Chapter25ComplianceII.pptx
Chapter 25
Research Facilities
Learning Objectives
Scope and diversity of biomedical research
4 high legal risk areas in biomedical research
“Significant financial interest” & “conflict of interest”
Responsibilities to maintain research objectivity
Managing conflicts of interest and research bias
Learning Objectives
Financial management of research grants
Forms of research misconduct and the “Final Rule”
Purpose of a “written assurance”
Composition and duties of an IRB
Introduction
Size and accomplishments of biomedical research
Sources and amounts of funding for biomedical research
Reasons for government regulation of research institutions
Areas of High Compliance Risk in Biomedical Research
Conflicts of interest and objectivity in research
Cost allocation and reporting under NIH research awards
Clinical research misconduct
Protection of human research subjects
Conflicts of Interest and Objectivity in Research
The NIH has published mandatory standards designed to ensure that the design, conduct, and reporting of research funded by it will be free from bias resulting from investigator financial conflicts of interest.
The standards apply to both the institution receiving the funding and the investigators participating in the research.
Conflicts of Interest and Objectivity in Research: Key Terms
Institution
Investigator
Financial conflict of interest
Significant financial interest
Responsibilities of Institutions
The NIH prescribes a list of 15 responsibilities that each institution must carry out with regard to its research projects.
Most of them concern its dealings with the investigators on the projects.
When the institution identifies a conflict of interest, it must implement a plan to manage it, including actions specified by the NIH.
Cost Allocation and Reporting Under NIH Research Awards
Draft OIG Compliance Program Guidance for Recipients of PHS Research Awards
Includes traditional 7 elements of a compliance program, plus an 8th element on assignment of oversight responsibilities, plus 3 risk areas unique to research institutions
Time and effort reporting
Properly allocating charges to award projects
Reporting financial support from other sources
9
Clinical Research Misconduct
The competition for funding to support research is intense. It sometimes leads researchers to behave in unethical ways – to engage in research misconduct.
Defined: fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or reporting research results
Governed by the Public Health Service Policies on Research Misconduct (“Final Rule”)
“Final Rule” on Research Misconduct
3 elements to a claim of research misconduct
Duties imposed on institutions engaged in federally funded research
Written assurance of compliance with Final Rule
Policies and procedures covering specified points
ORI may conduct own inquiry or recommend certain administrative actions to DHHS
Protection of Human Research Subjects
“Clinical trials” on human beings with some risk of negative side effects or death
Legal requirements depend on federal funding and FDA involvement
Basic HHS Policy for Protection of Human Research Subjects (“Common Rule”)
Written Assurance of IRB Functions
Every institution engaged in covered research must provide a written assurance to the NIH that it will comply with the provisions of the Common Rule.
Principles on protection of human subjects
Designation of IRB’s
List of IRB members and qualifications
Procedures that the IRB will follow
Procedures for reporting unanticipated problems
Institutional Review Board Membership
The Common Rule gives very detailed specifications for the composition of the IRB.
Number
Experience and expertise
Scientific vs non-scientific interests
Demographic diversity
Knowledgeable in research conduct rules
Institutional Review Board Membership
The amount of time spent in each stage varies across populations.
Progress through the stages may not be linear (e.g. relapse, cycling and recycling through stages).
Health promotion efforts may include stage movement as a goal.
Other IRB Features
IRB duties: review research activities, document informed consent, notify parties of its decisions, continuing review of research it has approved
Criteria for IRB approval of research: specified by the Common Rule, all criteria must be satisfied, IRB may suspend/terminate prior approval
IRB records: mandatory documentation of IRB activities
Informed Consent
An investigator may not involve a human being as a subject in an NIH research project without obtaining the subject’s informed consent.
A person has given his/her consent to play a role in a research project after being fully informed of what the role will entail.
Common Rule specifies elements of effective informed consent.
Office of Human Research Protections
OHRP is responsible for ensuring compliance with the regulations governing the protection of human research subjects.
It has the authority to conduct both for-cause and not-for-cause compliance oversight evaluations.
As a result of its compliance oversight evaluations, the OHRP may take or recommend several actions.
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