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448945-762000LIFEBRIDGE HEALTH Department of Research PolicyIRB REVIEW OF RESEARCHTABLE OF CONTENTS Section Page NumbersPurpose2Scope2Definitions2Policy2Procedures5.1 – Determinations that May be Made by the IRB5.2 – Review Process for New Submissions5.3 – Continuing Review5.4 – Changes to Already Approved Research5.5 – Calculation of Approval Period and Interim Reports5.6 – Institutional Approval5.7 – Notification of IRB Approval or Disapproval5.8 – Investigator Appeal of IRB Action5.9 – Notification of Suspension or Termination of IRB Approval for Cause2244555566PURPOSEAll requests for initial Research approval, continuing reviews, and modifications to previously approved Research must meet regulatory criteria for approval set out in HHS and FDA regulations, as applicable (21 CFR 56.111). The regulatory criteria for approval are based on the principles of justice, beneficence and respect for persons as discussed in the Belmont Report and specified further below. The purpose of this policy is to set out criteria and processes for IRB determinations relating to proposed research activity.SCOPEThis policy applies to all Human Subject Research conducted by researchers or staff at or affiliated with LBH, conducted at any LBH facility, or utilizing individually identifiable data of LBH patients when LBH IRB serves as IRB of Record for such Research. DEFINITIONSHuman Subject criteria are met by either:(a) a living individual about whom an investigator conducting Research: (i) obtains information or biospecimens through Intervention or Interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates Identifiable Private Information or Identifiable biospecimens; or(b) an individual who participates in Research as a recipient of the article being tested or as a control. Institutional Official is the individual at LBH who is legally authorized to act for and on behalf of LBH in matters related to its human subject protection program.IRB of Record is the IRB that has oversight responsibility for the study, in accordance with applicable law.Principal Investigator is the physician or other individual assuming primary and ultimate responsibility for the conduct of a Research project.Research by definition is either:(a) a Systematic Investigation, including research development, testing and evaluation, designed to develop or contribute to Generalizable Knowledge; or(b) the use of a drug, biologic or device for a purpose or in a manner other than in the course of medical practice; or(c) the gathering of data that will be submitted to or held for inspection by FDA in support an FDA marketing permit. POLICYLBH Principal Investigators and research staff will submit information about Research to the LBH IRB for review and approval, and the LBH IRB will review and take action on such submissions, in accordance with applicable law.PROCEDURESDeterminations that May Be Made by the IRB The LBH IRB may make one of the following determinations as a result of its review of Research submitted for initial review, for continuing review (see Criteria for Continuing Approval Policy), or for the review of modifications to previously approved Research (Criteria for Continuing Approval Policy).These determinations apply to Research studies that qualify for either convened IRB or expedited review (see Expedited Review Policy), except that disapproval of a Research study may not be determined via expedited review and requires a vote at a convened IRB meeting.Approval: The protocol and accompanying documents may be approved as submitted. Final approval will commence on the day the study is approved by an action of the convened IRB or the IRB Chair or designee, and expires no later than one year from date of approval.The IRB may recommend minor language changes to the consent or submission documents that clarify information provided by the Principal Investigator/sponsor, but do not alter the IRB’s determination that the regulatory criteria for approval remain satisfied. In that event, the IRB Administrator or designee may revise the materials to incorporate the minor administrative changes in accordance with the IRB’s instructions. Such minor administrative changes are not required to undergo further review, and the documents are considered final upon completion of the minor administrative changes and verification of accuracy by the investigator.Deferred: When the convened IRB has significant questions or requests substantive clarifications or modifications regarding the protocol or informed consent documents that are directly relevant to the regulatory criteria for approval, IRB approval of the proposed Research is deferred pending subsequent review by convened IRB of responsive material.Conditional Approval: The protocol and accompanying documents may be approved with conditions at the time of initial review of the research, continuing review, or review of proposed changes to previously approved research if, given the scope and nature of the conditions, the IRB is able to determine that with satisfaction or the conditions, all of the regulatory criteria for approval are met. Final approval will commence on the day conditions are determined to be met, and expires no later than one year from date of approval. The revisions to consent documents, submission forms and other clarifications requested during convened IRB review as a condition of final approval may be reviewed by an IRB staff member. Final approval will be issued provided that the revisions or clarifications do not indicate or result in a change to the study or affect the regulatory criteria for approval.Conditions of approval of research may include, but are not limited to:Confirmation of specific assumptions or understandings regarding how the research will be conducted (e.g., confirmation that the research excludes children);Submission of additional documentation (e.g., documentation that physician-investigators of a device trial have been trained by the sponsor, as indicated in the protocol, prior to the enrollment of subjects); orPrecise language changes to protocol or informed consent documents.When the IRB approves research with conditions, verification procedures must be included as part of the IRB approval process. An individual designated by the IRB will review responsive materials from the investigator and determine whether the conditions of approval have been satisfied. Disapproval: The protocol and accompanying documents fail to meet one or more regulatory criteria for approval. Disapproval cannot be determined through expedited review and requires majority vote of the convened IRB.Review Process for New SubmissionsFor all new protocols submitted to the IRB for consideration of convened IRB or expedited approval, a Primary Reviewer is assigned. The Primary Reviewer uses the New Submission Checklist located in IRBNet to assist him/her in the review of the study and to ensure that all regulatory criteria for approval are addressed.During review by the convened IRB, the Primary Reviewer presents to and discusses with the LBH IRB each of the regulatory criteria for approval. The convened IRB may make any of the determinations listed in section 5.1 above. If an approval recommendation is made, the convened IRB must determine that all of the regulatory criteria are met. The IRB’s determinations are documented in the IRB meeting minutes. The convened IRB also makes any other required regulatory or HIPAA determinations, which are also documented in the IRB meeting minutes.For review using the expedited procedure, the Primary Reviewer also uses the New Submission Checklist to determine whether all of the criteria for approval have been met. The Primary Reviewer will make a determination as noted in section 5.1 (except that a recommendation for disapproval must be reviewed by the convened IRB). Documentation of the review determination is made via a completed Primary Reviewer Checklist. The completed checklist is retained in the study file. Other necessary regulatory and HIPAA determinations are also documented and retained in the study file Continuing ReviewContinuing IRB review is required as long as a study is open to enrollment, subjects are receiving research interventions, and/or individually identifiable data or specimens from subjects are collected or analyzed. Principal Investigators are required to submit a continuing review application prior to the expiration of the approval period or as requested by the IRB, but at least annually. For each study that is due for continuing review, a Primary Reviewer is assigned to conduct the review. After review of the submitted materials, and the complete protocol, the Primary Reviewer makes one of the determinations listed in section 5.1. Focus is on whether there is new information that alters the prior determination relative to the approval criteria. If the Primary Reviewer feels that there has been change to the risks or benefits that affect regulatory criteria for approval, (s)he may refer the study to the convened IRB for review. For studies requiring convened IRB continuing review, IRB members receive a copy of continuing review application materials; and additional information (e.g., protocol, IRB minutes of initial review) is available to IRB members on request. As an outcome of continuing review by the IRB, the IRB may require that the research be modified or stopped, and it may require special precautions or relax requirement previously imposed. A protocol that was originally verified using the expedited review procedure (see Expedited Review Policy) may undergo expedited continuing review. Expedited review may also be used for continuing review of research previously approved by the convened IRB if it meets criteria under Expedited Review Category 8. Also, continuing review may be expedited when the research is not conducted under an IND or IDE and no other expedited review category applies but the IRB has determined at a convened meeting that the research involves no more than minimal risks and no additional risks have been identified (Expedited Review Category 9).Changes to Already Approved Research (Modifications)All changes to already approved research undergo review as noted in the Criteria for Continuing Approval Policy. If the change(s) qualifies for expedited review, the designated expedited reviewer reviews the modification and makes a determination listed in section 5.1.If the proposed changes require convened IRB review, a Primary Reviewer with appropriate expertise is assigned to review the modification. The Primary Reviewer uploads his/her comments in to IRBNet, addressing how/whether the change affects the regulatory criteria for approval prior to the convened meeting. The convened IRB determines whether the regulatory criteria remain satisfied. The convened IRB’s determination is documented in the IRB meeting minutes. The convened IRB also makes any other required regulatory or HIPAA determinations, which are also documented in the IRB meeting minutes.Calculation of Approval Period and Interim ReportsThe IRB may approve research for a defined period of time, but in no case greater than one day less than one year from the date of initial approval. The approval period is calculated based on the date of the convened meeting at which the IRB approved the study or the date the study was approved by expedited review. The IRB may approve a project for a period of less than one year. The IRB approval automatically expires at 23:59 on the expiration date, unless otherwise specified in the IRB approval. Both approval and expiration dates are specified on the approval letter sent to the Investigator. In determining the approval period, the IRB will consider the risks posed by the study intervention, the type of safety monitoring provided in the protocol, the study population, and any other factors that may affect the health and welfare of the study participants. If the IRB’s review is not completed prior to the approval expiration date, the Principal Investigator must stop all research activities, including recruitment, advertisement, enrollment, consent, interventions, data collection and data analysis until reports are reviewed and approved. The IRB may request interim reports at intervals deemed appropriate by the IRB in addition to the required continuing review. The determinations will be made by the convened IRB and documented in the minutes.Institutional ApprovalThe Institutional Official, in consultation with the IRB Chair, may review a research study that has been approved by the IRB and either disapprove or impose additional conditions on the conduct of such research study. However, the Institutional Official shall not have the authority to approve the conduct of a research study or any use of an investigational drug or investigational device when the IRB has not approved the research study.Notification of IRB Approval or DisapprovalThe Principal Investigator will be notified via IRBNet of the IRB’s decision as soon as possible after the IRB meeting/review. For conditional approval requiring additional or revised materials or responses from the Principal Investigator or sponsor, such information must be submitted to the LBH Department of Research within 90 days of the date of notification. If there is no communication by the Principal Investigator within the 90-day period, the LBH Department of Research will notify the Principal Investigator that the submission is deemed to have been withdrawn. The Principal Investigator will be notified via IRBNet of the final approval. The IRB approved consent/authorization documents will be available to the Principal Investigator (or his/her representative) for use upon approval. If the IRB disapproves the research study, the Principal Investigator will also be notified via IRBNet as soon as possible. Correspondence will include the reason(s) for disapproval and instructions for the Principal Investigator to appeal such decision.Investigator Appeal of IRB ActionA Principal Investigator may appeal the IRB’s revisions required to satisfy the regulatory criteria for approval (“conditions of approval”) by submitting a written appeal to the IRB Chair via the LBH Department of Research. The Principal Investigator may also appeal an IRB decision to disapprove a study. Any such appeal must be submitted to IRBNet and must be reviewed by the IRB at a convened meeting, at which the Principal Investigator may appear.Notification of Suspension or Termination of IRB Approval for CauseThe IRB may suspend or terminate approval of a research study when the research is not being conducted in accordance with the IRB’s requirements or the study has been associated with unexpected serious harm to subjects (Reporting and Review of Unanticipated Problems in Human Subject Research Policy). If the IRB suspends or terminates IRB approval, the suspension or termination will be reported to regulatory agencies, Institutional Official(s), and others in accordance with the External Reporting Policy. ................
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