CITI+Course+and+Ethics


 * ** EDU7702-8 ** ||  ||
 * ** Research Design ** || ** 3 CITI Ethics Course ** ||
 * Stephen **
 * It is clear that you have a good grasp on the concepts of ethical research and how it applies to your own study. I made only a few observations and comments in the paper – one consideration that I did not see is that somehow in the informed consent it needs to be clear to students that in no way does participation affect the course grade – and that their responses would not be shared individually with their instructor. Perhaps that is assumed but you should state it overtly. **
 * Keep up the good work, **
 * Keep up the good work, **

=Ethical Concerns of Research = I have chosen a quasi-experimental design for the research I expect to conduct. Classes at my organization are scheduled at the discretion of management and based upon various factors, such as popularity and instructor availability. Classes can be conducted or cancelled and students rescheduled depending on the number of enrollments in each class. Whether a student purchases a technological course that is conducted in a traditional, face-to-face environment or in a digital online classroom may not be completely at the discretion of the learner, providing institution, or presenting instructor. Without randomization there can be no true experimental design; without an experiment it is more difficult to determine cause and effect. I chose a quasi-experimental methodology because it is not possible to randomly place learners into separate control and test groups since learners purchase the appropriate class for their professional development needs and such other motivators personal to each student.* I expect to collect data from a minimum of ten instructors who teach various technologies. Each instructor will teach two instances of two different online classes of five-days or less duration. These classes will be paired, such that one instance of the class will be taught according to that instructor’s normal delivery (the control) and one instance will be taught in the normal style with the addition of a webcam transmitting the instructor’s image to the class during interactive periods of the class (the experiment). Whether the control class or experimental class will be taught first will be randomized. Each student will be encouraged at the end of the class to fill out a short online survey, in addition to the regular course evaluation. Incomplete or surveys that have the same value for all sixteen questions will be discarded. The data will then be separated into pertinent constructs for this study; satisfaction, engagement, and perceived learning. An ANOVA will be conducted to determine if significant differences exist between the means of control and experimental groups in the appropriate measures. Since respect for persons, beneficence, and justice constitute the basic fundamental principles of ethical research in the social sciences ( “Belmont”, 1979 ), this paper will explore any ethical concerns deriving from my proposed research as introduced above. Included will be major ethical issues in research as identified by the CITI course on ethics, including (a) privacy in research, (b) confidentiality in research, (c) informed consent in research, (d) exempt research, (e) Internet research, and (f) additional ethical considerations when working with vulnerable populations. Finally, a conclusion is provided to summarize the specific ethical concerns and their proposed solution in the study.

Ethical Issues in Research
Ethical concerns must be couched and evaluated in terms of violations, either small or large. These violations can take the form of not treating individuals as autonomous agents, undermining their well-being or placing individuals into harmful situations, or denying care or placing a burden on one individual when another is granted care or no burden is placed ( “Belmont”, 1979 ). The first assumption of ethical research is that each individual is autonomous and can make decisions in their own best interests, and must not be coerced or tricked into participating in research ( “Belmont”, 1979 ). In some circumstances, however, autonomy is diminished or does not exist in the individual and ethics require that provisions be enacted to protect him or her from being coerced or tricked ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). This first assumption is called respect for persons ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). An extension of respect for persons is that before participating in a study subjects must receive full disclosure of what may happen to them in a manner comprehensible to them and give their specific assent to participate ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). There are restrictive provisions for subjects who are not capable of understanding or agreeing to participate, and situations where full information may compromise the study ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). This extension and restrictive provisions is called informed consent ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">).* <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">A second assumption of ethical treatment of human beings in research is that the maximum benefit will be sought while minimizing the potential harm within the confines of doing no permanent physical, psychological, legal, social, or economic harm for each subject ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). To implement this concept it is necessary to assess the nature of potential harm subjects may encounter or experience, as well as the likely benefits ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Once determined, these risks and benefits should be included in the original extension of informed consent ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). This assumption regarding minimizing harm and maximizing benefit to participants is called beneficence ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">The final assumption regarding ethical research is that of justice; that each individual should benefit from research equally, qualified by need, effort, contribution, and merit ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Justice in research, to be ethical, must be just for the individual and for society ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Justice on the part of individuals requires that each subject within the study population be equally likely to be selected, and once selected, treated equally and fairly without discrimination with regards to benefits and risks ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Justice regarding society requires that subjects be selected from classes of individuals within the study population best able to handle the burdens the study may place upon them without regard to convenience or cost ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">).

<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Basic Ethical Considerations Regarding Respect of Persons
<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">To protect individuals from harm in research while treating each as an autonomous person, several principles are necessary; privacy, confidentiality, and informed consent ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Privacy of the individual extends from respect, and is based on that person’s expectations of privacy regardless of their physical location ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Privacy extends to protection of identifiable information in a study that can reflect on a specific subject ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Confidentiality is a principle based upon respect for the individual and the possible harm that may accrue to that individual if their private thoughts or feelings are revealed ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">**Privacy concerns in my research.** My study is intended to measure differences in student satisfaction, engagement, and perceived learning due to the inclusion of a specific mode of instruction delivery. I am making no differentiations between the characteristics of students in each class or between classes except in those measured concepts. The data that I intend to collect for my study will be collected over the Internet, and will not include any identifying information except that which is obtained in the informed consent.* If additional data is required from the existing course evaluation surveys it will be provided anonymously. No possibility will exist for collecting data unknowingly from participants since informed consent will be presented to each participant before collection. Therefore, my study has no ethical concerns regarding privacy. The only possible identifiable information will be in regards to informed consent, which will be discussed subsequently. <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">**Confidentiality concerns in my research.** The nature of the questions in my research is such that negative comments are reflective of the instructor rather than the participant. Regardless, consent and identifying information will be retained separately from responses to survey questions. The data will be stored separately from identifying information, and will only be presented in the aggregate. By this means confidentiality of participants will be preserved. Although data will be collected regarding responses to student satisfaction, engagement, and perceived learning in relation to specific classes, control and experiment data will be aggregated separately across instructors and presented so that no specific instructor can be identified in the findings. Though the instructors are not subjects of the study, they are also not the focus of the study, and their anonymity will be maintained in data storage, and in the findings of the study. <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">**Informed consent regarding my research.** In the research that I am considering, informed consent will be in writing, and will be the first screen that students will see when they enter the survey. Included in the statement, written at an eighth grade comprehension level, will be the following elements; (a) an explanation of the research being conducted, (b) associated risks, (c) what I hope to learn, (d) a statement regarding confidentiality, (e) researcher contact information, and (f) a statement regarding voluntary participation and non-consequential withdrawal (“Belmont”, 1979). Since the informed consent will be entered online, acceptance will consist of the participant typing their full name and clicking on a link to enter the study.

<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Ethical Considerations for Low Risk Research
<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Certain research is exempt from IRB review ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). The researcher, however, does not determine that his or her research is exempt ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). The researcher’s institution must make the determination regarding exemption ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">**Exempt research.** My research consists of a single survey in which no identifiers will be collected, and will be conducted after a regularly scheduled and delivered professional development class. A survey allows me to collect information regarding the feelings and views of participants about their classroom experience, and therefore consists of no more than minimal risk ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). My research should therefore be exempt from continuing review because (a) it will be conducted in an educational setting and involves evaluating educational practices, (b) includes responses to survey procedures that if disclosed would not put participant’s at risk legally, financially, socially, physically, or psychologically, and (c) will not involve minors ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">**Internet considerations of my research.** Certain ethical considerations regarding research conducted on the Internet are unique to that environment and must be considered ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). On the Internet, for example, it is easy to create and manifest a fake persona; validating the real person behind this persona may be difficult. In my proposed study the participants will be known and the URL to the survey will be provided to them through the chat functionality of the online classroom. The consent form will require each participant to acknowledge informed consent and include the typing of their name. While the consent and identifying information will be kept separate for storage purposes, in the unlikely event of a subject filling out two surveys, it will be possible to eliminate the duplicate data. The survey would be of little interest to people who did not attend a class, but again in the unlikely event of a subject who was not registered for the class; his or her information would be eliminated.* <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;"> The survey questions will be contained on one page. The informed consent will identify that while participants may choose to answer any and all questions and withdraw at any time; surveys with unanswered questions will not be used in the study. This eliminates the possibility of creating the survey in a way to prevent participants from continuing without answering specific questions ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Participants in these classes are employed adults engaging in additional technical professional development. A concern of Internet research is that minors may participate in research contrary to applicable law ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). My research would be such that parental permissions could be waived, but the demographics of these classes preclude this being necessary.

<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Additional Ethical Considerations for Vulnerable Populations
<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">The concept of respect for persons is based on the reasonable assumption that properly informed people can best determine what is or is not in their best interests. Special restrictions are placed on researchers when potential subjects may not be able to give informed consent due to law, diminished capacity, or because they belong to a disadvantaged or vulnerable group ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). These restrictions allow expanded review to increase protections to these groups so that they will not inordinately be burdened or taken advantage of ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont”, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). Specific vulnerable groups are identified in the law and include pregnant women, fetuses, neonates, prisoners, and children ( <span style="font-family: "Times New Roman",Times,serif; font-size: 90%;">“Belmont, 1979 <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">). <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">My proposed research does not focus on or use as a criteria for selection any of the vulnerable populations indicated in the law. The students in the study classes will not be children, either in or out of a public school setting, will not be conducted in an international setting, nor will it specifically involve pregnant women. It is possible that a student in any of the classes may be female and also pregnant, or taking the class in a country other than the U.S. The purpose of the research, however, is not focused on either of these vulnerable groups, and the risk to any subject is no more than minimal. Therefore the ethical considerations related to these vulnerable groups are not pertinent to the proposed study. =<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Conclusion = <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;">Due to the design of the proposed research it should be exempt from continuing review by the IRB. The proposed research does not select vulnerable groups; it consists of a survey that presents no more than minimal risk to the subjects, and will be conducted in an educational setting regarding an educational process. Issues of privacy and confidentiality are always important considerations in any study. In this study identifying information regarding subject and specific class and instructor will be kept separate from the survey responses, and survey responses will be manipulated, analyzed, and reported only in the aggregate. After ensuring that the data comes from students enrolled in the specified classes and that there are no duplicates the data will be stored separately from identifying information preserving privacy and maintaining confidentiality of participants and instructors.

<span style="font-family: "Times New Roman",Times,serif; font-size: 120%;"> - Good point and explained well in terms of why you have selected this design. <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;"> - <span style="color: #ff0000; font-family: "Times New Roman",Times,serif; font-size: 120%;">You don’t need to cite every sentence here – only the main ideas which come from Belmont. Try to use more of your own thoughts vs. continued citations. <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;"> - Are you sure? <span style="font-family: "Times New Roman",Times,serif; font-size: 120%;"> - How will you know if the subject is registered in the class if you are not using any identifying data?


 * = References ||
 * * U.S. Department of Health and Human Services, National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979). //The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research// (45 CFR 46). Retrieved from http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html ||