The Federal Regulations - SBE
If you're unsure about the particulars of HIPAA research requirements at your organization or have questions, you can usually consult with:
An organizational IRB or Privacy Board, privacy officer ("Privacy Officer"), or privacy official ("Privacy Official"), depending on the issue.
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.
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.
The history of ethical regulations in human subjects research began with the
Nuremberg Code
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 IRB approval
The Belmont principle of beneficence requires that:
Potential benefits justify the risks of harm.
According to the federal regulations, which of the following studies meets the definition of research with human subjects?
An analysis of aggregate data comparing statewide high school graduation rates provided by the State Department of Public Instruction, using county tax information
Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply):
- Equity/stock interests (regardless of value) in a non-publicly traded company. - Intellectual property rights upon receipt of income related to such rights. - Consulting payments in excess of $5,000.
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 care givers 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
Neither Subpart C (Prisoners) nor Subpart D (Children) applies to juveniles in the correctional systems since Wardens of Juvenile prisoners - unlike those for adult prisoners - act in loco parentis for juvenile offenders. This statement is false because:
Both subparts apply since these individuals are under the legal age of consent and are incarcerated
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Ensuring that risks are reasonable in relationship to anticipated benefits.
The most important ethical concerns related to conflicts of interest in research are:
Ensuring the objectivity of research and the protection of human subjects
Which example of research with prisoners would be allowable under the regulations?
Examining age at first arrest as a predictor of adult criminal history.
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
Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?
Faculty advisor and IRB office
The researcher's failure to protect research subjects from deductive disclosure is the primary ethical violation in which of the following studies?
Harvard "Tastes, Ties, and Time (T3)" study (2006-2009)" study
According to the federal regulations, human subjects are living human beings about whom an investigator obtains data through interaction or intervention with the individual or:
Identifiable private information.
Risk of harm in social and behavioral sciences generally fall in three categories, which are:
Invasion of privacy, breach of confidentiality, and study procedures
What is the Institutional Review Board (IRB) charged with? (There may be more than one correct answer. Please be sure to select all correct answers.)
Protecting the rights and welfare of human subjects. - Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed. - Reviewing subject recruitment materials and strategies.
As part of the consent process, the federal regulations require researchers to
Provide potential subjects with information at the appropriate reading comprehension level.
A financial conflict of interest could involve
Receiving stock in a company funding your research.
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 statements about prison research is true?
Researchers may study the effects of privilege upgrades awarded by the prison.
Which of the following are the three principles discussed in the Belmont Report
Respect for Persons, Beneficence, Justice
The specific Department of Health and Human Services (DHHS) Regulations that apply to research with children are known as:
Subpart D: Additional Protections for Children Involved as Subjects in Research
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 federal regulation or law governs how researchers can obtain data about subjects' disciplinary status in school from academic records?
The Family Educational Rights and Privacy Act.
A professor at Big State University is writing a biography about Bill Gates and conducting oral histories with all of Bill Gates' friends, family members and business acquaintances. The researcher submits the research proposal to the institution's IRB. What action can he expect by the IRB?
The IRB will not review this study because it is not research as defined by the federal regulations.
A master's degree candidate needs to conduct a research project for her master's thesis. She is interested in the types of junk food available to the public. She plans on going to the local convenience stores and asking the owners what types of junk food the store normally stock and which are the biggest sellers. Identifiers will not be collected. This study would fall under which of the following?
not human subjects
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.
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.
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.
In addition to pregnant women, fetuses, and neonates, another subpart of the DHHS regulations provides additional protections for which of the following vulnerable populations?
prisoners
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.
A HIPAA authorization has which of the following characteristics:
Uses "plain language" that the data subject can understand, similar to the requirement for an informed consent document.
Which of the following elements must be included in an informed consent?
all foreseeable risks and discomforts
The primary purpose of a Certificate of Confidentiality is to
allow law enforcement to investigate abuse cases
Identify the example of when situation and time is key to assessing risk of harm in a research study:
asking women if they've had an abortion
How can faculty researchers avoid coercion of student subjects?
avoid using their own students in their research
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity is an example of:
conflict of interest
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
A medical record is an example of
private information
Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:
designated institutional officials
Data are made anonymous by
destroying all identifiers to the data
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
Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?
exempt
A student is conducting a research project that involves using a survey. The survey asks participants about their highest level of education, political affiliation, and views on various social issues. No identifiable information will be collected. This study would be categorized as which type of review?
exempt review
A student working on his dissertation plans on interviewing 15 principals in neighboring high schools. The student plans to collect data about the personal experiences the principals have had with disruptive students, what types of disciplinary actions were taken (including decisions they may have personally made), and their feelings or thoughts as to whether those actions were appropriate. Identifiers will be collected. This study would be categorized as which type of review?
full board review
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.
According to the Belmont Report, the moral requirement that there be fair outcomes in the selection of research subjects, expresses the principle of:
justice
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.
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
A researcher asks an IRB to waive the requirement for parental permission for a study conducted in schools because the nature of the research requires participation of all the children present in classrooms on the day the research will take place. Assuming that the basic research design could be approved by the IRB and the school, which of the following requirements must be met before an IRB could waive parental permission?
research must pose no more than minimal risk
According to Subpart D, research with children may be eligible for exemption when:
research uses educational tests
Humphreys collecting data for the Tearoom Trade study under the pretense that he was a lookout is an example of a violation of the principle of:
respect for persons
What statement about risks in social and behavioral sciences research is most accurate:
risks are specific to time, place, and culture
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 the following studies need IRB approval?
studies with living individuals
HIPAA's protections for health information used for research purposes...
supplement those of the Common Rule and FDA.
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
Vulnerable persons are those who are less able to protect themselves than other persons in a given situation. The Common Rule (45 CFR 46) has specific requirements for the following vulnerable populations, except:
workers
