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    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.

    Questions ???

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