Research Ethics, Governance, Oversight And Public Interest
- Author:
Abu Bakar Suleiman
;
Joon-Wah Mak
- Publication Type:Review
- Keywords:
Declaration of Helsinki, ethics, Institutional Review Boards, research governance, research oversight
- From:International e-Journal of Science, Medicine and Education
2008;2(supp1):35-38
- CountryMalaysia
- Language:English
-
Abstract:
A better educated public has started to challenge
the way decisions are made in medical research activities.
Although Institutional and National Guidelines on
Research are in place, there are fears that Institutional
Review Boards (IRBs) and funding agencies are only fairly
active in scientific and ethical reviews of research proposals
but not on oversight of projects after their initiation. These
issues are integral to good research governance and
researchers and custodians of research ethics must ensure
that public interest is not compromised.
Medical progress is based on research including human
experimentation carried out according to guiding
principles as enunciated in the Declaration of Helsinki
(2000), but the quality of compliance with the
Declaration is an important issue.
Better choice and appropriate training of members of IRBs
to improve the quality of decision making and governance
processes are urgently needed. Competency in evaluation
of proposals requires not only the appropriate scientific
knowledge but also access to relevant preclinical and
other data. Unfortunately, the completeness and quality of
such data may not be adequate.
Public interest demands that injury to trial subjects in
clinical trials is minimized if not avoided completely.
Unfortunately this is not always possible with trials
where novel biological modes of action are tested.
A more robust evaluation mechanism for project
approval may minimize but not completely avoid injury
to subjects; thus insurance cover to provide care and
compensation to subjects must be compulsory.
The decision to approve or reject a project must be
based on the balance of potential risks and benefits,
taking into consideration justifiable distributive risks to
target communities and populations. Economic
considerations should never be the primary focus,
especially when there are real concerns that the
migration of early phase clinical trials including vaccine
trials to developing countries is based on the perceived
less stringent ethical requirements and oversight there.
- Full text:W020150928399053100814.pdf
