A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct?

Answer: The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children.

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Answer: 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.

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent:

Answer: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.

A waiver of the requirement for documentation of informed consent may be granted when:

Answer: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality.

As part of the consent process, the federal regulations require researchers to:

Answer: Provide potential subjects with information at the appropriate reading comprehension level.

An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent from the individual’s legal representative and no alternative method or recognized therapy is available. Under the FDA regulations for using test articles, which of the following describes the best course of action for the investigator:

Answer: The investigator and an independent physician agree that the situation necessitates the use of the test article. An exception or waiver for informed consent can be made under these circumstances. The IRB will be notified later.

The purpose of informed consent is:

Answer: To provide a potential subject with appropriate information in an appropriate manner and allow that person to make an informed decision about participation in research.

A general requirement for the informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language?

Answer: I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.

An elderly gentleman, whose wife is his legally authorized representative since his strokes several years ago, was recently diagnosed with lung cancer. He is eligible for a clinical trial using a new investigational drug that aims to treat lung cancer. He is able to express interest, shows a basic understanding of the nature of the trial, and gives his assent to participation. The subject’s wife is out of town on a business trip.

Which of the following is the most appropriate action to take for the investigator?

Answer: Send a copy of the informed consent via facsimile to the subject’s wife. After she has had the opportunity to speak to the investigator, she can sign the informed consent and fax it back.

A 46-year-old man is currently enrolled in a Phase 2 study of a drug for severe diabetic neuropathy. While the study is on going, a new drug becomes commercially available that may have equal or greater benefit to the subject. The investigator should do which of the following?

Answer: Give the subject comprehensive information about the new drug, including its side effects. Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Continuing review of an approved and ongoing protocol

Answer: Must occur within 12 months of the approval date

According to federal regulations, the expedited review process may be used when the study procedures pose

Answer: No more than minimal risk and the research activities fall within regulatory categories identified as eligible

Which of the following statements about the relationship between an institution and the institution’s IRB(s) is correct

Answer: Officials of the institution may overrule an IRB approval

According to the federal regulations, research is eligible for exemption, if

Answer: The research falls into one of six categories of research activity described in the regulations

In addition to pregnant women, fetuses, and neonates, another subpart of the HHS regulations provides additional protections for which of the following vulnerable populations

Answer: Prisioners

A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency. She is also a doctoral candidate who proposes using data she has and will collect about the children for a case-based research project. Which of the following statements about parental permission is correct

Answer: The parents of the children might feel pressure to give permission to the therapist to use their children’s data so that she will continue to provide services to their children

A general requirement for informed consent is that no informed consent may include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject’s legal rights or releases or appears to release those conducting the research from liability for negligence. Which of the following statements in a consent form is an example of exculpatory language

Answer: 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

A criterion for waiving informed consent is that, when appropriate, subjects are provided additional pertinent information after the study. In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent

Answer: A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team

A waiver of the requirement for documentation of informed consent may be granted when

Answer: The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality

As part of the consent process, the federal regulations require researchers to

Answer: Provide potential subjects with information at the appropriate reading comprehension level

In a longitudinal study that will follow children from kindergarten through high school and will collect information about illegal activities, which of the following confidentiality procedures would protect against compelled disclosure of individually identifiable information

Answer: Securing a Certificate of Confidentiality

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. The consent form said that no identifying information would be retained, and the researcher adhered to that component. Which of the following statements best characterizes what occurred

Answer: There was neither a violation of privacy nor a breach of confidentiality

Data are made anonymous by

Answer: Destroying all identifiers connected to the data

When a focus group deals with a potentially sensitive topic, which of the following statements about providing confidentiality to focus group participants is correct

Answer: The researcher cannot control what participants repeat about others outside the group

Which of the following constitutes both a breach of confidentiality (the research data have been disclosed, counter to the agreement between researcher and subjects) and a violation of subjects’ privacy (the right of the individuals to be protected against intrusion into their personal lives or affairs)

Answer: A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified

As part of a research study, a physician plans to review medical records of the next 50 of her patients who require magnetic resonance imaging (MRI) scans for clinical treatment to explore factors related to patients requiring MRI scans. The physician will review the medical records, and write down the clinical indication for the scans, any existing injuries, current prescriptions, as well as other clinical data. The clinical indication for the scans and the other clinical data will be collected in the medical records for treatment purposes as part of standard clinical care. The physician will use a coding system to be able to identify the patient’s information; however, the “key” to the coding system will be stored separately from the data in a locked cabinet that only she will have access to. Which of the following is true

Answer: The study is human subject research which is eligible for expedited review

An investigator obtains consent from subjects to review their medical records and HIV status. He plans to go back to the medical record, so the HIV status information is stored along with patient identifiers in a database that he keeps on his laptop computer. His laptop is stolen. This incident constitutes

Answer: A breach of confidentiality

A researcher wants to conduct a secondary analysis using a Centers for Disease Control and Prevention (CDC) database that was collected by the agency solely for surveillance purposes from 1996-2006. The researcher did not participate in the initial collection of the data. The database is publicly available. The database does not include any identifiers. The IRB makes a determination that the individuals whose records will be reviewed do not meet the federal definition of human subjects

Answer: The researcher will not be interacting/intervening with subjects and the data has no identifiers

A recommended recruitment strategy for older adult subjects is

Answer: Involve local leadership in recruitment

Federal regulations require that additional safeguards have been included in a study to protect the rights and welfare of these subjects

Answer: children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons

Regulations require that IRB membership include

Answer: Members with sensitivity to community attitudes

Clinicians find it difficult to care for older adults because

Answer: They have not been included in studies so prescribing drugs involves a lot of unknown risk

Legally Authorized Representatives (LARs) should be involved in the consent process when

Answer: Prospective subjects are assessed and determined to lack capacity to make consent decisions