Ethical and legal issues in research involving human subjects: do you want a piece of me?

Abstract

The conduct of biomedical research involving the participation of human beings implicates a variety of ethical concerns pertaining to such values as dignity, bodily integrity, autonomy, and privacy. These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality. A topic of particular interest for pathologists is the handling of human tissue specimens that may be used for present, or stored for future, research purposes. This article examines the ethical and legal ramifications of obtaining and storing tissue samples for research purposes, with special attention to the issues of informed consent and confidentiality.

The Ethics of Research Biobanking: A Critical Review of the Literature

“…But despite the heterogeneity of the problems debated, informed consent once more became a key element of the "solutions" considered when contemplating the "biobank problem" and the consent requirement was entrenched in law already in 1994 (Godard et al, 2003). The plethora of new laws and circulars, nationally and internationally, has caused considerable confusion and has given rise to a call for harmonization of the consent requirement (Bauer et al, 2004;Clayton, 2005 ;Kapp, 2006;Morente and Alonso, 2005). But as pointed out by Maschke and Murrey, it is rarely debated who should be invited to do the harmonization, whether harmonization is indeed feasible, and in whose interest such harmonization would be (Maschke and Murray, 2004).…”

Newborn screening programmes: Emerging biobanks?

“…The use of tissues such as newborn blood spots is considered critical for medical research advances including for example, identifying various biomarkers [58], validating drug discoveries or, isolating the impact of environmental contaminants [59]. Typically parents are not aware that the NBS are being stored [60,61] and the possibility of requesting to use dried blood spots for research was not mentioned in the educational materials provided to the parents.…”

What Happened to Research in Clinical Microbiology in the United States?

“…It is our belief that the IRB process has become progressively more complex, and it is viewed by many laboratorians to be overly burdensome. Much attention has been devoted to approaches and controversies regarding informed consent and confidentiality when obtaining and using human specimens in research protocols (2). This can be an impediment to conducting research.…”