Missing CITI Training Quizlet

The provisions of Subpart D, of the HHS regulations, Additional Protections for Children Involved as Subjects in Research apply to:

All research funded by HHS

Parental notification, in lieu of active parental permission, is allowed when:

An IRB has approved a waiver of the requirement for parental permission.

Recruiting into research ...

Can qualify as an activity "preparatory to research," at least for the initial contact, but data should not leave the covered entity.

A researcher is examining the quality of life for prisoners who are HIV-positive using surveys followed by interview. The IRB must ensure that:

Confidentiality of the prisoners' health status is maintained.

Under HIPAA, "retrospective research" (a.k.a., data mining) on collections of PHI generally ...

Is research, and so requires either an authorization or meeting one of the criteria for a waiver of authorization.

What consideration should researchers take into account when designing an online study that presents participants with misleading information?

Researchers cannot guarantee that participants reached the end of the study, and read and understood the debrief.

The purpose of the Family Educational Rights and Privacy Act (FERPA) is to:

Provide parents certain rights over their children's educational records.

During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should:

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

A researcher's study uses an identifiable dataset of prisoner demographic characteristics. This dataset includes criminal history data that predates incarceration and includes data on disciplinary behavior while in prison. There is no interaction with prisoners. The researcher claims, and the IRB chair agrees, that the study is exempt from IRB review. This decision:

Is wrong because 46.104 states that research conducted in prisons is not exempt if the subject population is only prisoners.

A graduate student wants to examine the effect of print media versus televised media on individuals' position on several social issues. The superintendent of a local work release facility, a family friend, will allow the graduate student access to the prison population to help her quickly accrue subjects. The student's IRB should:

Not approve this project because the prisoners are merely a population of convenience for the student.

If research in a private school is directly funded by the Department of Education, then:

PPRA applies.

According to federal regulations, "children" are defined as:

Persons who have not yet attained the legal age of consent under the applicable laws in the jurisdiction in which the research will be conducted.

The specific U.S. Department of Health and Human Services (HHS) regulations that apply to research with children are known as Subpart D: Additional Protections for Children Involved as Subjects in Research.

True

An example of an institutional COI is:

- An industry sponsor pays for the construction of a new research laboratory at the organization

An example of an individual financial COI is:

A researcher's spouse holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher's study.

Researcher access to confidential records adds to the vulnerability of workers who participate in workplace studies. Inappropriate release of identifiable private information could adversely affect a worker's retention of a job, insurance, or other employment related benefits. To avoid or minimize these risks, the study design must include adequate safeguards to protect the confidentiality of the information collected. A plan for the proper management of study data and records should clearly def

All of the Above

In addition to the general provisions of the Common Rule (the federal regulations for protecting research subjects), the following regulations also govern research in the public schools:

FERPA, PPRA, and Subpart D of the federal regulations

A researcher is studying women recently admitted to a state prison. All potential subjects must have children under the age of five. Research subjects will be given a basket of toys to use at their children's first visit that the children can then take home. In assessing this proposal, the IRB needs to determine that the toys are:

Not an excessive incentive.

What consideration should researchers take into account when designing an online study that presents participants with misleading information?

Adding attention or logic checks can affect the way participants understand misleading information.

HIPAA protects a category of information known as protected health information (PHI). PHI covered under HIPAA includes:

Identifiable health information that is created or held by covered entities and their business associates.

If the research is subject to Subpart D, which of the following research activities with children would qualify for an exemption under Category 2 (research that includes educational tests, surveys, interviews, observation)?

Research about aptitude testing

The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?

Researcher