EXPEDITED REVIEW - 45 CFR 46.110
There is no submission deadline for research that meets the criteria for expedited review found in Section F. To obtain IRB approval of such research, you must send to the IRB office, one completed paper copy of the following items, along with a CD containing the submitted materials (in Word format):
Section 1
1. Core Application - completion of A & B is required
2. The research protocol and/or grant application, (A copy of the entire grant, from cover to cover, is required for federally funded research.)
3. Consent document(s) including a valid HIPAA compliant authorization if protected health information (PHI) will be involved in the research. PLEASE USE THE TEMPLATE in Section 2. (IRB Forms)
4. Data collection forms, instruments, questionnaires, interview questions, and/or recruitment materials.
5. Application(s) for waivers or partial waivers of consent and authorization when needed (see guidance at http://research.uthscsa.edu/irb/guidance.doc) These forms are located in Section 2 and Section 3.
(Please download the IRB forms from the IRB WEB site to ensure you are using the most current versions. Refer to Section I for instructions for completion of protocol submission forms.)
After it is determined that the proposed research meets the criteria for expedited review and all necessary clarifications and/or revisions have been made, an approval letter is sent to the principal investigator, indicating the category(ies) under which the research was approved, the investigator's responsibilities (see Section M), the duration of approval, and the date of continuing review. The study may be implemented only after the investigator has received the IRB approval. Investigators must also be aware of other committees at institutions serving as study sites, whose approval must also be obtained, such as the University Health System’s Research Committee and the VA R&D Committee. The approval of expedited protocols is reported to the appropriate IRB at the next convened IRB meeting and is recorded in the minutes. While it rarely occurs, the IRBs have the authority to question any of the expedited approvals given on their behalf.
IRB-1 and IRB-3 --FULL BOARD REVIEW
IRB-1 can review new submissions of any specialty (e.g., psychiatric, pediatric, obstetric, dental, oncologic, etc). IRB-3 is no longer limited to Oncology studies.
There are two phases in submitting a protocol for review by the convened IRB-1 or IRB-3:
-- administrative pre-review submission and
-- submission for an IRB meeting agenda
Deadlines for these submissions are published and vary from month to month.
All studies considered by the convened IRB-1 or IRB-3 must undergo pre-review. The purpose of the administrative pre-review is to ensure the materials being forwarded for IRB consideration are complete. Applications will not be placed on an agenda until the materials are deemed complete by the IRB office. Please the IRB webpage for detailed instructions. Look for a link to “How to Prepare a New IRB Submission”.
The Deadlines are set to ensure that the investigators have adequate time available to respond to administrative pre-review and prepare their submission materials, and the IRB members have adequate time to review the submissions prior to attending the Board meeting.
It generally takes 8-10 weeks from pre-review to final approval, with all conditions met. This is an estimate and meant to serve only as a guideline for funding deadlines.
Phase 1 - PRE-REVIEW
As soon as the protocol is ready, but no later than 9:00 a.m. on the Pre-Review deadline (33 days before the IRB), submit one paper copy and one electronic copy on a CD (or other media) of the complete IRB application: the IRB forms, the complete protocol, including a copy of the grant or sponsor's protocol, instruments to be administered if not routinely used in clinical practice, data collection forms and the consent documents. (Refer to Section I for instructions for completion of protocol submission forms.)
The application will be reviewed for obvious deficiencies or points needing clarification. The reviewers contact the investigator by email to convey revisions and clarifications which may be necessary.
Pre-review does not guarantee immediate full board approval. The intent of the pre-review is to assist the research investigator to meet IRB requirements and to facilitate review by the full board. While the investigator is not required to comply with every pre-review concern, the investigator should offer a rebuttal or explanation for those with which s/he does not comply.
Phase 2 - FULL BOARD REVIEW AT THE CONVENED MEETING
By 9:00 a.m. on the deadline for final submission, for IRB-1 and 3, submit 1 electronic copy (CD/disk) containing all documents being submitted for Board review and 24 copies (23 copies + original) of the complete revised IRB application WITH TWO EXCEPTION:
-Protocol - Only 4 copies of the sponsor’s protocol or grant application must accompany this package. The remainder of the sets must include the IRB submission forms, but do not have to include the sponsor's protocol, with the following exception. If the IRB submission forms reference pages in the protocol, either the protocol or the referenced pages should be attached to the submission forms (with the exception of background information; instructions on form indicate page numbers are sufficient for the background). You are not required to submit copies of highlighted changes or emails concerning pre-review in your packages for final submission.
- Investigator Drug/Device Brochure – Only submit 1 copy.
The IRB staff will try to check submissions for completeness and adherence to guidelines; however, it is the investigator's responsibility to ensure his/her submission is complete and properly prepared. PLEASE PROOF READ AND DOUBLE CHECK THAT EACH ITEM REQUIRED IS ACTUALLY INCLUDED. Failure to provide proper materials will likely result in the protocol being TABLED by the Board.
Applications which meet the appropriate deadlines and contain all essential elements are placed on the agenda for the next scheduled IRB meeting.
The IRB-1 generally meets on the second Tuesday of each month at 2:00 p.m. IRB-3 generally meets on the 4th Tuesday of each month (except December). The schedule of meeting dates is published annually in August, is posted on the IRB webpage and should be consulted to confirm meeting dates. Occasionally deadlines are modified after first published, so always verify.
Each IRB member receives a copy of each of the applications on the agenda, for their review prior to the meeting.
At the Board meeting, the primary and secondary reviewers present the protocol, summarizing the application, and any issues they may have identified. After the reviewers make their own recommendations for further clarification or revision, the discussion is open to the full board. Upon termination of the discussion, the members identify the various determinations made by the board and a motion is made, to either: (a) approve the application as submitted; (b) approve the application contingent upon specific conditions; or (c) defer the application. A majority vote of those present is required for any IRB action. If the motion is to approve the application with conditions, the conditions are enumerated. The Board then considers whether the conditions are minor and what type of review the reply to the conditions may have.
If the protocol application involves pregnant women or children, the special considerations required by Subparts B or D of the regulations must also be made. If the application involves prisoners, the prisoner representative must either attend the meeting or participate by conference call and the Board must make the determinations required by Subpart C of the regulations.
Approval is given for a period of no more than one year. Continuing review of the study will be performed at least annually but may be required at shorter intervals (e.g. semi-annual, quarterly, or after a number of subjects have been enrolled), depending upon the degree of risk to subjects.
The Chair conveys the decision of the board in writing to the investigator after the meeting:
1. Approved as submitted. A letter of approval is sent to the principal investigator indicating the investigator's responsibilities (see Section M), the duration of approval, and the date of continuing review. The consent document is stamped with the official date of approval and a copy is provided.
It is the responsibility of the principal investigator to provide notification of approval to funding agencies or other committees (e.g., VA Research & Development, Clinical Research Center, University Health System) in accordance with the appropriate guidelines (refer to Section below and the IRB Forms)
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2. Contingent approval. A letter outlining necessary revisions and/or clarifications required for approval is sent to the principal investigator. The conditions are addressed by the principal investigator by submitting a point by point reply, an amended protocol, additional information and/or revised consent documents for consideration. If the IRB determined the conditions for approval were minor and the review of the reply could be performed by the Chair or his/her designee without the amended application being seen again by the full board, the response will be reviewed by the Chair or his/her designee. If the reply is deemed satisfactory, approval to implement the study may be granted and the study may begin. If the Board determined that the conditions for approval were not minor, the response to the conditions must be considered by the convened IRB, therefore the appropriate number of copies of the necessary materials would have to be prepared and submitted by the appropriate deadline. (Consult the IRB office for instructions if this occurs.) The result of the review is conveyed in writing to the PI. When no conditions remain,a letter is sent to the principal investigator indicating the approval date, the investigator's responsibilities (see Section M), the duration of approval, and the date of continuing review. The consent document is stamped with the official date of approval to implement the study and a copy is provided with the approval letter. Subjects may not be recruited nor involved in the study until all conditions have been addressed and approval to implement the study has been given. This action, if taken on behalf of the IRB by the chair or his/her designee, will be conveyed to the IRB at the next convened full Board meeting and recorded in the minutes.
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3. Deferred. When the changes required in the protocol or questions raised by the Board are significant enough to warrant tabling or disapproving the study, the investigator's replies will require review at a subsequent convened Board meeting. A letter outlining necessary revisions and/or clarifications is sent to the principal investigator. A revised application may then be submitted following the procedures and deadlines for new submissions. The "new" protocol application will be reviewed by the IRB in the standard manner. Whether pre-review will be required again is determined by the IRB.
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IRB-2 – CONTINUING REVIEW
Purpose:
IRB protocol approval is an ongoing process. IRB approval is a temporary authority that may be withdrawn at any time if warranted by the conduct of the research. Initial approval is based on whether the Board deems that the researcher’s assessment about anticipated results, risk, and procedures is reasonable and supportable, given currently available evidence and information. At the initial review, the IRB also determines how often the research project should be reevaluated . The maximum time interval between periodic continuing reviews is one year, commencing from the date of the full IRB meeting at which approval (with or without conditions) is granted.
Continuing review is just as important as the initial review and approval. It is only after research has begun that the real risks can be evaluated and the actual risk/benefit ratio calculated to determine whether the Board was correct in its initial judgment about the protocol. Further, the risk/benefit ratio may change over time. Unexpected results and effects of the research project itself as well as new knowledge resulting from other research (e.g., alternative treatments now available, newly identified side effects of the study drug) may affect the balance between benefits and risk. Based on its assessment at the time of continuing review, the IRB may require that the research be modified (by imposing special precautions or by relaxing special requirements previously imposed on the research) or halted altogether.
Notification that Continuing Review is Due:
The IRB Office generates Progress Report notices for each study due to undergo continuing review. The Progress Report notices are generated approximately two months prior to the expiration date, to permit adequate time to complete the process prior to the approval expiring. The PI submits the completed progress report for his/her study. Progress Reports must be submitted as long as any research activities are being conducted. For example, if all subjects have completed the study and subjects are only being followed, the study is still “active” because research activities that may affect the risk assessment are still being carried out. If the only activity is data analysis, the study may be inactivated if certain conditions are met. Contact the OIRB for details.
Failure to submit the progress report and obtain reapproval will result in the IRB taking action to inactivate the study protocol. Subsequent reactivation would require complete resubmission for pre-review, as a new study.
Progress Reports (see IRB Forms):
Information provided in the Progress Report and copies of the consent documents currently in use, are reviewed by the IRB with the original protocol, using the same criteria used at the initial review. Special attention in paid to investigator compliance including whether the protocol has been followed, new information discovered, whether the number of subjects is within approved limits, reasons for subjects not enrolling or not continuing in the study, whether any unanticipated problems posing risks to subjects and others occurred during the investigation and whether the latter were appropriately reported to the IRB.
Number of Copies to Submit and Review Procedures:
The number of copies to be submitted depends on the type of review necessary. The federal regulations define when review by a convened IRB is required and when an "expedited" review is permitted, meaning that it would be reviewed by a single reviewer designated by the IRB. The regulations state that continuing review may be done by an expedited review procedure under any of the following conditions:
a. the research was originally approved by expedited review (this information appears in your original approval letter)
Or if the research was originally approved by the convened IRB,
b. the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions and the research remains active only for long-term follow-up of subjects; or
c. no subjects have been enrolled since the initial IRB approval and no additional risks have been identified; or
d. the remaining research activities are limited to data analysis; or
e. the research does not involve a drug requiring an IND number nor a device requiring an IDE, the research was originally approved by the full (convened) IRB but the IRB determined and documented that the research involves no greater than minimal risk and no additional risks have been identified.
The investigator should examine the above categories to determine whether the study is eligible for an “expedited” continuing review. If the Progress Report can be reviewed by an "expedited" review procedure, the investigator submits only one copy of the materials, which is the original.
If the the research does not fall into one of the above categories, then the Progress Report must go before the convened IRB2, and the investigator must submit 13 copies plus the original (14 total.)
IRB-2 has 13 members. Each member must receive a copy of the materials for review. The original copy becomes part of the permanent record the IRB maintains about the study protocol.
IRB-2 Submission Deadline:
The Progress Report and necessary related documents such as the consent forms, must be received by the IRB office by 5 pm on the deadline. The date of expiration is shown on the Progress Report notice. The deadline for submission is six weeks (42 days) prior to the study expiration. The deadline and multiple copies of the progress report are required because the materials must be sent to the IRB members giving ample time for their review prior to the IRB-2 meeting. To ensure the members have an opportunity to prepare for the meeting, the members must have the materials about 10 working days before the meeting. Only materials received by the deadline will be put on the IRB-2 meeting agenda. Only materials on the agenda will be sent to the IRB members. Any materials received after the deadline may be held for the next month's agenda.
IRB2 meets once a month and is scheduled to meet on the third Tuesday of the month.
At the IRB-2 meeting, any issues and concerns are discussed and recommendations are made if further clarification or revisions are needed. The discussion is open to all attending board members. Upon termination of the discussion, a motion is made, including (a) an assessment of risk to the subjects; . (Risk is categorized as "minimal" or "more than minimal.") (b) whether the risk/benefit ratio continues to be acceptable; and (c) at what interval the next continuing review will be required. The motion may be to : (a) reapprove the study without conditions; (b) reapprove the study contingent upon specific conditions; (c) table or (d) disapprove the study. A majority vote of those present is required for any IRB action. If the motion is to approve the study with conditions, the conditions are enumerated. The Board then considers whether the conditions are minor and what type of review the reply to the conditions may have. If the study involves pregnant women or children, the Board must determine whether the criteria to include those vulnerable populations continue to be met (per Subparts B or D of the regulations.) If the study involves prisoners, the prisoner representative must either attend the meeting or participate by conference call and the Board must determine whether the criteria required by Subpart C of the regulations continue to be met.
Reapproval is given for a period of no more than one year. Continuing review of the study will be made at least annually but may be made at shorter intervals, depending upon the degree of risk to subjects.
The result of the IRB-2’s review will be communicated in writing, usually within a week of the IRB-2 meeting.
1. Reapproved as submitted. A letter of reapproval is sent to the principal investigator indicating the investigator's responsibilities (see Section L), the duration of approval, and the date of continuing review. If the consent document was revised, it is stamped with the official date of reapproval and a copy is provided with the approval letter. If no revisions were made, the consent form is not re-stamped; the consent form last approved would continue as the current, approved consent document.
It is the responsibility of the principal investigator to provide notification of reapproval to funding agencies or other committees (e.g., VA Research & Development, Clinical Research Center, University Health System) in accordance with the appropriate guidelines (refer to Section below and IRB Forms)
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2. Conditional reapproval. A letter outlining necessary revisions and/or clarifications required for reapproval is sent to the principal investigator. The conditions are addressed by the principal investigator submitting a point by point reply, an amended progress report, amended protocol, additional information and/or revised consent documents for consideration. If the IRB determined the conditions for reapproval were minor and the review of the reply could be performed by the Chair or his/her designee without the amended application being seen again by the full board, the response will be reviewed by the Chair or his/her designee. If the reply is deemed satisfactory, approval to continue the study may be granted. If the Board determined that the conditions for approval were not minor, the response to the conditions must be considered by the convened IRB-2. Original plus (13) copies of the point-by-point response and any revised materials must be submitted by the appropriate deadline for inclusion on the next agenda. The result of the review is conveyed in writing to the PI. When no conditions remain, a letter is sent to the principal investigator indicating the reapproval date, the duration of approval, and the date of the next continuing review. If the consent document was revised, it is stamped with the official date of reapproval and a copy is provided with the approval letter.
If the reapproval is not in place before the expiration date, research activities must cease. New subjects may not be recruited nor new study procedures undertaken until all conditions have been addressed and reapproval of the study has been given. The only exception is if the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. However, enrollment of new subjects cannot occur after the expiration of IRB approval.
If the response to conditions for reapproval was reviewed by an expedited review procedure, the action, will be conveyed to the IRB at the next convened IRB-2 meeting and recorded in the minutes.
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3. Tabled or Disapproved. When the Board has serious concerns about the study or questions raised by the Board are significant enough to warrant tabling or disapproving the study, and the investigator's replies will be reviewed at a subsequent convened IRB-2 meeting. A letter outlining necessary revisions and/or clarifications is sent to the principal investigator. Original plus 13 copies (14) of the materials being submitted in response to the concerns must be received in the IRB office by the deadline for the IRB-2 meeting. If the IRB approval expires in the course of the review, the research activities must cease. The only exception is if the IRB finds that it is in the best interests of individual subjects to continue participating in the research interventions or interactions. However, enrollment of new subjects cannot occur after the expiration of IRB approval.
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Continuing Review by “Expedited” review:
If Continuing Review is eligible to be handled by the “Expedited Review Procedure”, the materials submitted by the investigator along with the original protocol, will be reviewed by the designated expedited reviewer for IRB-2, which is generally the Deputy Chair or the Chair. The expedited reviewer may grant reapproval, may request additional information, may inactivate the study or may defer the review to the convened IRB-2. The results of the expedited continuing review will be communicated to the principal investigator in writing, usually within a week of the IRB-2 meeting. In the case that the designated expedited reviewer determines the continuing review should be handled at a convened meeting, the principal investigator will be contacted with a request to submit the necessary copies of the materials for distribution to the IRB-2 members. All actions taken on behalf of IRB-2 by the designated expedited reviewer are conveyed to IRB-2 in a written report, at its next convened meeting.
Applications which meet the appropriate deadlines and contain all essential elements are placed on the agenda for the next scheduled IRB-3 meeting.
The IRB-3 generally meets on the fourth Tuesday of each month at 2:00 p.m. The schedule of meeting dates is published annually in August and should be consulted to confirm meeting dates.
Each IRB member receives a copy of each of the applications and amendments on the agenda, for their review prior to the meeting.
At the Board meeting, the assigned reviewers act as primary and secondary presenters, summarizing the application, and any issues or concerns the reviewers identified. After the assigned reviewers make their recommendations, the discussion is open to the rest of the board members. Upon conclusion of the discussion, a motion is made by the primary review, including (a) an assessment of risk to the subjects; . (Risk is categorized as "minimal" or "more than minimal.") (b) whether the 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; and (c) at what interval continuing review will be required. The motion may be to: (a) approve the application as submitted; (b) approve the application contingent upon specific conditions; (c) table or (d) disapprove the application. A majority vote of those present is required for any IRB action and of course a quorum must be present. If the motion is to approve the application with conditions, the conditions are enumerated. The Board then considers whether the conditions are minor and what type of review the reply to the conditions may have. If the protocol application involves pregnant women or children, the special considerations required by Subparts B or D of the regulations must also be made. If the application involves prisoners, the prisoner representative must either attend the meeting or participate by conference call and the Board must make the determinations required by Subpart C of the regulations.
Approval is given for a period of no more than one year. Continuing review of the study will be made at least annually but may be made at shorter intervals, depending upon the degree of risk to subjects.
The Chair conveys the decision of the board in writing to the investigator after the meeting:
1. Approved as submitted. A letter of approval is sent to the principal investigator indicating the investigator's responsibilities (see Section M), the duration of approval, and the date of continuing review. The consent document is stamped with the official date of approval and a copy is provided.
It is the responsibility of the principal investigator to provide notification of approval to funding agencies or other committees (e.g., VA Research & Development, Clinical Research Center, University Health System) in accordance with the appropriate guidelines (refer to Section below and IRB Forms)
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2. Conditional approval. A letter outlining necessary revisions and/or clarifications required for approval is sent to the principal investigator. The conditions are addressed by the principal investigator submitting a point by point reply, an amended protocol, additional information and/or revised consent documents for consideration. If the IRB determined the conditions for approval were minor and the review of the reply could be performed by the Chair or his/her designee without the amended application being seen again by the full board, the response will be reviewed by the Chair or the Chair’s designee. If the reply is deemed satisfactory, approval to implement the study may be granted and the study may begin. If the Board determined that the conditions for approval were not minor, the response to the conditions must be considered by the convened IRB. Nine copies of the point-by-point response and revised protocol materials must be submitted by the appropriate deadline for inclusion on the next IRB-3 agenda. The result of the review is conveyed in writing to the PI. When no conditions remain, a letter is sent to the principal investigator indicating the approval date, the investigator's responsibilities (see Section M), the duration of approval, and the date of continuing review. The consent document(s) is (are) stamped with the official date of approval to implement the study and a copy is provided with the approval letter. Subjects may not be recruited nor involved in the study until all conditions have been addressed and approval to implement the study has been given. This action, if taken on behalf of the IRB by the chair or his/her designee, will be conveyed to the IRB at the next convened full Board meeting and recorded in the minutes.
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3. Tabled or Disapproved. When the changes required in the protocol or questions raised by the board are significant enough to have warranted tabling or disapproving the study, and the investigator's replies will be reviewed at a subsequent convened Board meeting. A letter outlining the issues and concerns identified by the IRB will be prepared and sent to the principal investigator, so that the necessary revisions and/or clarifications that would be needed for reconsideration are clear. If the principal investigator decides to pursue approval of the study, a revised application may be submitted, following the procedures and deadlines for new submissions. The revised protocol application must include a point by point reply to all of the IRB’s concerns when it was tabled or disapproved, with all changes made in the consent(s) and the protocol being highlighted in yellow. The resubmission will be reviewed by the IRB in the standard manner.
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APPROVAL OF OTHER COMMITTEES
In addition to IRB approval, a research project may need the approval of other committees before it is implemented. For instance, a project to be conducted at the General Clinical Research Center (GCRC) must be also be approved by both the Veteran's Administration Research & Development (V.A. R & D) committee and the GCRC Advisory committee. If radioactive substances are to be used or the research subject is to be exposed to X Rays or other radiation for research purposes, approval must be obtained by the investigator from the Radiation Safety Control Committee and possibly from the Radioactive Drug Research Committee. All cancer related clinical trials must be reviewed by the San Antonio Cancer Institute’s Protocol Review and Monitoring System Committee. Investigators should submit to the SACI PRMS Committee concurrently with IRB submission so that the results of the SACI PRMS Committee review may be included with the materials disseminated to the IRB members.
Submission of a protocol to committees other than the IRB
is the responsibility of the investigator.
A chart briefly describing the deadlines and guidelines of some of the other relevant committees is given in the IRB Forms.
A protocol may be submitted for initial IRB review without the approval of these committees, however, in the case that approval is needed for use of radiation or for use of biohazardous agents such as viral vectors, final IRB approval to begin the study will not be given until documentation of the appropriate committees' approval (e.g. Radiation Safety Committee of the study site, Radioactive Drug Research Committee or Biohazard Safety Committee) has been received by the IRB.
Frequently, other committees will require the principal investigator to make changes in a protocol or consent documents after they have been approved by the IRB. When such changes are made, the investigator must submit the changes to the IRB for approval. While the protocols and consent documents may vary between the sites, all documents to be used at the various sites must be approved by the IRB. Initiation of a study without final IRB approval of all modifications constitutes a violation of Federal regulations and institutional policy.
APPROVAL BY OTHER IRBs
The approval of faculty, staff or students' research by another institution's IRB cannot substitute for the requirement to have the protocol reviewed by the appropriate UTHSCSA IRB. When the research involves a site that has its own IRB, evidence of formal approval by that institution's IRB or equivalent must be submitted to the UTHSCSA IRB before the study can begin. This applies to research being done across the street (Methodist Hospital, St. Luke's Baptist Hospital), across the state (MD Anderson, Rio Grande Valley) and outside of this country. When research is being done in other countries, evidence should be provided that the laws governing research in the respective country and institution are also being upheld.
In addition to the above, an institution collaborating with UTHSCSA in federally funded research must have a Federalwide Assurance, if the nature of the collaboration is defined as being “engaged in research” according to OHRP’s definitions (http://www.hhs.gov/ohrp/policy/index.html#engagement) and the “draft” of the revised guidance is at http://www.hhs.gov/ohrp/requests/com120806.html.
When the study site institution has no IRB and desires to rely on the UTHSCSA IRB, an IRB Authorization Agreement (see the IRB Forms) must be signed by the institutional officials of both the collaborating institution and UTHSCSA. Consult the IRB staff for assistance. |
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