COLLABORATIVE
IRB TRAINING INITIATIVE - CITI
HUMAN SUBJECTS
RESEARCH TRAINING SITE
For a downloadable instruction page click here.
WHO
IS REQUIRED TO COMPLETE THE TRAINING?
IRB members,
investigators, research coordinators, and any other individuals in
contact with subjects and/or human research subject data will need
to complete the training.
WHEN
DO I HAVE TO COMPLETE THE TRAINING?
Any investigator
and his/her staff conducting research involving humans must complete
the training before approval of their proposal is granted by the IRB.
The Principal Investigators should ensure that all key personnel have
completed the training prior to submitting their new proposals or progress
reports on continued projects. Approval will be suspended until
all key personnel have completed training. IRB members are also requested
to take this exam before January 1, 2002.
WHAT DO
I DO FIRST?
To receive
your USERNAME AND PASSWORD please go to the CITI site at: http://www.citiprogram.org
Click once
on “Register for the Course.” This action will open
a new screen that requests your institution or organizational connection. Under “All
Others” (at the bottom of the screen), please choose “Maine
Medical Center.” Then click “submit.” You
will then be asked to create a username and password. When you
have completed the requested information, click “submit.” The
next page requests your registration information. Please complete
at least all of the items marked with an asterics, and then click “submit.” The
next page requests that you “select your group.” Please
choose “Group 1” if you will be conducting research on
drugs or devices (investigational or non-investigational), or any non-behavioral/non-social
research. Please choose “Group 2” if you will be
conducting social and/or behavioral research.
HOW
DO I BEGIN THE TRAINING COURSE?
Go to the
training site at http://www.citiprogram.org
Enter your
USERNAME and PASSWORD (both are case sensitive).
Begin your
training by clicking on the Link to "Basic Course". Follow
the directions to complete the course.
DO
I HAVE TO COMPLETE ALL OF THE MODULES AT ONE TIME?
No. The
software will keep tract of your progress and keep track of the quizzes
that you have completed. When you re-enter the site click on
the “Basic Course” link to return to the menu of modules.
HOW
LONG WILL IT TAKE TO COMPLETE THIS COURSE?
Each module
should take no longer than 30 minutes, or approximately 4-6 hours to
complete the entire course.
WHO
DO I CONTACT IF I HAVE A QUESTION?
Please
call the Office of Research Affairs at 885-8240. The Maine Medical
Center CITI Coordinator is Linda Reinholdtsen, Research Compliance Administrator, reinhl@mmc.org.
Complete
the quizzes as you complete each module. After you have completed
all of the required modules, a completion report will be sent to your
CITI coordinator. Once the IRB office receives the notice of
completion of the course, they will mail a certificate of completion
to you for your records.
Module |
Biomedical
Research |
Social
/ Behavioral Research |
1 |
Introduction
(no quiz) |
Introduction
(no quiz) |
2 |
History & Ethical
Principles |
History & Ethical
Principles - SBR |
3 |
Basic
IRB Regulations and Review Process |
Defining
Research with Human Subjects - SBR |
4 |
Informed
Consent |
The
Regulations & the Social & Behavioral Sciences - SBR |
5 |
Social & Behavioral
Research for Biomedical Researchers |
Assessing
Risk in Social & Behavioral Sciences - SBR |
6 |
Records-Based
Research |
Informed
Consent - SBR |
7 |
Genetic
Research in Human Populations |
Privacy & Confidentiality
- SBR |
8 |
Vulnerable
Subjects – Research w/ Prisoners |
Research
with Prisoners - SBR |
9 |
Vulnerable
Subjects – Research involving Minors |
Research
with Children - SBR |
10 |
Vulnerable
Subjects – Research involving Pregnant Women and Fetuses
in Utero |
Research
in Public Elementary & Secondary Schools - SBR |
11 |
Group
Harms: Research with Culturally or Medically Vulnerable Groups |
International
Research - SBR |
12 |
FDA
Regulated Research |
Internet
Research – SBR |
13 |
Maine
Medical Center (no quiz) |
Maine
Medical Center (no quiz) |
14 |
Human
Subjects Research at the VA (not required) |
15 |
HIPAA
and Human Subjects Research (not required) |
16 |
Workers
as Research Subjects – A Vulnerable Population (not
required) |
17 |
Hot
Topics (not required, but recommended) |
18 |
Conflicts
of Interest in Research Involving Human Subjects (not required,
but recommended) |
