• Research Compliance Office

IRB Forms

• Social Behavioral Application (updated 6/08)
  Application for nonexempt research examining topics such as normal behavior, opinions, personal and social history, and educational practice.
  • Social Behavioral Application Instructions and Checklist

• Bioscience Application (updated 6/08)
  Application for research involving invasive procedures (saliva, tissue, urine, or blood samples etc), exercise science, dietary manipulation, human physiology, and studies that evaluate the safety or effectiveness of a medical product or procedure.
  • Bioscience Application Instructions

• Application for Exempt Research (updated 4/08)
  Application for research projects that fall under any exempt category as defined by 45 CFR 46.101(b).

• Continuing Review Form
  Form to use if approval is due to expire and researchers intend to keep a study open. This form should be used for non exempt studies which are approved for up to 1 year.

• Close Out Form
  Form to use to report closure of non exempt study. A study is complete when data collection and data analysis are complete.

• Modification Form
  Form to submit any proposed changes to a non-exempt study. All changes must be reviewed and approved before they can be implemented. Changes to exempt studies do not need to be reviewed, unless the change would cause the study to no longer be exempt.

• Translation Certification Form

• Adverse Event Reporting Form

Templates (Cover Letters and Recruitment Scripts)

• Recruitment Script(updated 7/31/07)
  Sample of language to include when recruiting subjects to participate in the study.

• Basic Cover Letter (updated 9/20/07)
  Sample of a letter that would typically accompany a survey in which the results will be anonymous (exempt studies).

• Information Letter (updated 5/08)
  Used for interviews when the research could not reasonably place the subjects at risk of criminal or civil liability and in which the results will be anonymous (exempt studies).

• Information Letter for group interviews
  Used for group interviews and/or focus groups

Consent and assent Form templates

• Child Assent Form

Directions for Writing the Informed Consent Form

• Informed Consent- More than minimal risk (Full Board studies)

• Informed Consent - Minimal Risk (Social Behavioral)                   

• Informed Consent - Minimal Risk (Bioscience)                             

• Parental Permission Form - More than minimal risk (Full Board studies)
                                                      
• Parental Permission Form

• Confidentiality Statement
  This form should be signed by the research team when the study includes sensitive information.

• ASU Standard Rights as a Research Participant Statement
  This statement should appear at the bottom of all consent and assent forms and other documents as appropriate.

HIPAA Forms & Templates