Ethical Regulations in Human Subject's Research, Exams of Training and Development

Download Ethical Regulations in Human Subject's Research and more Exams Training and Development in PDF only on Docsity! CITI Training Co urse Exam (120 Questions with 100% Correct Answers) Three principles of Belmont Report - Correct answer Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - Correct answer MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - Correct answer TRUE The Belmont Report Respect for Person - Correct answer requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent) The Belmont Report defines and delineates... - Correct answer "Practice" and "Research" The Belmont Report The Principle of Justice - Correct answer Research benefit and burden distribution and that selection of subjects is fair. T/F The Belmont report describes the necessity to effectively manage conflicts of interest - Correct answer FALSE Students in Research The history of ethical regulations in human subject’s research began with the - Correct answer Nuremberg Code Nuremberg Code - Correct answer Human subjects research guidelines and regulations Year of the Nuremberg Code - Correct answer 1949 P a g e 1 | 16 Additional resources regarding IRB approval process - Correct answer Faculty advisor/Research Mentor IRB office Human subject’s research websites What element must be included in an informed consent? - Correct answer all foreseeable risks and discomforts Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? - Correct answer if the study qualifies for EXEMPTION Another name for the "Exempt" status - Correct answer the Common Rule Stated in Title 45 Part 46 Subpart A How can faculty researchers avoid coercion of student subjects? - Correct answer Avoid using their own students in their research Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information. - Correct answer Exempt Review category 2 Name the type of review: A study involving data collected that could have an impact on human subject's careers and it contains identifiers of the subjects. - Correct answer Full Board Review Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal - Correct answer Expedited review Type of review: data that is collected does not meet definition of human subject’s research as stated by federal regulations. No info ABOUT human i.e. info about a business - Correct answer Not Human Subjects P a g e 2 | 16 assessments of reading comprehension for each child over 3-month period - Correct answer Yes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation Human subject study or not? Info collected by playground designer - Correct answer No: does not involve info about human subjects even though there is interactions between designer and school staff. Human subject study or not? An analysis of aggregate data - Correct answer No: doesn't involve interactions w/ living individuals nor collection of private identifiable data Human subject study or not? An economic feasibility study - Correct answer No: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer "about what”? Rather than "about whom”? According to fed. Regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or: - Correct answer identifiable PRIVATE information (Public info does not meet criteria) Subpart of DHHS regulations provides additional protections for which vulnerable populations? - Correct answer 1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners Subpart of DHHS regulations does NOT provide additional protections for which vulnerable populations? - Correct answer 1. Elderly 2. Students 3. for persons whose decision-making capabilities are impaired The expedited review process may be used when the study procedures pose: - Correct answer No more than minimal risk and the research activities fall within regulatory categories identified as eligible P a g e 5 | 16 The expedited review process may NOT be used when the study procedures pose: - Correct answer -more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research Continuing review of an approved and ongoing protocol...? - Correct answer must occur within 12 months of the approval date (Even if no additional risks have been identified) Continuing review process must include: - Correct answer -unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form T/F Officials of the institution may overrule an IRB approval - Correct answer True, however no one may overrule if an IRB disapproved a protocol An investigator wishes to study generational differences in coping mechanisms among adults who experiences abuse as children. Adequate measure will be instituted to obtain consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may: - Correct answer Experience emotional or psychological distress If disclosure of a subject's involvement in a specific research study can be potentially harmful to the subject, and the consent form is the only record linking the subject to the research, which would be the most helpful? - Correct answer Obtain a waiver of documentation of informed consent The primary purpose of a Certificate of Confidentiality is to: - Correct answer Protect identifiable research info from compelled disclosure Certificates of Confidentiality protect sensitive info provided by research subjects from: - Correct answer civil, criminal, or administrative subpoena T/F P a g e 6 | 16 Risk should be evaluated solely by the magnitude or severity of expected harm, not probability - Correct answer False: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered. Risks are specific to: - Correct answer Time, situation, and culture A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will: - Correct answer not affect future care T/F The fact that a therapist has access to her clients' records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assent - Correct answer False: S/he needs both parental permission & child assent T/F School authority's permission to conduct research replaces the need for permission and assent - Correct answer False T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interest - Correct answer True, it cannot be overridden Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the study - Correct answer informing participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion A waiver of the requirement for documentation of informed consent may be granted when: - Correct answer the only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality As part of the consent process, the federal regulations require researchers to: - Correct answer Provide potential subjects with information at the appropriate reading comprehension level. P a g e 7 | 16 Parental notification, in lieu of active parental permission, is allowed when: - Correct answer An IRB has approved a waiver of the requirement for parental permission. According to Subpart D, which of the following research activities with children would qualify for an exemption? - Correct answer Research about educational testing The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: - Correct answer Provide parents certain rights over their children's educational records. Which federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records? - Correct answer The Family Educational Rights and Privacy Act. Which of the following is the LEAST important activity when protecting human subjects in international research? - Correct answer assessing transportation conditions The age of majority in international research is determined by the - Correct answer Laws, customs, and norms in the area in which the research will be conducted. Which of the following activities constitutes engagement in research? - Correct answer obtaining informed consent and conducting research interviews. Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to Internet-based research. One of these risks is: - Correct answer Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? - Correct answer a researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond. P a g e 10 | 16 Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study? - Correct answer designing the survey so that subjects are not forced to answer one question before going to the next. To minimize potential risks of harm, a researcher conducting an on-line survey can: - Correct answer Design the survey so that no direct or indirect identifiers are collected. Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects? - Correct answer conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects' significant others to be a part of the focus group. A HIPAA authorization has which of the following characteristics: - Correct answer Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document. When required, the information provided to the data subject in a HIPAA disclosure accounting ... - Correct answer must be more detailed for disclosures that involve fewer than 50 subject records If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with: - Correct answer an organizational IRB or Privacy Board, privacy official ("Privacy Officer"), or security official ("Security Officer"), depending on the issue. Recruiting into research ... - Correct answer can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity. HIPAA's protections for health information used for research purposes... - Correct answer supplement those of the Common Rule and FDA. HIPAA - Correct answer Health Insurance Portability and Accountability Act of 1996 P a g e 11 | 16 HIPAA privacy protections supplement those of - Correct answer other federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements. HIPAA protects - Correct answer protects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either Under HIPAA, research activity using PHI generally requires - Correct answer authorization. However, there are several alternatives that allow bypassing the authorization requirement. Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must be - Correct answer understood by researchers when HIPAA applies If you're unsure about the particulars at your organization or have questions, - Correct answer consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official. Specified identifiers - Correct answer 1.Names 2.All geographic subdivisions smaller than a State, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: Anthem geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and Bathe initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000. 3.All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older; 4. Telephone numbers; 5. Fax numbers; 6. Electronic mail addresses; P a g e 12 | 16 oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA. Other research could not practicably be conducted without the PHI. Other research could not practicably be conducted without the waiver. Activities preparatory to research, decedents' information exceptions - Correct answer •Where the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. •Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects T/F A researcher may use fully "de-identified" health data without any authorization from data subjects - Correct answer True Grandfather research - Correct answer if all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required. Minimum necessary standard - Correct answer the uses/disclosures must be no more than the minimum required for the described research purpose Accounting of disclosures - Correct answer •A list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. •The purpose of those protocols, and the types of PHI sought. •The researcher's name and contact information for each study Characteristics of authorizations - Correct answer •in "plain language" so that individuals can understand the information contained in the form, and thus able to make an informed decision. •Executed in writing, and signed by the research subject (or an authorized personal representative). T/F Revocations for HIPAA authorizations for research can be revoked at any time - Correct answer True Provided that the revocation is in writing P a g e 15 | 16 T/F It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate - Correct answer True Retrospective" research - Correct answer use or disclosure of PHI for retrospective research studies may be done only with patient authorization -- or with a waiver, alteration, or exception determination from an IRB or Privacy Board P a g e 16 | 16