CITI Study 2

Researchers must report potential unanticipated problems that involve risks to others directly to the:

Institutional Review Board (IRB)

What statement about risks in social and behavioral sciences research is most accurate:

Risks are specific to time, situation, and culture.

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category do discussions with family members go?

Uses or disclosures that generally require oral agreement only.

With respect to permissions for uses and disclosures, HIPAA divides health information into three categories. Into which category does information related to research, marketing, and fundraising go?

Uses or disclosures that generally require specific written authorization.

What is the term for management controls that are built in to a research study (for example, independent data analysis)?

Inherent controls

The COI management plan aims to:

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

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A study of twenty 4th grade classrooms in which researchers ask the schools to systematically vary the time of day reading is taught, and collect weekly assessments of reading comprehension for each child over a three-month period.

One of your subjects is half way through a study of an investigational antidepressant that is injected weekly. The drug requires a taper-down regimen, that is, it should not be stopped abruptly. You learn that the subject will be admitted to prison next week prior to the next scheduled injection. What is the appropriate response for the researcher?

The researcher should contact prison authorities about the medical issue , and report the events to the IRB of record.

HIPAA allows healthcare organizations to control many information decisions. However, where the patient retains control, which of the following is true?

If a person has a right to make a healthcare decision, then generally that person has a right to control information associated with the decision.

A researcher proposes to conduct a study at a foreign site. The research has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required at the foreign site?

If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted.

What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects?

In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought?

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

Which of the following statements about prison research is true?

Researchers may study the effects of privilege upgrades awarded by the prison

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?

There was neither a violation of privacy nor a breach of confidentiality.

A researcher wants to observe preschoolers at a local public playground to evaluate levels of cooperation. The researcher will not interact with the children or record information in such a manner that the identity of the subjects can be readily ascertained. Which of the following statements is true?

This research would be eligible for exemption because the researcher is not interacting with the children and the playground is a public setting.

Which of these is not a right under HIPAA?

To control all disclosures of information in the health record.

A researcher wants to do a web-based survey of college students to collect information about their sexual behavior and drug use. Direct identifiers will not be collected; however, IP addresses may be present in the data set. Risk of harm should be evaluated by:

Both the magnitude (or severity) and the probability (or likelihood) of harm.

Which of these is not a good security practice for portable devices?

Disabling any remote-locate, remote-shutdown, and remote-erase capabilities because these can accidentally erase data.

How are the ethical standards for student uses and disclosures of patients' health information different from those for regular members of the healthcare workforce?

Some would say it is higher, because patients do not always benefit from students' access to their data.

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?

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.

Which of the following is a correct statement about the balance among prevention, detection, and response (PDR)?

The greater the sensitivity and quantity of the data at issue, the more carefully the balance among these three must be evaluated.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A cognitive psychologist enrolls undergraduate students for a computer-based study about the effect of mood on problem-solving behaviors.

According to the federal regulations, which of the following studies meets the definition of research with human subjects?

A developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression.

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)?

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.

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:

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.

The internet can be used as a research tool or as the object of a study. Which of the following examples best describes an investigator using the internet as a research tool?

An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey.

The FDA regulations governing disclosure of individual COIs require:

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

Under HIPAA, an organization is required to do which of the following?

Appoint a Privacy Officer to administer HIPAA rules.

A covered entity may use or disclose PHI without an authorization, or documentation of a waiver or an alteration of authorization, for all of the following EXCEPT:

Data that does not cross state lines when disclosed by the covered entity.

Use of social media tools and other new technologies to facilitate training-related communications is:

Depends on the organization's policies, so you should check with your organization's officials about what is allowed or prohibited.

To minimize potential risks of harm, a researcher conducting an on-line survey can:

Design the survey so that no direct or indirect identifiers are collected.

Data are made anonymous by

Destroying all identifiers connected to the data.

The procedures for reporting potential unanticipated problems involving risk to subjects or others to the IRB are:

Determined by the institution in its written policies and procedures

Which of the following types of information may schools disclose without consent from the parent or student to a researcher at a local university?

Directory information.

A researcher wants to contact former prisoners who are now on parole. She wants to study the difficulty of obtaining employment based on whether the subjects had been convicted of felony versus misdemeanor crimes. She needs to:

Do nothing in regards the Subpart C because the research does not meet the criteria for prison research -- individuals on parole are not considered prisoners. The definition applies to both minors and adults.

Which example of research with prisoners would be allowable under the regulations?

Examining age at first arrest as a predictor of adult criminal history.

Patients have to provide an additional, specific authorization for training uses and disclosures of their information.

False

In the U.S., privacy protections for health information come from:

Federal, state, local, and private certification organizations' requirements

HIPAA privacy protections cover identifiable personal information about the "past, present or future physical or mental health condition." What does that include?

Health information in any form or medium, as long as it is identified (or identifiable) as a particular person's 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.

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

The age of majority in international research is determined by the

Laws, customs, and norms in the area in which the research will be conducted.

Which of these is not a good practice for controlling computer access?

Logging into systems with a shared user-ID or password.

Continuing review of an approved and ongoing study posing more than minimal risk that was initially approved by a convened IRB:

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:

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

For health information privacy and security, are the legal and regulatory requirements for students different from those for regular members of the healthcare workforce?

No, students must meet the same standards as a regular member of the workforce performing the same tasks.

A researcher conducts a focus group to learn about attitudes towards hygiene and disease prevention. Two weeks after the focus group, the researcher learns one of the subjects had a heart attack at home and was hospitalized, but made a full recovery. Based on HHS regulations, should the researcher report this event to the IRB?

No, this does not need to be reported because it is unrelated to participation in the study.

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.

According to the federal regulations, human subjects are living individuals about whom an investigator conducting research obtains information through interaction or intervention with the individual, and uses, studies, or analyzes the information; or:

Obtains, uses, studies, analyzes, or generates identifiable private information.

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

Officials of the institution may overrule an IRB approval.

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

PPRA applies

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

Prisoners

A medical record is an example of:

Private information

What procedures must be described in an agreement called an "assurance of compliance" with a U.S. federal agency?

Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB.

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure.

Organizations covered by the federal HIPAA privacy law are expected to:

Protect the health information under their control, train their workers in how to protect information, and help patients exercise their rights under the law.

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?

Securing a Certificate of Confidentiality

Which of these is not a good security practice for email?

Sending sensitive information in email messages or in attachments to such messages, as long as a legally-binding confidentiality notice is included.

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

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

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?

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.

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.

According to Subpart D, research with children may be eligible for exemption under Category 2 when:

The research involves the use of educational tests

The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show:

There may be bias by the peer reviewer as to the area of research

Which of these is not a good practice for physical security?

To preserve good customer relations, visitors are generally allowed access to all areas of a facility unless it appears they are doing something suspicious.

When a research project includes the collection of biological samples, all planned future uses of the samples, identifiers, and the data obtained from the samples, must be fully explained to the research subject.

True

According to OHRP, a problem is an "unanticipated problem" when it meets which of the following criteria:

Unexpected, related or possibly related to the research, suggests the research puts subjects or others at greater risk

When required, the information provided to the data subject in a HIPAA disclosure accounting ...

must be more detailed for disclosures that involve fewer than 50 subject records.

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

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 define:

All of the above

When workers are asked to participate in a research study, vulnerabilities related to the subject's employment may include:

All of the above

Which of the following are important for protecting computing devices and systems?

All of the above

The HIPAA "minimum necessary" standard applies...

To all human subjects research that uses PHI without an authorization from the data subject.

Information security's goals are sometimes described by the letters "CIA." Which of the following is correct definition of C, I, or A?

All of the above

Researchers endeavoring to conduct an on-line study should consider that there are some potential risks of harm to subjects unique to internet-based research. One of these risks is:

Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers.

PPRA gives parents some level of control over their child's:

Participation in third-party survey research or exposure to instructional materials developed by researchers

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

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

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.

Which of the following methods could be considered a "best practice" in terms of informing respondents how their answers to an on-line survey about personal information will be protected?

The investigator uses the informed consent process to explain how respondent data will be transmitted from the website to his encrypted database without ever recording respondents' IP addresses, but explains that on the internet confidentiality cannot be absolutely guaranteed.

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

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

Which of the following is a good practice if one wishes to avoid "social engineering" attacks?

All of the above

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

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

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.

Under the federal HIPAA regulations, state health privacy laws:

Can remain in force if "more stringent" than HIPAA, complementing HIPAA's foundation of protections, provided there is no direct conflict in requirements.

Consent to participate in research is an ongoing process. Which of the following strategies would help ensure that participation in a survey about a sensitive personal topic remains voluntary throughout a study?

Designing the survey so that subjects are not forced to answer one question before going to the next.

A researcher wishes to study generational differences in coping mechanisms among adults who experienced abuse as children. Adequate measures will be instituted to obtain informed consent and ensure that there is no breach of confidentiality. The most likely additional risk is that some subjects may:

Experience emotional or psychological distress.

A study that involves interviews of adults is eligible for expedited review. The researcher wants to add an adolescent population (aged 12 to 17) to the study and has designed a parental permission and assent process. No additional changes are planned. Which of the following statements about review of the revised protocol is accurate?

Unless the nature of the questions would raise the level of risk to more than minimal for adolescents, the research would still qualify for expedited review.

Which of these is generally not a good practice with respect to oral communications (that is, talking) in organizations like healthcare facilities?

Use of full names in public areas or on intercom/paging systems, because there is no security issue with identifying persons in public areas and using full names helps avoid misidentification.

What does HIPAA's "minimum necessary" and related standards require of healthcare workers?

Use or disclose only the minimum necessary amount of health information to accomplish a task.

Which of these is not generally a good practice for telephone use?

Using voicemail systems and answering machines that do not require a password or PIN for access.

Which of the following is the least important activity when protecting human subjects in international research?

Assessing transportation conditions

A researcher conducting behavioral research collects individually identifiable sensitive information about illicit drug use and other illegal behaviors by surveying college students. One of the subjects is in an automobile accident two weeks after participating in the research study. Is this an example of an unanticipated problem that requires reporting to the IRB?

No, this does not need to be reported because it was assessed by the researcher as unrelated to the research study.

Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46, Subpart A) has specific requirements for the following vulnerable populations, except:

Workers

In regard to reporting privacy or security problems, are the requirements for students the same as for regular workers?

Yes. Like any other member of the workforce, students are obligated to report problems they are not in a position to correct.