Biology Reference
In-Depth Information
The guidelines acknowledge the central role and relevance of human rights
instruments in the application of ethics to research on human subjects. They are
non-binding and may therefore seem 'aspirational' in so far as they aim to draw
the attention of sponsors, investigators and ethical review committees to the ethical
implementation of research protocols. However, this impression may be countered
with the claim made earlier in this chapter, namely that such guidelines can be
regarded as customary international law. Scholars have lauded the CIOMS guide-
lines for encompassing the three basic principles of respect, beneficence and jus-
tice (King
1998
: 187). The principle most relevant here is that of justice, which
as King has proposed 'should be reflected … in the distribution of the benefits
and burdens' (King
1998
: 187). Responding to the demands of justice, the CIOMS
guidelines give broad support for benefit sharing.
In general, the research project should leave low-resource countries or communities better
off than previously or, at least, no worse off. It should be responsive to their health needs
and priorities in that any product developed is made reasonably available to them, and as
far as possible leave the population in a better position to obtain effective health care and
protect its own health (CIOMS
2002
: 18).
The CIOMS guidelines that deal directly with benefit sharing are guideline 5
(paragraph 12), which focuses on the information given to research participants
about post-study access to interventions; guideline 10, which focuses on post-
study access to beneficial interventions, as well as responsiveness to local health
needs; and guideline 21, which focuses on the provision of services that are neces-
sary for making a beneficial intervention/product available. These guidelines are
discussed below.
3.4.1 Post-study Access to Beneficial Interventions
Guidelines 5 and 10 are discussed together as they both deal with the issue of
post-study obligations. Guideline 5 (paragraph 12) states that as part of the
informed consent process, participants should be informed
whether, when and how any products or interventions proven by the research to be safe
and effective will be made available to subjects after they have completed their participa-
tion in the research, and whether they will be expected to pay for them; …
Guideline 10 deals with research in populations and communities with limited
resources.
Before undertaking research in a population or community with limited resources, the
sponsor and the investigator must make every effort to ensure that:
• the research is responsive to the health needs and the priorities of the population or
community in which it is to be carried out; and
• any intervention or product developed, or knowledge generated, will be made reason-
ably available for the benefit of that population or community.
