Approved by: Human Protections Administrator, Director of OPRS, and Executive IRB Chair
AAHRPP REF#: 130
AAHRPP Elements: II.2.C, II.2.D, II.2.D.2., II.2.E.
- In accordance with federal regulations, initial and continuing reviews of research must be conducted by the IRB at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas (i.e., a quorum), except where expedited review is allowed under HHS regulations at 45 CFR 46.110.
- The IRB Chair may expand the required member representation for quorum on a protocol-specific basis secondary to the scope of the research being reviewed or involvement of vulnerable groups in the study. The presence of an unaffiliated member and member representing the perspective of the participant at the meeting is highly desirable but not mandatory per UIC policy. Refer to UIC HSPP Policy IRB Composition and Membership.
- Review of amendments (i.e., proposed changes to previously approved research) must be conducted by the IRB at convened meetings, except when changes are minor (refer to UIC OPRS Policy Amendments to Previously Approved Research).
- The UIC IRBs use a primary reviewer system with two reviewers having scientific expertise and research experience relevant to the study assigned as primary reviewers. For initial reviews, a nonscientific reviewer is also generally assigned. The review by this individual focuses on the viewpoint of research participant, acceptability of the consent process and understandability of the consent document. For Continuing Reviews and Amendments, two primary reviewers are assigned.
- An IRB panel may, at 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.
- Convened meetings of the IRB require a majority of IRB members and at least one member whose primary concerns are in a non-scientific area.
- The expiration date listed in the electronic database and approval letter to the investigator represents the last date on which research activities may occur. All research activities must stop at 11:59 PM on that date unless re-approval by the IRB has occurred, or a protocol exception granted.
- The effective approval date for calculating the approval period following initial review is the date when conditions for IRB approval are met. At subsequent continuing reviews, the IRB has adopted the fixed anniversary date approach.
- Application Materials
- Initial Review: Materials required for submission for convened or expedited initial review of research are outlined on the Initial Review checklists for biomedical research, social behavioral research and research conducted at Jesse Brown VAMC located on the UIC OPRS website.
- Continuing Review: Materials required for submission for convened or expedited continuing review of research are outlined on the Continuing Review checklists for UIC and Jesse Brown VAMC research located on the UIC OPRS website.
- Amendments: Materials required for submission for convened or expedited review of amendments to previously approved research are outlined on the Amendment checklists for UIC and Jesse Brown VAMC research located on the UIC OPRS website.
- Convened Meeting Schedule
- Each of the four (4) IRBs meets twice monthly, except when there is a lack of submissions, the meeting falls within a UIC- or VA -mandated holiday or a quorum is not available. Whenever possible, cancelled meeting are re-scheduled. Schedules for the board meetings are posted on the UIC OPRS website.
- The IRB Chair in consultation with the Director, OPRS and Executive Chair may convene an IRB to conduct an unscheduled meeting as needed. Examples of reasons for this include but are not limited to: emergency use of an investigational drug or device, treatment IND, humanitarian use device, or sponsor deadline or pending expiration of IRB approval for a protocol of high institutional importance.
- IRB meetings last until determinations have been made for all items of business on the agenda or until quorum is no longer maintained.
- Submission deadlines for convened review by the IRB are provided on the OPRS website and typically are two weeks before the meeting. Items may be added to the agenda after this date with the approval of the IRB Chair and Director, OPRS, provided adequate time for evaluation exists (generally > 48 hours before the meeting).
- Pre-meeting Review Procedures
- Submission Intake by OPRS: OPRS intake staff reviews protocols at the time of submission to ensure their completeness, i.e., inclusion of appropriate materials and any required departmental, college or subcommittee approvals. The OPRS Check-In Process checklists guide this review. Any deficiencies identified are corrected before the submission is formally accepted by OPRS.
- Assignment of Submissions to an IRB
- Submissions for convened review are assigned to an IRB based on:
- performance site (i.e., IRB 4 for VA research).
- IRB conducting the initial review, and
- vulnerable populations (e.g, prisoner research IRB 2),
- type of research (biomedical [IRBs 1,3 or 4] or social behavioral [IRB 2,4],
- next available IRB meeting date,
- While all JBVAMC research must be assigned to IRB 4, IRB 4 may review non-VA research.
- While continuing review and amendments are typically assigned to the IRB performing the initial review, protocols may be transferred to another board due to considerations of expertise and workload with agreement of both Chairs and the Executive Chair.
- A protocol that has been disapproved by one IRB may not be submitted or transferred to another IRB.
- IRB Staff Pre-Review
- After acceptance of the submission, IRB staff performs a pre-review. The pre-review is guided by the UIC OPRS Pre-Review Checklist, and serves the following functions:
- identifies issues and concerns that the IRB may wish to consider.
- (at continuing review) confirms that the informed consent documents, recruitment material and protocol submitted by the investigator matches the current IRB-approved documents; and
- determines whether supplemental reviews from other committees are required and their status;
- assesses the appropriate level of review;
- confirms that all documents required by the IRB have been submitted by the investigator;
- Pre-review comments are provided in writing to IRB members in advance of the meeting.
- IRB staff members contact researchers following the pre-review and attempt to resolve any outstanding issue before the meeting.
- Committees Supplementing the IRB Review
- Depending on the protocol, committees providing supplemental reviews for initial review, continuing review or amendment submissions to the IRB may include: the Cancer Center-Protocol Review Committee, Conflict of Interest Resolution Committee, Clinical Interface Core, Institutional Biosafety Committee, Investigational Drug Service, Embryonic Stem Cell Research Oversight, Radiation Safety Committee, and Radioactive Drug Review Committee. Separate policy and procedures describe the interactions and communication timelines between the IRB and these committees.
- Once completed, the written reviews from these committees are provided to the IRB members. While the goal is to have these reviews and/or approvals completed at the time of submission, the IRB may initiate their review of the research before reviews from the other committees are completed, except for the Investigational Drug Service and Radiation Safety Committee. IRB approval may not however occur until final committee reports have been reviewed and considered by the IRB.
- Preparation of Meeting Agenda
- The Assistant Director uses the Agenda Worksheet Tool to assist in constructing the agenda and assessing the review requirements of the submissions.
- IRB members, alternates and ad hoc consultants are notified of their assignments through the agenda. The agenda is prepared by the IRB Assistant Director and Coordinators, and distributed along with the review materials approximately one week before the meeting.
- Revision of the agenda may occur as a result of additional submissions or issues for consideration. A revised agenda is prepared and distributed.
- In addition to listing the initial reviews, continuing reviews and amendment submissions and assigned primary reviewers , the agenda also informs IRB members concerning research protocols approved by expedited procedures since the last IRB meeting, emergency use of a test article, unanticipated problems or allegations of serious or continuing noncompliance, protocols closed or suspended, protocols whose IRB approval has expired, past meeting minutes for review or approval, continuing education or policy discussions, and protocols requiring waiver determinations or vulnerable population determinations.
- IRB Reviewer Assignments
- Assignment of primary reviewers and verification of appropriate representation at the meeting for any vulnerable groups involved in the protocols to be reviewed is performed by the IRB Assistant Director in consultation with the Chair as described in UIC OPRS Policy Scientific and Scholarly Review of Research.
- The Assistant Director and Chair also identify whether a need exists for ad hoc reviewers (refer to UIC HSPP Policy Identification and Use of Ad Hoc Consultants).
- The IRB Chair and Assistant Director document through the agenda approval sheet whether adequate expertise is available to review the protocols assigned to the meeting or whether additional expertise is needed.
- Materials Provided to reviewers
- Primary reviewers are provided and expected to perform an in depth review of the complete set of documents submitted by the investigator (refer to Application Materials above). Their review includes but is not limited to the following, when applicable: complete protocol with any IRB approved amendments incorporated, Investigator’s Brochure (when applicable), federal grant or contract, any appendices to the IRB application, DHHS approved consent templates and protocols, current consent and recruitment documents, UIC IRB Initial Review, Continuing Review and Amendment applications and appendices.
- Ad Hoc consultants generally receive the same materials as the primary reviewers.
- Other IRB Members Scheduled to Attend the Meeting (Including Alternates)
- Initial Review
- Full protocol, application or a protocol summary of sufficient detail to allow the determinations under 45 CFR 46.111 to be made,
- Proposed informed consent document(s), and
- Any recruitment materials.
- Continuing Review
- Full protocol, application or a protocol summary of sufficient detail to determine whether the proposed research continues to fulfill the criteria for approval,
- Current consent documents,
- Any newly proposed consent documents, and
- Status report on research, including:
- Number of subjects accrued,
- Summary since last IRB review of:
- any amendments,
- adverse events and adverse outcomes experienced by subjects,
- unanticipated problems involving risks to subjects or others,
- subject withdrawals,
- reasons for withdrawals,
- complaints about the research,
- any relevant recent research,
- any interim findings.
- Any relevant multi-center trial reports or DSMB or DMC reports, and
- Researcher’s current risk-benefit assessment.
- Amendments to Previously Approved Research
- Amendment application and
- Any modified or revised documents.
- The complete IRB file for the protocol, including initial review and approval and any other previous reviews, including ad hoc, continuing reviews, reviews of amendments to the research or unanticipated problems, is made available to primary reviewers and other IRB members prior to the meeting at which the research is to be reviewed and is accessible during the meeting.
- Requests for additional information
- If the IRB members, alternates or ad hoc consultants require additional information or guidance, these individuals may contact any combination of the following persons: the Assistant Director of the IRB, the OPRS Director or Associate Director, the IRB Chair or Vice Chair, other IRB members, or OPRS staff.
- The IRB members, alternates or ad hoc consultants may also directly contact the investigator or a member of research team listed on the application as a contact to obtain additional information or clarification. IRB members, alternates or ad hoc consultants should forward any information that may assist other IRB members and staff in their evaluation.
- If IRB members, alternates or ad hoc consultants would like to remain anonymous to the investigator, these individuals may request that OPRS staff make requests on their behalf.
- IRB Meeting Procedures
- Attendance at convened meetings is captured by documenting in the minutes, Meeting Attendance Sheet and Protocol Voting Record:
- IRB members (voting, alternates) in attendance,
- IRB members not in attendance,
- Replacement of a member in voting by an alternate,
- continued presence of quorum for all votes, including a member whose primary concern is in a nonscientific area,
- Attendance of members and alternate members who participate through videoconference or teleconference along with documentation that those members received all pertinent material before the meeting and had the opportunity to actively and equally participate in all discussions,
- IRB members who are recused due to a conflicting interest,
- IRB members who leave the meeting, are not present during a vote, and are not counted as part of the quorum,
- Others present (e.g., invited guests, investigators invited to address the IRB, ad hoc consultants, OPRS/OVCR administration).
- Quorum and Voting Requirements
- The IRB Chair and Vice Chairs are voting members of the IRB.
- The IRB Chair with assistance of the Assistant Director of the IRB determines that quorum is established and maintained. Quorum is documented by the IRB in the minutes using the Meeting Attendance Sheet and Protocol Voting Record.
- Standards for quorum and voting are:
- A majority of voting members of the IRB (or their designated alternates), including at least one member whose primary concerns are in non-scientific areas, must be present in person or via audio- or videoconference to conduct a convened meeting.
- In order for research to be approved, it must receive the approval of a majority of such members present at the meeting. Voting occurs by a show of hands or voice vote. Voting is documented in the Protocol Voting Record. Voting by proxy is not permitted.
- Members leaving the meeting room due to a conflicting interest or any other reason are not counted as part of quorum for a particular protocol.
- If quorum is lost during a meeting, due to either lack of a majority of IRB members being present or absence of a non-scientist or another required member (e.g., physician for FDA research, representative of a vulnerable group), the IRB cannot take any further actions or vote until quorum is restored. If quorum is not restored, the protocol is tabled.
- Presence of an un-affiliated member is desirable.
- A non-scientist or un-affiliated member represents the perspective of research participants
- Protocol-Specific Quorum Requirements
- When the IRB reviews research that involves participants vulnerable to coercion or undue influence, at least one member must be present who is knowledgeable about or experienced in working with these participants.
- When the IRB reviews research that involves prisoners, the prisoner representative must be present.
- At least one VA member must be present when reviewing research to be conducted at JBVAMC.
- In accordance with VHA handbook 1200.05 and FDA guidance, UIC policy requires that an IRB member who is a licensed physician be present for protocols involving FDA regulated articles.
- When the IRB reviews VA research that involves mentally disabled persons or persons with impaired decision-making capacity, an IRB member who is an expert in the area of the research must be present.
- In accordance with 34 CFR Parts 350 and 356, if an IRB reviews research that is supported by the U.S. Department of Education and subject to 34 CFR 97 and that purposefully includes children with disabilities or individuals with cognitive impairment and decisional impairment as research subjects, at least one member primarily concerned with the welfare of these research subjects must be present.
- Conflict of Interest
The IRB Chair asks at the beginning of the meeting in reference to the entire agenda or before each protocol in reference to that protocol whether any members have a conflict of interest as defined in UIC HSPP Policy IRB Member, Ad Hoc Consultant, and OPRS Staff COI.
- Protocol Review
- Posters containing the approval criteria (45 CFR 46.111 and 21 CFR 56.111) and the basic and additional elements of informed consent (45 CFR 46.116 and 21 CFR 50.25) are available in the IRB meeting room for reference during the meeting. IRB members are also provided with a booklet containing tip sheets with the regulatory information and approval criteria and review guides to assist in conducting their reviews.
- IRB discusses each protocol individually and applies the criteria for approval as described in the applicable review guides, which each IRB member utilizes to facilitate their review.
- The primary reviewers provide a summary of the protocol and lead the discussion of the protocols assigned to them. They are expected to have a thorough understanding of the research and conduct an in-depth review using the materials submitted by the investigator and the IRB Review Guides relevant to the research.
- A primary reviewer presents a summary highlighting:
- critical issues for consideration of the IRB ,
- when reviewing an amendment
- changes being proposed,
- impact of changes on approval criteria,
- any significant new findings have arisen from the review process and that might relate to subjects’ willingness to continue participation, and
- whether and how these finding should be provided to subjects.
- when conducting a continuing review
- concerns that have arisen since the prior IRB review,
- whether adverse events are of the type or frequency expected,
- changes to the protocol or consent being proposed or required,
- whether verification is needed from someone other than the researcher that no material changes have occurred since the prior IRB review,
- any significant new findings have arisen from the review process and that might relate to subjects’ willingness to continue participation should be provided to subjects,
- whether and how these finding should be provided to subjects, and
- current consent documents are complete and accurate.
- recommendations for action by the IRB (i.e., approval, issues requiring modifications or clarifications),
- whether the criteria for approval under 45 CFR 46.111 (and subparts B, C, and D, when applicable) or 21 CFR 56.111 and any other required determinations are met (initial review), continue to be met (continuing review) or are not met. The criteria for approval must also be assessed for amendments when the changes affect a criterion for approval, and
- whether the required elements of informed consent are present (45 CFR 46.116 or 21 CFR 50.250) or waiver or alteration granted according to the regulations and the consent process is appropriate . .
- The other primary reviewer and, if an initial review, the nonscientific reviewer provide any additional information and recommendations.
- The other IRB members are then provided the opportunity to express their views. These members are expected to have reviewed the materials provided them and have sufficient understanding of the protocol to assess its acceptance.
- An IRB member who cannot attend the convened meeting may submit written feedback by email or fax to the IRB Assistant Director so that the convened IRB may consider their comments. IRB members who do not attend the IRB meeting do not count toward quorum and cannot vote
- Ad Hoc Consultants are present only for the discussion involving the relevant protocol, speak to the area of knowledge in their written report, and remain present until the IRB is ready to vote to allow any questions or concerns to be addressed. Ad Hoc consultants are not permitted to vote and do not count toward quorum.
- After the IRB completes their deliberation, the IRB Chair (or designee) calls for a motion and formal vote for all determinations related to approval of the new protocol, previously deferred protocol, continuing review request or amendment of research previously approved by the IRB.
Discussions of controverted issues and actions taken by the IRB , and separate determinations and protocol specific justifications for the determinations are documented in the minutes as described in UIC HSPP Policy Documentation of IRB and OPRS Activities .
- Range of possible actions by the IRB
- Approval: An approval is granted if the research activities meet the criteria for approval (45 CFR 46.111 or 21 CFR 56.111 and, if applicable Subparts B, C and D) and no changes to the research are required by the IRB .
- Modification: also referred to as approval with conditions or pending modifications to secure approval. The IRB requires as a condition of approval that the investigator (a) make specified changes to the research protocol or informed consent document(s), (b) confirm specific assumptions or understandings on the part of the IRB regarding how the research will be conducted, or (c) submit additional documents, such that, based on the assumption that the conditions are satisfied, the IRB is able to make all of the determinations required for approval (under 45 CFR 46.111 and, if applicable, subparts B, C, or D). Under this scenario, further review of the research by the convened IRB is not necessary. The IRB may designate the Chair (or other designee) to review the written response from the investigator, determine whether the conditions for approval have been met and, when they are met, approve the research. The date of approval is the date the IRB Chairperson (or designee) determines the conditions for approval have been met.
- Approval with Conditions: This action is limited to continuing review. The action is similar to modification in that the IRB is able to make all of the determinations required for re-approval (under 45 CFR 46.111 and, if applicable, subparts B, C, or D) and further review of the research by the convened IRB is not necessary. With this action, the IRB allows the investigator to continue some research activities but not those affected by the conditions required for approval. For example, due to new information, the IRB requires the investigator to lower the age limit for eligibility from 75 to 60 years as a condition for approval. The IRB re-approves the protocol for current subjects, but no new subjects may be enrolled until a revised protocol including the new age requirements is reviewed and approved by the Chair or designee. With this action, the IRB will generally set a time limit of 30-60 days for meeting the conditions for approval.
- Deferral: Substantial modifications, requests for more information for IRB consideration or other additional documentation are required, and preclude the IRB from making the determinations required for approval. The response to the IRB’s concerns and any revisions to the protocol or consent documents must be reviewed at a convened meeting of the IRB.
- Tabled: Criteria for a convened IRB meeting or review of the protocol are not met (e.g., loss of quorum, appropriate expertise or representation for a vulnerable group is not present). Study is reviewed at a subsequent meeting when criteria for review are met.
- Disapproval: A study is disapproved if it is found to be unethical, without scientific or scholarly merit and/or does not meet the criteria for approval . Written notification from the IRB of a decision to disapprove a protocol is accompanied by the IRB panel’s reasons for the decision and an invitation for reply by the Investigator . A protocol may not be disapproved under expedited review procedures.
- Not Research Involving Human Subjects: Refer to UIC HSPP Policy Institutional Authorization for Determining whether Research or Other Activities Represent Human Subjects Research .
- Not Engaged in Human Subjects Research. UIC HSPP Policy Engagement of UIC in Human Subjects Research .
- Approval Periods (implementation date: 6/15/2012)
- Following approval or modification (to secure approval) of the initial or continuing review of a protocol, the IRB determines the continuing review interval appropriate to the degree of risk, but not less than once per year.
- Approval of amendments to previously approved research does not change the currently assigned expiration date.
- The maximum continuing review interval is one year.
- The IRB may require continuing review more frequently than once per year. Studies that the IRB focuses on for imposing review intervals of less than a year include :
- studies that pose a very high level of risk to individual participants (very high risk to individuals);
- high risk studies that are expected to have a large number of participants involved (high cumulative risk);
- phase I drug and device studies;
- investigator-initiated studies of investigational drugs or devices; and
- studies conducted by PIs who have been non-compliant with the protocol at issue or other protocols, are currently involved in a for-cause compliance investigation, or studies being conducted by new investigators.
- Actual Date of Approval
- The actual date of approval represents the date that the research activities (or change of activities) reviewed and approved by the IRB may begin. For initial reviews, continuing reviews and amendments to previously approved research, this is the date the convened IRB or the Chair (or designee) designated by the IRB determines that all conditions for approval have been met.
- Continuing review approval
- or approval with conditions as defined in IV.F.3. must be secured before IRB approval expires. The consequences and handling of a lapse in IRB approval are described in UIC HSPP Policy Study Closure, Lapse in IRB Approval and Withdrawal of Research.
- Effective Date of IRB Approval
- Effective date refers to the last permissible date that may be used to calculate the expiration date. For initial review, the effective and actual approval dates are the same. However, the effective and actual approval dates differ at continuing review.
- Initial Review by IRB at Convened Meeting
- Scenario I. Convened IRB approves the protocol without conditions: effective approval date is date of the meeting where approval occurs OR
- Scenario II. Convened IRB requires modification to secure approval without the need for further review at a convened meeting: the date when the IRB Chair (or designee) approves all changes required by the IRB from the investigator is the effective approval date.
- Initial Review by IRB Under Expedited Procedures
- Date when the IRB Chair (or designee) approves the research without conditions.
- Continuing Review by IRB at Convened Meeting
- Actual and effective dates differ.
- The effective date is the date of the convened meeting where the IRB approves or modifies (without the need for further review at a convened meeting determines) the protocol.
- Continuing Review by IRB Under Expedited Procedures
- The date when the IRB Chair (or designee) last reviews and either approves or modifies (without need for further review by the Chair or other IRB member) the protocol.
- Expiration (Continuing Review) Date
- Expiration Date (first continuing review date) for Research Reviewed at a Convened Meeting or by Expedited Procedures at the Time of Initial Review
- The expiration date is set at 11:59 PM on the date determined by adding the IRB approved continuing review interval to the effective approval date.
Example 1: IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting and approves the protocol without conditions for 1 year. The effective approval date is 4/1/2012. The expiration date is 4/1/2013, and continuing review must occur before 11:59 PM on this date.
Example 2: IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is modified with editorial changes to the consent form prescribed to secure approval without the need for further review at a convened meeting. The IRB sets the continuing review interval at 1 year. The Chair receives and reviews the revised consent form on 4/20/2012 and determines the changes made by the investigator are satisfactory. The effective approval date is 4/20/2012. The expiration date is 4/20/2013, and continuing review must occur by this date.
Example 3: IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is deferred with substantive changes to the consent form required to obtain approval at a subsequent convened meeting. The revised consent form is reviewed by the IRB at the 5/1/2012 convened meeting, and the changes were found to be acceptable with the exception of minor changes to the consent and documentation of training. The IRB issues a modification determination with an approval interval of 1 year. The modifications were reviewed and approved by the IRB Chair outside a convened meeting on 5/15/2012. The effective approval date is 5/15/2012 and the expiration date is 5/15/2013.
Example 4: A protocol qualifying for initial review by expedited procedures was reviewed and modified by the Chair outside a convened IRB meeting on 4/2/2012. The revisions from the investigator were subsequently reviewed by the Chair on 4/26/2012, the modifications found to be acceptable and the protocol approved for 1 year. The effective approval date is 4/26/2012 and the expiration date is 4/26/2013.
Example 5: IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is modified with revisions to the recruitment poster prescribed to secure approval without the need for further review at a convened meeting. Due to prior compliance issues, the IRB sets the continuing review interval at 6 months. The Chair receives and reviews the revised consent form on 4/20/2012 and determines the changes made by the investigator are satisfactory. The effective approval date is 4/20/2012, and the expiration date is 10/20/2012.
- Expiration Date for the Second and Subsequent Continuing Reviews for Research Reviewed at a Convened Meeting or by Expedited Procedures
- The UIC HSPP has adopted a procedure for maintaining fixed anniversary dates for expiration of annual IRB approval.
- As a result, when the IRB performs continuing review and re-approves the research within 30 days before IRB approval expires, the IRB retains the anniversary of the expiration date of the initial IRB approval as the expiration date of each subsequent one-year approval period (for approvals less than 1 year, the same process is followed, however changes occur in increments of less than a year).
- Thus, if the initial (or prior) IRB approval expires on 7/31/2011, the expiration date following re-approval would be 7/31/2012 providing the IRB re-approved the research between 7/1/2011 and 7/31/2011.
- If the IRB reviews and re-approves the protocol prior to 30 days before expiration, the new expiration date is calculated based on the date of the convened meeting where the IRB approves or modifies (without the need for further review at a convened meeting) the protocol or, for review by expedited procedures, the date when the IRB Chair (or designee) last reviews and either approves or modifies (without need for further review by the Chair or other IRB member) the protocol.
- When re-approval is not obtained by the expiration date (i.e., approval lapses), the expiration date when re-approval is finally obtained reverts to the anniversary date. Thus, if the expiration date is 7/31/2011 but the continuing review submission occurs after this date and re-approval is not obtained until 9/1/2011, the new expiration date is 7/31/2012.
Example 1 (continued): IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting and approves the protocol without conditions for 1 year. The effective approval date is 4/1/2012 and the expiration date is 4/1/2013. The IRB conducts the first continuing review of the protocol at a convened IRB meeting on 3/8/2013 and reapproves the protocol for 1 year. The expiration date for the second approval period is 4/1/2014, and continuing review must occur by this date.
Example 2 (continued): IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is modified with minor wording changes to the consent form prescribed to secure approval without the need for further review at a convened meeting. The IRB sets the continuing review interval at 1 year. The Chair receives and reviews the revised consent form outside a convened meeting on 4/20/2012 and determines the changes made by the investigator are satisfactory. The effective approval date is 4/20/2012 and the expiration date is 4/20/2013. The IRB conducts the first continuing review on 4/2/2013 and defers the protocol requiring the investigator to explain the higher than expected frequency of skin rash and institute additional protections. Re-approval is not obtained by 4/20/2013, approval lapses and research activities stop. The IRB reviews the clarification and protocol revision from the investigator at a convened meeting on 5/6/2013 and reapproves the protocol for 1 year. Because re-approval did not occur until after the expiration date, the expiration date for the second approval period reverts to 4/20/2014, and continuing review must occur by this date.
Example 3 (continued): IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is deferred with substantive changes to the consent form required to obtain approval at a subsequent convened meeting. The revised consent form is reviewed by the IRB at the 5/1/2012 convened meeting, and the changes were found to be acceptable with the exception of minor changes to the consent and documentation of training. A modification determination was issued by the IRB with an approval interval of 1 year. The modifications were reviewed and approved by the IRB Chair outside a convened meeting on 5/15/2012. The effective approval date is 5/15/2012 and the expiration date is 5/15/2013. The IRB conducts the first continuing review at a convened meeting on 4/1/2013, and reapproves the protocol without conditions for 1 year. Because the re-approval occurs more than 30 days before the expiration date, 4/1/2013 becomes the new effective approval date and the expiration date for the second approval period is 4/1/2014.
Example 4 (continued): A protocol qualifying for initial review by expedited procedures was reviewed and modified by the Chair outside a convened IRB meeting on 4/2/2012. The revisions from the investigator were subsequently reviewed outside a convened meeting by the Chair on 4/26/2012, the modifications found to be acceptable and the protocol approved for 1 year. The effective approval date is 4/26/2012 and the expiration date is 4/26/2013. The continuing review submission is reviewed by expedited procedures by the Vice Chair on 4/20/2013 and the protocol re-approved for 1 year. The expiration date for second approval period is 4/26/2014.
Example 5 (continued): IRB conducts an initial review of a protocol at the 4/1/2012 convened meeting, and the protocol is modified with revisions to the recruitment poster prescribed to secure approval without the need for further review at a convened meeting. Due to prior compliance issues, the IRB sets the continuing review interval at 6 months. The Chair receives and reviews the revised consent form outside a convened meeting on 4/20/2012 and determines the changes made by the investigator are satisfactory. The effective approval date is 4/20/2012 and the expiration date is 10/20/2012. The continuing review submission is reviewed at a convened meeting on 10/1/2012, and modifications to secure approval without the need for further review at a convened meeting required. The IRB chair reviews the modifications submitted by the investigator outside a convened meeting on 10/10/2012 and determines that the conditions for approval are met. The expiration date for the second approval period is 10/20/2013.
- Post meeting activities.
- The notification letter includes:
- when IRB approves submission
- approval date
- approval period (initial and continuing review only)
- rationale if approval period is less than a year
- amendment number (amendments only)
- amendment summary (amendments)
- approved number of subjects
- additional determinations for vulnerable groups
- performance sites
- sponsor (and grant or contract number for federal research)
- titles, version numbers and version dates of approved protocol, investigational brochure, informed consents and HIPAA authorizations,
- waiver or alteration of consent or waiver of documentation determinations,
- approved informed consent document(s) and recruitment material(s) stamped with the new approval period,
- approved HIPAA authorization stamped with the approval date,
- statement that only the most recent IRB-approved and stamped consent documents and HIPAA authorizations should be used to enroll subjects, and
- copy of investigator responsibilities poster.
- review history for current submission
- When IRB disapproves research
- Description of reasons for disapproval
- Description of how researcher may respond
- description of modifications, information requests or clarifications
- basis for requiring modification
- instructions for submitting written response
- process for IRB review of response
- notice that submission will be withdrawn in 90 days if no response
- when the IRB requires modifications to the protocol/application or consent documents, further information or clarifications for approval (i.e., review action modification, deferral or approval with conditions):
- decisions of the IRB
- process of review
- what was reviewed (i.e., protocol IRB number, title)
- date of review
- In instances where the IRB did not approve the study under review, the investigator must respond to the IRB’s findings in writing . The IRB may also provide the investigator with an opportunity to respond to the IRB in person at a convened meeting. The IRB generally makes every effort to accept the investigator’s request for an in person or telephone conference, especially following a deferral. However, the IRB Chair in consultation with the Director, OPRS and Executive Chair makes the final decision based on logistics and the findings.
- Reporting Findings to OrganizationThe IRB notifies the investigator in writing via e-mail and campus mail concerning the IRB’s findings. The notification letter is prepared by the IRB staff. When stipulated by the IRB, the letter is reviewed by the Chair or other IRB member after preparation. The staff may also request the Chair or IRB members for their input.
- The investigator’s department head and, if applicable, faculty sponsor are copied on all communications.
- The Institutional Official, i.e. Vice Chancellor of Research, Human Protections Administrator and Executive Chair are informed of the IRB’s review actions through the IRB minutes.
- Review of Investigator’s responses to the IRB
- The IRB Coordinator or Assistant Director reviews responses from investigators for modification or approval with conditional determinations. The IRB Coordinator or Assistant Director notes on the Pre-Review Guide whether there are any issues with the response. The IRB Coordinator assigns the protocol to the appropriate Chair or designated member and informs them that the responses are ready for review and determination.
- Responses from PIs for deferrals are reviewed by the IRB Coordinator or the Assistant Director and changes are verified. The deferral responses are then assigned to the next IRB meeting for further review by the convened IRB. The IRB that originally reviewed the protocol must review the resubmitted protocol, unless it was stipulated that a different committee is able to review the resubmission. The re-review is assigned to the original primary reviewers whenever possible.
- Responses and resubmissions from investigators for disapproved motions are prepared for convened IRB review. The IRB that originally reviewed the protocol reviews the resubmitted protocol, unless it was stipulated that a different IRB is able to review the resubmission.
- Investigators are provided 90 days to respond to the IRB’s findings. UIC HSPP Policy Study Closure, Lapse in IRB Approval and Withdrawal of Research describes the policy and procedures related to withdrawal of research due to a failure to respond.
- The consequences of a failure to obtain continuing review approval by the expiration date are described in UIC HSPP Policy Study Closure, Lapse in IRB Approval and Withdrawal of Research .
- Review of Research at the JBVAMC by the Convened IRB Refer to UIC HSPP Policy Operating and Coordinating Procedures for the Administration of the Collaborative JBVAMC/NU /UIC IRB ( UIC IRB #4).
21 CFR 50.25(b)(5), 21 CFR 56.108(a), 21 CFR 56.109
45 CFR 46.103(b)(4), 45 CFR 46.109, 45 CFR 46.116(b)(5)
FDA Guidance for IRBs, Clinical Investigators, and Sponsors: IRB Continuing Review after Clinical Investigation Approval. US FDA, DHHS, February 2012.
OHRP Guidance on Continuing Review of Research, OHRP, DHHS, November 10, 2010
OHRP Guidance on IRB Approval of Research with Conditions, OHRP, DHHS, November10, 2010
OHRP Guidance on Written IRB Procedures OHRP, DHHS, July 1, 2011
OHRP Frequently Asked Questions: IRB Procedures
VHA Handbook 1200.05, vs. 10/15/2010, paras. 10, 22, 44
|Version (#, date)
||Replaces (#, date)
||Summary of changes
||Revised policy to be more inclusive of both convened and expedited review. Changed title to reflect this from “Convened Review Process” to “IRB Review Process.”
||Included a description of the quorum requirements, a description of the calculation period, the list of items reviewed by the primary reviewer and other IRB members, the list of items reviewed by the primary reviewer and other IRB members for continuing review.
||Updated IRB review procedures, quorum requirements, and IRB actions. Method for calculating expiration date and approval period revised.