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NEW!—May 15
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| WIRB Online Submissions & Updated Fee Schedule Posted May 15, 2012 Sample Assent Form Updated 5/1/2012 (removed initial lines from bottom of page 1-2) IRB Membership Updated March 13, 2012; IORG registration expires March 13, 2015. FWA00005960 — U Alabama Birmingham Approved 02/14/2006, Renewed 01/24/2012, Expires 01/24/2017 New Learning Management System for IRB training
For UAB Employees:
NOTE: You are allowed to take the assessment 3 times. If you fail all 3 attempts, it will be recorded on your transcripts as a failed course and will not be removed. You will then have to re-enroll in the course. WIRB’s initial review submission forms have been revised WIRB encourages you to begin using the new format; however, use of the updated forms will not be required until March 1, 2012. Older versions of the submission form will not be accepted after that date. Posted January 11, 2012 Partial Waiver of Authorization for Recruitment/Screening Revised 12/09/11 Posted 12/12/11 New OIRB Director Named The Office of the Vice President for Research and Economic Development is pleased to announce the appointment of Mr. Jonathan E. Miller as the new Director of the Office of the Institutional Review Board (IRB). Mr. Miller will assume this role on January 4, 2012. Mr. Miller earned his BS degree in Microbiology and MS in Public Policy and Administration from Mississippi State University and is credentialed as a Certified IRB Professional (CIP). He will bring to the Office over ten years’ experience in supporting IRBs responsible for oversight of biomedical as well as social and behavioral research. He most recently served as IRB Officer and Assistant Director in the Office of Regulatory Compliance and Safety at Mississippi State University and was a valued member of the UAB IRB Office staff from 2006-2008. We are pleased to welcome Mr. Miller on his return to UAB. IRB Member Roster Updated November 22, 2011 IRB Guidebook for Investitgators Updated (October 27, 2011) Gene Therapy Project Review Veteran's Administration IRB CCC Clinical Trials Review Committee (CTRC) Gene Therapy Project Review Panel meetings - September 22, 2011 Previously, the IRB required a face-to-face meeting of the panel and investigator for all new protocols involving gene therapy, as well as for renewals when new risks had been identified. These meetings are still required but may be done face to face or by teleconference. The Guidebook for Investigators and Report of the Project Review Panel form have been revised to reflect this revision. Sample Consent Form 08/08/11: Updated contact information for MSO Compliance Billing and for Medicare Advantage Retirement Announcement—July 26 Ms. Sheila Moore has announced her retirement. Ms. Moore has been with the Office of the IRB since 1988 and served as its Director for almost 20 years. Ms. Denise Ball, Associate Director of the Office of the IRB, will serve as Interim Director while a national search is conducted for Ms. Moore’s replacement. Consent forms that list Ms. Moore in the Questions section should be updated at the next renewal, or when a change is made to the consent form, to read as follows:
If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the Office of the Institutional Review Board for Human Use (OIRB) at (205) 934-3789 or 1-800-822-8816. If calling the toll-free number, press the option for “all other calls” or for an operator/attendant and ask for extension 4-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday. You may also call this number in the event the research staff cannot be reached or you wish to talk to someone else.
UAB-WIRB Sample Consent Updated 06/20/11 POL042 - UAB Policy on Determination of Human Subject Research on Cell Lines Posted May 25, 2011 POL043 - UAB Policy on Case Reports Posted May 25, 2011 OSP Offers Seminars for Research Community Posted April 19, 2011 Information for Student Researchers Guidance for student researchers and their mentors — www.uab.edu/irb/students Sample Consent Form Updated 02/14/2011: Revised instructions about Genome-Wide Association Studies (GWAS) NEW WIRB Consent Form Changes Posted February 9, 2011 Forms Updated: Investigator's Progress Report and Project Revision/Amendment Form The revised forms are available on the IRB Forms page—Investigator's Progress Report, Project Revision/Amendment Form—and should be used for all applicable submissions. The IRB will no longer accept the old forms after the Thursday, February 17th, deadline. Anyone who submits old forms on or after February 18th will need to resubmit using the new forms. Posted January 19, 2011 Sample Consent Form Updated January 5, 2011: Revision to Confidentiality section to address data submission to ClinicalTrials.gov. Policies and Procedures Updated Posted December 22, 2010 Information on the 1946-1948 United States Public Health Service STD Inoculation Study Posted 11/03/10 Posted November 1, 2010 WIRB's initial review submission forms have been revised and investigators should begin to use them as of November 1, 2010. Use of the updated forms is required as of January 1, 2011. Only the initial review submission forms with the revision date of 11-01-2010 will be accepted after January 1, 2011. The revision date is located in the lower left hand corner of the form. Copies of the new forms may be downloaded from the Download Forms page of our website (www.wirb.com), or you may request a copy via fax, e-mail or postal mail by contacting a WIRB Client Service Representative at 1-800-562-4789 or e-mailing clientservices@wirb.com. 2011 IRB Deadline and Meeting Schedule Posted October 6, 2010 FWA00005960 — U Alabama Birmingham Approved 02/14/2006, Renewed 01/24/2012, Expires 01/24/2017 OHRP Guidance on Withdrawal of Subjects from Research “Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues.” Posted 09/21/10 IRB Continuing Education 2009 -2010 In 2009, the IRB changed its requirement for continuing IRB training. Instead of being required every year, continuing training (with a quiz as an evaluation component) is now required every two years. For 2009-2010, the only course approved for continuing IRB training is an online course about informed consent. People who completed initial IRB training in 2009 or before will have to complete that course, whereas people who completed their initial IRB training in 2010 will not. However, it may be helpful for researchers to complete the course to gain more understanding of the informed consent requirements at UAB. On December 31, 2010, all individuals who have not completed the informed consent course will need to cease all research activities involving human subjects. The only exception is for individuals who began human subjects research activities and completed initial training in 2010. IRB training records can be checked through the IRB e-reports system by anyone with a BlazerID . See http://main.uab.edu/show.asp?durki=120973 for how to use IRB e-reports. (BlazerNET includes many IRB training records, but they are currently not as complete as those available through IRB e-reports.) In about a month, the Office of the IRB will be sending reminder emails to individuals who have not yet completed the informed consent course. Another final reminder will be sent in late November or early December. If you have questions about continuing training for 2009-2010 and do not find them answered on the IRB website (http://main.uab.edu/show.asp?durki=56078), please contact the Office of the IRB (934-3789, irb@uab.edu). Emailed and posted 09/20/2010 Use of ResearchMatch as a Recruitment Tool A request to use
ResearchMatch as a recruitment tool for a new
IRB-approved protocol must be submitted to the UAB IRB as a part of the Human
Subjects Protocol application. In order
to use ResearchMatch as a recruitment tool for an existing IRB-approved protocol, an amendment must be submitted to
the UAB IRB. The recruitment language you
submit to IRB and send through ResearchMatch must exclude your direct contact
information (name/email/phone) and contain no more than 800 characters. ResearchMatch provides the following template
containing standard notification language.
You must obtain IRB approval for the specific “Contact Message” that you
wish to send through ResearchMatch: A research team with The University of Alabama at “Contact Message” to submit to UAB IRB If you are interested in this study and having the research
team contact you directly, please select the "Yes, I'm interested"
link below. By clicking the "Yes, I'm interested" link, your contact
information will be released to the research team. If you select the "No,
thanks." link or do not respond to this study message, your contact
information will not be released to the research team. Yes, I'm interested! No, thanks. Once
a set of potential matches has been identified, ResearchMatch will send out the
IRB-approved recruitment message imbedded in the ResearchMatch standard
template. OHRP Videos on YouTube OHRP is pleased to announce the availability for the first time of educational videos on the HHS YouTube channel. The videos are accessible through the OHRP playlist at http://www.youtube.com/user/USGOVHHS#g/c/5965CB14C2506914 and include
June 22 HIPAA Announcement from Shelia T Searson The link below is an article that provides current statistics about the breaches of protected health information (PHI) affecting 500 or more persons, which updates the information we sent a few weeks ago. As you recall, these breaches are posted by the Department of Health and Human Services Office for Civil Rights on their website. This article from HealthcareInfoSecurity.com reminds us of the risks related to mobile/portable computing devices, such as laptops and thumb drives, and of the importance of knowing where PHI resides. An added bonus is that the article includes quotes from our own HIPAA Security Officer, Terrell Herzig, and Information Security Consultant, Tom Walsh. Please review this article and share with others as appropriate: http://www.healthcareinfosecurity.com/articles.php?art_id=2675&pg=1. It is a quick and informative read. Thank you. June 7 Form Revisions Please note that the following forms have been updated and revised and are now available on this website. In addition, for investigators submitting to the Western IRB (WIRB), the fee schedule has been updated, effective June 1, 2010 for all items reviewed by WIRB. Investigators should have already received notification from WIRB of this change. Please call or email the OIRB should you need a copy of the fee schedule: (205) 934-3789 or irb@uab.edu. Updated to Gene Therapy Review Panel Members Members of the UAB Gene Therapy Project Panel (* indicates original panel members) Ronald Alvarez, M.D.* David Curiel, M.D.* Charles Elson, M.D.* Harold Kincaid, Ph.D.* Albert LoBuglio, M.D.* Mansoor Saleh, M.D.* Eric Sorscher, M.D.* Mack Barnes, M.D. Roger Berkow, M.D. William Carroll, M.D. Yancey Gillespie, Ph.D. Kevin Harris, M.D. John Kappes, Ph.D. James Markert, M.D. John Mountz, M.D. John Anthony Thompson, Ph.D. Tim Townes, Ph.D. Richard Whitley, M.D. (Updated in IRB Guidebook 05/03/10) Medicare Advantage: Update to Sample Consent Form Please note the following update for the language in the Costs section of the sample consent form: "If you are in Medicare Advantage (Medicare managed care plan), you should contact someone at your plan before you start a clinical trial. They can provide more information about additional costs you could incur from participating in clinical trials." An updated sample consent form should be available in April. Informed Consent Course Records in IRB E-Reports Completion records for UAB personnel who have done the 2009-2010 continuing IRB training course are now available in IRB e-reports. See "Documentation" for more information. WIRB Initial Review Submission Form Updated Updated January 11, 2012 HRPP Policy and Procedure Revisions, 12/22/09 The following Policies and Procedures of the UAB Human Research Protection Program have been revised or added during 2009. The revised documents can be found at http://www.uab.edu/uabra/irb/polproc.pdf.
Revised POL024 - UAB Policy on Reporting to Institutional Officials, Regulatory and Other Federal Agencies, and Sponsors. POL026 - UAB Policy on Maintenance of IRB Records PRO100 - Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program PRO106 - Procedure To Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB PRO110 - Procedure for Policy Development and Communication for the Human Research Protection Program PRO113 - Procedure for the Informed Consent Process and Documentation of Informed Consent PRO115 - Procedure for Organization of Protocol Files PRO117 - Procedure for Not Human Subjects Research Designation PRO120 - Procedure for Initial review Using the Expedited Procedure PRO126 - Procedure for Maintenance of IRB Records PRO145 - Procedure for Timing of Document Distribution for Meetings PRO148 - Procedure for Review of Modifications to Previously Approved Research by the Convened IRB PRO150 - Procedure for Continuing Review of Research by the Expedited Procedure
Added PRO156 - Procedure for Reviewing and Signing of Independent Investigator Agreements (IIA) 2010 International Compilation of Human Subject Protections Updated 12/08/09 Join national volunteer-recruitment registry for clinical research  UAB is participating in ResearchMatch.org, the first national online, volunteer-recruitment registry developed to improve the way biomedical research is conducted across the country. This easy-to-use tool can help match researchers and people who want or need to volunteer for clinical trials. Volunteers are notified electronically that they are a possible match, and then they may decide whether or not to release their contact information to member researchers. Register online at ResearchMatch.org.Read more about this innovative opportunity for investigators and participants at NIH News or UAB Media Relations. Continuing IRB Training - Informed Consent The UAB IRB is registered to review FDA-regulated research The FDA's Final Rule issued on January 15, 2009 (http://edocket.access.gpo.gov/2009/E9-682.htm) requires IRBs that review FDA-regulated products to be registered through the existing OHRP system. The regsitration information for UAB IRB 01 and UAB IRB 02 has been updated and now show an IRB Type of "OHRP/FDA." Fees Charged by the IRB Updated April 14, 2009 IRB Members Membership updated March 9, 2009 What should I do if... I completed initial training in 2008? I haven't completed training since 2001? More... Beginning January 1, 2009, IRB training will be tracked by BlazerID Posted December 8, 2008 Prevent Loss of Research Data Software and common sense can help NIH Launches New Web Site for Parents on Medical Research Studies for Children Award-winning video clips feature children, parents discussing clinical studies 02/15/08 Exemption approval is valid for 1 year only and exempt status must be recertified each year, if the research is not complete, by submitting a "Continuing Review" IRB Exemption Review Application. If the research is complete, the investigator should submit a "Final Report" IRB Exemption Review Application. IRB Guidebook for Investigators Updated September 22, 2011: Revision of Gene Therapy section to allow teleconference meetings of the Gene Therapy Project Review Panel. Revision of NHSR application requirements to allow staff changes by amendment. New Law Requiring Registration at Clinical Trials.gov Memorandum from Dr. Richard Marchase December 6, 2007 New Clinical Trials Indirect Cost Rate - Effective January 1, 2008 Posted 11/09/07 NEW! Information Security Handbook A condensed version of UAB/UABHS standards, policies, and guidelines on information security Revised March 2009 Noteworthy Dates There are no deadlines to apply for
Federalwide Assurance (FWA) FWA00005960 Assurance details and associated IRBs (from OHRP) Selected Updates Back to June 2003 |
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