Transcript Research Governance

Research Governance
Where Does Ethical Review Fit?
Relationship Between RECs and
Competent Authorities
• What are “competent authorities”?
– Drug agencies
– Ministries of Health
– Authority can be delegated to other agencies
• What are RECs?
– National ethics committees
– Institutional committees
Country Examples
Romania
• State administrative agency deals with
“bureaucratic decisions” (GCP)
• National ethics committee for drug studies
reviews ethical issues of protocols
Country Examples (cont.)
Norway
• Developing new law, in response to researchers’
complaints about requirement for multiple
approvals
• All research protocols will go first to ethics
committee
• Ethics committee will be responsible for dealing
with all other approvals
• Researcher only needs to communicate with
one entity
Country Examples (cont.)
Ethiopia
• Institutional ethics board
• National ethics committee (part of Ministry
of Science and Technology)
• Drug Administration and Control Authority
(independent authority) can override
national ethics committee decision
– More common to override approvals (e.g., if
participants < 18 years old) than rejections
Country Examples (cont.)
Estonia
• Prior review by institutional committee (e.g., do
researchers have enough time to do project?)
• Bioethics committee (two committees in country;
applicants can choose where to submit)
• Drug agency must approve studies involving
investigational drugs; doesn’t consider issues
addressed by bioethics committee
• All committees are independent, but they
coordinate work
• Ministry of Health oversees entire process
Country Examples (cont.)
EU
• Must consult REC for clinical trials
• Trial cannot be conducted without REC
approval
• Also need approval of member state
authority
Should REC Decision
Be Legally Binding?
• REC process should be mandatory
• But REC shouldn’t have final say
• Ministry of Health should have option of
overriding REC decision
Grounds for Overriding
REC Decision
• View #1: CA should be permitted to
override REC decision based on different
interpretation of ethical guidelines
• View #2: CA should be permitted to
override REC decision on other grounds
as well
– I.e., it should be permitted to override REC’s
rejection of a study because it believes that
the value of the study overrides the ethical
considerations
Underlying Question: What Is the
Status of International Ethics
Guidelines?
• Are international guidelines legally binding
or just advisory? Do some guidelines
(e.g., Helsinki) have the status of
customary international law?
• Even if countries don’t have to follow
international ethical guidelines, should
they be encouraged to do so?
• National laws may limit grounds for
overriding REC decisions
Relationship Between Ethical and
Scientific Review
Arguments for separating scientific and ethical
review
• Do RECs have competent to look at scientific
issues? Should there be limits on RECs’ ability
to question scientific determinations made by
other review bodies?
• Would giving RECs responsibility for scientific
review be inconsistent with goal of creating
diverse REC membership (including ethicists,
lawyers, etc.)?
Relationship Between Ethical and
Scientific Review (cont.)
Arguments for combining scientific and
ethical review
• But judgments of “scientific merit”
incorporate value judgments; should not
be left solely to scientists
• Practical considerations: burden of having
to establish two different committees