Forgo the Fear Factor:
It’s Not That Scary!
Holly Gutman, LEJA Graduate Student
Research Symposium Spring 2011
Introduction
• Purpose: To alleviate the fear of beginning a
research project.
• Learning Objectives:
The researcher will understand the process of…
– coming up with a research topic.
– completing human subjects training.
– obtaining approval from the Institutional
Review Board (IRB).
The Research Topic
• Things to consider:
– Is it interesting?
– Is it relevant to your area of study?
– How accessible is the data?
– Is it feasible?
– How long will it take to research?
• Tips for finding a topic:
– Listen to topics discussed in class.
– Do a literature review.
– Talk to professors and practitioners.
WARNING!
• Do not pick a topic that is too broad.
• The more narrow the topic, the easier it is to
input and analyze the data.
• Example
– Too broad: Abused and neglected children
– Narrowed down: Factors that contribute to
delinquency among abused and neglected
children in Des Moines County, Iowa
Institutional Review Board (IRB)
• What is the IRB?
– Independent ethics committee that reviews research
involving human subjects at an educational institution
– Regulated by the Office for Human Research Protections
(OHRP) within the Dept. of Health and Human Services
– Purpose: to protect rights and welfare of research
subjects
• What type of research is required to go through
the IRB process?
– Human subjects
– Identifiable private data
Step 1: Human Subjects Training
• If doing research on human subjects or obtaining
and analyzing identifiable private data, the
researcher must complete mandatory human
subjects training:
http://phrp.nihtraining.com/users/login.php
or
http://www.citiprogram.org/
National Institute of Health (NIH)Training
• For: Biomedical or Social/Behavioral Research
• Time to complete: Less than 1 hour
Collaborative Institutional Training Initiative (CITI)
• For: Social and Behavioral Research
• Time to complete: ~2 hours
Step 2: Preparing Consent Documents
• Informed Consent/Assent
– Needed if interacting with human subjects
– Prepare document and language to be approved
and stamped by IRB
• Letter of Support
– Needed if obtaining data from an outside entity
(community org., govt. agency, etc.)
– Include in IRB proposal
Step 3: IRB Review Forms
• Exempt Review:
– Lowest risk to human subjects
– Anonymous or publicly-available data
– Least potentially-harmful experiments
• Expedited Review:
– Minimal risk to human subjects
– Not anonymous
– Requires informed consent/letter of support
• Full Review:
– Greater than minimal risk to human subjects
– Can include: non-exempt research involving children,
vulnerable populations, experimental drugs or devices,
invasive procedures, or sensitive questions about sexual
practices or illegal behavior
Tips for filling out IRB review form
1.Clearly state purpose, aims and objectives of project and
justification for research.
2.Describe data collection methods and collection dates,
location, frequency and duration.
3.State sample size and describe population, including
vulnerable populations.
4.Explain screening procedures and inclusions/exclusion
criteria.
5.Describe why vulnerable populations are necessary and
justify any inclusion/exclusion of these populations.
Tips cont…
6. Describe setting, location and timing of recruitment.
7. Describe recruitment methods and any compensation or
reimbursement.
8. State timing, location and setting of obtaining consent and
who it will be obtained from (participant or legally
authorized representative).
9. Describe how identifiers will be removed and information
will be kept private.
10. Describe how risks to human subjects will be minimized.
11. Describe anticipated benefits of research and how
participants will be notified of results.
Step 4: Submitting IRB Forms
• Fully complete form
• Include all supporting documentation,
material, consent, and/or cover letter
• Submit to Office of Sponsored Projects:
Western Illinois University
Office of Sponsored Projects
Sherman Hall 320
1 University Circle
Macomb, IL 61455
Step 5: Waiting for Approval
• Exempt and Expedited Reviews
– 7 to 10 days
• Full Review
– Up to 30 days
Conclusion
• Remember: It’s not that scary!
• Do a little advanced leg work and it will be a
simple process.
• Do not hesitate to ask for help from
professors.
DO IT RIGHT, DO IT ONCE.
Special Thanks To:
Angela Tee, IRB Compliance Specialist
and
Faculty Advisors
Jill Joline Myers and Kimberly Dodson