eIRB Overview

1
eIRB Overview

• Fall 2008

2
Agenda

• IRB overview
• eIRB
• Forms

3
Institutional Review Board

• What is it? Why is it important?
• The Tuskegee Syphilis Experiment
• IRB _at_ WFU
• http//www.wfu.edu/rsp/irb/
• Objective is to protect human participants.

4
Getting Started

• CITI Training is required.
• http//www.wfu.edu/rsp/irb/education.html
• Very straightforward
• You need to be in Group 2
• Before collecting ANY data
• Approval from IRB
• Approval from WS/FCS
• (I would complete IRB first, and then WS/FCS)

5
Getting Started, contd

• Dr. McCoys Steps in the Research Process.
• Lets look at 2 for a few minutes
• My tip here is to be as clear as possible, and
  avoid using jargon (particularly with consent
  forms).
• Check out Checklist for Easy to Read Informed
  Consent on http//www.wfu.edu/rsp/irb/forms.html

6
eIRB

• Fairly self-explanatory
• Sometimes easier to keep all IRB docs in a
  separate folder.
• Much of the form is answering the questions.
• Although some people dread it, I find it
  extremely useful, as it makes me think through my
  study

7
5 Ws

• Who is involved (and to what extent)
• What are they doing
• When is the study taking place
• Where is the study taking place
• Why are you conducting this study (because you
  want to is not a good answer ?).

8
Lets do it

• We will log in, take a look around, create a
  sample application.
• Link from IRB page
• http//www.wfu.edu/rsp/irb/index.html
• Use Internet Explorer (as opposed to Mozilla
  Firefox)
• Log in to VPN if off campus
• Save each page before hitting continue

9
Some Documents

• These can all be found on the Forms
  Instructions link on the IRB home page.
• Make sure to follow bold, italics directions
• The key is to be concise.
• Protocol Document
• Describes an overview of the study
• Consent Form
• Permission to participate in study
• Assent Form
• To be used for minors
• Also include ALL surveys, questions, etc.
• WS/FCS Proposal (found on Dr. Macs page)

10
Getting Feedback

• It is difficult (but not impossible) to get
  approved by the IRB on the first trybut they are
  extremely helpful in giving feedback.
• You can then re-submit, tracking changes, called
  redlining, and then accept these changes.
• Lets look at our protocol document.

11
Finally

• All proposals must be submitted by your adviser,
  although you and your adviser can both log in to
  the site.