Biology Reference
In-Depth Information
developing country that has appropriate ethical guidelines and regulations in place,
but lacks proper implementation mechanisms to monitor misuse.
The potential for obtaining valuable information which may result in academic
laurels or commercial benefits is leading to increasing instances of biopiracy. Of
late, more and more instances are coming to light of guidelines being flouted by
researchers associated with foreign investigators who are funded by agencies that
in their own countries are required to adhere strictly to high ethical standards con-
cerning human research.
For instance, samples from two Indian tribes were subjected to genetic analysis
without permission being obtained from the local authorities concerned. This situ-
ation arose in relation to a study funded by the US National Institutes of Health,
the European Commission and the Estonian Medical Research Council and
published in the
American Journal of Human Genetics
(Kivisild et al.
2003
). It
listed 18 authors from seven institutions in six countries. It was not clear who had
given permission to collect the samples, nor was any Indian institution or author
acknowledged for any kind of collaboration. The article mentions that informed
consent was obtained. On enquiry however, the European Commission could only
provide the information that the samples had been collected 25 years previously
and kept in the archives of one of the collaborators. Considering that even today
the concept of informed consent is still not understood by many Indian patients or
volunteers, particularly those from the tribal populations, the possibility of having
obtained valid informed consent 25 years ago is highly questionable.
Later, a number of further articles on the genetic make-up of Indian tribes were
published by the same team in the
European Journal of Human Genetics
and
Current Biology
(See Cardaux et al.
2003
,
2004
) but this time with the name of an
Indian investigator and institution that had contributed the samples. However, it
appears that approval from the authorities concerned was not obtained for sending
the samples abroad for the study. The issues of prior informed consent, ownership of
the biological material, appropriate MTA and ABS remained unattended to. The onus
of vigilance about this in collaborative studies falls on the editorial boards of journals
and the ethics committees of the developed world's partner institutions (The Hindu,
2006
). However, as the next chapter explains (
Chap. 8
on ethics review), these parties
may, for a variety of reasons, fail to ensure that such issues are addressed.
China
The controversial case of Harvard researcher Dr Xu Xiping, who took and
exported millions of DNA samples from poor areas in Anhui province, central
China, sparked heated international, national, and local debates on bioethics issues
such as informed consent and benefit sharing. This episode came to light in 1999,
when Dr Gwendolyn Zahner, a former faculty member at the Harvard School of
Public Health, exposed the unethical conduct in Dr Xiping's research programme.
These debates led to in-depth discussions on the protection of vulnerable par-
ticipants in biomedical research, and on the pursuit of best practices in informed
