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CITI Training and Belmont report Test Questions and Answers
Three principles of Belmont Report - ✅✅✅Respect for Persons Beneficence Justice The Belmont Report Principle of Beneficence - ✅✅✅MAXIMIZATION of benefits and MINIMIZATION of risks T/F Belmont Report indicates it is necessary to rigorously avoid conflicts of interest - ✅✅✅TRUE The Belmont Report Respect for Person - ✅✅✅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... - ✅✅✅"Practice" and "Research" The Belmont Report The Principle of Justice - ✅✅✅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 - ✅✅✅FALSE Students in Research The history of ethical regulations in human subjects research began with the - ✅✅✅Nuremberg Code Nuremberg Code - ✅✅✅Human subjects research guidelines and regulations Year of the Nuremberg Code - ✅✅✅ 1949 Additional resources regarding IRB approval process - ✅✅✅Faculty advisor/Research Mentor IRB office Human subjects research websites What element must be included in an informed consent? - ✅✅✅All foreseeable risks and discomforts Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB? - ✅✅✅If the study qualifies for EXEMPTION Another name for the "Exempt" status - ✅✅✅the Common Rule stated in Title 45 Part 46 Subpart A
- Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed
- Reviewing subject recruitment materials and strategies T/F IRB's investigate scientific misconduct - ✅✅✅False T/F IRB's do not review manuscripts prior to submission for publication - ✅✅✅True DHHS FDA - ✅✅✅Depts. IRB's review for current policies -Department of Health and Human Services -Food and Drug Administration Name the study that links most directly to the establishment of the National Research Act in 1974 and ultimately the Belmont Report and Federal regulations for human subject protection - ✅✅✅The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male The Tuskegee Study relates to which Belmont principle? - ✅✅✅The principle of beneficence: Potential benefits justify the risks of harm Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of: - ✅✅✅Respect for persons
Belmont Report According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of: - ✅✅✅Justice How is the principle of beneficence applied to a study involving human subjects? - ✅✅✅Ensuring that risks are reasonable in relationship to anticipated benefits. Human subject study or not? Developmental psychologist videotapes interactions between groups of toddlers and their care givers to determine which intervention methods most effectively manage aggression - ✅✅✅Yes Human subject study or not? The study of a list with deceased passengers - ✅✅✅No:Human subject is a living individual Human subject study or not?Questioning individuals to acquire data about the number of newly diagnosed HIV cases? - ✅✅✅No: 'what' question rather than 'who' question Human subject study or not? Conducting linguistic analysis of comments posted on a public blog - ✅✅✅Not: involves neither interaction with individuals nor collecting private identified info Human subject study or not?
Human subject study or not? An economic feasibility study - ✅✅✅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: - ✅✅✅identifiable PRIVATE information (Public info does not meet criteria) Subpart of DHHS regulations provides additional protections for which vulnerable populations? - ✅✅✅1. Pregnant women
- Fetuses
- Neonates
- Prisoners Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations? - ✅✅✅1. elderly
- students
- for persons whose decision-making capabilities are impaired The expedited review process may be used when the study procedures pose: - ✅✅✅No more than minimal risk and the research activities fall within regulatory categories identified as eligible
The expedited review process may NOT be used when the study procedures pose:
- ✅✅✅-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...? - ✅✅✅Must occur within 12 months of the approval date (even if no additional risks have been identified) Continuing review process must include: - ✅✅✅-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 - ✅✅✅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 meausre 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: - ✅✅✅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
School authority's permission to conduct research replaces the need for permission and assent - ✅✅✅False T/F Children's right to choose cannot be overridden in the pursuit of an indeterminate community interest - ✅✅✅True, it cannot be overridden Appropriate criterion for waiving informed consent when subjects are provided additional pertinent information after the study - ✅✅✅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: - ✅✅✅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: - ✅✅✅Provide potential subjects with information at the appropriate reading comprehension level. Data are made anonymous by - ✅✅✅Destroying all identifiers connected to the data. In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which confidentiality procedure would protect against compelled disclosure of individually identifiable information? - ✅✅✅Securing a Certificate of Confidentiality.
When a focus group deals with a potentially sensitive topic, which statement about providing confidentiality to focus group participants is correct? - ✅✅✅The researcher cannot control what participants repeat about others outside the group. A researcher leaves a research file in her car while she attends a concert and her car is stolen. The file contains charts of aggregated numerical data from a research study with human subjects, but no other documents. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred? - ✅✅✅There was neither a violation of privacy nor a breach of confidentiality Which of the following constitutes both a breach of a confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects' privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)? - ✅✅✅A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de- identified. An investigator is examining the quality of life for prisoners who are HIV positive using surveys followed by interview. The IRB must ensure that: - ✅✅✅Confidentiality of the prisoners' health status is maintained Which of the following statements about prison research is true? - ✅✅✅Researchers may study the effects of privilege upgrades awarded by the prison.
and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate? - ✅✅✅Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review. Parental notification, in lieu of active parental permission, is allowed when: - ✅✅✅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? - ✅✅✅Research about educational testing The purpose of the Family Educational Rights and Privacy Act (FERPA) is to: - ✅✅✅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? - ✅✅✅The Family Educational Rights and Privacy Act. Which of the following is the LEAST important activity when protecting human subjects in international research? - ✅✅✅Assessing transportation conditions The age of majority in international research is determined by the - ✅✅✅Laws, customs, and norms in the area in which the research will be conducted. Which of the following activities constitutes engagement in research? - ✅✅✅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: - ✅✅✅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? - ✅✅✅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. 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? - ✅✅✅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: - ✅✅✅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? - ✅✅✅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: - ✅✅✅Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must be - ✅✅✅understood by researchers when HIPAA applies If you're unsure about the particulars at your organization or have questions, - ✅✅✅consult with your organization's IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization's Security Official. specified identifiers - ✅✅✅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: a.The geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and bThe 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; 7.Social security numbers; 8.Medical record numbers;
9.Health plan beneficiary numbers; 10.Account numbers; 11.Certificate/license numbers; 12.Vehicle identifiers and serial numbers, including license plate numbers; 13.Device identifiers and serial numbers; 14.Web Universal Resource Locators (URLs); 15.Internet Protocol (IP) address numbers; 16.Biometric identifiers, including finger and voice prints; 17.Full face photographic images and any comparable images; and 18.Any other unique identifying number, characteristic, or code. Vulnerable persons are - ✅✅✅those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, - ✅✅✅Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D). T/F Workers are considered vulnerable populations - ✅✅✅False When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include: - ✅✅✅pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.
What constitutes "research" according to HIPAA? - ✅✅✅HIPAA defines research as any "systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge Who enforces HIPAA's protections? - ✅✅✅IRB Privacy Board Privacy Officer Waivers and alterations of authorization requirement - ✅✅✅•Use or disclosure of the PHI involves no more than minimal risk to the privacy of the research subjects, based on the following elements: oAn adequate plan to protect any data identifiers from improper use and disclosure. oAn adequate plan to destroy data identifiers at the earliest opportunity consistent with conduct of the research (unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law). oAdequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research for which the use or disclosure of PHI would be permitted by HIPAA. oThe research could not practicably be conducted without the PHI. oThe research could not practicably be conducted without the waiver. Activities preparatory to research, decedents' information exceptions - ✅✅✅•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 - ✅✅✅True Grandfatherd research - ✅✅✅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 - ✅✅✅the uses/disclosures must be no more than the minimum required for the described research purpose accounting of disclosures - ✅✅✅•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 - ✅✅✅•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 - ✅✅✅True Provided that the revocation is in writing
