Biology Reference
In-Depth Information
already required in the protocol in terms of the Declaration of Helsinki puts only a
limited extra burden on the existing approval process.
Assuming that benefit-sharing requirements for human research participants
were to be regulated through the CBD framework, another approval process would
have to be added. According to Laird and Wynberg (
2008
), '[t]he negotiation of
consent and benefit sharing agreements between those who access and those who
provide non-human genetic resources takes on average 1-2 years and sometimes
longer' This would be a significant additional burden with considerable impact on
the timeliness of research. Especially in health research, such delays can be highly
detrimental to global public health and individual patients.
8.4 Post-study Access
The constraints we have listed so far concern enforcing the provision of post-study
access to successfully tested interventions and 'other benefits'. However, some
challenges are limited to ensuring post-study access.
8.4.1 Unrealistic Timeframe for Post-study Access
By the time a post-study obligation becomes relevant, some of the researchers
involved are likely to have left the study site and even the country. In 'helicop-
ter research' (flying in and out of locations, for instance in a current epidemic),
researchers leave as soon as the data is obtained. Many research units have long-
standing collaborations with host countries, but some do not, leaving research eth-
ics committees with no recourse to researchers after the completion of their study.
In any case, it takes on average a decade to bring a drug to market (Trade and
Industry Select Committee
2002
). To be required to return to participants a decade
after the study to see whether they are in need of the developed intervention is
rather unrealistic and cumbersome to say the least. More importantly, for the pur-
poses of this chapter, it would be highly unrealistic to expect research ethics com-
mittees to ensure compliance ten years after a project's completion.
8.4.2 Inbuilt Unfairness in Post-study Access: The Research
Participant
Research ethics committees aim to protect
fail
human research participants from
exploitation, not just some.
Failure rates in drug development are extremely high. Of those developments
that make it into clinical trials, 38% fail Phase I (safety), 60% of the remainder fail
