Forgo the Fear Factor:It’s Not That Scary!

Holly Gutman, LEJA Graduate StudentResearch 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.phpor

http://www.citiprogram.org/

• For: Biomedical or Social/Behavioral Research• Time to complete: Less than 1 hour

National Institute of Health (NIH)Training

• For: Social and Behavioral Research• Time to complete: ~2 hours

Collaborative Institutional Training Initiative (CITI)

• 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 2: Preparing Consent Documents

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

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 for filling out IRB review form

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.

Tips cont…

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 UniversityOffice of Sponsored ProjectsSherman Hall 3201 University CircleMacomb, 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

andFaculty Advisors

Jill Joline Myers and Kimberly Dodson