New guide on how to write a "Telephone script" for recruiting subjects
IRB-01 is pleased to offer a guide for researchers to use when writing "telephone scripts" for recruiting subjects. This guide provides the structure and information that the IRB needs in order to approve your phone script. The guide can be found on our "Positions Paper" page.
IRB-01 annually processes over 700 new studies and 10,000 submissions. The PowerPoint below shows how long it took IRB-01 to review new studies for thefirst half of 2013. It also provides data over the the same period for the prior two years, along with some comparison data from other institutions.
IRB-01 routinely assesses turnaround times. Over the years we've implemented a variety of mechanisms to improve our efficiency. For example, we run weekly reports that show all of the submissions that are in process. These reports sort the items by how long they've been outstanding and help us prevent items from falling through the cracks.
Speed however isn't the IRB's primary mission nor the most important measure of our success. Protecting subjects rights and welfare and insuring regulatory compliance take precedence over speed. IRB-01 routinely passes all of its external audits with little to no issues identified. To that end, sometimes serious concerns about a submission lead to ongoing and protracted correspondence with an investigator, thereby increasing the turnaround time.
One area that could greatly help improve our ability to quickly approve submissions is beyond our control: the quality of submissions. Here are some of the most frequent issues that prevent submissions from being approved which could be easily addressed by the research team prior to submission:
- Inconsistent documents: protocol, consent, and/or other IRB paperwork contains information that is inconsistent. (E.g. the protocol indicates 50 subjects will be enrolled but the consent form states 85).
- Missing forms
- Unanswered questions.
- Complex language in the informed consent form (should be readable by an eighth grader)
- Missing template language and cut/paste errors in the informed consent form.
Office of Research announces Guidelines for PI Qualifications & Student Roles
This morning the Vice President for Research, Dr. David Norton, announced new qualifications for (1) Principal Investigators conducting human subjects research and (2) student roles. The memo stated:
Working with the three UF IRB’s (IRB-01, 02, 03), faculty stakeholders, and research deans in affected colleges, the Office of Research has developed guidelines to better define the qualifications needed to be a Principal Investigator (PI) of a human subjects research project. The new guidelines are posted on the UF IRB website and specifically address the role that students can play in overseeing human subject research. The University must ensure that PIs are suitably qualified and accountable for all aspects of research projects, and that other investigators are qualified to fulfill the requested role. The IRBs designate as Principal Investigator the person who either conducts and\or oversees the entire protocol. The PI is also the person held accountable by the University and IRBs to insure all human subjects’ regulations and any financial issues are addressed. A PI often delegates some of the research activities to students, study coordinators or others, the P.I. remains accountable for the protocol. These guidelines were updated to be consistent with peer institutions.
The new guidelines are effective July 15, 2013, and will apply to any new protocol or revision request submitted. The guidelines are available at: http://irb.ufl.edu/docs/studentpolicy.pdf.
Click here to view a copy of the memo that was emailed to the UF Administrative Memo.
Important Continuing Review change: Cumulative Deviation Table revised
IRB-01 has determined that the Cumulative Deviation Table submitted with Continuing Reviews needed to include not only minor deviations as it has in the past, but also major deviations. As a result the form has been updated to include all deviations along with a column to indicate if the deviation is major.
Please note that researchers will be required to include this new form with all Continuing Reviews submitted on or after June 1st, 2013.
Important note: IRB-01 is not applying this requirement retroactively, i.e. you do not have to list any major deviations that occurred prior to this requirement on June 1st, 2013. PIs must only include major deviations that occur on or after June 1st 2013 and after on the table. Minor deviations that occurred on or after January 1st, 2008 must still be listed.
The new form is available on our alphabetical listing of forms at: http://irb.ufl.edu/irb01/forms1.htm
July 2013 meeting dates and deadlines changed!
Due to the July 4th holiday, IRB-01 has decided to reschedule the full Board meetings this July to the 2nd and 4th Wednesdays of the month. As a result the meeting dates and deadlines have changed. Please note this as you prepare to submit full Board items to IRB-01.
The updated meeting schedule and associated deadlines is available at: http://irb.ufl.edu/irb01/deadlines.htm (please be sure to refresh your browser. The old meeting dates are struck out on the current web page). Our current dates are:
- Meeting: July 10
Deadline: June 17
- Meeting: July 24
Deadline: July 1
URGENT change to all banking studies
The Privacy Office and IRB have determined that our banking consent and storage of tissue informed consent addendum need to be revised to better comply with the HITECH ACT (ie: the recent update to the HIPAA rule). In particular, after March 26th 2013 HITECH requires research consent forms to detail that researchers could potentially bill secondary researchers who receive banked data/tissue in order to recover their costs. As a result we have revised our banking consent form templates to include appropriate language. The language that has been added is as follows:
Your <tissue/data/tissue and data, whichever is appropriate> may be shared with other research centers or private companies, in which case the University of Florida may charge the research center or private company a fee in order to recover the University of Florida’s costs of sharing your <tissue/data/tissue and data>.
Even if you do not anticipate sharing your banked tissue or data in the future, ALL existing studies that meet the following two conditions MUST submit a revision before June 15th, 2013 to update their informed consent forms into the current format: The two conditions are that the existing study is (1) a tissue and\or data bank and (2) you obtain informed consent from subjects either as a stand-alone consent form or the banking addendum.
In order to update your banking consent or banking addendum form, please submit a revision to delete certain language and add the new language above. The following is an example of what should be edited from the old banking informed consent template. The language that needs editing is right before the signature section:
<Name of PI or group> and/or <other named or class of individuals> will be allowed to collect, use and/or give out your tissue/data. They may give your tissue/data to other researchers whose research is approved by an Institutional Review Board (IRB) (An IRB is a group of people who are responsible for looking after the rights and welfare of people taking part in research). They may also give your tissue/data to a study sponsor, the Food and Drug Administration, the Department of Health and Human Services, the Office of Human Research Protections, or other Government agencies. Your <tissue/data/tissue and data, whichever is appropriate> may be shared with other research centers or private companies, in which case the University of Florida may charge the research center or private company a fee in order to recover the university of Florida’s costs of sharing your <tissue/data/tissue and data>. There is a risk that information received by these authorized persons or agencies could then be passed on to others beyond your authorization and not covered by the law.
In general, presenting research results helps the career of a scientist. Therefore, the Principal Investigator may benefit if the results of this study are presented at scientific meetings or in scientific journals.
Although your tissue or data will never be sold, it It is possible that new treatments, medicines, therapies or products could be created from studies that use your tissue or data. If that happens, the Principal Investigator and the University of Florida could receive significant financial benefits. You will not be offered any payment or any other financial benefit.
This is an example of the edit for the banking addendum. The language that needs editing is currently right before the banking choices:
There will be no cost to you for any specimens collected and stored in the _____________ (type of specimen) specimen storage bank. Your tissue will be used only for research
and will not be sold. Your <tissue/data/tissue and data, whichever is appropriate> may be shared with other research centers or private companies, in which case the University of Florida may charge the research center or private company a fee in order to recover the University of Florida’s costs of sharing your <tissue/data/tissue and data>. Some new products might be made because of the results of the research that uses your samples. These products might be sold sometime in the future, but, should this occur, you will not get paid.
For all new banking studies, you must download the new banking templates on the IRB website. The updated forms are available at the following links:
If you have any questions please contact the IRB at UFIRB-L@lists.ufl.edu. Please include the IRB number about the study in question.
The myIRB team is pleased to announce that we have a Technical Assistance hotline and dedicated email address:
myIRB Technical Assistance is intended to help users with computer related issues such as:
- Using the VPN to access myIRB when you are logging in outside of the Gainesville Health Science Center.
- Issues with updating your mandatory training (CITI/NIH, HIPAA, and IRB-01 Video)
myIRB Technical Assistance cannot help you with research specific questions. Those questions should still be directed to the IRB-01 office at (352) 273-9600 or email@example.com.
The Office of Research has prepared a web based query that allows department administrators to look up training completion records for individuals in their department.
This link may only be used by UF employees with the following PeopleSoft roles:
- NOTE: If you believe you have the appropriate PeopleSoft role but cannot access the report, please email Cheryl Bearden (firstname.lastname@example.org) or Nick Dunham (email@example.com). They can research user assignments after you have tried to login to the training page.
The report allows you to search for training completed by an individual or the entire department. You must select one specific course at a time. Available courses are not only include those required by IRB-01 but also other Office of Research related courses.
- PRV801: HIPAA & Privacy – Research
- IRB800: IRB01 Mandatory Local Training (video)
- H70: CITI Mandatory IRB Trng-Biomed
- NIH: NIH Extramural Education
Other Research Courses (not required by IRB)
- H64: NSF Responsible Conduct of Research
- RSH250: Effort Management for Investigators
- RSH260: Cost Principles
- RSH240: Effort fundamentals for Investigators
- DSR810: Financial Conflict of Interest
- RAC810: HSC Research Billing Risks
Many thanks to the Office of Research IT team for providing these reports!
As you should know IRB-01’s Mandatory Training went into effect this past Monday January 7th, 2013. This requirement was announced by the VP for Research, Dr. David Norton, on 10/31/12 (http://irb.ufl.edu/irb01/news.htm#training).
We thank the hundreds of researchers who have diligently completed the training. If you have not completed the training, please review the training requirements and how to complete the training at http://irb.ufl.edu/education/trainreq.htm.
- Once completed, training results usually take at least several days to migrate across several systems before they can be imported into myIRB.
- Students need to contact their Departmental HR administrator to receive the “Person of Interest” (POI) role in order to complete training via myUFL. We have asked if all students could automatically be assigned this role to avoid these extra steps and will keep you posted.
- Research staff at Shands, the VA, or who are unaffiliated need to contact Melissa Beatty to receive the POI role.
- NOTE: the POI role may take some time to update in the system before the training can be completed.
- LOOK UP THE STATUS OF YOUR TRAINING: Here’s a guide on how to check your traininghttp://irb.ufl.edu/myIRB/cheatsheets/cs-traininglookup.docx
- We’re working on providing departmental administrators a web based tool to look up the training status of the people in their department.
- When creating a new study, the second smart form page will show you the status of the training for everyone on the study team.
- Email questions to: UFIRB-L@lists.ufl.edu
- If you cannot log into myUFL contact UF’s Help Desk at (352) 392-HELP (392-4357)
- If you can log into myUFL but cannot access register for or complete the training:
- Students, VA, Shands, and Unaffilaited investigators need to be assigned the POI role and/or wait for it to take effect in the myUFL system.
- If you are UF faculty or staff OR your HR administrator can confirm that you have the POI role, contact Jaime Cooke at firstname.lastname@example.org
- If you can access the Video training but do not see the video:
- Try using a different web browser
- Contact the IT professionals who manage your computer, you may be missing some software.
- Wait and try again later – your network may not have the bandwidth to show the video.
- You’ve completed the training, but it isn’t showing in myIRB
- It typically takes *at least* three business days for training to migrate through the various systems and be uploaded into myIRB. Please be patient. If your training still isn’t showing after 3 business days, please email us at UFIRB-L@lists.ufl.edu