irb orientation new member helen panageas, cip associate director nyu school of medicine...
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- IRB ORIENTATION New Member Helen Panageas, CIP Associate Director NYU School of Medicine INSTITUTIONAL REVIEW BOARD Kim Diccianni, CIP Investigator Liaison www.med.nyu.edu/irb
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- Welcome to the IRB
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- What we will Cover Today What is the IRB and how does the IRB work? Mechanics: how to review a protocol. 10 minute BREAK History and Regulations Research ethics & essence/spirit a bit distilled Wrap Up: Questions, issues, considerations.
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- What is an IRB? An Institutional Review Board (IRB) is a group of people formally designated (by feds and Institution) to review and monitor research involving human subjects. Direct arm of the federal government when it comes to protection of human subjects New York University School of Medicine has three IRBs
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- What is the IRB? The purpose of the IRB is to protect the rights and welfare of individuals who are participating as subjects in research. The IRB has the authority to approve, disapprove, and require modifications to research projects involving human subjects.
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- What is an IRB? Federal Government says: Federal Government says: An Institutional Review Board is a federally mandated group required to review and approve human research projects in accordance with Title 45 Public Welfare DHHS, PART 46 PROTECTION OF HUMAN SUBJECTS and FDA regulated studies in accordance with TITLE 21 FOOD AND DRUGS, PART 50 PROTECTION OF HUMAN SUBJECTS, PART 56 INSTITUTIONAL REVIEW BOARDS
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- What is an IRB? NYU SoM holds a Federalwide Assurance (FWA) 00004952 The FWA assures that the Institution will be compliant with the federal regulations for the protection of human subjects for all research regardless of funding source The FWA is also approved by OHRP
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- IRB Membership At least 5 members IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas. Federal Regulations at 45 CFR 46.107
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- IRB Membership (Continued) IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution. Federal Regulations at 45 CFR 46.107(d)
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- IRB Membership (Continued) Consultant as Reviewers An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB. Federal regulations at 45 CFR 46.107(f)
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- The Individual IRB Member Its tough job but you add to the process Your unique professional and personal perspective. This includes your scientific, social, ethical, community, minority, legal, administrative or operational perspectives, maybe all of these.
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- The Individual IRB Member Members must attend a minimum of ten meetings annually, Members must attend a minimum of ten meetings annually, should attend all meetings for which they are scheduled. should attend all meetings for which they are scheduled. If a member is unable to attend a scheduled meeting, that member should inform the IRB Chair, Vice Chair, or an IRB Office staff member. If a member is unable to attend a scheduled meeting, that member should inform the IRB Chair, Vice Chair, or an IRB Office staff member.
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- How does it Work?
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- Human Subjects Protection is a Shared Responsibility IRB Investigator/ Researcher Institution
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- Team Approach
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- Institutional Official obligations: Sets tone for culture for respect of human subjects Serves as Signatory official on Federalwide Assurance Is Knowledgeable contact for OHRP/FDA Ensures effective communication and access to human subject information Ensures investigators fulfill responsibilities Facilitates educational activities Holds administrative responsibilities which include appoint IRB members and chair provide IRB with resources and staff support IRB authority and decisions
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- Institutional Obligations: Assure that the IRB has necessary resources to support the review of human subject research at the institution Assure autonomy of IRB decision making process Provide education and training in the responsible conduct of research for all researchers and key personnel Develop policies and procedures to administer human subject program Ensure assurances are in place and certification of IRB review submitted (include collaborating performance sites) Implement oversight to ensure compliance with regulations Promptly correct any situations of non-compliance with rules and regulations which could jeopardize research, funding, or reputation
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- IRB Chair role: Full knowledge of regulations and their application Maintain current knowledge of trends and changes in protection requirements Convene IRB meetings Perform review functions as needed for new, and continuing research Assist institution in review of non-compliance Perform expedited review and/ or designate experienced reviewers Assist in the education and development of IRB members Assure that documentation (minutes etc.) adhere to regulatory requirements Assure that all members have equal voice in meeting deliberations and voting Keep deliberations of IRB confidential
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- IRB panel obligations: Apply the rules and regulations to specific projects/protocols Provide constructive review of research proposals (in a timely manner) Assist with education of research community Respond to staff requests for attendance and information Communicate new developments to research community Seek outside consultation when lacking expertise Model exemplary research behavior
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- IRB member roles: Full knowledge of regulations and their application Maintain current knowledge of trends and changes in protection requirements Attend IRB meetings Perform review functions as needed for new, and continuing research Perform expedited review if designated Keep deliberations of IRB confidential
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- Principal Investigator Obligations Protect Human Subjects Know and apply rules and regulations Apply for prospective IRB approval Follow dictates of IRB Report unanticipated problems to IRB Report changes in research activities and ensure changes not initiated without IRB approval (except to eliminate immediate hazard to subject) Provide continuing reports of research Obtain informed consent/assent Retain records as required by regulation Train and supervise research team and associates
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- IRB Autonomy and Support Autonomy of IRB decision making is mandated by regulation and assured by the institution through the Federalwide assurance. (FWA) In essence, the IRB is a franchise of the federal agencies, OHRP and FDA when operating as a duly constituted IRB.
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- Review by Institution 45 CFR 46.112 and 21 CFR 56.112 Research may be subject to further appropriate review and approval or disapproval by officials of the institution. However, these officials may not approve the research if it has not been approved by an IRB.
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- System Integrity Team system is based on trust and open communication Issues and problems should be openly reviewed and addressed Complaints or problems should be handled fairly and efficiently The Primacy of the Rights and Welfare of subjects should guide us all decisions
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- How does it work? Basically: Protocols submitted for review IRB Admin Office processes review Reviews to ensure conformity to regs and NYU policy Forwards all full board reviews up to board IRB meets once a month (sometimes more by teleconference) to review and make decisions on new research and the continuation of research IRB also may, at times, have to make tough decision disapprove, suspend, terminate etc..
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- How does it work? In detail: That is what we will discuss today How this IRB works Your responsibilities as a member History of research and the development of regulations and ethical principles
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- Mechanics Background Background Types of review and how this is determined Types of review and how this is determined Some IRB speak Some IRB speak The process The process Meeting materials Meeting materials What happens at the meeting What happens at the meeting Meeting Time Meeting Time Quorum Quorum Voting and COIs Voting and COIs Review Process at the meeting and the Belmont Review Process at the meeting and the Belmont
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- Types of IRB Review Expedited Full Exempt
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- How is Review Type Determined? Four Basic Questions: 1. Is the Proposed project Research? 2. Does the proposed project involve Human Subjects? 3. What type of Risk is involved in the proposed project? 4. Does the proposed project meet the criteria for the Review Category?
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- Research is defined as a systematic investigation, including research development, testi
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