irb belmont report federally mandated risks -> minimized & reasonable informed consent...

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IRB Belmont Report • Federally mandated Risks -> minimized & reasonable Informed consent P rospective rospective Approval Approval Monitoring for subject & info safety

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Page 1: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

IRB• Belmont Report• Federally mandated• Risks -> minimized & reasonable• Informed consent• Prospectiverospective Approval Approval• Monitoring for subject & info safety

Page 2: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

• “Human Subject” §46.102(f)

Living indivs’Data via intervention or interactionIdentifiable private info

How do you know if you’re using human participants?

Page 3: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

Risks minimizedRisk vs. Benefits ratio Equitable selection Informed Consent appropriatePrivacy, confidentiality, safety - maximizedSafeguardsDesign - scientifically sound

What does the IRB look for?

Page 4: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

Inclusion of Human Participants

• Respect for Persons

• Beneficence

• Justice

Page 5: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject
Page 6: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

What is Informed Consent?• Process throughout

• Means to ensure:– “respect for persons”– mutual understanding– continuous, voluntary

• PARTS:– Initial consent– Continual understanding-assessment– W/draw anytime

Page 7: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

Analyzing Risks & Benefits

• To judge, IRB needs full info about:– WHO & HOW: selection & recruitment of subjects– WHAT, WHEN, WHERE: research design – WHY: scientific rationale

• conflicts of interest?

Page 8: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

• Confidentiality– Trust– Candor– Access to “private” data– “Sensitive” topics

– Thus…lends credibility to research

• Increase protections w/ likelihood of disclosure/harm

Page 9: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

3 “Levels” of Review• Exempt• Expedited• Full• Check Yourself (before you wreck yourself!)

– A quantitative, non-identifying (i.e., anonymous) survey about what adults (convenience sample) eat each day

– Qualitative, in-depth, in-person interview study about people’s divorce experiences

– Survey study about communication abilities to figure out if you’ve learned anything through a class. I don’t plan to use it for publication – just for class evaluation purposes

• www.wcsu.edu/irb/Research%20Proposal%20Guide.pdf

Page 10: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject
Page 11: IRB Belmont Report Federally mandated Risks -> minimized & reasonable Informed consent rospective Approval Prospective Approval Monitoring for subject

A SURVEY ON YOUR EXPERIENCES WITH A FORMERLY ABUSIVE PARTNERThis research is being conducted by Jessica Eckstein and Katie Lever-Mazzuto, faculty members in the Communication Department at WesternConnecticut State University.This study will survey men and women who have experienced any type of physical and/or psychological abuse fromromantic partners. The survey will be conducted online and will take approximately 20-25 minutes to complete.

Computer use can be monitored and is impossible to completely clear. If you are afraid your Internet and/or computer usage might be monitoredby your former partner or otherwise present a danger to your safety, please consider taking this survey at another time or at a location at whichyou will not be monitored.

Your participation in this research is entirely voluntary. You must be at least 18 years of age or older to participate and must be a U.S. resident or reside in the U.S. The survey contains items about you and your relationship, the kinds of abuse you experienced, the types of communication youused with this person, and how you felt about the abuse. There are no direct benefits to you from participating. However, the information youprovide may help us better understand the experiences of abuse victims.

If you are free to respond without your computer being monitored by an abusive partner, the only risks to you would be any discomfort you mayexperience when thinking about your abuse.

Your information will remain anonymous. You don’t have to answer any questions you don’t want to answer, and you can stop the survey oremail us with questions at any time. If you choose to contact us via email, we will not retain your email address and it will not be linked to anyinformation you provide in the survey.

The results of this study may be used for publication in an academic journal or presentation at an academic conference, but I will change or omitany information that could identify you before using quotations taken from your responses. In other words, quotations will not be linked to you.

Before proceeding, you must agree to the following:

• I am 18 years of age or older.• I reside in the United States and/or am a U.S. citizen.• I am not currently living with an abusive partner.• I understand that it may be unsafe for me to take this survey using a computer monitored by an abusive partner.• I have read and understand the above consent form and voluntarily agree to participate in this study.

Please print a copy of this consent form for your records.

If you want to speak to a counselor, to learn more about domestic violence, or to learn more about resources available in your community, youmay contact the Domestic Abuse Helpline for Men and Women toll-free 24-hours a day [phone: 1-888-7HELPLINE, website:http://www.dahmw.org] or the National Domestic Violence Hotline [phone: 1-800-799-SAFE, website: http://www.ndvh.org/].

If you have questions about the study, you may contact us at [email: [email protected], phone (203) 837-8873, address: 120 BerkshireHall, 181 White St., Danbury, CT 06810].

This research project (Proposal #0809-77) has been reviewed and approved by the WCSU Institutional Review Board. If you have questionsconcerning the rights of the subjects involved in research studies please call the WCSU Assurances Administrator, at (203) 837-8281.

This study is valid until February 4th, 2010.