IRBLectronics: Web Site, Forms, and Training

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IRBLectronics: Web Site, Forms, and Training

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Title: IRBLectronics: Web Site, Forms, and Training

1
IRB-Lectronics Web Site, Forms, and Training

IRB Open Library
Dec. 12, 2003
Mr. Lee Griner
lgriner_at_uab.edu

2
Topics 1 2

Web site
URLs, Content
Forms
New Forms, Revisions, Working with MS Word Forms
Training
Requirements, New Options

3
1. IRB Web Site Revamped

Find us at www.uab.edu/irb
NEW! and Noteworthy
Contact Information
Research Training
Forms and Documents
IRB Web Links
Search IRB site

4
www.uab.edu/irb URLs

UAB Links
/forms Most Recent IRB Forms
/guidebook UAB IRB Guidebook and Revisions
/training IRB Training
/training/current Current IRB Training
Opportunities
/faq Frequently Asked Questions
/hipaa News About HIPAA
/wirb News About Western IRB
/aihsp Alabama Initiative for Human Subjects
Protections (NIH Grant)
/assurance Current Federal Assurance

5
www.uab.edu/irb URLs (cont.)

Other Links
/fda1571 Help on FDA Form 1571
/fda1572 Help on FDA Form 1572
/prisoner New OHRP Guidance on Research
Involving Prisoners
/recombinant NIH Guidelines on Recombinant DNA
Molecules

6
Web Content

New and Noteworthy
FWA00005960 Approved Expires November 24, 2006
Upcoming Events (e.g., training)
Contact Information
Several new staff members
Direct phone lines, no direct e-mail, yes

7
Web Content (cont.)

Training
Old and new FAQ
Options for initial IRB training and continuing
IRB education
Link to Verification Memo
Forms and Documents
Covered in detail on later slides

8
Web Content

Web Links
URLs for UAB IRB
Alabama Initiative for Human Subjects Protection
(AIHSP)
Web Links about Human Participants in Research
Sites Devoted to Human Participation in Research
Federal Offices
The Bases of Human Research Protections
General Ethics
Search IRB site

9
2. Current IRB Forms

New black-and-white headers
Listed by categories
New Protocol Submissions
Special Approvals
Revisions and Renewals
HIPAA (April 2003, new forms)
Special Events (e.g., contact change form)
Revision dates listed below form links
Full Review ApplicationRevised 11/13/03.
Guidebook Section 11.

10
Revisions to Forms

Revision date included on all IRB forms
Some revisions result from
Federal regulations (e.g., HIPAA)
UAB policies (e.g., billing compliance, PORF)
IRB decisions (e.g., clarity of closed studies)
Check for latest versions
www.uab.edu/irb/forms
www.uab.edu/irb/guidebook
Click Recent Changes to the Guidebook

11
Electronic Forms

PDF (Adobe Acrobat) vs DOC (Word)
PDF produces image DOC produces text
PDF restricts much editing DOC allows most
editing
PDF requires software purchase for advanced
operations DOC software is often preinstalled
Both formats are loaded with options
PDF used for IRB Guidebook DOC used for forms

12
Word Forms Back-up Copy

For the best results, right-click the underlined,
green text of the form title and choose Save
Target As. . .
Save the filecarefully noting its name and
location on your computer.
Open Word, click File, choose Open, and navigate
to the file you saved.
Open the file and make a back-up copy so you can
save changes (to a file with a different name)
without losing the original.
Save your work often.
Each form contains a link to the most recent
version of the form (i.e., a blank one).

13
Word Forms Entering Text

To enter text in form fields
For text, place your cursor anywhere in the
shaded area, and type your entry. Use the mouse
to check or uncheck shaded boxes (by
double-clicking).
The text you type should appear in the Times New
Roman underlined italic 12 font, to help
reviewers differentiate between IRB form text and
your response text. You can change this font to
insert symbols, but avoid Verdana regular 12 and
fonts smaller than 12.

14
Entering Text (cont.)

Copy/Paste
Copy text from one document
Paste into the form field
Check and double-check for font changes in text
after pasting
Pasting formatted text may alter the formatting
of the form
Print a blank form for reference
Save an electronic blank form

15
Other Word Options

Header/Footer
Ideal for revision date and page numbers
AutoText entry for Page X of Y
Section Break allows changes within document
Settings at File ? Page Setup ? Layout tab
determine whether first page of each section
differs from others. This setting applies to all
subsequently inserted breaks.

16
AutoText Entries

Consistency for Common Text
Standard language (e.g., billing compliance,
tissue storage, contact info)
Entity names (e.g., UAB Centers)
Chemical names
Hard-to-spell words and names

17
AutoText Entries (cont.)

New Entries
Highlight the text to save
Click Insert, Choose AutoText ? New
Name the entry something easy to remember
While typing, when AutoText balloon pops up,
press Enter to insert that entry

18
Consent Form Layout

IRB Note on Sample Consent Form
Please use a 12 pt font for this document.
Margins should be 1.
Please write the document in the 2nd person and
keep the pronoun usage consistent throughout the
document.
Number each page of the consent form Page of ,
etc.
Leave an area approximately 1 inch by 2 inches on
the bottom of the first page for the IRB approval
stamp.

19
Consent Form Layout (cont.)

FontsConsistency
May vary, but no more than 3 per document.
Consistency within variation (Heading 1, Contact
Information, etc.)
BordersImpact
Apply to text or paragraph for emphasis or
sidebar
Helpful to distinguish Text Boxes
Bold, Italics, UnderliningReadable
Italics sometimes difficult to read
All lose impact if overusedchoose one, not all

20
Bulleted and Numbered Lists

In general, use only if list has three or more
items
Bullet items of equal importance within a list
Each participant must . . ., . . ., . . .
Number items to be completed sequentially or if a
number has been used
Four clinic visits will be required 1. . ., 2. .
., 3. . ., 4. . .
Use a consistent style of bullet or numeral
throughout a document

21
3. Training

Training
Initial and annual requirements
New options
Upcoming options

22
Training Requirements

4-hour initial IRB training
Most online (CITI, NIH)
One annual live session on campus
1.5 hours of IRB continuing education (CE)
required each year
Online and in-person
Off-campus options often available or eligible
Requirements, options, and records listed at
www.uab.edu/irb/training

23
New Initial Training Options

CITI online training now in two tracks
Biomedical, Social and Behavioral
Choose one and complete modules in that track
http//jaguar.ir.miami.edu/citireg/page2core.htm
NIH Online Training now accepted as initial
training (cme.cancer.gov/c01)
Current version only, not retroactive
Investigator 101 CD and WebCT quizzes
Check out CD from OIRB, register for WebCT
course, successfully complete quizzes

24
New Annual Training Options

CITI online CE course
So long as the UAB IRB has a record of your
initial training, you can complete the CITI CE
course.
http//jaguar.ir.miami.edu/citireg/page2CE.htm
Some pre-approved off-campus events
Investigator 101 CD and WebCT quizzes
Check out CD from OIRB, register for WebCT
course, successfully complete quiz for Part 2.

25
Upcoming Options