2) Select ONLY the “Responsible Conduct of Research” box.<\/p>\n
3) For our seminar,\u00a0select the “Social and Behavioral” RCR course, and successfully complete the 10 required modules.<\/p>\n
4) Email me a screenshot (see instructions<\/a> or download free Skitch for Mac tool<\/a>) or other proof of successful completion.<\/p>\n If you’ve already met this requirement for another class or project, simply send me proof of completion.<\/p>\n <\/p>\n PS: For what it’s worth, here are some notes that I took while completing my version of the CITI online course a couple of years ago at Trinity. No guarantee that this will help you pass the quizzes, but might be worth a read.<\/p>\n Ask “Is It Research?” “Research” generally does not include operational activities such as practice activities in medicine, psychology, social work, and public health (for example, routine outbreak investigations and disease monitoring) and studies for internal management purposes such as program evaluation, quality assurance, quality improvement, fiscal or program audits, marketing studies, or contracted-for services. It generally does not include journalism or political polls. However, some of these activities may include or constitute research in circumstances where there is a clear intent to contribute to generalizable knowledge.<\/p>\n Ask “Does It Involve Human Subjects?” Observational studies of public behavior (including television and public Internet chat rooms) do not involve human subjects as defined when there is no intervention or interaction with the subjects and the behavior is not private. Also, studies based on data collected for non-research purposes may not constitute human subjects research if individual identities are not available (for example, programmatic data such as service statistics, school attendance data, crime statistics, or election returns).<\/p>\n Studies based on data that are individually identifiable but are also publicly available may not constitute human subjects research. However, the term “publicly available” is intended to refer to record sets that are truly readily available to the broad public, such as census data. An investigator should not assume information qualifies as “publicly available” merely because it has been posted on an electronic website and can be accessed without authorization.<\/p>\n Studies that are NOT Human subjects research: For human subjects to participate in a research study, they need to have enough information to give a truly voluntary informed consent. Information subjects must be given include: A more recent example of research that obtained personal information about individuals without their knowledge is the Harvard “Tastes, Ties, and Time (T3)” study (2006-2009). Sociologists at Harvard University gleaned voluminous and detailed personal information from the Facebook profiles of an entire class of undergraduates and followed those students over four years. The research team created an extensive data set that included students’ gender, home state, major, political and group affiliations, friend networks, photographs, and tastes in music, books, and film. In 2008, the researchers made the data publicly available through the Dataverse Network Project. Although no students were identified by name, some of data were specific enough to allow for re-identification of students by an outside researcher (Zimmer 2010; Parry 2011).<\/p>\n In both of these studies, the ethical concerns are invasion of privacy, lack of informed consent, and a failure to protect against deductive disclosure of identity.<\/p>\n Refraining from collecting subject names is a simple way of reducing risk of harm due to inadvertent disclosure of private information. As we have seen from the Harvard T3 study, however, it is rarely sufficient as data re-identification has emerged as growing computer science specialization. Latanya Sweeney, director of the Data Privacy Lab at Harvard, has demonstrated that 87% of Americans can be uniquely identified by only three bits of demographic information: five-digit zip code, gender, and date of birth (Sweeney 2000).<\/p>\n Defining Research with Human Subjects Privacy page Exempt research with children: Re-identification methods are unique to Internet-based research. Two examples of re-identifying presumably de-identified datasets are the Harvard \u201cT3\u201d Study incident in 2008 and the AOL search data leak in 2006.<\/p>\n \u201cTaste, Ties, and Time (T3)\u201d was a longitudinal study conducted by a group of researchers at Harvard University and the University of California\u2014Los Angeles. The team was investigating the nature and dynamics of social networks using Facebook data from an entire cohort of undergraduate students at a university in the northeastern United States. The researchers began collecting data in 2006 and continued data collection through 2009, at one-year intervals, for each year of the cohort\u2019s college career. The result was a dataset that included \u201cmachine-readable files of virtually all the information\u201d from 1,700 students\u2019 Facebook profiles (Berkman Center 2008).<\/p>\n Because the project was funded in part by an award from the National Science Foundation (NSF), the researchers were obligated by the terms of the award to share some of their data. In an attempt to protect the privacy of their subjects, the researchers did not identify the institution, removed student names and identification numbers from the dataset, and delayed releasing the cultural interests of subjects, such as movies, books, TV shows, and music. Additionally, the researchers required other researchers to agree to a \u201cterms and conditions for use\u201d that prohibited any attempts to re-identify subjects, to disclose any identities that might be inadvertently re-identified, or otherwise compromise the privacy of the subjects. In September 25, 2008, the researchers made the first wave of de-identified data public (Zimmer 2010).<\/p>\n Within days a researcher from the University of Wisconsin\u2014Milwaukee was able to determine that the data came from Harvard, and did so without accessing the full dataset (Zimmer 2010, Perry 2011). Although he did not identify individual students, it was clear that the dataset included enough unique indirect identifiers to re-identify the students (Zimmer 2010, Perry 2011).<\/p>\n In the American online (AOL) search data leak of 2006, the Internet service provider AOL released a dataset that included the search records of 500,000 of its users. AOL, in good faith, had intended to make the data available to benefit academic researchers. AOL had stripped the names from the data released, and provided only what were supposed to be unidentifiable user numbers. However, within days journalists from the New York Times were able to discover the identity of user number 4417749 by simply investigating the unique search queries, which were notable due to various reasons. The company eventually removed the data (Hafner 2006, Jones 2006, Zeller 2006).<\/p>\n","protected":false},"excerpt":{"rendered":" During spring break, Wesleyan staff notified faculty that all students engaged in human subjects research (such as our seminar) must complete the appropriate online course on responsible conduct of research offered by the\u00a0Collaborative Institutional Training Initiative. To receive full credit for revised Exercise F, email me proof that you have successfully completed the quizzes for … Continue reading Ex F: Online CITI course for research ethics<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"parent":2400,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/pages\/12255"}],"collection":[{"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/comments?post=12255"}],"version-history":[{"count":4,"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/pages\/12255\/revisions"}],"predecessor-version":[{"id":12271,"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/pages\/12255\/revisions\/12271"}],"up":[{"embeddable":true,"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/pages\/2400"}],"wp:attachment":[{"href":"https:\/\/commons.trincoll.edu\/cssp\/wp-json\/wp\/v2\/media?parent=12255"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"CITI-RCR-Social-Behavioral-Modules\"](\"http:\/\/commons.trincoll.edu\/cssp\/files\/2015\/04\/CITI-RCR-Social-Behavioral-Modules.png\")
<\/a><\/p>\n
\nFederal regulations define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45CFR46.102(d)). As described in theBelmont Report “…the term ‘research’ designates an activity designed to test a hypothesis [and] permit conclusions to be drawn… Research is usually described in a formal protocol that sets forth an objective and a set of procedures to reach that objective.”<\/p>\n
\nA human subject is defined by federal regulations as “a living individual ABOUT whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” (45 CFR 46.102(f)(1),(2))<\/p>\n
\nInformation-gathering interviews where questions focus on things, products, or policies rather than about people or their thoughts regarding themselves are not human subjects research. Example: canvassing librarians about inter-library loan policies or rising journal costs
\nBiography or oral history research involving a living individual that is not generalizable beyond that individual may not be considered human subjects research. Researchers are advised to contact their local IRB as these studies may be subject to local interpretation.
\nPublicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB is they are unsure if their data qualifies as “publicly available.”
\nCoded specimens and\/or data sets that were not collected for the currently proposed projects do not need IRB review as long as the investigator receiving the data\/specimens cannot link the data\/specimens back to individual subjects. If the data\/specimen provider can ascertain the identity of the subjects (for example, subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data\/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator.Note: Investigators are not allowed to make this determination. These projects require verification from the IRB or the IRB liaison\/designee
\nStudies that ARE human subjects research:
\nStudies that involve human subjects to test or develop devices, products, or materials that have been developed through research for human use.
\nStudies that collect data through intervention or interaction with individuals. Examples of this type of research include the evaluation of teaching methods and programs, Internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors about family values in a foreign country that contribute to generalizable knowledge. Data collection using non-identifiable information may be exempt. (Students are advised to discuss with the applicable IRB the process for determining exemptions.)
\nStudies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
\nWhat elements should be included in an informed consent?<\/p>\n
\nPurpose of the research
\nProcedures involved in the research
\nAlternatives available should a subject decide not to participate in the research
\nAll foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience.
\nBenefits of the research to society and possibly to the individual human subject
\nLength of time the subject is expected to participate
\nPayment for participation (if applicable)
\nPerson to contact for answers to questions or in the event of a research-related injury or emergency
\nStatement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive
\nSubjects’ right to confidentiality and right to withdraw from the study at any time without any consequences
\nHistory and Ethical Principles<\/p>\n
\nhttps:\/\/www.citiprogram.org\/members\/index.cfm?pageID=125
\n[Jack’s note: This contradicts what appears above about oral history]
\nSome researchers in the social and behavioral sciences and humanities contend that the regulations were designed to govern only biomedical research. They then, reasonably, assume that “generalizable knowledge” is only that which is hypothesis driven, quantitative, and replicable. While it is true that abuses in biomedical research drove the development of the current regulations, the regulations were designed to cover all research with human subjects. The regulations specifically refer to interviews, oral history, focus groups, and other qualitative methods. Therefore, the concept of “generalizable knowledge” has to be broadened.<\/p>\n
\nCan research that uses individually identifiable information be exempt? Yes, a research project involving individually identifiable information about respondents can be exempt under two conditions:
\nThe information is either not linked to the respondents’ identities, that is, it is anonymous, or
\nThe information is linked to the respondents’ identities, but the nature of the information is such that disclosure will not be reasonably expected to cause harm. In other words, non-anonymous data recording can be exempt if any breach of confidentiality would not cause harm beyond that encountered in everyday life.<\/p>\n
\nThe exemption categories that may be used with children include:
\nResearch conducted in established or commonly accepted educational settings, involving normal educational practices.
\nResearch about educational tests.
\nObservations of children in public settings, providing the researcher does not participate in the activities being observed.
\nStudies using existing data about children, (a) if the data are publicly available, or (b) if they are recorded in such a way by the investigator that the identity of the children cannot be determined either directly or indirectly.
\nStudies conducted by federal departments or agencies about government programs, such as welfare programs.
\nTaste and food quality evaluations and consumer acceptance studies, under some circumstances.
\nAccording to Subpart D, exemptions may not be used for any of the following:
\nResearch involving interviews.
\nResearch involving surveys.
\nObservation in which the researcher participates in the activities observed.
\nInternet and re-identification of individual data
\nRe-identification of Data<\/p>\n