|
Archive: News & Announcements
NEW IRB-1 FORM ONLY REQUIRED FOR NEW PROTOCOLS 2.13.06
New Protocol Applications (filed from 2/13/06 on)
Investigators! You only have to use the revised IRB-1 Protocol Application Form when you are applying for IRB approval of a new study.
Amendments and Re-Approval of these protocols will then be made to that revised IRB-1 Form.
Protocol Applications already filed with the IRB
If you are applying for Re-approval or Amendment of a study you already filed on the old IRB-1 Form, you may make the changes directly on that unrevised IRB-1 Form.
(No doubt you saved it on your computer.) However, if you would like to like to use the New IRB-1 Form for this purpose we certainly wouldn't object.
SIGNIFICANT CHANGES TO THE IRB-1 2.06.06
Remember to use the latest forms on the IRB website when filing any request with the IRB.
Changes are regularly made to the forms due to respective changes in the regulations and university policies but also to help elicit more accurate and complete information from the applicants. When a significant number of changes are made an announcement will be made in this section. However, frequently, small changes will be made without any announcement. Therefore, it is important to use the latest forms on the website.
Changes have been made to the following Sections:
- Section I. General Information
- Other IRB Reviews
- Collaborating Institutions
- Study Location
- Section II. Funding
- Totally Revised
- Section III. Human Subjects
- Recruitment
- Special Populations: Now requests the ones you are TARGETING.
- UConn Students or Employees/ Explain why using.
- Section V. Research Plan
- Data and Safety Monitoring
- Section VI. Informed Consent
- PI responsibility
- HIPPA "covered entities" at Storrs noted.
- PI Certification:
- CITI training of Research Team
- Consistent w/ UConn Conflict of Interest Policy
WINTER/SPRING 2006 IRB MEETINGS 12.02.05
Winter/Spring 2006 IRB meeting have been finalized. Click the Deadlines and Meeting Dates link on the right menu to find out when the meetings will take place.
2nd REMINDER
IRB TRAINING REQUIRED BY DEC 1, 2005 11.30.05
Effective December 1, 2005, the Office of Research Compliance is requiring that UConn faculty, staff, and students/grads and undergrads at the Storrs and regional campuses making an IRB submission (new protocol, amendment, request for re-approval) complete the research-appropriate course on the CITI website and secure certification before protocols for such research will be approved by the IRB. For those with ongoing human subjects research protocols, training must be completed prior to the annual re-approval of the protocol.
The IRB will accept CITI training taken at another institution in lieu of the UConn CITI Training. Evidence of having completed the CITI training must be provided to the IRB with the protocol submission. If the certification is more than two years old, the investigator will be required to take the UConn CITI refresher course. The IRB will only accept CITI training from another institution; no other forms of training will be accepted.
The IRB reserves the right to require that an investigator complete any or all of the optional training modules before approving a protocol.
WHO NEEDS TO TAKE THE CITI PROGRAM TRAINING?
All Investigators named on a UConn IRB-1 or IRB-5 protocol application (and "Key Personnel") who are "engaged in" research with living human beings, human tissue samples or identifiable private information, are required to take the CITI Training Program.
Key Personnel who are "engaged in research with human subjects" are staff or students who:
- enroll individuals,
- obtain subjects' informed consent by doing more than handing out or collecting forms or telling subjects how to get in touch with the Investigators;
- intervene or interact with subjects by performing invasive (e.g., drawing blood) or non-invasive (e.g., survey) procedures on them,
- collect data directly from or follow-up directly with participants
- collect identifiable private information from participants or
- have access to information that links participants' names or other identifiers with their data, or
- act as authoritative representatives for the investigators.
THE RE-APPROVAL/TERMINATION FORM (IRB-2) HAS BEEN REVISED 11.07.05
In answer to Faculty Suggestions:
The Re-Approval/Termination Form (IRB-2) has been revised.
- If there have been no changes to the protocol, since the last IRB review, you do not have to submit a new IRB-1 protocol application. (IRB-2, pg.2, #2. No amendment)
- Blanket Protocol is now included as a study type. (IRB-2, pg.1, Nature of Study)
- Language has been clarified in several places to make sure it is understood that the questions relate to the study "since the last IRB approval."
- If using more than one type of Consent Form, submit signed versions of each type. (IRB-2, pg. 3, #11)
TIMING OF CONTINUING REVIEW OF IRB APPROVED PROTOCOLS 10.20.05
To help Investigators comply with federal regulations, the Office of Research Compliance will send ONE REMINDER NOTICE (per protocol) to investigators whose protocols are due for annual IRB review APPROXIMATELY 60 DAYS PRIOR TO THE EXPIRATION DATE. About twice per year, we will also send to each PI, a list of all approved studies and expiration dates.
Continuing review and re-approval of research must occur on or before the date when IRB approval expires. IF AN INVESTIGATOR FAILS to provide re-approval materials (an IRB-2 and updated IRB-1) to the IRB and TO OBTAIN CONTINUED IRB APPROVAL PRIOR TO THE EXPIRATION DATE, ENROLLMENT OF NEW SUBJECTS AND CONDUCT OF THE RESEARCH MUST STOP.
In order to accommodate reasonable delays, the ORC policy will permit investigators to submit re-approval materials within 30 days from the expiration date. However, new enrollment and conduct of the research may not resume past the expiration date until the IRB has notified the investigator that the study has been re-approved.
AS OF DECEMBER 1, 2005, submission of re-approval materials after the 30 day time limit, will be rejected and the protocol will be administratively CLOSED by the IRB. To continue such research, a new IRB-1 application must be submitted.
In addition to an updated Protocol Application (IRB-1), you will need to submit the following to the IRB for review:
- A written explanation as to why the study was allowed to expire, including
- A written statement indicating that a) no subjects have been enrolled since the expiration date, b) no subjects will be enrolled until the new study has been approved and c) no research has been conducted after the expiration date.
| NEW STAFF, OLD STAFF AT THE ORC/IRB OFFICE
Ilze Krisst, Assistant Vice Provost for Research and Director of Research Compliance, announces the following changes at the Office of Research Compliance/IRB Office:
The ORC welcomes Nancy Wallach, the new Associate Director of Research Compliance/IRB. Nancy is a Certified IRB Professional. She comes to UCONN from St. Francis Hospital in Hartford where she worked with the IRB for four years and brought their Human Subjects Protection Program through the AAHRP accreditation process. Nancy will administer the UCONN program day-to-day and will lead us through the accreditation process as well.
Christine Malloy is now the IRB Monitor and Education Coordinator. Christine is an attorney and was Interim Associate Director of Research Compliance/IRB. In her new capacity, Christine will work to increase understanding of the Federal Regulations and of the UCONN IRB policies and procedures and will be monitoring investigator compliance with CITI Training and with the Human Subjects Protection Program.
Ann Mathewson, who is Assistant to Ilze Krisst, is now also part-time IRB Coordinator for the ORC. Ann is a quick learner and has been helping to review the protocol applications and we thank her for her help!
Doug Bradway, Senior IRB Coordinator, has kept the protocols moving while all the changes have taken place at the ORC. Thank you Doug!
Marita Decozio-Wiley, Business Manager and Administrator for IRB and Internal RAC Programs has also facilitated and worked through the changes at the ORC and we thank her too!
Contact Information |
NEW CONSENT FORM / INFORMATION SHEET CHECKLIST
The Office of Research Compliance developed a consent form/information sheet checklist to guide investigators in how to prepare consent documents since approval of protocols is often delayed because of problems with the format and content of the forms. The checklist will also give investigators a better understanding of what the IRB looks at when it reviews consent forms. We strongly urge all investigators to review the document before submitting a consent form for IRB review. We welcome your feedback on the checklist. Please send your comments and concerns to doug.bradway@uconn.edu.
| IRB TRAINING REQUIRED FOR ALL BY DEC 1
Effective December 1, 2005, Storrs and regional campuses are requiring that UConn faculty/appointments, staff, and students/grads and undergrads who need to make an IRB submission (new protocol, amendment, request for re-approval) complete the appropriate course on the CITI website before protocols for such research can be reviewed by the IRB. For those with ongoing human subjects protocols, training should be completed prior to the annual re-approval of the protocol.
The IRB will accept CITI training taken at another institution in lieu of the UConn CITI Training. Evidence of having passed the CITI training must be provided to the IRB with the protocol submission. If the certification is more than two years old, the investigator will be required to take the UConn CITI refresher course. The IRB will only accept CITI training from another institution; no other forms of training will be accepted.
The IRB reserves the right to require that an investigator complete any or all of the optional training modules before approving a protocol. |
NEW FORM IRB-5 REQUEST FOR EXEMPTION
As of August 1, 2005, the Office of Research Compliance is requiring that all PIs use the new IRB-5 Form when applying to the IRB for exempt review of a study. Although the form is longer, we hope it will help minimize requests for additional information and thus speed up the process! After August 1, the old forms will be returned for resubmission on a new form before the study will be reviewed. The old IRB-5 has been replaced with the new IRB-5 on the Forms page.
IRB-1 APPLICATION CHANGE
Please note that the IRB has added a "validation receipt" to the last page of the (IRB-1) Application. The receipt is considered a part of the application and will be returned to you with the assigned protocol number for your study. You do not need to provide any information on this page.
| IRB NOW REQUIRES USE OF NEW FACE PAGE WITH EVERY SUBMISSION
As of February 1, 2005, the Office of Research Compliance ("ORC") is requiring that all PI's use the IRB-Face Page that will help us process your IRB-forms faster. It is modeled after the routing sheet used by the Office for Sponsored Programs for your grant proposals. The IRB-Face Page is currently on the IRB website listed under "Forms". It must be used as a cover sheet/checklist when submitting any forms to the IRB/ORC. To complete the Face Page, check off which forms and attachments are being submitted, and if they are part of an approved protocol, give the protocol number. If the Face Page is not attached and fully completed, all documents will be returned to you. |
SUBMISSION CHANGES
As of March 1, 2005, all submissions must be on the appropriate new form IRB-1, etc. and the Consent or Information Sheet must be on the Templates posted under "Forms" or the submission will be returned to you unreviewed.
Change
in Number of copies for IRB Submissions
Investigators must now submit one (1) original and fifteen (15)
copies of the full protocol application for any protocol requiring
full IRB review. Formerly, investigators were asked to submit
one original and 12 copies. As a reminder, investigators should
take special care to review the requirements for full IRB review
to be certain that the correct number of copies are being submitted.
This rule will be in effect as of the August 23, 2004 submission
deadline.
For those
protocol applications that meet the criteria for expedited review,
the number of copies remains the same. Investigators should submit
one (1) original and one (1) copy.
UConn
IRB Update
The IRB has made a slight modification to the Reapproval/Termination
Form (IRB-2); specifically, the "Status" section of the
face page has been changed to more accurately reflect IRB review
considerations. Reminder: always access forms directly from
the IRB website to ensure that you are using the most current
version.
Please feel
free to call the Office
of Research Compliance at 486-8802 if you have any questions.
Important Information for Human Subjects Researchers - New Rules for IRB Submissions
To combat increasing administrative burdens, and to facilitate the smooth processing of IRB submissions, the following new procedures will be implemented and existing ones enforced. Investigators should read through these procedures carefully, as they may impact upcoming IRB submissions:
1) New procedure: The IRB will no longer accept electronic submissions of documents including protocols, amendments, requested revisions, reapprovals or exemption requests. All IRB submissions must be made in hard copy only.
2) Existing procedure: Investigators are expected to submit the appropriate number of copies requested in either the IRB's decision letter or submission instructions. If the IRB does not receive the number of copies requested, then the PI will be instructed to submit additional copies as appropriate and the submission will not be reviewed until all copies have been received.
3) Existing procedure: A comprehensive protocol must be submitted with all amendment requests or the amendment will not be reviewed. The comprehensive protocol is inclusive of all approved amendments; meaning that all changes to the study design, consent form, and those administrative in nature, must be written directly into the body of the document. The comprehensive protocol will serve as a file copy and represent the study's current status - it will not need additional IRB review.
Note: If an amendment is made to a protocol that already has IRB approval, the PI must submit a revised comprehensive protocol using the new protocol application form (IRB-1).
4) New procedure: Investigators must submit one (1) original and twelve (12) copies of the full protocol application for any protocol requiring full IRB review. Investigators should take special care to review the requirements for full IRB review to be certain that the correct number of copies are being submitted. This rule will be in effect as of the March 17, 2004 submission deadline.
This site contains new forms and templates.
All submissions received by the IRB as of March 1, 2004, must be on the appropriate new form or they will be returned to the researcher without being reviewed.
|
