University of Nebraska – Lincoln Office of Research Responsibility

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

Institutional Review Board – [email protected] - 402.472.6965

Becky FreemanIRB & Research Compliance [email protected]

mailto:[email protected]


Categories of Review

• Exempt: less than minimal risk

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

• Full Board: greater than minimal risks


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?


• 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


Special Situations

• Secondary data

• Waivers of Informed Consent

• Research in Other Countries

• Oral History projects

• Journalistic Interviews

• Class Projects & Evaluations


Examples of Research

• Internet Research

• Paper based surveys

• Interviews/Focus Groups

• Exercise Studies

• Student Research


How long will review take?


Exempt Protocols


Expedited Protocols


Full Board Protocols


Continuing Review

• Must occur annually – based off date of final approval

• Required for exempt, expedited, and full board review

• Form submitted via NUgrant


Change in Protocol

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



Final Report

• Can be submitted any time

• Allows us to close the project



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


NUgrant

• Online protocol submission process

• http://nugrant.unl.edu

http://nugrant.unl.edu/


RESOURCES


IRB Website: (Guidance and Forms Page)

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

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


Federal Guidance (45 CFR 46.101)

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




NUgrant help tab:


IRB Office:

Becky Freeman [email protected]

Patty Swanson 472-6907 [email protected]

Melissa Meyer 472-8196 [email protected]





QUESTIONS??

Documents

University of Nebraska – Lincoln Office of Research Responsibility