. It is maintained that while regulatory measures have brought a lot of sanity to medical research and the medical profession, some measures are building walls inhibitory to research activities. Research being integral to the development and growth of healthcare delivery, there is need for reformation of current medical law for balance between patient protectionism and progress in medical research for effective patient care.
authors.affiliation: Holistic Medicals Limited, 64 Birrell Gardens, Livingston, EH54 9LF, UK. yohanest@dangata.freeserve.co.uk
authors.forename: Yohanna Yanshiyi
authors.initials: YY
authors.lastname: Dangata
mesh_terms: D035843:Biomedical Research / Q000331:legislation & jurisprudence*; D003219:Confidentiality / Q000331:legislation & jurisprudence; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence*; D016743:Mental Competency / Q000331:legislation & jurisprudence; D033242:Minors / Q000331:legislation & jurisprudence