What statement about risks in social and behavioral sciences 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 are the safeguards in a social and behavioral study?
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. A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use.
What is the principal risk in conducting a research study?
The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. Provide potential subjects with information at the appropriate reading comprehension level.
What are the 6 traits of a research subject?
The traits may be thought of as falling into six broad areas: cognitive or communicative, institutional, deferential, medical, economic, and social. Prospective research subjects who are not able to comprehend information, deliberate, and make decisions about participation in a proposed research study have a:
What are the three categories of risk of harm in social and behavioral sciences?
Risk of harm in social and behavioral sciences generally fall into these three categories: Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally falls in.
Which of the following is true regarding the US federal research misconduct policy Citi?
Which of the following is true regarding the U.S. Federal Research Misconduct Policy? To have a misconduct finding, the action must have been committed intentionally, knowingly, or recklessly.
Which member of a study team is ultimately responsible for the conduct of the study at a site?
Principal InvestigatorResponsible or Principal Investigator: The person responsible for the conduct of a human research study at one or more sites, whether on- or off-campus. If the human research study is conducted by a team of individuals, the responsible/principal investigator is the responsible leader of the team.
Which of the following studies is linked most directly to the establishment of the National research?
Which of the following studies is linked most directly to the establishment of the National Research Act in 1974 and ultimately to the Belmont Report and Federal regulations for human subject protection? The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male.
Which of the following most accurately describes the process that must occur when working with research animals covered by US federal regulations?
Which of the following most accurately describes the process that must occur when working with research animals covered by U.S. federal regulations? The research team must obtain IACUC approval for the proposed research procedures prior to starting the work.
Which of the following statements is true regarding the responsibilities of reviewers quizlet?
Which of the following statements is true regarding the responsibilities of reviewers? Reviewers should identify the positive and negative aspects of a manuscript, and indicate where improvements are needed.
Which statement about risk and social and behavioral sciences 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.
Who is ultimately responsible for the safety and welfare of the human subjects in a research study?
The IRB must conduct periodic reviews of research to ensure continued protection of the welfare of human subjects and compliance with relevant regulations. The membership of an IRB is defined to include at least five members.
Who is ultimately responsible for the ethical conduct of research?
The principal investigatorThe principal investigator (PI) on any project is ultimately responsible for the ethical conduct of research with human subjects.
Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report?
Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report: The Tuskegee Study.
Which of the following statements most accurately describes the requirement for the documentation of minors assent to participate in research?
Which of the following statements most accurately describes the requirement for the documentation of minors' assent to participate in research? Documentation is required unless waived by an IRB.
Which statement best describes what an IRB is responsible for reviewing?
Which statement best describes what an IRB is responsible for reviewing? Which of the following best describes when a protocol may be eligible for expedited review by the IRB? The study involves no more than minimal risk and meets one of the allowable categories of expedited review specified by the federal government.
Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure?
Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure of significant financial interests? Any equity interest in a non-publicly traded company must be disclosed.
Which of the following is considered to be research misconduct?
Research Misconduct is defined as fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results. (a) Fabrication is making up data or results and recording or reporting them.
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.)
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.
What are the most likely additional risks of social and behavioral studies?
The most likely additional risk is that some subjects may: Experience emotional or psychological distress. Additional safeguards that may be included in a social and behavioral study may include:
What are the three categories of risk of harm in social and behavioral science?
Risk of harm in social and behavioral sciences generally fall in three categories, which are: Invasion of privacy, breach of confidentiality, and study procedures.
Is research eligible for exemption?
According to the federal regulations, research is eligible for exemption, if: The research falls into one of eight categories of research activity described in the regulations. Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB.
Can a researcher control what participants repeat about others outside the group?
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.
How does a research study affect an employee?
The research study's finding could affect an employee's pay, benefits or promotion potential. The employer may encourage or deny participation of workers. Employees may experience pressure from management to participate in the study because the employer perceives the study to be advantageous to the organization.
What are ethical concerns related to conflicts of interest in research?
The most important ethical concerns related to conflicts of interest in research are: Maintaining a supply of volunteers for research studies and their active involvement in research. Ensuring the objectivity of research and the protection of human subjects.
Why do researchers ask for parental permission?
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place.
What is a plan for the proper management of study data and records?
A plan for the proper management of study data and records should clearly define: Who will have access to the data. If personal identifiers will be retained and used in the data analysis. How the data will be collected and secured. If the study results, if any, will be included in the employee's personnel records.
Do you need informed consent for online studies?
People assume pseudonymous on-line identities, such as an avatar in an MMORPG. Online studies do not require the documentation of informed consent. Recruiting, consenting and debriefing subjects takes place on-line, and may require little to no interaction with the subjects.
Can a researcher control what participants repeat about others outside the group?
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.
What is the only record linking the subject to the research?
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 of the following would be most helpful: Obtain a waiver of documentation of informed consent.
What are the risks of harm in SBE research?
Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally fall in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent.
What are the risks of obtaining informed consent?
The most likely additional risk is that some subjects may: Experience emotional or psychological distress. Some subjects may experience emotional or psychological distress.
What are the three risk categories of harm?
Risk of harm in social and behavioral sciences generally fall in three categories, which are: Invasion of privacy, breach of confidentiality, and study procedures. Identify the example of when situation and time are key to assessing risk of harm in a research study: Asking women if they have had an abortion.
Does research in social and behavioral sciences pose risks?
Research in the social and behavioral sciences sometimes does pose risks to subjects. Risks can be time, situation, and context specific. What may be a socially sensitive issue or topic at a given time and/or place may not be so at another time and/or place.
Is harassment a risk in research?
Research on the prevalence of harassment in different academic disciplines may stigmatize the community being studied in certain extreme cases, but the risk should be assessed as subject population, not situation and time either. ... Research in the social and behavioral sciences sometimes does pose risks to subjects.