The group, including an advocate, researcher, journalist and others, have submitted a 15-page document calling for more transparency, clear definitions of ‘deliberate infection’ and ‘deliberate harm’ and specific assurances on compensation for adverse events
Before embarking upon controlled human
infection studies, the government must ensure that there is a public discussion
with regard to this, and must also ensure that people are protected against
unfortunate results, a group of activists has said.
The group that includes an advocate, an
independent journalist, an independent researcher and other activists,
submitted its comments on the Controlled Human Infection Studies (CHIS)
consensus policy statement that
the Indian Council of Medical Research (ICMR) has released
recently.
In a 15-page statement, group has also
said that the the proposed guidelines or statements must offer opportunities to
all people to air their views on this subject. It has called for providing
of the names of the individuals who drafted the CHIS document, a list of those consulted,
and a list of the reviewers. The ICMR statement on CHIS is vague,
and “allows loopholes, and leeway for legal and ethical violations,” the
document said.
The group has sought to know how CHIS
can take place when laws such as the Madras Public Health (Amendment) Act 1958,
state that any act performed with a deliberate intention to cause an infection,
is illegal. A CHIS may be in direct contravention of Acts such as this one, the
group has pointed out.
The group has also given suggestions,
and expressed reservations about various issues regarding clinical trials with
healthy individuals and the introduction of disease-causing pathogens in
them.
It has also called for gender inclusive
language and definitions of terms used. It calls for information on the
capacity, effectiveness and efficiency of current regulatory mechanisms for
clinical trials. It has also called for the publication of all results of
CHIS – including of failed CHIS, and negative results. These publications must
include a clear estimation of adverse events and harms, it said.
The group has demanded a specific
assurance of compensations in case a person is adversely injured during the
trial. All those involved in the research should be accountable for adverse
events, the group has said.
The drug control regulators’ ethical
obligations must be specified, and a separate section with “complete details of
safety requirements” should be created.
The ICMR statement should describe a
“knowledge threshold” so that healthy participants in the drug trial are not
exposed to something about which the researchers do not have adequate
knowledge, the group’s statement said.
The terms “Deliberate infection” and
“Deliberate harm” must be defined and the conceptual difference between the two
explained. The “Deliberate harm” in Phase I clinical trials may be different
from that in CHIS. The notion of a “permissible” level of harm, how the limit
would be set, and by whom must be stated. The possibility of long-term harm in
CHIS -- the need for monitoring for this, and how this would be factored in for
compensation – must be stated, the group has said.
It is necessary to engage with the
public to prepare and train the community on safety measures in case of a
spread of infection with challenging strains of pathogens, as the statement has
mentioned a risk of challenging strains.
No comments:
Post a Comment