Tracy Ruscetti-BSP IRB Assignment #2
IRB Policies (3-part activity): Due June 19
Activity I - Meet the Research Residency Lead Facilitator: Loretta Brancaccio-Taras
1.
Watch Loretta Brancaccio-Taras' 3-minute introduction
I attended Loretta’s talk at ASMCUE on curriculum mapping. I didn’t put those two
things together until I saw her introduction video.
Activity II - Watch the Institutional Review Board Presentation by Loretta Brancaccio-Taras
1.
Watch the 17-minute presentation by Loretta Brancaccio-Taras, Research
Residency facilitator
2.
If you have any questions regarding this webinar presentation, please post them to
your team's Wiki page (located in the Wiki’s left-hand navigation bar under the “PreInstitute Assignments” page).
I will post this to the page as well. My institution developed a flowchart to help with
deciding how to apply to IRBs. This may be helpful if incorporated into this video.
Activity III - Your Institution's Institutional Review Board (IRB) Policy
1. Locate your institution's IRB protocol. This is what you will need to fill out and
submit before you start a classroom research project. You may also want to find out a little
bit about the process such as the submission deadlines and how long it takes to get
approval. If you can, talk to someone on the IRB committee and describe your project to
see what they think will be needed. The IRB process can be a huge block to your research
project moving forward, so it pays to be informed. Copy and paste the IRB information
into a Word document.
2.
Log in to the Wiki and navigate to your team's Wiki page (Find Your Team) in
the left-hand navigation bar, under the "Pre-Institute Assignments" page. Post your IRB
document to your team's page by clicking the "attach file or image" button at the bottom.
Note that you must be logged in to attach a file. Feel free to read the other responses and
add a question or comment if you like!
IRB process at Santa Clara is web based and the full set of instructions can be found in the
appendix of this document. Here, I’ve created a “to do” table for myself to keep track of what
I’ve done and need to do.
Tracy Ruscetti-BSP IRB Assignment #2
Step
Description
Completed/result
1
Contact the site administrator for online access
(username and password) to CITI course in social
and behavioral research
March 19, 2015
2
complete module 1 (Belmont report)
June 15, 2015
3
complete module 2 (unexpected issues)
June 15, 2015
4
complete module 3
June 16, 2015
5
complete module 4
June 16, 2015
6
Request username and password for eprotocols to
start application process
June 16, 2015
7
Determine whether to apply for EXEMPT status
(flowchart)
June 16, 2015
8
Fill out eprotocol form for EXEMPT status
9
Wait. Exempt IRB approval is usually within one
week of submission.
10
Contact the IRB representative EACH time you
change the protocol.
Appendix:
complete instructions from SCU for IRB application and approval process.
1. To begin application via eProtocol. (Click Here)
2. Identify the research category. To assist you in determining which type of review you should request for
your research we have developed a flowchart and a text checklist. The Santa Clara Human Subjects Policy divides
research into three categories: Exempt from Full Review, Expedited Review, and Regular (Full Committee) Review.
How your application is reviewed depends on which of the three types of research you plan to conduct. Definitions
for each of the three categories can be found in the Human Subjects Policy.
In general, research qualifying for Exempt Review includes activities that involve "no more than minimal risk" to
human participants. Applicants requesting Exempt Review must indicate which of the five kinds of research eligible
for Exempt Review they are conducting (see Human Subjects Policy, Section IV. B. 1.). Note that Exempt Review
applications still must be reviewed and approved before data collection is started. Research qualifying for Expedited
Review includes activities that involve "no more than minimal risk" to human participants, but also involves one or
more of the procedures listed in Section IV. B. 2. of the Human Subjects Policy. Research that does not qualify for
Tracy Ruscetti-BSP IRB Assignment #2
either Exempt Review or Expedited Review falls into the Regular (Full Committee) Review category. Please note
that certain kinds of research always require Regular Review (see Human Subjects Policy Section IV. B. 3.). These
include studies using deception and studies with minors.
3. Complete the application form as fully as possible. Respond to each item on the form, even if your answer
is "not applicable." Provide enough information for the committee to understand how you will deal with each of the
concerns asked about in the application form. For example, it is not sufficient to simply state that you will keep
data confidential. Rather, you should explain how you will ensure data remain confidential. In some cases, you may
need to provide lengthy answers, such as when describing the procedures. You may respond to these questions by
entering "see attached" on the form and sending a separate attachment with your answer along with the
application. As a rule, the committee also will want to see copies of any tests or questionnaires you will be
distributing and a copy of your consent form.
4. Complete on-line training. All researchers must complete an on-line training module on the Belmont Report
before submitting an application for review. Researchers must complete the training once every three years. To
access the on-line course, go to the CITI site, register as a Santa Clara University member, and select the human
subjects training module.
Students must complete the student training sessions offered through CITIbefore submitting and application. To
access the on-line course, go to theCITI site, register as a Santa Clara University member, and select the student
version of human subjects training modules
5. Submit form and relevant materials to Office Research Compliance & Integrity Protocols@scu.edu.
The Human Subjects Committee prefers that researchers submit their applications and relevant materials
electronically. When submitting electronically, ignore requests on the forms for multiple copies.
What educational training programs are available?
Starting in the Fall of 2008, all researchers must complete an on-line training module on the Belmont Report
before submitting an application for review. Researchers must complete the training once every three years. To
access the on-line course, go to the CITI site, register as a Santa Clara University member, and select the human
subjects training module.
Students must complete the student training sessions offered throughCITI before submitting and application. To
access the on-line course, go to the CITI site, register as a Santa Clara University member, and select the student
version of human subjects training modules.
Human Subjects Committee members must complete extensive training through CITI. To access the on-line
modules, go to the CITI site, register as a Santa Clara University member, and select the human subjects
committee member training modules.