CITI Module #3 Quiz and Flashcards on Research Ethics

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Questions and Answers

Which of the following statements about parental permission is correct?

If it is in the best interests of the community that the children participate in the study, parental permission is optional.

The therapist creates her clients' records; therefore, she does not need parents' permission to use the information for research purposes.

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. (correct)

The superintendent of the school system can give permission for children to be in the study; therefore, the therapist doesn't have to ask the parents for permission.

Which of the following statements in a consent form is an example of exculpatory language?

The researcher may stop you from taking part in this research without your consent if you experience side effects that make your emotional condition worse. If you become too emotionally distressed during the research, you may have to drop out.

Your participation in this research is voluntary. If you choose not to participate, or change your mind later, your decision will not affect your relationship with the researcher or your right to other services that you may be eligible for.

In the event of any distress you may have related to this research, you will be given access to appropriate resources.

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. (correct)

In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent?

A study involving decision-making games in which subjects were led to believe they were interacting with another student but were actually interacting with a computer.

A study in which researchers told students that they would be given a quiz after reading some study materials when the researchers did not intend to use a quiz.

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. (correct)

A study in which subjects were told they performed in the third quartile on an anagram task when in reality students were randomly assigned scores.

When can a waiver of the requirement for documentation of informed consent be granted?

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

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

Provide potential subjects with information at the appropriate reading comprehension level. Signup and view all the answers

Data are made anonymous by which of the following methods? (Select all that apply)

Requiring all members of the research team to sign confidentiality agreements. Signup and view all the answers

Which confidentiality procedure protects against compelled disclosure of identifiable information in a longitudinal study?

Securing a Certificate of Confidentiality. Signup and view all the answers

If group members know each other, confidentiality is not an issue.

False Signup and view all the answers

What occurred when a researcher left a research file in her car that was subsequently stolen?

There was neither a violation of privacy nor a breach of confidentiality. Signup and view all the answers

Which situation constitutes both a breach of confidentiality and a violation of privacy?

A faculty member makes identifiable data about sexual behavior available to graduate students. Signup and view all the answers

What must IRB determine about toys given to research subjects' children in prison?

Not an excessive incentive. Signup and view all the answers

What must the IRB ensure regarding prisoners' health status in research?

Confidentiality of the prisoners' health status is maintained. Signup and view all the answers

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

True Signup and view all the answers

What should the student's IRB do regarding access to prisoners for research?

Not approve this project because the prisoners are merely a population of convenience for the student. Signup and view all the answers

What describes the requirement for documentation of minors' assent to participate in research?

Federal regulations do not require the documentation of minors' assent. Signup and view all the answers

When can research with children be exempt?

The research involves the use of educational tests. Signup and view all the answers

What must be met for an IRB to waive parental permission?

The research must pose no more than minimal risk. Signup and view all the answers

What happens when adolescents are added to a study that was eligible for expedited review?

Unless the nature of the questions raises the level of risk, the research qualifies for expedited review. Signup and view all the answers

When is parental notification in lieu of active parental permission allowed?

An IRB has approved a waiver of the requirement for parental permission. Signup and view all the answers

Which research activity with children qualifies for an exemption?

Research about educational testing. Signup and view all the answers

What is the purpose of the Family Educational Rights and Privacy Act (FERPA)?

Provide parents certain rights over their children's educational records. Signup and view all the answers

Which regulation governs how researchers can obtain data about subjects' disciplinary status from academic records?

The Family Educational Rights and Privacy Act. Signup and view all the answers

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

Assessing transportation conditions. Signup and view all the answers

How is the age of majority determined in international research?

Laws, customs, and norms in the area in which the research will be conducted. Signup and view all the answers

What constitutes engagement in research?

Obtaining informed consent and conducting research interviews. Signup and view all the answers

What is a risk of harm in online research?

Individuals may post private identifiable information about themselves online without intending it to be public. Signup and view all the answers

Which online research strategy raises ethical concerns regarding informed consent?

A researcher proposes to join a moderated support group for cancer survivors posing as a survivor. Signup and view all the answers

Which strategy helps ensure that participation in a survey remains voluntary?

Designing the survey so that subjects are not forced to answer one question before going to the next. Signup and view all the answers

How can a researcher minimize potential risks in an online survey?

Design the survey so that no direct or indirect identifiers are collected. Signup and view all the answers

Which example meets the federal definition of research with human subjects?

Conducting an online focus group with cancer survivors to determine familial support systems. Signup and view all the answers

A covered entity may use or disclose PHI except for which circumstance?

Data that does not cross state lines when disclosed by the covered entity. Signup and view all the answers

When is a disclosure accounting required under HIPAA?

For all human subjects research that uses PHI without an authorization from the data subject, except for limited data sets. Signup and view all the answers

What does PHI include under HIPAA?

Identifiable health information that is created or held by covered entities. Signup and view all the answers

When is the information in a HIPAA disclosure accounting required to be more detailed?

Must be more detailed for disclosures that involve fewer than 50 subject records. Signup and view all the answers

HIPAA involves research activities related to what?

Development of generalizable knowledge. Signup and view all the answers

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

Workers Signup and view all the answers

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

All of the above Signup and view all the answers

To avoid or minimize risks in workplace studies, the study design must include adequate safeguards to protect confidentiality. This includes defining:

All of the above. Signup and view all the answers

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

True Signup and view all the answers

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 Signup and view all the answers

A situation in which financial or other personal considerations have the potential to compromise professional judgment is an example of:

Conflict of Interest Signup and view all the answers

According to the DHHS 2011 update of the PHS federal regulations, the threshold amount for reporting a significant financial interest is:

Greater than $5,000 of ownership in any single public entity/company. Signup and view all the answers

The most important ethical concerns related to conflicts of interest in research are:

Ensuring objectivity and protection of human subjects Signup and view all the answers

A conflict of interest implies:

The potential for bias. Signup and view all the answers

What are the 3 principles discussed in the Belmont Report?

Respect for Persons, Beneficence, Justice Signup and view all the answers

What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

Determining that the study has a maximization of benefits and a minimization of risks. Signup and view all the answers

All of the following are true regarding the Belmont Report, EXCEPT:

False Signup and view all the answers

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

Nuremberg Code Signup and view all the answers

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?

Faculty Advisor/Research Mentor, IRB Office Signup and view all the answers

Which of the following elements must be included in an informed consent?

All foreseeable risks and discomforts. Signup and view all the answers

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

Exempt Signup and view all the answers

How can faculty researchers avoid coercion of student subjects?

Avoid using their own students in their research Signup and view all the answers

A student conducting a research project using a survey with no identifiable information would categorize this study as which type of review?

Exempt Review Signup and view all the answers

A student working on his dissertation plans to interview 15 principals and collect personal experiences. This study would be categorized as which type of review?

Full Board Review Signup and view all the answers

A master's degree candidate planning to ask store owners about junk food availability would categorize this study as which of the following?

Not Human Subjects Signup and view all the answers

Which of the following studies need IRB approval?

Studies collecting data about living individuals. Signup and view all the answers

What is the Institutional Review Board (IRB) charged with?

Protecting the rights and welfare of human subjects, assuring compliance with research policies, and reviewing recruitment materials. Signup and view all the answers

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974?

The Public Health Service Tuskegee Study of Untreated Syphilis in the Negro Male Signup and view all the answers

The Belmont principle of beneficence requires that:

Potential benefits justify the risks of harm. Signup and view all the answers

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 Signup and view all the answers

According to the Belmont Report, the moral requirement of fair outcomes in the selection of research subjects expresses the principle of:

Justice Signup and view all the answers

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. Signup and view all the answers

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

A researcher videotapes interactions between groups of toddlers to determine effective intervention methods. Signup and view all the answers

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

An experiment is proposed on gender-related stereotypes and performance on tests. Signup and view all the answers

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

A cognitive psychologist enrolls undergraduate students for a computer study on mood effects. Signup and view all the answers

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

A study varying classroom reading times and assessing comprehension over a period. Signup and view all the answers

According to 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. Signup and view all the answers

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

The research falls into one of six categories described in the regulations. Signup and view all the answers

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. Signup and view all the answers

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

No more than minimal risk and research activities fall within eligible categories. Signup and view all the answers

Continuing review of an approved and ongoing protocol:

Must occur within 12 months of the approval date. Signup and view all the answers

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. Signup and view all the answers

An investigator studying coping mechanisms among adults who experienced abuse as children may:

Experience emotional or psychological distress. Signup and view all the answers

If disclosure of a subject's involvement in a research study can be potentially harmful, the most helpful action would be:

Obtain a waiver of documentation of informed consent. Signup and view all the answers

The primary purpose of a Certificate of Confidentiality is to:

Protect identifiable research information from compelled disclosure. Signup and view all the answers

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

False Signup and view all the answers

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

Risks are specific to time, situation, and culture. Signup and view all the answers

Study Notes

Data Anonymization and Confidentiality

Data are anonymized by destroying all identifiers linked to subjects.
Certificates of Confidentiality are essential for protecting sensitive individual information, especially in longitudinal studies.
In focus groups, researchers can't control the dissemination of shared information outside the group.

Research Ethics and Privacy

If identifiable data about sexual behavior is shared with students against prior agreements, it constitutes a breach of confidentiality and privacy.
The IRB (Institutional Review Board) must verify that toys provided to child subjects in studies are not excessive incentives.

Regulations and Procedures

Confidentiality must be maintained regarding health status in studies involving HIV-positive prisoners.
Researchers can study effects of privilege upgrades awarded by prisons within ethical guidelines.
The IRB can waive parental permission for research if proper notification is given and the risk is minimal.

Special Populations in Research

Educational testing research with children may qualify for exemption under Subpart D.
Federal regulations don’t mandate documentation of minors' assent unless specifically required by the IRB.
Research involving adolescents still qualifies for expedited review unless it poses increased risk.

Parental notification can replace active permission if an IRB approves it.
Research about educational testing qualifies for exemption under specific guidelines.

Laws Protecting Educational Information

FERPA safeguards parents' rights over their children's educational records.
HIPAA regulates the use and disclosure of protected health information in research settings.

Ethical Considerations in Online Research

Risks unique to online research include unintended public disclosure of private identifiable information.
Ethical concerns arise when researchers manipulate their identity or roles in online support groups.

Consent must be an ongoing process; surveys should allow participants to skip sensitive questions.
Researchers should minimize risks in online surveys by omitting identifiers and ensuring adult participation.

Vulnerable Populations and Workplace Studies

Vulnerable groups include pregnant women, prisoners, and children; the Common Rule outlines specific protections for these groups.
Workers in research studies face vulnerabilities due to potential employer influence, which must be carefully addressed.

Biological Samples in Research

Any research involving biological samples must fully disclose future uses and all identifiers to subjects.

Key Considerations for Researchers

Proper management plans must outline who accesses data, retention of identifiers, data security, and how results may be used in personnel records to protect worker privacy.### Financial Disclosure and Conflict of Interest
FDA regulations from 1998 require disclosure of any equity interest exceeding $50,000 in publicly held companies.
A conflict of interest arises when financial or personal considerations affect professional judgment, highlighting the potential for bias.

Ethical Principles and the Belmont Report

The Belmont Report outlines three key principles: Respect for Persons, Beneficence, and Justice.
Beneficence emphasizes maximizing benefits while minimizing risks in human subjects research.

Informed consent must disclose all foreseeable risks and discomforts involved in a study.
Exempt review studies do not require full IRB approval but need a determination by the IRB.
Full board review is necessary when research involves identifiers or significant emotional risk to participants.

Vulnerable Populations and Data Protection

DHHS regulations provide additional protections for vulnerable populations, including prisoners.
Risks should be assessed based on both severity and probability, considering the context of research.

Research with Human Subjects

Studies involving living individuals typically require IRB approval, particularly if they collect identifiable private information.
Research is eligible for exemption if it serves specific categories outlined in regulations.

Factors Affecting Ethical Research

The relationship between institutions and IRBs can have implications; institutional officials can overrule IRB approvals but not disapprovals.
A Certificate of Confidentiality is crucial for protecting participants' identifiable information from legal disclosure.

Risks and Emotional Distress in Research

Emotional or psychological distress is a considerable risk in studies involving sensitive topics, such as childhood abuse.
Researchers must ensure that consent processes minimize undue pressure on participants, especially when vulnerable subjects are involved.

Informed consent should avoid exculpatory language, which waives participants' legal rights.
A waiver of documentation may be permitted under specific conditions, especially regarding the withholding of post-study information when required.

General Ethical Considerations

The potential for bias in research necessitates careful oversight and adherence to ethical protocols, as highlighted by historical precedents like the Tuskegee Study.
The selection of research subjects must follow fair outcomes, aligning with the Belmont principle of Justice.### Language Proficiency
Subjects are literate in their native language but lack proficiency in English (reading, writing, speaking).

Potential subjects may feel that research questions are embarrassing or intrusive, potentially affecting participation.

Confidentiality Risks

Consent forms are the only records linking subjects to the research, raising confidentiality risks.
A breach of confidentiality is the principal risk associated with the consent process.

Researchers must inform potential subjects about penalties for non-participation.
It is recommended that subjects consult family members before deciding to participate.
Researchers should disclose the names of IRB members who reviewed the protocol.
All information provided to potential subjects must be tailored to their reading comprehension level to ensure clarity.

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Test your knowledge with these flashcards based on CITI Module #3. This quiz covers key concepts such as data anonymization and longitudinal studies. Perfect for researchers and students in the field of research ethics.

CITI Module #3 Flashcards

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Questions and Answers

Which of the following statements about parental permission is correct?

Which of the following statements in a consent form is an example of exculpatory language?

In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent?

When can a waiver of the requirement for documentation of informed consent be granted?

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

Data are made anonymous by which of the following methods? (Select all that apply)

Which confidentiality procedure protects against compelled disclosure of identifiable information in a longitudinal study?

If group members know each other, confidentiality is not an issue.

What occurred when a researcher left a research file in her car that was subsequently stolen?

Which situation constitutes both a breach of confidentiality and a violation of privacy?

What must IRB determine about toys given to research subjects' children in prison?

What must the IRB ensure regarding prisoners' health status in research?

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

What should the student's IRB do regarding access to prisoners for research?

What describes the requirement for documentation of minors' assent to participate in research?

When can research with children be exempt?

What must be met for an IRB to waive parental permission?

What happens when adolescents are added to a study that was eligible for expedited review?

When is parental notification in lieu of active parental permission allowed?

Which research activity with children qualifies for an exemption?

What is the purpose of the Family Educational Rights and Privacy Act (FERPA)?

Which regulation governs how researchers can obtain data about subjects' disciplinary status from academic records?

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

How is the age of majority determined in international research?

What constitutes engagement in research?

What is a risk of harm in online research?

Which online research strategy raises ethical concerns regarding informed consent?

Which strategy helps ensure that participation in a survey remains voluntary?

How can a researcher minimize potential risks in an online survey?

Which example meets the federal definition of research with human subjects?

A covered entity may use or disclose PHI except for which circumstance?

When is a disclosure accounting required under HIPAA?

What does PHI include under HIPAA?

When is the information in a HIPAA disclosure accounting required to be more detailed?

HIPAA involves research activities related to what?

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

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

To avoid or minimize risks in workplace studies, the study design must include adequate safeguards to protect confidentiality. This includes defining:

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

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

A situation in which financial or other personal considerations have the potential to compromise professional judgment is an example of:

According to the DHHS 2011 update of the PHS federal regulations, the threshold amount for reporting a significant financial interest is:

The most important ethical concerns related to conflicts of interest in research are:

A conflict of interest implies:

What are the 3 principles discussed in the Belmont Report?

What is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

All of the following are true regarding the Belmont Report, EXCEPT:

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

Where could student researchers and/or student subjects find additional resources regarding the IRB approval process?

Which of the following elements must be included in an informed consent?

Which type of IRB review does not require an IRB approval but does require a determination by the IRB or an IRB designee?

How can faculty researchers avoid coercion of student subjects?

A student conducting a research project using a survey with no identifiable information would categorize this study as which type of review?

A student working on his dissertation plans to interview 15 principals and collect personal experiences. This study would be categorized as which type of review?

A master's degree candidate planning to ask store owners about junk food availability would categorize this study as which of the following?

Which of the following studies need IRB approval?

What is the Institutional Review Board (IRB) charged with?

Which of the following studies is linked most directly to the establishment of the National Research Act in 1974?

The Belmont principle of beneficence requires that:

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:

According to the Belmont Report, the moral requirement of fair outcomes in the selection of research subjects expresses the principle of:

Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects?

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

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

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

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

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

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

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

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

Continuing review of an approved and ongoing protocol:

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

An investigator studying coping mechanisms among adults who experienced abuse as children may:

If disclosure of a subject's involvement in a research study can be potentially harmful, the most helpful action would be:

The primary purpose of a Certificate of Confidentiality is to:

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