15.03. Clinical Drug Studies
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
The federal government has very specific regulations
that deal with drug studies involving human patients. These
regulations include requirements and documentation for
informed consent by the study participants. In most cases,
each clinical trial in the US must be approved and monitored
by an Institutional Review Board (IRB) to ensure that the
risks are minimal and are worth any potential benefits. An
IRB is an independent committee that consists of physicians,
statisticians, and members of the community who ensure that
clinical trials are ethical and that the rights of participants
are protected. Federal regulation requires all institutions in
the US that conduct or support biomedical research involving
people to have an IRB initially approve and periodically
review the research. A clinical study is led by a principal
investigator, who is often a doctor. Members of the research
team regularly monitor the participants’ health to determine
the study’s safety and effectiveness. Charging patients for
medications in a clinical trial is governed by 21 CFR 312.8(a)
and (b). In most cases, a study sponsor must obtain prior
written authorization from Food and Drug Administration
to charge for drugs used in an investigational drug study,
and under 21 CFR 312.8(d)(1), a sponsor may recover only
the direct costs of making its investigational drug available.
Pharmacies and pharmacists must exercise caution in
their involvement in a business model that purports to be a
“study” or “survey” involving human patients, and ensure
that if they are involved in such a study, they have followed
all applicable federal regulations. In the absence of a real
“study,” a pharmacist or pharmacy that pays a prescriber to
write prescriptions as a study director or medical advisor
may be in violation of Board regulations and rules as well as
both state and federal anti-kickback statutes. Additionally,
prescribers who are requested to be participants in a drug
“study” should request and review a copy of the official IRB
study protocols and applicable federal study approvals before
accepting a role in the study. In the absence of following the
federal regulations that apply to human drug studies, prescribers
may also be charged with state and federal law violations
quoted from here
No comments:
Post a Comment