Who should be a partner with the chair in running an efficient and compliant IRB meeting?
  • Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed.
  • The IRB Administrator
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
Additional safeguards that may be included in a social and behavioral study may include the removal of...
  • The removal of all direct identifiers from the data as soon as possible. When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
  • Time, situation, and culture. 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. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.
What does appropriate provenance mean with regards to the embryo?
  • The embryo is no longer required for reproductive purposes and the donor of the embryo consented to the use of the derived hESCs.
  • Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
Does HIPAA prohibit physicians from discussing recruitment into studies with patients for whom involvement might be appropriate?
  • Disclose their potential COI and may answer questions, but recuse themselves from voting.
  • Physicians can continue to discuss such options with their own patients, since this would be part of treatment.
  • Yes, research authorizations for may be combined with any other legal permission related to the research study, including another authorization or consent to participate.
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
True or False: A researcher must provide a copy of the research authorization to the covered entity where he/she wants to look at or obtain PHI about the subject.
  • True
  • False
All of the following are examples of new enforcement rules under HITECH, EXCEPT:
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
  • Revocation of medical licensing by the Department of Health and Human Services
  • Protect identifiable research information from compelled disclosure.
  • Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally falls in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
A researcher's membership on an advisory board with an organization sponsoring research can create a COI because:
  • It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success.
  • No later than the time of proposal submission.
  • The embryo is no longer required for reproductive purposes and the donor of the embryo consented to the use of the derived hESCs.
  • Physicians can continue to discuss such options with their own patients, since this would be part of treatment.
In general, ESCRO Committees specifically include this type of person:
  • The IRB Administrator
  • The embryo is no longer required for reproductive purposes and the donor of the embryo consented to the use of the derived hESCs.
  • A member of the lay public.
  • Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed.
Which of the following is true with respect to IRB chair time commitments?
  • The embryo is no longer required for reproductive purposes and the donor of the embryo consented to the use of the derived hESCs.
  • Revocation of medical licensing by the Department of Health and Human Services
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
Risk of harm in social and behavioral sciences generally fall into these three categories:
  • Revocation of medical licensing by the Department of Health and Human Services
  • Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally falls in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
  • Time, situation, and culture. 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. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.
  • Both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.
True or False: Encryption is an effective deterrent against breaches of PHI maintained electronically.
  • True
  • False
Risks in social and behavioral sciences research are specific to these three things:
  • The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings
  • Time, situation, and culture. 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. The risk of emotional distress cannot be managed by anonymizing data, but rather by developing a plan to respond to the distress should it occur. Risks must always be minimized to the extent possible, regardless of the potential for benefit.
  • The removal of all direct identifiers from the data as soon as possible. When a possible disclosure of subjects' responses is the primary source of potential harm, collecting data anonymously may provide the best protection and removing direct identifiers is an additional safeguard. The other responses are additional safeguards, but refer to studies that may involve investigational drugs or are biomedical and not social behavioral.
  • Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally falls in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
Risk of harm should be evaluated by these two things:
  • Both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.
  • 1.) Take Immediate action to stop the activity causing the breach, if applicable2.) Conduct a detailed analysis to determine threshold of financial, reputational, or other harm that may have occurred.3.) Notify the Privacy Official
  • Invasion of privacy, breach of confidentiality, and study procedures are the three categories that risks of harm in SBE research generally falls in. Invasions of privacy can occur if personal information is accessed or collected without the subjects' knowledge or consent. Confidentiality can be compromised through an unauthorized release of data, which could have a negative impact on the subjects' psychological, social, or economic status. In some cases, simply taking part in research can put subjects at risk. For example, if a researcher is conducting interviews with individual gang members, it may be necessary to find places to meet where other members of the gang could not observe the interaction.
  • The organization's policies and procedures governing human subject protections, which should define the IRB's jurisdiction and processes which will, in turn, define the IRB Chair's responsibilities as well.
IRB chairs must be familiar with what?
  • Both the magnitude (or severity) and the probability (or likelihood) of harm. Both elements must be considered. Although the probability that an individual subject could be identified is low, the magnitude of the possible harm is high given the sensitivity of the information.
  • 1.) Take Immediate action to stop the activity causing the breach, if applicable2.) Conduct a detailed analysis to determine threshold of financial, reputational, or other harm that may have occurred.3.) Notify the Privacy Official
  • The organization's policies and procedures governing human subject protections, which should define the IRB's jurisdiction and processes which will, in turn, define the IRB Chair's responsibilities as well.
  • The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
True or False: After a breach, patients should be notified.
  • True
  • False
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