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Which of the following is a reason that prisoners need special protection? Prisoners have limited free choice because their autonomy is restricted.A waiver in whole occurs when the IRB determines that no Authorization will be required for a covered entity to use or disclose PHI for a particular research project because certain criteria set forth in the Privacy Rule have been met (see section 164.512(i) of the Privacy Rule).Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
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Who determines whether an authorization is required or whether the requirement for an authorization may be waived?
A waiver in whole occurs when the IRB determines that no Authorization will be required for a covered entity to use or disclose PHI for a particular research project because certain criteria set forth in the Privacy Rule have been met (see section 164.512(i) of the Privacy Rule).
Which of the following is are included in the federal regulations for basic elements of informed consent?
Valid informed consent for research must include three major elements: (1) disclosure of information, (2) competency of the patient (or surrogate) to make a decision, and (3) voluntary nature of the decision. US federal regulations require a full, detailed explanation of the study and its potential risks.
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Which example of research with prisoners would be allowable?
Which example of research with prisoners would be allowable under the regulations? Examining age at first arrest as a predictor of adult criminal history. Examining age at first arrest is the correct answer.
Which of the following brought increased public attention to the problems with the IRB system Citi?
Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
What is included in protected health information?
Protected health information (PHI), also referred to as personal health information, is the demographic information, medical histories, test and laboratory results, mental health conditions, insurance information and other data that a healthcare professional collects to identify an individual and determine appropriate …
Under what circumstances can a covered entity disclose PHI without an authorization quizlet?
A covered entity is permitted, but not required, to use and disclose protected health information, without an individual’s authorization, for the following purposes or situations: (1) To the Individual (unless required for access or accounting of disclosures); (2) Treatment, Payment, and Health Care Operations; (3) …
Which of the following describes the main purpose of the regulatory system for the protection of human subjects quizlet?
Which of the following describes the main purpose of the regulatory system for the protection of human subjects? The system is designed to uphold the ethical principles described in the Belmont Report.
See some more details on the topic Which of the following is a reason that prisoners need special protection? here:
Know Your Rights | Prisoners’ Rights – American Civil Liberties …
Federal law provides special protections for prisoners’ religious exercise. · Depending on your particular circumstances, prison officials may be required to …
Research Involving Prisoners – UCSF IRB
Because prisoners are a vulnerable research population, the Office of Human Research Protection (OHRP) requires and enforces additional …
Research Involving Prisoners – Pitt HRPO
the possible causes, effects, and processes of incarceration, … In cases in which those studies require the assignment of prisoners in a manner consistent …
Basic Principles for the Treatment of Prisoners | OHCHR
The responsibility of prisons for the custody of prisoners and for the protection of society against crime shall be discharged in keeping with a State’s other …
What are the 5 essential components of informed consent in the therapeutic setting?
In current clinical practice, these four elements translate into five components that should be included in a discussion seeking to obtain informed consent: the diagnosis, the proposed treatment, the attendant risks and benefits of the treatment, alternative treatments and their risks and benefits, and the risks and …
What are the 4 principles of informed consent?
There are 4 components of informed consent including decision capacity, documentation of consent, disclosure, and competency.
When reviewing federally supported research involving prisoners an IRB must have Which of the following in addition to the standard requirements for?
In addition to the “standard” regulatory requirements for IRB composition, when reviewing research involving prisoners the following requirements also apply: At least one member of the IRB must be a prisoner, or a prisoner representative with appropriate background and experience to serve in this capacity.
Which of the following studies would need IRB approval quizlet?
Which of the following studies need IRB approval? Studies collecting data about living individuals. If a study intends to collect data or information about the living individual, an IRB review and approval must be obtained.
Which of the following types of information may Schools disclose without consent from the parent or student to a researcher at a local university Citi quizlet?
Schools may disclose, without consent, directory information such as a student’s name, address, telephone number, date and place of birth, honors and awards, and dates of attendance.
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What did the National Research Act of 1974 do quizlet?
The National Research Act of 1974 established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The identification of guidelines, ethical principles and regulations came as a result of the deliberations of the National Commission.
Which of the following are the three principles discussed in the Belmont Report?
Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.
When an IRB is reviewing a research study and they are considering?
When an IRB is reviewing a research study and they are considering if a potential subject population is vulnerable, they should consider: Is there a power differential between researchers and subjects?
Which of the following is required for releasing protected health information for reasons other than treatment payment or health care operations?
Which of the following is required for releasing protected health information for reasons other than TPO? An authorization to disclose PHI that a patient signs must have all except: signature of the nurse who treated the patient.
What is protected health information quizlet?
Protected health information (PHI) is information that relates to healthcare or payment for a patient’s services and is: Information that identifies – or could identify a patient.
Which of the following is an example of protected health information quizlet?
Examples of PHI
Dates — Including birth, discharge, admittance, and death dates. Biometric identifiers — including finger and voice prints. Full face photographic images and any comparable images.
Under which of the following circumstances may PHI be disclosed?
Covered entities may disclose protected health information to law enforcement officials for law enforcement purposes under the following six circumstances, and subject to specified conditions: (1) as required by law (including court orders, court-ordered warrants, subpoenas) and administrative requests; (2) to identify …
Under which circumstances can you disclose PHI?
We may disclose your PHI as authorized to comply with workers’ compensation laws and other similar programs. Threats to Health or Safety. We may disclose limited PHI if we believe it is necessary to prevent or lessen a serious and imminent threat to you or to the public. Specialized Government Functions.
Which of the following is considered protected health information PHI?
Health information such as diagnoses, treatment information, medical test results, and prescription information are considered protected health information under HIPAA, as are national identification numbers and demographic information such as birth dates, gender, ethnicity, and contact and emergency contact …
Which of the following will be the most important issue for the researcher to consider when planning the research?
The most important issue that the researcher addressed in planning the research is the confidentiality of the individual subject’s responses.
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Which of the following is the most important factor in determining who should be entitled to authorship?
Which of the following is the primary criterion for authorship? Having made a significant intellectual contribution to the work.
Which of the following statement is true regarding the responsibilities of a reviewer?
Which of the following statements is true regarding the responsibilities of a reviewer? A reviewer’s conflict of interest should be disclosed to the journal editor or grant agency. Reviewers have a responsibility to promote ethical peer review by: Preserving the confidentiality of the submission.
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