SPE567- CITI training Questions with complete solutions 2023

SPE567- CITI training Questions with complete solutions 2023 Belmont report Outlines three key ethical principles for conducting research with human subjects: respect for persons, beneficence and justice. Autonomy People must be empowered to make decisions concerning their own actions and well-being. Informed consent process involves three key features 1) disclosing to potential research subjects information needed to make an informed decision 2) facilitating the understanding of what has been disclosed 3) promoting the voluntariness of the decision about whether or not to participate in the research. Voluntariness An essential Component of respect for persons. Research subjects must be free to choose to participate in research. Beneficence Acts of kindness or charity that goes beyond strict obligation. The standford Prision Experiment Zimbardo assigned roles to normal male student volunteers to create groups of prisoners and guards. It became so intense physically and psychologically abuse Institutional Review Board Studies must be reviewed by this only if both definitions of both "research" and "human subject" are applied. Research Defined by federal regulations at 45 CFR 46.102 a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge Systematic investigation Researchers need to have constructed a research plan with ideas about what they want to learn and how best to do that. Quantitative researchers Test hypotheses and theories with the data they collect Qualitative researchers Hypotheses or theories based on the data they gather. Interactions Communication or interpersonal contact between the subject and the researcher. Interventions Physical procedures through which data is gathered, such as measuring brain function or behavioral interventions. Private information Information about bx that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. Family Education Rights and Privacy Act Protects the privacy of school records. Assurance Identifies the regulations for protecting research subjects that the institution will abide by and the ethical principles it will adopt. Expedited review Conducted by one or more experienced IRB members. Cant pose no more than minimal risk to subjects. And consist of only one or more research activities specified regulations as eligible for expedited review. 3 types of reviewers -Individuals identified by the instituation to screen research for exempt status. -One or more experienced IRB members conducting expedited reviews. -Members of convened IRB for studies requiring IRB review. IRB review committee established to ensure that the rights and welfare of human research subjects are protected. IRB requirements: Must have at least 5 members, must be diverse, including considerations of race, gender and cultural background. The most important requirement is that an IRB must have the expertise and professional competence to evaluate the research it reviews. Exempt Research When research is exempt from the provisions of the Common Rule, it follows that the review criteria provided for expedited and IRB review would not apply. All Research should abide by the three basic ethical principles: Respect for persons, beneficence and justice. Federal regulations permit: Expedited review procedures to be used for continuing review if the initial review was expedited and no new risks were identified. Challenging task researches and IRB face: -Identifying and evaluating risks of harm associated with participation in research. Risk of harm in social and behavioral sciences generally fall into three categories: -Invasion of privacy -breach of confidentiality -study procedures Two probabilities of Harm: - The likelihood that a specific harm might occur -magnitude or severity of harm should it occur. Certificates of Confidentiality Are used by the national Institutes if Health (NIH) to protect identifiable research information from compelled disclosure There are two parts to informed consent: ding information to prospective subjects 2. documentation that the process took place and is a record of the subjects' agreement to take part in the study. Informed Consent A process that begins with the recruitment and screening of a subject and continues throughout the subjects involvement in the research. Minimal risk The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in the daily life or during the performance of routine physical or psychological examination Impracticable It means that securing consent is not feasible, regardless of cost and time. Deception Outright deception can sometimes be justified as essential for investigating a particular phenomenon Complete Non-Disclosure If people know that they are being observed, they may alter their behavior in such a way that obtaining meaningful results is not possible. When is the documentation of consent waived: The principal risks are those associated with a breach of confidentiality concerning the subject's participation in the research. And when study participation presents minimal risk of harm to subject and the research involves no procedures requiring consent outside the context of participation in a research study. Privacy Having control over the extent, timing and circumstances of sharing oneself with others Confidentiality The treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others, in ways that are inconsistent with the understanding of the original disclosure without permission. Reasonable assumptions regarding privacy will vary from culture to culture and setting to setting. Snowball sampling Recruitment technique in which research participants are asked to assist researchers in identifying other potential subjects. The Family Education Rights and Privacy Act (FERPA) Protects the disclosure of educational records. Gives parents certain rights over the content of their children's educational records. Applicable program Any program for which the secretary or the Department has administrative responsibility as provided by law or by delegation of authority pursuant to law. Data scraping When researchers use computer programs to extract information from people's profiles on social networking websites or from MMORGs. Documenting Consent Documenting consent in person often consists of a signed form that researchers and subjects keep, online an electronic signature is placed. Vulnerable persons Those who may be less able to protect themselves and their interests relative to other persons in a given setting or situation. Diminished autonomy The "study becomes research when The intent of the of the project is to gather data and contribute to generalize knowledge. Conflict of interest (COI) Situations in which financial or non-financial considerations may compromise, or have the appearance of compromising a researcher's objectivity in meeting duties responsibilites. Individual COI An individual has a personal, financial, or other interest which may affect or appear to effect the design, conduct, or reporting of the research. Institutional COI When the financial or other interests of an organization or institutional official, acting within his or her authority on the organization's behalf, may affect or appear to affect the objectivity of research conducted under the organizations auspices.