Question 16 The best Data Safety Monitoring

Question 16 The best Data Safety Monitoring Plan (DSMP) should include which of the following? Question 16 options: A plan for examining the interim data and possible changes in methodology, if indicated. Possible circumstances in which the research project might be stopped or halted. If and when adverse effects warrant discontinuing one or more arms of the study. All of the above. Injustice may arise from overburdening certain groups of people who are selected as research subjects as a result of which circumstances? Question 17 options: Cultural biases. Social biases. Sexual biases. All of the above. Question 18 The Office of Research Integrity, U.S. Department of Health & Human Services defines research misconduct as which of the following concept(s)? Question 18 options: Plagiarism. Fabrication. Falsification. All of the above. Question 19 Human genetics ethics in research generally covers which of the following topics? Question 19 options: Informed consent – Example: physician disclosure and patient consent. Health Insurance Portability and Accountability Act for clinical patients vs. research subjects. Return of Results – Example: incidental and secondary findings, future research test results. Privacy and confidentiality -Example: duty to warn family members of their genetic risk. All of the above. Question 20 Low consent rates in a research study may cause researchers to be concerned about what indications? Question 20 options: Excessive participants vying for inclusion. Bias due to limited generalizability of the study. High risk of harm or injury to the study reviewers. Lack of interest in the results of the study. Question 21 In order to protect human subjects who participate in research which ethical principles should be followed? Question 21 options: Beneficence and non-malfeasance Group determination and privacy Beneficence and liability Uninformed consent and malfeasance Question 22 The Belmont Report warns that which group(s) constitute subjects that are readily available in certain settings and may be continuously sought as research subjects? Question 22 options: Racial minority groups. Economically disadvantaged. The institutionalized. All of the above. Question 23 A full disclosure explanation of research must include which of the following? Question 23 options: Who to contact if questions arise. No penalties for withdrawing. Alternate treatments available. All of the above. Question 24 (Mandatory) (1 point) Which group of people are considered to be “vulnerable populations” requiring special handling in research studies? Question 24 options: Cognitively intact adults Non-terminally ill out-patients, Non-incarcerated adults. Mentally impaired patients. Question 25 People participating in ethically conducted human subject research should expect the ideal consent process to ideally include which factor(s)? Question 25 options: Thorough discussion of penalties for early withdrawal from the study. Forfeiture of the right to self-determination as an autonomous agent. Medical jargon will be confusing, clinically scientific, and erudite. The explanation of risk versus benefit should be easy to understand. Which description is the best example of protecting the anonymity and confidentiality of human research subjects? Question 26 options: Removing possible identifiers to the subject’s identity during data analysis, safe storage of the data collected, and aggregating data into tables to decrease the likelihood of guessing a particular subject’s identity. When entering surveys into the public use computer use a coded system to protect the identity of all the subjects, and only disclosing the identity of the subjects in the published research study reports. Allowing only research team members access to the surveys and witnessed consent forms, requiring written permission to publish the data collected and retaining identifying information in the tables. Storing all the research surveys in the researcher’s unlocked shared office, avoiding hand-written responses that might be recognized by others, and storing the signed consent forms with the surveys. Question 27 Ideally research consent forms should be comprised of which of the following design components? Question 27 options: Minimal medical jargon. Large, clear margins. Simple language. All of the above. Question 28 Social Behavioral research may include which type of observation? Question 28 options: Peoples interaction or behavior with the observer. Experimental designs involving exposure to stimulus. Conducted in a public or private setting All of the above. Question 29 Guidelines for developing ethical principles for conducting human research were derived from which of the following historical event(s)? Question 29 options: The Nuremberg Code of 1947. The Declaration of Helsinki in 1964. The National Research Act of 1974. All of the above. Question 30 Which principle means the person’s right to make his/her own decision in accordance with his own beliefs and values? Question 30 options: Autonomy. Concordance. Maleficence. Concentration. Question 31 Why must research personnel involved in a study show evidence of participation in a human subject protection training? Question 31 options: The research investigator may not fully appreciate the harm that can come to human subjects. Conflict of interest may result in potential or actual harm to human subjects. Research personnel realize the value of human subject protection after proper comprehensive training. All of the above. Question 32 The Institutional Review Board (IRB)’s exempt from review category includes which type of research? Question 32 options: Research conducted in established or commonly accepted educational testing. Research involving use of educational tests (cognitive, diagnostic, aptitude, achievement). Research or study involving the collection or study of existing data. All of the above. Question 33 Components of informed consent include which of the following? Question 33 options: Involuntary authorization. Incompetence. Non-disclosure of information. Comprehension. Question 34 Social Behavioral Research may include which of the following methods? Question 34 options: Personal interviews. Focus groups. Surveys All of the above. Question 35 Which is a justified scientific reason for terminating an ethical research study? Question 35 options: Another study confirming the same intervention(s). A published study with the same intervention(s). New discovery of a potentially alternate treatment. New discovery of possible harm to study participants.

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