Computer–Based Training for NIH IRB Members

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ComputerBased Training for NIH IRB Members. Lesson 1 Introduction Lesson 2 Using NIH IRB Review Standards Lesson 3 Continuing IRB Review, IRB Minutes, and Other Issues. ComputerBased Training for NIH IRB Members. Lesson 1: Introduction. - PowerPoint PPT Presentation

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  • ComputerBased Training for NIH IRB MembersLesson 1 Introduction

    Lesson 2 Using NIH IRB Review Standards

    Lesson 3 Continuing IRB Review, IRB Minutes, and Other Issues

  • ComputerBased Training for NIH IRB Members

    Lesson 1:

    Introduction

  • ComputerBased Training for NIH IRB Members: IntroductionThis computer-based training course is designed to help you understand the responsibilities of NIH's Institutional Review Boards (IRBs). It is designed primarily for NIH IRB members but its content is also useful for clinical researchers submitting protocols for review by an NIH IRB.

    The NIH values highly the important work of its IRBs and appreciates your willingness to serve as a member.

    NIH's IRBs are critically important to its overall system of human subject protections.

    Before we focus entirely on IRBs let's review some general issues about the NIH's overall system for the protection of human subjects.

  • ComputerBased Training for NIH IRB Members: IntroductionUpon completing this lesson you should know:

    The basic ethical and regulatory foundations of NIH's system for the protection of human research subjects

    The importance of NIH's Institutional Review Boards (IRBs) to this overall system, and

    Some unique features of NIH's IRB system.

  • ComputerBased Training for NIH IRB Members: IntroductionThe National Institutes of Health (NIH) is the Federal Government's primary agency for advancing knowledge in the biomedical and behavioral sciences. It has a long and distinguished history of rapidly applying basic scientific discoveries in the laboratory to the design and conduct of clinical research at the bedside.

  • ComputerBased Training for NIH IRB Members: Introduction

    The NIH is funded by the American taxpayer and is held publiclyaccountable for the scientific worth and ethical integrity of its researchactivities, including those involving human subjects.

    The NIH expects researchers in its Intramural Research Program (IRP)to share its commitment to the conduct of high quality research thatpromotes the rights and welfare of research subjects.

    The IRP consists of researchers working on the NIH's Bethesdacampus and other sites in Maryland, Montana, North Carolina andArizona.

  • ComputerBased Training for NIH IRB Members: IntroductionResearch investigators have a fundamental responsibility to safeguardthe rights and welfare of people participating in their research activities.

    Also, in the U.S. it has been decided that prospective review ofresearch activities involving human subjects by a group of diverseindividuals, not involved in the conduct of the research, is most likely toprotect human subjects and promote ethically sound research.

    Generally this review is performed by committees called InstitutionalReview Boards (IRBs).

  • ComputerBased Training for NIH IRB Members: IntroductionThe NIH IRP has established a system to help IRP researchersunderstand and fulfill their responsibilities when they conduct orcollaborate in research involving humans. IRBs are an important part ofthis system.

    The NIH's system for the protection of human subjects is described inits Human Research Protection Program (HRPP).

    You should be familiar already with the NIH HRPP. It was discussed inthe NIH's Computer-Based Training(CBT) Course on Protecting HumanResearch Subjects. If you would like to review the CBT lesson on theNIH HRPP, you may go to the Web site of NIH's Office of HumanSubjects Research (OHSR) at http://ohsr.od.nih.gov and click onTraining for NIH Researchers.

  • ComputerBased Training for NIH IRB Members: IntroductionThe HRPP incorporates the basic ethical principles of TheBelmont Report and is consistent with requirementsprovided in Title 45 Code of Federal Regulations, Part 46,Protection of Human Subjects (45 CFR 46).

    The Belmont Report and 45 CFR 46 are available forreview and for printing from the OHSR Web site.

  • ComputerBased Training for NIH IRB Members: IntroductionThe NIH HRPP provides policies and procedures for research involving human subjects and describes the responsibilities of:

    NIH officials who oversee human subjects research;

    Intramural researchers, and other NIH employees, who conduct, support or collaborate in research involving human subjects at the NIH or elsewhere;

    NIH's IRBs, and

    The NIH's Office of Human Subjects Research (OHSR).

  • ComputerBased Training for NIH IRB Members: IntroductionOverall responsibility for the NIH HRPP rests with the Deputy Director for Intramural Research (DDIR), Office of the Director (OD), NIH.

    Other NIH Institute and Center officials who share this responsibility include: the Director of the Clinical Center, Clinical and Scientific Directors; Laboratory, Branch and Section Chiefs; research investigators, and other research personnel.

    All IRP personnel who oversee, conduct or collaborate in research involving human subjects are expected to be familiar with the NIH HRPP. Dr. Michael Gottesman, Deputy Director for Intramural Research (DDIR)

  • ComputerBased Training for NIH IRB Members: IntroductionAlthough you should be familiar with the HRPP, the Chair of your IRB is an important resource on its content and how it applies to the work of the IRBs in protecting human subjects.

    For more information or questions about issues related to the protection of human subjects, you may call the Office of Human Subjects Research (OHSR).

    OHSR's address is: NIHBuilding 10Room 2C-146Bethesda, MD 20892

    The phone number is:301-402-3444

  • ComputerBased Training for NIH IRB Members: IntroductionOHSR works for the DDIR. It is the IRP's central office for information and education about the protection of human research subjects.

    OHSR's Web site at http://ohsr.od.nih.gov contains much information about research involving human subjects at the NIH. You will be given an opportunity to go directly to this Web site at the end of the CBT.

  • ComputerBased Training for NIH IRB Members: IntroductionNow, let's look at the role of IRBs in NIH's overall system to protect human subjects.

    As of January, 2007, the NIH has 12 IRBs which are composed of over 180 members with expertise in science, ethics, and other non-scientific areas. This diversity fosters a comprehensive approach to safeguarding the rights and welfare of subjects involved in NIH IRP research activities.

    When reviewing research protocols, regardless of their professional backgrounds, or on which of the NIH's IRBs they serve, IRB members are responsible for assuring that minimal regulatory review requirements are met and that these requirements are properly documented in the IRBs' minutes.

    In the next lesson we will discuss the IRB review standards and how IRB members can implement them in a methodical way.

  • NIH IRB CONTACTS

    Institute:Chair:Coordinator:Phone:Address:CNS W: NIAAA, NIMHCNS B: NINDS, NIDCD, NIA, NIEBarbara KarpBarbara KarpJeanne Radcliffe, Cathy Little, Donna Howard, Jennifer Morris, Marge Gillespie, Alex Noury, Latasha Terrell, Nanette Suksta, Mike Chapple301.496.8967301.594.019610 CRC 6-5700NCIWanda SalzerLinda Adams301.496.637582/117NCIssNancy PotischmanLynn Sayers, Suzan Privot301.402.7221EPN/5143NHLBIAlison WichmanMelissa Bryant, Patty Sweet301.594.837810 CRC 4-1581NIAIDV. Koneti RaoDoreen Chaitt301.451.51396700B RockledgeRoom 1116NICHDGilman GraveLin Aspinall301.496.837010 CRC 5-2571NIDABarbara KarpAnne Gupman, Cecile Shindell443.631.8020251 Bayview Blvd., Suite 200Baltimore, MDNIDDK/NIAMSHoward AustinGlynnis Vance301.496.418210 CRC 5-2551NIDCRReuben SiraganianRachel Topper-Greco301.827.455710 CRC 5-2531NIEHSDavid ResnikJane Lambert, Craig Wladyka919.541.5047919.541.3822Nottingham Room 275NHGRIFabio CandottiVictoria Willits301.496.190610/1C118

  • ComputerBased Training for NIH IRB Members: Introduction

    These IRBs oversee about 1300 active protocols being conducted in the Clinical Center (CC) and about 200 protocols for research collaborations in which the human subjects are located at domestic non-NIH sites and at many sites around the world.

  • ComputerBased Training for NIH IRB Members: IntroductionIt is unusual for one research institution to have so many IRBs.

    This large number of IRBs reflects the history and organization of the NIH IRP in which the various NIH Institutes have a high degree of freedom in the kinds of research they conduct and in the administration of their programs.

    There are relative advantages and drawbacks to the NIH's multi-IRB system.

  • ComputerBased Training for NIH IRB Members: IntroductionSome advantages of the NIH's multi-IRB system:

    It allows for IRB members who have specialized scientific and ethical expertise in the area of the Institutes' research activities. For example, persons with expertise in the scientific, ethical and legal aspects of research on the human genome are important to an IRB that reviews genetic research. On the other hand, an IRB that reviews cancer clinical trials using highly experimental drugs is better served by having members with expertise in the scientific, ethical, statistical, and nursing aspects of clinical trials involving persons with cancer.

  • ComputerBased Training for NIH IRB Members: IntroductionSome advantages of the NIH's multi-IRB system:

    A lighter work load for each IRB allows time for more thorough, thoughtful review of research protocols.

    In many other research institutions the IRB workload is much higher.

    For example, in 1996, the Chair of one University IRB reported that atits monthly meetings it reviewed up to 40 to 80 new protocols (JAMANovember 27, 1996, Vol. 276, No. 20).

    In comparison, most NIH IRBs review no more than 5 new protocolsper meeting.

  • ComputerBased Training for NIH IRB Members: IntroductionSome drawbacks to the multi-IRB system:

    Even though each NIH IRB is governed by the policies and procedures of NIH's MPA, as well as some Clinical Center policies, the IRBs vary in how they implement these policies.

    Some degree of flexibility is desirable because it allows IRBs to applythe policies in ways that are most relevant and appropriate to theirparticular research population and environment.

    However, all NIH IRBs are expected to fulfill basic requirements for thereview and approval of research. Therefore, the NIH has implementedminimal review standards for its IRBs. You will learn more about the IRB reviewstandards and how to apply them in the next lesson.

  • ComputerBased Training for NIH IRB Members: IntroductionSome drawbacks to the multi-IRB system:

    Educating new IRB members, providing continuing education and oversight of so many IRBs is a formidable task.

    Currently, minimal NIH educational requirements for all ofits new IRB members include:

    Completion of the NIH's computer-based training program (CBT) on Protecting Human Research Subjects;

    Completion of this CBT (CBT for IRB members), and

    A one-on-one orientation session with a member of the OHSR staff.

  • ComputerBased Training for NIH IRB Members: IntroductionSummary points:

    The NIH's overall system for the protection of human subjects is described in its Human Research Protection Program;

    NIH's IRBs are a critical element in this overall system;

    The major mandate of IRBs is to protect the rights and safeguard the welfare of the subjects, and

    The NIH depends on the knowledge and judgment of its many IRB members to make this system work effectively.

    If you have any questions, comments or suggestions concerning your serviceas an NIH IRB member, please contact the Chair of your IRB or call OHSR(phone301-402-3444).

  • ComputerBased Training for NIH IRB Members

    Lesson 2:

    Using NIH IRB Review Standards

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards Upon completing this lesson you should know:

    Understand that the NIH IRB review standards incorporate minimal regulatory requirements for the review and approval of research protocols;

    Understand that the standards were developed to help NIH IRB members address these requirements methodically and consistently;

    Understand how to apply the standards when reviewing research protocols, and

    Appreciate the NIH's requirement that, for each protocol they review, NIH IRBs' discussions of the review standards are documented in their minutes.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards NIH IRB review standards were developed to:

    Assure that regulatory requirements for the review and approval of research protocols are addressed by and documented consistently in the minutes of all NIH IRBs;

    Improve NIH IRBs' efficiency and save IRB members' time;

    Assure NIH's leadership that NIH IRBs' procedures and minutes can withstand evaluation and/or audit by the NIH, other governmental, regulatory or private groups.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards IRB Review Standards Goal #1:

    Assure that minimal requirements for the review and approval of research protocols areaddressed by and documented consistently in the minutes of all NIH IRBs.

    IRB decisions are matters of judgment and therefore they depend onan understanding and wise application of ethical guidelines andregulatory requirements as well as an appreciation of specificrequirements of the NIH HRPP.

    When reviewing research protocols, it is important that NIH's IRBmembers not only know the minimal regulatory requirements for theapproval of research but also assure that IRBs thoroughly discuss anddocument them in their minutes for each new protocol.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards IRB Review Standards Goal #2:

    To improve NIH IRBs' efficiency and save IRB members' time.

    IRB agendas are often long. Implementing reviewstandards will focus IRBs' attention on basic reviewrequirements and therefore streamline their activities.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards IRB Review Standards Goal #3:

    Assure NIH's leadership that NIH IRBs' procedures and minutes can withstandevaluation and/or audit by the NIH, other governmental, regulatory or private groups.

    As discussed in the Introduction, the NIH is a publicly funded institution andtherefore many of its records, including research protocols and IRB minutes,are available for review under the Freedom of Information Act (FOIA).

    Also, the NIH's clinical research and IRB activities receive close scrutiny by NIHand non-NIH groups; therefore, it is particularly important that NIH IRBsdecisions are properly documented in their minutes and reflect anunderstanding and appreciation of minimal regulatory requirements.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards

    The NIH IRB review standards are based on "Criteria for IRBapproval of research" as provided in 45 CFR 46.111.

    This lesson is designed to familiarize you with the required NIHIRB review standards and to provide some advice on how toapply them when you are reviewing protocols.

  • ComputerBased Training for NIH IRB Members: Using NIH IRB Review Standards

    Practice will guide new IRB members to the most effective ways ofapplying the standards when they review prot...