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Appendix B Table of Committee-Recommended Levels of IRB Review and Oversight 153

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154 PROPOSED REVISIONS TO THE COMMON RULE Not Human-Subjects Research Human-Subjects Research EXCUSED FROM IRB REVIEW Classification and Procedures: Classification and Procedures: • Classified as “not human-subjects • Classified as human-subjects research research” because it involves either because there is interaction or o cholarship or other information S intervention with human subjects or use gathering activities that are not of data with private information: covered by the intent or spirit o tudies using pre-existing research or S of the term “human-subjects non-research data that include private research.” information.c o  esearch activities in which the R o tudies where the research procedures S investigator is not obtaining data involve informational risk that is through interaction or intervention no more than minimal risk (when with living subjects or is not appropriate data security and obtaining identifiable private information protection plans are in information.a place). • Falls outside of the Common Rule • Investigators register the study, describe regulations. consent procedures, and provide a data • Not subject to IRB determination, protection plan calibrated to type and review, monitoring, or auditing. level of information risk. (The committee • Investigators are responsible for the does not endorse HIPAA as the mandated ethical conduct of their research and data security and protection standard.d) its accurate classification. • IRBs have oversight of the registration • Investigators are expected to observe through prospective and retrospective professional standards appropriate to audits, and data protection plan provided. their fields and to responsible conduct requirements of their institutions.

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APPENDIX B 155 Human-Subjects Research EXPEDITED IRB REVIEW FULL IRB REVIEW Classification and Procedures: • No major changes proposed in ANPRM or • Classified as research that poses no by committee. more than minimal risk and is on the OHRP-approved list of types of • To avoid overestimation of risk, expedited studies that can be expedited. This review should be considered the default list of studies should be expanded and procedure for evaluating social and periodically reviewed. behavioral science research that is not • Some research that might usually excused. Decisions to require full board be classified under the new excused review should be based on established category might instead be appropriate scientific or professional knowledge for expedited review. Research might indicating a significant probability that require expedited review when participants will experience a magnitude of the specific nature of the research risk that is greater than minimal and that procedures and/or the characteristics cannot be adequately reduced through risk- of the subject population, require minimizing procedures. 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. continued

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156 PROPOSED REVISIONS TO THE COMMON RULE Not Human-Subjects Research Human-Subjects Research EXCUSED FROM IRB REVIEW Study Types/Examples: Study Types/Examples: • Scholarship outside of the definition • Use of pre-existing research and non- of human-subjects research, such as research data that includes private biographies, personal observation, or information, including use of extant fact checking with sources for non- research data under restricted use fiction writing. provisions or use of non-research data • Public information outside of the that is accessible but includes private definition of human-subjects research information about individuals that they from these types of sources: may not expect to be public. o  bserving, coding, or recording O • Benign interactions or interventions the behavior of individuals in that involve methodologies that are public settings where there is no very familiar to people in everyday interaction or intervention and life and in which verbal, behavioral, no assumption of privacy,b such or physiological responses would be as recording admissions lines to the research data being collected (e.g., study social interaction in crowds educational tests, surveys, focus groups, at sporting or cultural events, interviews, fieldwork or “participant coding informational content of observation,” and similar procedures; and publicly published Facebook pages; sociolinguistic studies; simulation studies; observing differences in tipping games, markets, negotiations, voting; behavior in restaurants. individual or group decision making; o  emographic, sociological, or D studies of educational processes, teaching, other research that uses publicly and learning; studies of social perception available data sources, such as and judgment; personality, achievement, birth or decedent records, home and ability tests, and role playing ownership, court records where the involving routine activities or tasks under information is public and there is different scenarios and that do not in no assumption of privacy. and of themselves introduce or heighten o  esearch that uses certified R physical pain or psychological discomfort. public-use data files; that is, data • Would not be limited to adults. 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. 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 assump- tion 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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APPENDIX B 157 Human-Subjects Research EXPEDITED IRB REVIEW FULL IRB REVIEW 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. 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.

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