Biology Reference
In-Depth Information
the population of the host country or community at the conclusion of the prelimi-
nary phase of its development'.
The CIOMS guidelines focus on benefits to the community/country rather
than just those for individual participants (CIOMS
2002
: guideline 5, paragraph
11; guideline 10). This approach has caused uneasiness among stakeholders who
find reference to 'community' rather nebulous, and the obligation that is imposed
on sponsors too stringent. For instance, Bruce Innis, vice-president of clinical
research and development at GlaxoSmithKline, argues:
Our first concern is to be sure we have a clear contract with each volunteer in the study …
This is a balanced discussion between potential volunteers being solicited and investiga-
tors who want to conduct the trial, the authorities who authorize the trial and the sponsors,
whether they be academic institutions or private parties, developers and manufacturers.
The community part is much more nebulous (Wolinsky
2006
: 672).
3.4.2 Provision of Services that are Necessary for Making
a Beneficial Intervention or Product Reasonably
Available
The third of the CIOMS guidelines to deal with benefit sharing is guideline 21,
concerning the ethical obligations of external sponsors to provide health-care
services.
External sponsors are ethically obliged to ensure the availability of:
• services that are a necessary part of the commitment of a sponsor to make a beneicial
intervention or product developed as a result of the research reasonably available to
the population or community concerned.
The commentary on guideline 21 acknowledges that sponsors are not obliged
to provide health care services beyond those necessary for the conduct of the
research, and that such services are not a necessary part of their commitment to
make available a beneficial intervention or product developed as a result of the
research. However it emphasizes that it is morally praiseworthy to do so, and gives
examples such as treating cases of an infectious disease contracted during a trial of
a vaccine designed to provide immunity to that disease, or providing treatment of
incidental conditions unrelated to the study.
The rather stringent requirements on sponsors of research have been criticized
as too demanding (Emanuel et al.
2004
: 935), perhaps surprisingly also by stake-
holders from developing countries such as Uganda. Julius Ecuru, from the Uganda
National Council for Science and Technology in Kampala, commented as follows
on the Declaration of Helsinki and CIOMS:
I think they are overly stringent when it comes to the obligation of the sponsors to pro-
vide the best proven care and research product to the host communities during and after
the research. I could take that as a desirable standard, but not an absolute moral or ethical
requirement without which research would not be allowed to proceed (Wolinsky
2006
: 672).
