Upload File

university of nebraska – lincoln office of research responsibility what information does the irb...

  • Home
  • Documents
  • University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional
22
University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional Review Board (IRB) – [email protected] -

Post on 21-Dec-2015

212 views

Category:

Documents


0 download

Report

TRANSCRIPT

Page 1: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

University of Nebraska – LincolnOffice of Research Responsibility

What information does the IRB need? How do they make their

decisions?

May 19, 2009

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Page 2: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board – [email protected] - 402.472.6965

Becky FreemanIRB & Research Compliance [email protected]

mailto:[email protected]
Page 3: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Categories of Review

• Exempt: less than minimal risk

• Expedited: minimal risk (risks encountered in everyday life)

• Full Board: greater than minimal risks

Page 4: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Factors Considered in Risk Assessment

• Who are the participants?

• What will participants be doing?

• Are responses identifiable?

• How will results be reported?

• Who has access to the raw data?

Page 5: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

• Adults completing an on-line survey through a link they find on the web (no identifiers) – asks about child abuse

• Same survey questions – identifiable • Same survey questions– participants are

children• Same survey questions– teachers are

asked to complete it & raw data given to superintendent

Page 6: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Special Situations

• Secondary data

• Waivers of Informed Consent

• Research in Other Countries

• Oral History projects

• Journalistic Interviews

• Class Projects & Evaluations

Page 7: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Examples of Research

• Internet Research

• Paper based surveys

• Interviews/Focus Groups

• Exercise Studies

• Student Research

Page 8: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

How long will review take?

Page 9: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Exempt Protocols

Page 10: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Expedited Protocols

Page 11: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Full Board Protocols

Page 12: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Continuing Review

• Must occur annually – based off date of final approval

• Required for exempt, expedited, and full board review

• Form submitted via NUgrant

Page 13: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board – [email protected] - 402.472.6965

Change in Protocol

• Required for personnel changes (PI & SI), informed consent changes, addition/deletion of measures, etc

• Form submitted via NUgrant

Page 14: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board – [email protected] - 402.472.6965

Final Report

• Can be submitted any time

• Allows us to close the project

• Form submitted via NUgrant

Page 15: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board – [email protected] - 402.472.6965

Training

• CITI

• Complete the Human Research Curriculum (Group 1 or 2) Basic Course

• No need to complete the Responsible Conduct of Research (RCR) training

• http://www.citiprogram.org

Page 16: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

NUgrant

• Online protocol submission process

• http://nugrant.unl.edu

http://nugrant.unl.edu/
Page 17: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

RESOURCES

Page 18: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

IRB Website: (Guidance and Forms Page)

http://research.unl.edu/orr/forms.shtml

http://research.unl.edu/orr/forms.shtml
Page 19: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

Federal Guidance (45 CFR 46.101)

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
Page 20: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

NUgrant help tab:

Page 21: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

IRB Office:

Becky Freeman [email protected]

Patty Swanson 472-6907 [email protected]

Melissa Meyer 472-8196 [email protected]

mailto:[email protected]
mailto:[email protected]
mailto:[email protected]
Page 22: University of Nebraska – Lincoln Office of Research Responsibility What information does the IRB need? How do they make their decisions? May 19, 2009 Institutional

Institutional Review Board (IRB) – [email protected] - 402.472.6965

QUESTIONS??


University of Nebraska - Lincoln DigitalCommons ... - CORE

Lincoln Electric System - Lincoln, Nebraska

VITA - University of Nebraska–Lincoln

Nebraska Law Review - University of Nebraska–Lincoln

Aquatic Plants of Nebraska - University of Nebraska–Lincoln

Dan Claes University of Nebraska-Lincoln

Capital Improvement Program - Lincoln, Nebraska

RENTWISE - University of Nebraska–Lincoln

UNIVERSITY OF NEBRASKA-LINCOLN

University of Nebraska–Lincoln · 2012. 5. 3. · University of Nebraska–Lincoln

A STOCK COMPANY LINCOLN, NEBRASKA

KEY - University of Nebraska–Lincoln

Physics - University of Nebraska–Lincoln

University of Nebraska - Lincoln DigitalCommons@University of … · 2020. 10. 23. · University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Theses, Dissertations,

University of Nebraska - Lincoln DigitalCommons@University

Routines & Strategies - University of Nebraska–Lincoln

Feature writing Michelle Carr Hassler University of Nebraska-Lincoln Michelle Carr Hassler University of Nebraska-Lincoln

WILLING TO SERVE - Lincoln, Nebraska

Historic Preservation Commission - Lincoln, Nebraska

CITY OF LINCOLN, NEBRASKA, STANDARD SPECIFICATIONS …

lincoln.ne.gov | City of Lincoln, Nebraska

100 years 1911 2011 - Lincoln, Nebraska

Archaeoparasitology - University of Nebraska–Lincoln

Nebraska; Rainwater Plant List - Lincoln

UNIVERSITY OF NEBRASKA–LINCOLN ^ 98 2017 … of nebraska–lincoln 2017-2018 campus maps greek housing street direction visitor parking point of interest university of nebraska–lincoln

Results - University of Nebraska–Lincoln

UNIVERSITY OF NEBRASKA–LINCOLN COLLEGE OF …Engineering@Nebraska is published by the University of Nebraska–Lincoln College of Engineering. The University of Nebraska–Lincoln

Department Updates - University of Nebraska–Lincoln

Relocation Assistance - Lincoln, Nebraska

University of Nebraska - Lincoln DigitalCommons@University of … · 2020. 10. 22. · University of Nebraska - Lincoln DigitalCommons@University of Nebraska - Lincoln Faculty Publications:

PathogeNews - University of Nebraska–Lincoln

Hotel in Lincoln Nebraska

2020 Nebraska Farm Custom Rates · University of Nebraska–Lincoln Extension educational programs abide with the nondiscrimination policies of the University of Nebraska–Lincoln

CITY OF LINCOLN, NEBRASKA

HAMPTON ENTERPRISES - Lincoln, Nebraska