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Exempt Research Policy

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Exempt Research Policy

What has changed in the OPRS exempt research policy?

  • Amendments to exempt protocols will only be required if substantive changes are requested and/or the changes requested may affect the exempt determination
  • An exempt determination letter will be issued instead of an IRB approval letter
  • A compact exempt information sheet template is available here
  • No reliance agreements or documentation will be required for cooperative exempt research

Which changes do require an IRB amendment to my protocol?

  • Changing data collection methods from anonymous information to identified;
  • Asking about new, potentially harmful information (e.g., child abuse, immigration status, etc.);
  • Adding prisoners or children as research participants;
  • Adding a new research site (if the protocol is federally funded) that would require review by another IRB;
  • Adding primary data collection to a category 4 exempt determination;
  • Adding new personnel, including UIUC faculty members, staff and students;
  • Adding any recruitment or research activities to occur at any Carle facility;
  • Adding any participants that are physically located in the European Economic Area

Which changes do not require an IRB amendment to my protocol?

  • Adding a research aim that does not substantively change the intent or scope of the study or increase the risk to subjects;
  • Adding questionnaires/assessments/measures that contain minor modifications or question(s) that do not involve risks to subjects;
  • Making minor updates to the exempt application or consent script that do not change the scope of the study or the plan to keep subjects’ identities and their data confidential;
  • Making minor modifications to recruitment processes and recruitment materials

NOTE: This is not an exhaustive list. Researchers are encouraged to contact the OPRS if there are questions regarding the nature of their proposed changes.