Informational risk is the potential for harm from disclosure of information about an identified individual. For much of social and behavioral research, informational risk is the only or the primary risk, so social and behavioral research is particularly concerned with its management.
Which of the following are the three principles discussed in the Belmont Report?
The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice.
When a focus group deals with a potentially sensitive topic Which of the following statements about providing confidentiality to focus group participants is correct quizlet?
When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct? The researcher cannot control what participants repeat about others outside the group. Destroying all identifiers connected to the data.
Which of the following statements in a consent form is an example of exculpatory language?
Which of the following statements in a consent form is an example of exculpatory language? Taking part in the research is voluntary, but if you choose to take part, you waive the right to legal redress for any research-related injuries.
What statement about risks in social and behavioral research is most accurate?
What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. Additional safeguards that may be included in a social and behavioral study may include: Remove all direct identifiers from the data as soon as possible.
What is the most common risk that participants in social and behavioral trials might experience?
Privacy and Confidentiality: The most commonly perceived risks of social and behavior research are the consequences of breaches of confidentiality.
When evaluating risks of harm IRBs must determine that?
When evaluating risks of harm, IRBs must determine that: Risks are reasonable in relation to anticipated benefits.
What statement is correct about informed consent?
Which statement is correct about informed consent? The informed consent document, regardless of the research topic, must always include the following: A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
Who is responsible for making the initial risk determination for a device being used in a study?
The sponsor-investigator is responsible for making the initial risk determination and presenting it to the IRB. The FDA is available to help sponsor-investigators and IRBs in making the risk determination. The medicine manufacturer is not involved in the risk determination for a sponsor-investigator study.
Which of the following is one of the top reasons for Hipaa breaches under Hitech Act?
#1: Theft. According to the U.S. Department of Health and Human Services, theft is still the top cause of a HIPAA breach. The department defines theft as “equipment housing electronic protected health information or paper records stolen, or stolen.”
When the primary potential harm is the breach of individually identifiable data to protect against such disclosures researchers should?
When the primary potential harm is the breach of individually identifiable data, to protect against such disclosures researchers should: Encrypt the data and store it in password protected files on institutionally maintained servers with limited access.
Which of the following is the most appropriate way to handle a conflict of conscience relating to a project?
Which of the following is the most appropriate way to handle a conflict of conscience relating to a project? Notify relevant parties that a conflict may exist and seek advice about whether to accept or decline the project.
Which of the following statements is one of the requirements for obtaining 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.
What is the purpose of the informed consent form?
The main purpose of the informed consent process is to protect the patient. A consent form is a legal document that ensures an ongoing communication process between you and your health care provider.
What is the importance of informed consent Why?
Informed consent creates trust between doctor and patient by ensuring good understanding. It also reduces the risk for both patient and doctor. With excellent communication about risks and options, patients can make choices which are best for them and physicians face less risk of legal action.
Which of the following is the most effective strategy for preventing research misconduct?
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
What is one lasting result of the National Research Act of 1974?
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.
What brought increased public attention to the problems with the IRB system?
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.)
