The Role of the IRB Within the Greater Research Community

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The Role of the IRB Within the Greater Research Community. David Borasky, CIP Office of International Research Ethics Family Health International. Two Questions. How can we enhance community representation on institutional review boards (IRBs)? - PowerPoint PPT Presentation

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  • The Role of the IRB Within the Greater Research Community David Borasky, CIPOffice of International Research EthicsFamily Health International

  • Two Questions

    How can we enhance community representation on institutional review boards (IRBs)?How can we encourage collegial relationships between investigators, IRBs, and communities for advancing ethically-sound science that has community utility?

  • Community Members & IRBs45 CFR 46.107 / Common Rule The IRB must be able to consider cultural backgrounds and . . . community attitudes. Each IRB shall include at least one member whose primary concerns are in nonscientific areas.Each IRB shall include at least one member who is not otherwise affiliated with the institution.

  • Current Sources of Community Members for IRBs

    Retired facultyNon-scientific facultyFriend of faculty / IRB membersLocal church / mosque / synagogue

  • Problems with current system

    Often just one or two membersLack of training / do not understand roleFeel intimidatedNot representative of entire communityMeet the letter of the regs, but not the spirit!

  • How do we enhance community representation on IRBs?

    Recruit study participants and/or their familiesProvide them with better trainingIncrease number of community reps on IRBsNorwegian IRBs 50% community repsDeGette bill (2 members or 20%)Establish standing Community Advisory Boards

  • What weve got here is failure to communicate.

    IRBs and Investigators

  • Why Are We Failing?IRBsHeavy workloadFocus on regulatory complianceInvestigatorsTime pressuresBelief that IRB is another hoop to jump through

  • Improving Communication

    Make the IRB office more businesslikeConflict resolution trainingTransparencyMore face to face communicationReason behind IRB decisionsRespect

  • SummaryIRBs must reconsider how they connect with the communityReview membershipReevaluate how community members participate

    Improving communicationEstablishing collegial relationships take workPayoff is worth the effort

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including standards for design, implementation and reporting. Particularly, sponsors must commit to protect the participants in all research studies. Sponsors can accomplish these goals in several ways:Support the establishment and operation of an appropriate ethics committee, and ensure their review, approval and supervision of all research.Monitor the research according to a plan approved by the EC, ensuring that the study is conducted according to the approved protocol, and that all data are authentic, reliable and processed correctly.Select only qualified researchers and provide them with all the necessary means to implement the research properly. Provide all researchers with written policies, procedures and guidelines before the research is initiated.

    Slide 43. Sponsors Responsibilities

    Sponsors are responsible for providing an environment that promotes integrity, objectivity and the highest ethical standards of research, including s

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