Forgo the fear factor it s not that scary
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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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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

  • 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.


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.


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:

AngelaTee, IRBComplianceSpecialist

and

Faculty Advisors

JillJoline Myers andKimberlyDodson


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