CITI Defining Research with Human Subjects - SBE/ The Federal Regulations - SBE

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression. - The study of passenger lists is a study of individuals who are no longer living. A human subject is a living individual. Questioning individuals to acquire data about the number of newly diagnosed HIV cases is asking "about what" questions rather than "about whom" questions. Conducting a linguistic analysis of comments posted on a public blog involves neither interaction with individuals nor collecting private identified information and thus does not meet the definition of research with human subjects. The study proposed by the developmental psychologist does meet the definition of research with human subjects. It involves interactions with living individuals and is designed to contribute to a field of knowledge.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors. - A cognitive scientist studying the effect of moods on problem-solving behaviors is asking a research question and is interacting with living individuals. Questioning a superintendent of schools to acquire data about the ethnic composition of a school system is asking "about what" questions rather than "about whom" questions (if a study proposed interviewing the superintendent of public schools about his or her experience in the field of education or about his or her perceptions about the current problems within the school system and possible solutions, the questions would become "about whom"). Analyses of public behavior such as writing for a blog or a newspaper do not meet the definition because there is no interaction or intervention with a human subject and no collection of private information. Finally, in the class exercise described, the intention is pedagogical (to learn how to conduct and interview) rather than to answer a research question.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

Must occur within 12 months of the approval date. - Continuing review of an approved protocol must occur within 12 months of the approval date even if no additional risks have been identified. Review by a convened IRB is not always required (for example, if the study was complete and in data analysis only). Any unanticipated problems must be addressed during the continuing review process, but the review must include other information such as the number of subjects accrued, any relevant recent literature, and a copy of the current consent form.

According to federal regulations, the expedited review process may be used when the study procedures pose:

No more than minimal risk and the research activities fall within regulatory categories identified as eligible. - Research is eligible for expedited review when it poses no more than minimal risk to the participants and when all the activities fall within categories identified as eligible. Studies with more than minimal risk do not qualify for expedited review even if the subjects are adults, the sponsor is in a hurry, or the study replicates previously approved research.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

An experiment is proposed on the relationship between gender-related stereotypes in math and the subsequent performance by males and females on math tests. - In the study of the effects of evoking stereotypes on subsequent performance, the researcher has a research question and will be manipulating the behavior of individuals. An in-house study conducted with the intention of improving a department's mentoring programs is not research with human subjects, but rather program improvement. Receiving data with no identifiers is not research with human subjects because there is no interaction or intervention with a living human being and no collection of private identifiable data. In addition, creating a report for a membership organization does not involve a research question, as defined by the federal regulations, so it too is not research with human subjects.

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information. - In order to meet the definition of research with human subjects a researcher must obtain data about a living individual through interaction or intervention or, alternatively, obtain individually identifiable private information. If a researcher obtains public information or de-identified information about individuals, and has not interacted or intervened with the individuals, those individuals are not considered human subjects for the purposes of the research.

Which of the following statements about the relationship between an institution and the institution's IRB(s) is correct?

Officials of the institution may overrule an IRB approval. - If an IRB has disapproved a protocol, that disapproval may not be overturned by an institutional official or anyone at that institution, such as a department chair. However, an IRB-approved protocol may be subject to other reviews at the institution and may be disapproved (overruled).

A researcher is interested in assessing risk-taking by individuals. The researcher is sitting on a bench near a busy four-way stop intersection. She plans on recording the number of bike riders wearing a safety helmet and whether they stop at the intersection before proceeding in order to correlate use of safety apparel with risk-taking. This collection of information is an example of:

Public behavior - Public behavior occurs in a place where one does not reasonably expect privacy. The riders here are observed on public streets. These observations are public behavior. If the observation and recording of similar information occurred in a private training facility it could be considered private behavior and private information. Examples of public information would be donor lists in a concert program or names and addresses in telephone directories. Private information includes information that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place.

According to the federal regulations, research is eligible for exemption, if:

The research falls into one of eight categories of research activity described in the regulations. - Research is only eligible for exemption if all the activities associated with the research fall into one of eight categories of activities described in the federal regulations. The regulations do allow some research with children to be exempt (although institutional policy may not). The duration of the study and the experience of the researcher are not criteria for determining eligibility for exemption.

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations?

Prisoners - Prisoners are provided additional protections in the HHS regulations. The HHS regulations do not have specific additional protections for elderly, for students, or for persons whose decision-making capabilities are impaired. Researchers may consider and the IRB may require additional safeguards for these populations.