irb 101: irb review criteria; tips for submission columbia university medical center irb july 14,...

Download IRB 101: IRB Review Criteria; Tips for Submission Columbia University Medical Center IRB July 14, 2005

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  • Slide 1
  • IRB 101: IRB Review Criteria; Tips for Submission Columbia University Medical Center IRB July 14, 2005
  • Slide 2
  • Objectives 1.Describe how submissions are routed for review; 2.Provide return criteria; 3.Explain the requirements for approval; 4.Demonstrate where in RASCAL information should be entered; 5.Provide tips for a complete and accurate submission. Facilitate more timely review through a better understanding of the IRB review process and review criteria.
  • Slide 3
  • Submission Process: New Protocols Protocol submitted to the IRB (submitted/Log-in queue); Administrative review conducted by IRB staff: Reviewer form guides review; Performance standards provide timeline; Review comments entered into Notes.
  • Slide 4
  • Submission process: New Protocol (2) Protocol will be accepted (logged in/Chair queue) if complete. PI submits protocol Submitted (Log-in queue) Staff review Logged in (Chair queue)
  • Slide 5
  • Submission process: New Protocol (3) Return Criteria at log-in stage: Cancer Center is not listed in Facilities section, and the research is cancer-related; PI is not qualified; Consent and/or Assent is not attached, and a waiver has not been requested; Recruitment material is mentioned, but not attached; Study instruments are described, but are not attached; Sponsors protocol, IDB, or Package Insert is not attached; Grant, contract, or other documentation of funding agreement is not attached; There is insufficient information to make required determinations.
  • Slide 6
  • Submission process: New Protocol (4) Protocol will be returned (returned/ Investigator queue) if one or more return criteria are met. PI submits protocol Submitted (Log-in queue) Staff review Returned (Investigator queue) PI receives protocol Correspondenc e from Chair to PI Correspondenc e from logger to team Correspondenc e from team to Chair PI revises protocol
  • Slide 7
  • Submission process: New Protocol (4) Overview PI submits protocol Submitted (Log-in queue) Staff review Returned (Investigator queue) PI receives protocol Logged in (Chair queue) Correspondenc e from Chair to PI Correspondenc e from logger to team Correspondenc e from team to Chair PI revises protocol
  • Slide 8
  • RASCAL tip: Review IRB Submission Manual Posted on Columbia Universitys Office for Clinical Trials website: http://www.columbiaclinicaltrials.org
  • Slide 9
  • RASCAL tip: Clarity 1.Describe clearly and accurately what will be done at this site or under the direction of a Columbia investigator; 2.Identify related procedures that will be or have been done elsewhere or previously; 3.Provide clear descriptions of relationships; 4.Accurately describe funding mechanisms; 5.Consistently and precisely describe data collection.
  • Slide 10
  • Submission Process: Renewals Renewals: Similar process, different form Return criteria: Clean copies of consent documents or study instruments not attached; Enrollment information not provided; Documents or fields not updated; Conditions of previous approval not satisfied; All required attachments not provided.
  • Slide 11
  • RASCAL tip: Review attachments 1.Archive superceded, reference, HIPAA documents; 2.Review content of attachments for currency, accuracy, outdated approval stamps, and inclusion of new requirements; 3.Review correspondence from previous approval.
  • Slide 12
  • Submission Process: Modifications Modifications: Similar process, summary of modification, assessment of revision in all applicable documents Return criteria: Clear explanation of changes not provided; Description of modification does not match changes in documentation; Changes are described but not incorporated; Supporting documentation not attached.
  • Slide 13
  • Submission Process: Adverse Event Reports Adverse event report: Similar process, reconciliation of investigator assessment with AE policy Return criteria: All required documentation not attached; Event does not meet criteria to be reported individually; Investigators assessment does not comport with supporting information.
  • Slide 14
  • RASCAL tip: Name files logically
  • Slide 15
  • RASCAL tip: Include Correspondence 1.Cover letter with initial submission. 2.Correspondence or attached response with resubmissions. 3.Attached letter to IRB to explain unusual or complex collaborations, centers, affiliations, procedures, etc.
  • Slide 16
  • IRB Review Low risk protocols may be eligible for exemption (6 categories) Minimal risk protocols may be eligible for expedited review (9 categories) Protocols that are not exempt or cannot be expedited require review by the full Board Time required for review is dependent upon the type of review, complexity and risk level of procedures, and other factors Chair schedule IRB meeting schedule Completeness of submission Other required approvals Recommendation: Submit as soon as all protocol materials are available Allow 60 days for renewal of full Board protocol
  • Slide 17
  • Review Process: Overview Logged in (Chair queue) Chair reviews or distributes Exempt or expeditedFull Board ApproveReturn Defer Pending Approve Return Disapprove Distributed then Assigned to Meeting
  • Slide 18
  • Criteria for IRB approval of research: 45 CFR 46.111 and 21 CFR 56.111 (a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
  • Slide 19
  • (1)Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
  • Slide 20
  • New protocol considerations: Research versus clinical care? Design features? Types of risk: physical, social, psychological, economic? Risks reduced or managed to the extent possible? Safeguards incorporated? Potential for statistical validity demonstrated? Investigators competent? Inclusion and exclusion criteria clearly defined? Renewal: Is it the determination of the IRB, based on an evaluation of reported enrollment, adverse events, and unanticipated problems, that risks are still minimized?
  • Slide 21
  • RASCAL entry: Research Page
  • Slide 22
  • RASCAL entry: Study Description; attachments 1. Study Purpose and Rationale. 2. Study Design and Statistical Procedures. 3. Study Procedures 4. Study Drugs or Devices 5. Study Questionnaires 6. Study Subjects. 7. Recruitment 8. Confidentiality of Study Data 9. Potential Risks 10. Potential Benefits 11. Alternatives
  • Slide 23
  • (2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
  • Slide 24
  • New protocol considerations: Acceptable risk/benefit ratio? Ethically acceptable to expose participants to risk of harm? Available alternatives? Renewals: Is it the determination of the IRB that risks are still reasonable in relation to anticipated benefits? Have any subjects been seriously harmed? Should any new information be provided to subjects?
  • Slide 25
  • RASCAL entry: Study Description; attachments 1. Study Purpose and Rationale. 2. Study Design and Statistical Procedures. 3. Study Procedures 4. Study Drugs or Devices 5. Study Questionnaires 6. Study Subjects. 7. Recruitment 8. Confidentiality of Study Data 9. Potential Risks 10. Potential Benefits 11. Alternatives
  • Slide 26
  • RASCAL tip: 11 Elements 1.Ensure that all 11 elements of a research protocol are addressed in the Study Description and/or attached protocol; 2.Study Description may be the only protocol or serve as an overview of a sponsors protocol; 3.Avoid See attached protocol as the Board members will receive the Study Description but not attached protocols.
  • Slide 27
  • (3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
  • Slide 28
  • New protocol considerations: Easy availability, compromised position, or susceptibility to manipulation a factor? If potential benefit, particularly for conditions with no effective treatment, are recruitment methods and enrollment criteria objective? Are ethnic groups neither under- or over-represented? Are women and children included where appropriate? Renewals: Has the actual selection/enrollment of subjects

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