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

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.

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

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  1. Forgo the Fear Factor:It’s Not That Scary! Holly Gutman, LEJA Graduate Student Research Symposium Spring 2011

  2. 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).

  3. 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.

  4. 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

  5. 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

  6. 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/

  7. National Institute of Health (NIH)Training • For: Biomedical or Social/Behavioral Research • Time to complete: Less than 1 hour

  8. Collaborative Institutional Training Initiative (CITI) • For: Social and Behavioral Research • Time to complete: ~2 hours

  9. 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

  10. 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

  11. Tips for filling out IRB review form • Clearly state purpose, aims and objectives of project and justification for research. • Describe data collection methods and collection dates, location, frequency and duration. • State sample size and describe population, including vulnerable populations. • Explain screening procedures and inclusions/exclusion criteria. • Describe why vulnerable populations are necessary and justify any inclusion/exclusion of these populations.

  12. Tips cont… • Describe setting, location and timing of recruitment. • Describe recruitment methods and any compensation or reimbursement. • State timing, location and setting of obtaining consent and who it will be obtained from (participant or legally authorized representative). • Describe how identifiers will be removed and information will be kept private. • Describe how risks to human subjects will be minimized. • Describe anticipated benefits of research and how participants will be notified of results.

  13. 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

  14. Step 5: Waiting for Approval • Exempt and Expedited Reviews • 7 to 10 days • Full Review • Up to 30 days

  15. 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.

  16. Special Thanks To: AngelaTee, IRBComplianceSpecialist and Faculty Advisors JillJoline Myers andKimberlyDodson

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