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Not Human-Subjects Research |
Human-Subjects Research |
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EXCUSED FROM IRB REVIEW |
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Classification and Procedures: |
Classification and Procedures: |
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• Classified as “not human-subjects research” because it involves either o Scholarship or other information gathering activities that are not covered by the intent or spirit of the term “human-subjects research.” o Research activities in which the investigator is not obtaining data through interaction or intervention with living subjects or is not obtaining identifiable private information.a • Falls outside of the Common Rule regulations. • Not subject to IRB determination, review, monitoring, or auditing. • Investigators are responsible for the ethical conduct of their research and its accurate classification. • Investigators are expected to observe professional standards appropriate to their fields and to responsible conduct requirements of their institutions. |
• Classified as human-subjects research because there is interaction or intervention with human subjects or use of data with private information: o Studies using pre-existing research or non-research data that include private information.c o Studies where the research procedures involve informational risk that is no more than minimal risk (when appropriate data security and information protection plans are in place). • Investigators register the study, describe consent procedures, and provide a data protection plan calibrated to type and level of information risk. (The committee does not endorse HIPAA as the mandated data security and protection standard.d) • IRBs have oversight of the registration through prospective and retrospective audits, and data protection plan provided. |
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Human-Subjects Research |
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EXPEDITED IRB REVIEW |
FULL IRB REVIEW |
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Classification and Procedures: • Classified as research that poses no more than minimal risk and is on the OHRP-approved list of types of studies that can be expedited. This list of studies should be expanded and periodically reviewed. • Some research that might usually be classified under the new excused category might instead be appropriate for expedited review. Research might require expedited review when the specific nature of the research procedures and/or the characteristics of the subject population, require consideration of human subjects protections beyond those normally applied in the excused category to ensure that any harm or discomfort created solely by the research procedures is not greater than minimal risk. • Research is reviewed and overseen by IRB. • Eliminate annual continuing review. |
• No major changes proposed in ANPRM or by committee. • To avoid overestimation of risk, expedited review should be considered the default procedure for evaluating social and behavioral science research that is not excused. Decisions to require full board review should be based on established scientific or professional knowledge indicating a significant probability that participants will experience a magnitude of risk that is greater than minimal and that cannot be adequately reduced through risk-minimizing procedures. |
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Not Human-Subjects Research |
Human-Subjects Research |
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EXCUSED FROM IRB REVIEW |
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Study Types/Examples: |
Study Types/Examples: |
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• Scholarship outside of the definition of human-subjects research, such as biographies, personal observation, or fact checking with sources for nonfiction writing. • Public information outside of the definition of human-subjects research from these types of sources: o Observing, coding, or recording the behavior of individuals in public settings where there is no interaction or intervention and no assumption of privacy,b such as recording admissions lines to study social interaction in crowds at sporting or cultural events, coding informational content of publicly published Facebook pages; observing differences in tipping behavior in restaurants. o Demographic, sociological, or other research that uses publicly available data sources, such as birth or decedent records, home ownership, court records where the information is public and there is no assumption of privacy. o Research that uses certified public-use data files; that is, data files tested to ensure respondents cannot be identified; public-use files available from such studies as the Panel Study of Income Dynamics, Early Childhood Longitudinal Program, National Longitudinal Study of Adolescent Health, among many others. |
• Use of pre-existing research and non-research data that includes private information, including use of extant research data under restricted use provisions or use of non-research data that is accessible but includes private information about individuals that they may not expect to be public. • Benign interactions or interventions that involve methodologies that are very familiar to people in everyday life and in which verbal, behavioral, or physiological responses would be the research data being collected (e.g., educational tests, surveys, focus groups, interviews, fieldwork or “participant observation,” and similar procedures; and sociolinguistic studies; simulation studies; games, markets, negotiations, voting; individual or group decision making; studies of educational processes, teaching, and learning; studies of social perception and judgment; personality, achievement, and ability tests, and role playing involving routine activities or tasks under different scenarios and that do not in and of themselves introduce or heighten physical pain or psychological discomfort. • Would not be limited to adults. |
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aThis point is consistent with OHRP’s October 16, 2008 Guidance on Research Involving Coded Private Information or Biological Specimens. Available: http://www.hhs.gov/ohrp/policy/cdebiol.html [February 2014].
bNew forms of large-scale data that can often be obtained in real-time and continuously are classified as not human-subjects research if the information is publicly available to anyone (including for purchase), if persons providing or producing the information have no assumption that they are engaged in private behaviors or interactions, and if investigators have no interaction or intervention with individuals. If all three conditions are met, the data are public whether or not the identity of the individuals is also known. Investigators must observe the ethical standards for handling such information that guide research in their fields.
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Human-Subjects Research |
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EXPEDITED IRB REVIEW |
FULL IRB REVIEW |
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Study Types/Criteria to be Considered: • The participant population is known to have decisional vulnerabilities empirically established to require enhanced informed consent protections for the type of study to be conducted. • The study is designed to produce clinical changes in health, health-related behaviors or symptomology, and includes identifiable information. • Public awareness of recruitment procedures can jeopardize participants’ physical safety or reveal criminal behavior. • The nature of the research data collected requires specific plans for reporting illegal behaviors, providing emergency treatment, or protecting a participant or third party from physical harm. • Use of deceptive techniques are specifically designed to induce psychological, social, or physical discomfort. • When additional protections are necessary to avoid harms produced by an existing professional or service relationship with research staff that would compromise voluntary participation. |
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cThis category includes use of pre-existing research data under restricted conditions where investigators must adhere to consent agreements, including with respect to the confidentiality of the data. Also, excused from IRB review are studies using new forms of non-research data where individuals would typically assume their information is private.
dAlthough the committee does not endorse HIPAA as the mandated data security and protection standard (as proposed in the ANPRM), the committee acknowledges that social and behavioral science research conducted in HIPAA covered institutions would still need to comply with HIPAA rules with regard to protecting privacy of participants’ data.
