CITI Quiz Answers | Citi Questions and Answers

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1.) 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

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2.) An example of an institutional COI is:

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

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

Inherent controls

4.) A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.

No later than the time of proposal submission

5.) An example of an individual financial COI is:

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

6.) The FDA regulations governing disclosure of individual COIs require:

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

Latest CITI Answers: Human Subject Research – CITI Quiz Answers

7.) 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

8.) 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

9.) 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

Three principles of Belmont Report

Respect for Persons Beneficence Justice

Citi Quiz Answers
Human Subjects Research – CITI Quiz Answers

The Belmont Report
Principle of Beneficence

MAXIMIZATION of benefits and MINIMIZATION of risks

T/F
Belmont Report indicates it is necessary to rigorously avoid conflicts of interest

TRUE

The Belmont Report
Respect for Person

Requires that subjects freely choose to participate in research (voluntariness) and that they are adequately informed about a study (informed consent)

The Belmont Report defines and delineates…

“Practice” and “Research”

The Belmont Report
The Principle of Justice

Research benefit and burden distribution and that selection of subjects is fair.

T/F
The Belmont Report describes the necessity to effectively manage conflicts of interest

FALSE

Students in Research
The history of ethical regulations in human subjects research began with the

Nuremberg Code

Nuremberg Code

Human subjects research guidelines and regulations

Year of the Nuremberg Code

1949

Additional resources regarding the IRB approval process

Faculty advisor/Research Mentor IRB office Human subjects research websites

All foreseeable risks and discomforts

Which type of IRB review does not require and IRB approval but DOES require a Determination by the IRB?

If the study qualifies for EXEMPTION

Another name for the “Exempt” status

the Common Rule stated in Title 45 Part 46 Subpart A

How can faculty researchers avoid coercion of student subjects?

Avoid using their own students in their research

Name the type of Review: Research study that involves use of educational tests, survey, interviews, or observations of public behavior without identifiable information

Exempt Review category 2

Name the type of review: A study involving data collected that could have an impact on human subject’s careers and it contains identifiers of the subjects.

Full Board Review

Type of review that qualifies if no identification of subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal

Expedited review

Type of review: data that is collected does not meet definition of human subjects research as stated by federal regulations. No info ABOUT human ie. info about a business

Not Human Subjects

Federal regulations define human subjects as “living individual about whom an investigator conducting research obtains”…? (2 components)

“1.data through intervention or interaction with the individual 2. identifiable private information”

Name the 3 responsibilities the IRB is charged with

1. Protecting the rights and welfare of human subjects 2. Assuring that all applicable institutional policies and federal regulations related to research with human subjects are followed 3. Reviewing subject recruitment materials and strategies

T/F
IRB’s investigate scientific misconduct

False

T/F
IRB’s do not review manuscripts prior to submission for publication

True

DHHS
FDA

Depts. IRB’s review for current policies -Department of Health and Human Services -Food and Drug Administration

The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male

The Tuskegee Study relates to which Belmont principle?

The principle of beneficence: Potential benefits justify the risks of harm

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 Belmont Report

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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:

Justice

How is the principle of beneficence applied to a study involving human subjects?

Ensuring that risks are reasonable in relationship to anticipated benefits.

Human subject study or not?
Developmental psychologist videotapes interactions between groups of toddlers and their caregivers to determine which intervention methods most effectively manage aggression

Yes

Human subject study or not?
The study of a list with deceased passengers

No:Human subject is a living individual

Human subject study or not? Questioning individuals to acquire data about the number of newly diagnosed HIV cases?

No: ‘what’ question rather than ‘who’ question

Human subject study or not?
Conducting linguistic analysis of comments posted on a public blog

Not: involves neither interaction with individuals nor collecting private identified info

Human subject study or not?
A study proposed by developmental psychologist involving interactions with living individuals and designed to contribute to field of knowledge

Yes: humans

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

Yes: Interacting w/ living individuals.

Human subject study or not?
Questioning a superintendent of schools to acquire data about the ethnic composition of a school

No: it is an “about what” question rather than “about whom” question

Human subject study or not?
Study of 20 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 3-month period

Yes: contributes to generalizable knowledge about student performance and research question can only be answered using systematic investigation

Human subject study or not?
Info collected by playground designer

No: does not involve info about human subjects even though there is interactions between designer and school staff.

Human subject study or not?
An analysis of aggregate data

No: doesn’t involve interactions w/ living individuals nor collection of private identifiable data

Human subject study or not?
An economic feasibility study

No: does gather info from people with relevant info and expertise but does not meet the definition of research w/ human subjects, because the intention of the study is to answer “about what” ? rather than “about whom” ?

According to fed. regulations, human subjects are living human beings about whom an investigator obtains data through interactions or intervention with the individual or:

identifiable PRIVATE information (Public info does not meet criteria)

A subpart of DHHS regulations provides additional protections for which vulnerable populations?

1. Pregnant women 2. Fetuses 3. Neonates 4. Prisoners

Subpart of DHHS regulations Does NOT provide additional protections for which vulnerable populations?

1. elderly 2. students 3. for persons whose decision-making capabilities are impaired

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

The expedited review process may NOT be used when the study procedures pose:

-more than minimal risk, even if the subjects are adults, -the sponsor is in a hurry -the study replicates previously approved research

Continuing review of an approved and ongoing protocol…?

Must occur within 12 months of the approval date (even if no additional risks have been identified)

Continuing review process must include:

-unanticipated problems -number of subjects accrued -recent relevant literature -copy of current consent form

T/F
Officials of the institution may overrule an IRB approval

True, however no one may overrule if an IRB disapproved a protocol

Experience emotional or psychological distress

Obtain a waiver of documentation of informed consent

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research info from compelled disclosure

Certificates of Confidentiality protect sensitive info provided by research subjects from:

civil, criminal, or administrative subpoena

T/F
Risk should be evaluated solely by the magnitude or severity of expected harm, not probability

False: Risk must be determined by assessing magnitude (or severity) and probability (or likelihood) of harm. Both elements must be considered.

Risks are specific to:

Time, situation, and culture

A researcher who is also a care provider needs to be very clear that a decision to participate or not in a study will:

Not affect future care

T/F
The fact that a therapist has access to her clients’ records as a clinician entitles her to use info in the records for research purposes w/out parental permission nor child assent

False: S/he needs both parental permission & child assent

T/F
School authority’s permission to conduct research replaces the need for permission and assent

False

T/F
Children’s right to choose cannot be overridden in the pursuit of an indeterminate community interest

True, it cannot be overridden

informing participants they were assigned to a study based on undesirable or unflattering physical characteristics for example, or anything that may be judged negative or distressing would be considered appropriate criterion

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

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

Data are made anonymous by

Destroying all identifiers connected to the data.

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

Securing a Certificate of Confidentiality.

When a focus group deals with a potentially sensitive topic, which statement 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

Which of the following constitutes both a breach of a 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.

An investigator 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

Which of the following statements about prison research is true?

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

An investigator 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 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.

Which of the following statements most accurately describes the requirement for the documentation of minors’ assent to participate in research

Federal regulations do not require the documentation of minors’ assent.

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

The research involves the use of educational tests

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?

The research must pose no more than minimal risk.

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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.

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

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

According to Subpart D, which of the following research activities with children would qualify for an exemption?

Research about educational testing

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

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

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.

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

Assessing transportation conditions

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 the following activities constitutes engagement in research?

Obtaining informed consent and conducting research interviews.

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

Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. She plans to insert comments to see how the members respond.

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

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.

Which of the following examples of using the Internet to conduct research meets the federal definition of research with human subjects?

Conducting an on-line focus group with cancer survivors to determine familial support systems. The researcher also invites subjects’ significant others to be a part of the focus group.

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.

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

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 official (“Privacy Officer”), or security official (“Security Officer”), depending on the issue.

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.

HIPAA’s protections for health information used for research purposes…

supplement those of the Common Rule and FDA.

HIPAA

Health Insurance Portability and Accountability Act of 1996

HIPAA privacy protections supplement those of

other federal regulations (viz., the Common Rule and FDA), state law, and certification/accreditation requirements.

HIPAA protects

protects identifiable health information (PHI) originating or held in covered entities. De-identified data is not protected, and not all identifiable health information is considered PHI either

Under HIPAA, research activity using PHI generally requires

authorization. However, there are several alternatives that allow bypassing the authorization requirement.

Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations (when required) must be

understood by researchers when HIPAA applies

If you’re unsure about the particulars at your organization or have questions,

consult with your organization’s IRB, Privacy Board or Privacy Official. For data security issues, consult with your organization’s Security Official.

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,

Pregnant Women, Human Fetuses and Neonates (Subpart B), Prisoners (Subpart C) and Children (Subpart D).

T/F
Workers are considered vulnerable populations

False

pressure from their co-workers, unions and employers. Pressure can be applied to workers in subtle ways such as an employer who comments that if the research concludes that the organization is spending more on healthcare than other similar organizations, there may be lay-offs, etc.

T/F
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

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

Significant financial interest can be defined as:

– 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 DHHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is

Greater than $5,000 of ownership in any single public entity/public company.

The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold:

Any equity interest in a publicly held company that exceeds $50,000

Current NIH rules require investigators to disclose details regarding financial conflicts of interest to:

Designated institutional officials

What constitutes “research” according to HIPAA?

HIPAA defines research as any “systematic investigation, including research development, testing, and evaluation, designed to develop and contribute to generalizable knowledge

Who enforces HIPAA’s protections?

IRB Privacy Board Privacy Officer

Activities preparatory to research, decedents’ information exceptions

Where the PHI will be used solely for reviews preparatory to research (e.g., for protocol development) and will not leave the covered entity. Where the PHI refers solely to deceased persons (the covered entity may ask for documentation of death of all data subjects

T/F
A researcher may use fully “de-identified” health data without any authorization from data subjects

True

Grandfatherd research

if all informed consents and other legal permissions required at the time were in place before HIPAA took effect (April 2003 in most cases), and have not changed since, no new HIPAA authorization is required.

minimum necessary standard

the uses/disclosures must be no more than the minimum required for the described research purpose

accounting of disclosures

A list of all protocols for which their PHI may have been disclosed, along with the timeframe for those disclosures. The purpose of those protocols, and the types of PHI sought. The researcher’s name and contact information for each study

Characteristics of authorizations

In “plain language” so that individuals can understand the information contained in the form, and thus able to make an informed decision. Executed in writing, and signed by the research subject (or an authorized personal representative).

T/F
revocations for HIPAA authorizations for research can be revoked at any time

True Provided that the revocation is in writing

T/F
It is permissible under HIPAA to discuss recruitment into research with patients for whom such involvement might be appropriate

True

Retrospective” research

use or disclosure of PHI for retrospective research studies may be done only with patient authorization — or with a waiver, alteration, or exception determination from an IRB or Privacy Board

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