CITI Training

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.

1.) Take Immediate action to stop the activity causing the breach, if applicable 2.) Conduct a detailed analysis to determine threshold of financial, reputational, or other harm that may have occurred. 3.) Notify the Privacy Official

False

False

False

1.) The use and disclosure of PHI involves no more than the minimal risk to the subject's privacy rights 2.) The reason the information being sought is necessary 3.) The reason it is not practicable to obtain an authorization

False. This is not one of the criteria that must be met in order for the IRB or Privacy Board to approve the waiver or alteration of authorization.

Revocation of medical licensing by the Department of Health and Human Services

True

True

True. IVF patients who donate embryos for use in research are not considered human subjects under the Common Rule unless the investigator obtains data through interaction or intervention with the donor or obtains identifiable private information. In most cases, the identity of IVF patients who donate embryos for research purposes will not be known to the investigator. The investigator and the physician caring for the IVF patient should not be the same person to prevent conflict of interest. Consent should be obtained at the time of donation.

A member of the lay public.

True. The NAS Guidelines do not specifically require annual re-review and re-approval of hES cell research. However, many ESCRO Committees perform continuing review similar to the reviews performed by IRBs. ESCRO Committees are responsible for facilitating the education of hESC research investigators.

The embryo is no longer required for reproductive purposes and the donor of the embryo consented to the use of the derived hESCs.

True.

False. There is no requirement for hESC research to collect identifiable information.

Protect identifiable research information from compelled disclosure.

True. Asking women if they have had an abortion would carry very different risks in a country where abortion is a routine medical practice, a country where it is illegal, and a country in which it is legal but the issue is fraught with religious and political controversy. Purchasing tobacco products is generally illegal for persons under 18 years of age, so any assessment of the risk for teenagers will have to consider that the research focuses on an illegal activity and is assessing the subject population, not situation and time. Similarly, a survey about sexually transmitted diseases would carry different risks for middle class suburban men, clergy, and gang members and is assessing risk through the idea of subject population, not situation and time. Research on the prevalence of HIV-infected individuals in communities may stigmatize the community being studied, and the risk should be assessed as subject population, not situation and time either.

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.

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.

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.

Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed.

No later than the time of proposal submission.

It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research's success.

Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies.

Disclose their potential COI and may answer questions, but recuse themselves from voting.

The administrator may ensure that determinations for vulnerable populations are being considered at convened meetings

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 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.