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Not all research that involves living individuals as subjects requires review by the CUHS. In general, research that may present even a slight element of risk must be reviewed, either by "expedited review" (review outside of the committee's monthly meeting schedule by committee staff) or by the full committee. For these purposes the concept of "risk" is broad indeed and includes not only obvious physical risk but also less-apparent risks such as those relating to confidentiality of data, possible stress to subjects, or possible damage to a subject's reputation or personal relationships. The following list indicates some types of research that may or may not require review.
Determination of whether research involving human subjects is exempt from the need for CUHS review cannot be made solely by the investigator. If proposed research involves obtaining information about living individuals, whether through interaction with them, intervention (altering or affecting their environment or behavior), or collection of identifiable private information about them, the investigator should consult the committee staff about whether review, or determination of exemption, is required.
The mere fact that a research project requires review does not mean that there will likely be a problem, so long as the project is thoughtfully designed and proper consideration is given to the rights and welfare of the research subjects. Conversely, proposing a project that is exempt from the requirements of committee review does not relieve the investigator of any responsibilities relating to the research subjects; equal care must still be taken to ensure that subjects experience no harm to themselves or to their legitimate interests. If a research project includes some elements that may be exempt and some that may not, the more conservative judgment will obtain and the project should be submitted to the committee for review.
General survey and interview research Written and oral questionnaires or interviews where the investigator does not manipulate subjects' behavior or deceive subjects. Data may be collected with or without identifiers; if possible, responses should be anonymous (or identities should not be recorded together with subjects' responses.) |
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| May require review, either expedited or full: | May be exempt from committee review: |
Subjects are minors, or adults not competent to consent, or patients. Research deals with sensitive topics. Identifiers are recorded or linked to data. Subjects are recorded on audio or videotape (with their knowledge and consent). |
Subjects are competent adults, no identifiers are recorded with or linked to data, and the survey doesn't deal with "sensitive topics" (illegal or immoral activities, sexual behavior, or any information that could potentially harm a subject's reputation or legal or social standing or employability if it became known outside the research context) |
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Surveys/interviews with elites or government officials Written and oral questionnaires or interviews conducted with corporate, government, social, or religious officials or elites, other "public" figures |
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| May require review, either expedited or full: | May be exempt from committee review: |
| Research deals with sensitive topics relating to the subjects' own behavior. Subjects are recorded on audio or videotape (with their knowledge and consent). |
Surveys or interviews involving elected or appointed public officials or candidates for public office.
Surveys or interviews with elites or other officials where the research does not deal with "sensitive topics" related to the subjects' own behavior. |
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Observation Research Research where the investigator observes, and perhaps records, public or private behavior. May include interaction with subjects, such as participant observation studies. Subjects' identities may or may not be recorded. |
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| May require review, either expedited or full: | May be exempt from committee review: |
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| Investigator interacts with subjects and/or manipulates subjects' behavior.
Observation takes place in a private location, or in a place where subjects have reason to believe they are not being observed. Subjects' behavior is recorded on audio or videotape Research involves participant observation or other anthropological fieldwork. |
Investigator does not interact with subjects or manipulate their behavior, observation takes place in a public location, and subjects' identities are not recorded or otherwise linked to data. |
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Review of existing records Data already collected by another investigator or agency for research or other purposes, which are to be studied again or reanalyzed. Identifiers may or may not be associated. It is helpful to know under what circumstances the data were originally collected--that is, whether subjects understood the future uses to which identifiable information about them might be put. |
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May require review, either expedited or full: |
May be exempt from committee review: |
| Analysis of existing records or data with identifiers attached
Followup studies, where subjects are recontacted and new data are collected, to be correlated with existing data (additional special considerations may apply if subjects are not expecting a followup) |
Review or reanalysis of previously collected data from which all identifiers have been removed
Review of publicly-available records such as census data. |
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Case Studies Research where in-depth data are collected on one or more subjects, for the purpose of analysis to yield generalizable knowledge. Subjects may or may not be identified in the research report. |
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| May require review, either expedited or full: | May be exempt from committee review: |
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| Research involves sensitive data.
Subjects' identities may be determined from information in the research report. However: some biographical or narrative studies of adults, where there is no intention to develop generalizable knowledge, may not be considered "research involving human subjects" even though subjects are clearly identified. |
Research in which no sensitive data are collected and subjects' identities are impenetrably disguised in any research report. |
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Research involving deception "Deception" includes not only provision of false or misleading information to subjects prior to or during the research, but also the withholding of information that may be relevant to subjects' decision about participation or actions in the research context. Research involving deception is ordinarily approved only when (a) prior disclosure would harm the scientific validity of the study, so that the research could not be carried out without the deception; (b) the withheld information would not affect a subject's decision about participation; and (c) where appropriate, subjects are fully informed about the deception as soon as is practical. Prior explanation of risks cannot be withheld. |
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All research involving deception of subjects must be reviewed by the committee It is rare for the committee to approve research involving deception at the undergraduate level. Deception may be distinguished from incomplete prior explanation of experimental hypotheses; in some cases information is withheld from subjects to avoid prejudicing their responses or actions during the course of an experiment. If information is to be withheld this must be explained to the committee on the application. |
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