Collaborative Institutional Training Initiative (CITI)
Training Module Instructions
Step One: For Both Beaumont and Oakland University Research
Determine if your research is Biomedical
or Social, Behavioral And Education Research
Biomedical Research
Biomedical research includes studies:
1. Designed to evaluate the safety, effectiveness, or usefulness of an intervention (e.g.,
drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedure
(e.g., CAT scans, X-rays, ultrasound, etc.), or preventive measure (e.g., vaccines, diet,
or fluoridated toothpaste).
2. On normal human functioning and development can include studies of the human
body while exercising, fasting, feeding, sleeping, or learning, or responding to such
things as stress or sensory stimulation.
3. Comparing the function of a particular physiological systems at different stages of
development (e.g., infancy, childhood, adolescence, adulthood, or old age).
4. Utilizing medical records.
5. Utilizing the human genome and genetic markers.
Social, Behavioral and Education Research
This research includes studies:
1.
2.
3.
4.
Associated with human affairs
That may broaden understanding without any apparent or immediate application.
That may be directed at evaluating an intervention or social program.
Generating data by means of questionnaires, observation, studies of existing records,
and experimental designs involving exposure to some type of stimulus or non-medical
intervention.
5. Conducted in public places, in private settings (e.g., a clinic or therapist's office).
Interventions in such studies range from the innocuous, such as varying the package
design of commercial products, to the potentially significant, such as varying behavior
modification techniques in studying the treatment of alcoholism.
6. Most behavioral research involves no physical intervention and no physical risk.
However, some studies do present a risk of social harm (e.g., harm to a subject's
reputation, which is sometimes a danger if confidentiality is not maintained) or
psychological harm, which may occur if the research involves deception or provides
subjects with unwelcome and disturbing information about themselves. When deception
is involved, the IRB needs to be satisfied that the deception is necessary and that, when
appropriate, the subjects will be debriefed. (Debriefing may be inappropriate, for
example, when the debriefing itself may present an unreasonable risk of harm without a
counterveiling benefit.)
Definitions modified from: http://www.hhs.gov/ohrp/archive/irb/irb_chapter5.htm#h2
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Step 2:
Go to the CITI training website (https://www.citiprogram.org) and register.
Step 3:
Go to the Main Menu. If you are conducting research at Beaumont, affiliate with both
Beaumont and Oakland University.
Step 4: If you are conducting research only though Oakland University, only affiliate
with Oakland University.
If you are conducting research at Beaumont Hospital affiliate with both Oakland
University and Beaumont Hospital
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ALL STUDENTS CONDUCTING HUMAN SUBJECTS OR ANIMAL
RESEARCH MUST COMPLETE THE FOLLOWING
Step 5: Select “Add a Course or Update Learner Group” for Oakland University from the
Main Menu
Step 6: Answer the following 8 questions:
Question 1: Select “Student and Faculty Advisor”
Question 2: Select all options that apply to your research
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Question 3: Select “Not at this time”
Question 4: Select the HIPS course
Question 5: Select either “Biomedical Responsible Conduct of Research Course” or “Social
and Behavioral Responsible Conduct of Research Course”
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Question 6: Select “Yes”
Question 7: Answer this question only if you are going to work with animals
Question 8: Select “not at this time”
Hit the “submit” button at the bottom of the page, and the modules you will
have to complete will be populated for you.
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STUDENTS CONDUCTING RESEARCH AT BEAUMONT HOSPITAL
MUST COMPLETE THE FOLOWING
Step 1: Select “Add a Course or Update Learner Group” for William Beaumont Hospital
from the Main Menu
Step 2: Answer the following 3 questions
Select Curriculum “Alternative 1”
Question 1: Make a selection only if your research involves animals
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Question 2: Select “Mandatory-Biomedical Research Investigators and Key Personnel”
Question 3: Select “Biomedical Responsible Conduct of Research Course
Hit the “submit” button at the bottom of the page, and the modules you will
have to complete will be populated for you.
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MODULES THAT MUST BE COMPLETED FOR OAKLAND UNIVERSITY
CITI Courses for Biomedical Research
Courses:
Biomedical Researcher – Basic/Refresher
CITI Health Information Privacy and Security (HIPS)
Responsible Conduct of Research
CITI Conflicts of Interest
CITI Courses for Social, Behavioral, and Educational Sciences
Courses:
Social and Behavioral Responsible Conduct of Research Course
Student and Faculty Advisor Basic/Refresher
MODULES THAT MUST BE COMPLETED FOR BEAUMONT HOSPITAL
CITI Courses required for Biomedical Research and Social, Behavioral, and
Educational Sciences
Courses:
Biomedical Research Investigators and Key Personnel
Biomedical Responsible Conduct of Research Course 1
Module Titles
Introduction
History and Ethical Principles (ID 4581)
Basic Institutional Review Board (IRB) Regulations and Review
Process (ID:2)
Informed Consent (ID:3)
Records-Based Research (ID:5)
Genetic Research in Human Populations (ID:6)
Research With Protected Populations –Vulnerable Subjects: An
Overview (ID:7)
Vulnerable Subjects – Research Involving Children (ID:9)
FDA – Regulated Research (ID:12)
Research and HIPAA Privacy Protections (ID:14)
Conflicts of Interest in Research Involving Human Subjects
(ID:488)
William Beaumont Hospital and Research Institute (ID:532)
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Required
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Supplemental
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Additional Research Compliance Module for Beaumont Research Studies
Link to BRI Compliance Module:
https://beaunet.beaumont.edu/portal/pls/portal/cbt.login1_pkg.login
Once you log in, you need to complete the Research Institute Compliance Plan
If you have trouble logging in, please contact the Beaumont IT department at (248) 597-2727.
Please save a copy of your completed module. This will need to be uploaded under “other
documents” with your IMedris submission.
Animal Research at Beaumont Hospital
All students working on research projects involving the use of live animals must contact the
Assistant Director, Research Services to discuss the project prior to initiating an Animal Care
Committee (ACC) application. Please initiate this process by contacting Barbara Scott at the
Beaumont HIC (BScott@beaumont.edu).
Research Services Training Requirements include:
1. Review of the Research Services Training Manual (available from Michelle McGonagle)
2. Completion of a questionnaire documenting review of the Research Services Training
Manual
3. Complete the on-line CITI training course “Working with the IACUC”.
4. Complete project and species specific training as determined by the ACC.
Documentation of training completion must be provided to the oversight committee (either the
HIC or the ACC) before project approval is granted.
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To Print and Save Your CITI Completion Reports
Step 1: Click on Oakland University as your Institution and then on “My
Reports” on the horizontal menu across the top of the screen:
Step 2: Go to your File>print option on your apple menu. In the call out
box, select the PDF button in the lower left corner.
Step 3: Save the PDF file for submission with your IRB application.
Step 4: Do the same for your Beaumont CITI and Compliance modules.
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