Biology Reference
In-Depth Information
10.6.2 Compliance Through Ethics Committee Review
Since 2000, the Declaration of Helsinki has required benefit sharing with clini-
cal trial participants. In 2004 the declaration extended this requirement to study
participants from vulnerable populations, which includes human sample donors.
Relevant ethical guidelines thus do exist. A mechanism for achieving compliance
exists too, namely research ethics review. Yet, as noted above, very few benefit-
sharing success stories, if any, have emerged involving human sample donors.
The following recommendations are aimed at making the ethics review process
stronger in the area of benefit sharing.
Effective research ethics committees
have an important role and require
adequate resources, training and time to fulfil it.
As studies have shown, these
cannot be taken for granted in developing countries. There is already a pressing
need to facilitate innovative ways of providing those countries with training and
education in research ethics, as well as supporting and enhancing current training
programmes. A network of trainers located in developing countries must be built
up, and a process established for mentoring local ethics committees. In addition,
further ways of providing financial support to ethics committees in developing
countries need to be found.
Ethics committees need very specific guidelines, or access to a range of clear
case descriptions and success stories, in order to be able to assess whether a study
protocol sufficiently protects human research participants against exploitation.
More importantly, though, the Declaration of Helsinki is too vague on one particu-
lar aspect of this issue: research ethics committees and other parties need to know
whose duty it is to discharge post-study obligations. The researcher's? The spon-
sor's? The funder's?
6
We recommend that in its next revision, the Declaration
of Helsinki specify whose obligation it is to provide post-study access to suc-
cessfully tested drugs or alternative benefits.
.
As noted above, not all research undertaken in developing countries is exploita-
tive.
Applying post-study obligations to all types of research without fur-
ther refinement would be unlikely to achieve broad acceptance of the duties
entailed and may even lead to new injustices
, in particular if it led to the aban-
donment of valuable publicly funded research tailored to diseases prevalent in
developing countries. Such research could perhaps qualify for exemptions or waiv-
ers from post-study obligations, if it already complied with fairness requirements,
as suggested above.
Research ethics committees may need further guidance on how to assess a
study protocol to ensure that the general benefits to a community warrant the
waiving of post-study obligations in favour of the solidarity model. Minimum
requirements for such waiving are: that local researchers had input into the
6
The CIOMS International Ethical Guidelines for Biomedical Research Involving Human
Subjects (CIOMS
2002
) specifically mention sponsors and investigators as duty bearers, with the
main emphasis on the sponsors.
