INSTITUTIONAL REVIEW BOARD (IRB) HUMAN SUBJECTS RESEARCH CHECKLIST Instructions: Use this checklist to determine if your project will qualify for Exempt Review or not. YES NO NOT SURE Is the data being obtained about living individuals? SECTION A: Does your activity Is the data collected by intervention or interaction with involve human individuals? subjects? Does the data contain identifiable private information? If any question in to Section B. Section A is “YES”, go If any question in Section A is go to Section B & C. “NOT SURE”, If all questions in Section A is not required. are “NO”, IRB review Is the activity a systematic investigation, including SECTION B: research development, testing, and evaluation, designed to Is it Research? develop or contribute to generalizable knowledge? If any question in Section A is and Section B is submit a New Protocol Application form. “YES” “YES”, If Section B is go to Section D If Section B is go to Section C. “NO”, “NOT SURE”, Does the activity involve secondary data sets with identifiable private information? Does the activity use identifiable specimens or cell lines obtained either from other institutions or from commercial resources? Is the data collected for administrative purposes with the intention of publication? Does the activity involve the use of publically available SECTION C: data that contains sensitive, persona, or identifiable data? Is IRB review Does the interview or survey focus on experiences, required? opinions, and sensitive information about people? Is the activity a biography that is generalizable? Is the activity an oral history that is generalizable? Does the activity involve case histories of multiple individuals? Is the activity a genetic study providing private information about live relatives? Is the activity a class related project that will lead to publication or poster presentations? If any question in Section C is submit a New Protocol Application form. “YES”, If all questions in Section C are go to Section D. If any questions in Section C is contact OPRS. “NO” “NOT SURE”, Does the activity intentionally focus on one or more specific populations listed below? If check the “YES”, SECTION D: appropriate box(es). Is the focus on a Children (age < 18 years) specific population? Pregnant or lactating women Neonates/Fetuses/In vitro Fertilization Persons group(s)— describe: Mentally disabled or cognitively impaired persons
INSTITUTIONAL REVIEW BOARD (IRB) HUMAN SUBJECTS RESEARCH CHECKLIST Instructions: Use this checklist to determine if your project will qualify for Exempt Review or not. YES NO NOT SURE SECTION A: Does your activity involve human subjects? Is the data being obtained about living individuals? Is the data collected by intervention or interaction with individuals? Does the data contain identifiable private information? If any question in Section A is “YES”, go to Section B. If any question in Section A is “NOT SURE”, go to Section B & C. If all questions in Section A are “NO”, IRB review is not required. SECTION B: Is it Research? Is the activity a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge? If any question in Section A is “YES” and Section B is “YES”, submit a New Protocol Application form. If Section B is “NO”, go to Section D If Section B is “NOT SURE”, go to Section C. SECTION C: Is IRB review required? Does the activity involve secondary data sets with identifiable private information? Does the activity use identifiable specimens or cell lines obtained either from other institutions or from commercial resources? Is the data collected for administrative purposes with the intention of publication? Does the activity involve the use of publically available data that contains sensitive, persona, or identifiable data? Does the interview or survey focus on experiences, opinions, and sensitive information about people? Is the activity a biography that is generalizable? Is the activity an oral history that is generalizable? Does the activity involve case histories of multiple individuals? Is the activity a genetic study providing private information about live relatives? Is the activity a class related project that will lead to publication or poster presentations? If any question in Section C is “YES”, submit a New Protocol Application form. If all questions in Section C are “NO” go to Section D. If any questions in Section C is “NOT SURE”, contact OPRS. SECTION D: Is the focus on a specific population? Does the activity intentionally focus on one or more specific populations listed below? If “YES”, check the appropriate box(es). Children (age < 18 years) Neonates/Fetuses/In vitro Fertilization Persons Mentally disabled or cognitively impaired persons Pregnant or lactating women group(s)— describe: