CITI Training: Belmont Report Principles

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Questions and Answers

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

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?

Ensuring data confidentiality

Conducting risk assessments

Assessing transportation conditions (correct)

Obtaining informed consent

How is the age of majority in international research determined?

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

Which activities constitute engagement in research?

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

What is one potential risk of harm in internet-based research?

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

Which of the following online research strategies raises the most concerns regarding ethical principles?

Joining a moderated support group posing as a participant Signup and view all the answers

What strategy helps ensure participation in a survey about a sensitive personal topic 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 of harm when conducting an online survey?

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

Which example of using the Internet to conduct research 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

What characteristics does a HIPAA authorization have?

Uses 'plain language' that the data subject can understand. Signup and view all the answers

When required, information provided to the data subject in a HIPAA disclosure accounting must be more detailed for disclosures that involve fewer than 50 subject records.

True Signup and view all the answers

Who can you usually consult with if unsure about HIPAA research requirements?

An organizational IRB or Privacy Board, privacy official, or security official. Signup and view all the answers

Recruiting into research can qualify as an activity 'preparatory to research,' but data should not leave the covered entity. True or False?

true Signup and view all the answers

What do HIPAA's protections for health information used for research purposes do?

Supplement those of the Common Rule and FDA. Signup and view all the answers

What does HIPAA stand for?

Health Insurance Portability and Accountability Act of 1996. Signup and view all the answers

HIPAA privacy protections supplement those of which regulations?

Other federal regulations, state law, and certification/accreditation requirements. Signup and view all the answers

What does HIPAA protect?

Identifiable health information originating or held in covered entities. Signup and view all the answers

Under HIPAA, research activity using PHI generally requires what?

Authorization. Signup and view all the answers

What must researchers understand when HIPAA applies?

Minimum necessary standards, disclosure accounting requirements, and the characteristics of authorizations. Signup and view all the answers

If unsure about particulars at your organization regarding HIPAA, what should you do?

Consult with your organization's IRB, Privacy Board or Privacy Official. Signup and view all the answers

What are specified identifiers under HIPAA?

All of the above Signup and view all the answers

Who are considered vulnerable persons?

Those who are less able to protect themselves than other persons in a given situation. Signup and view all the answers

What are some of the vulnerable populations identified in the Common Rule (45 CFR 46)?

Pregnant Women, Human Fetuses and Neonates, Prisoners, and Children. Signup and view all the answers

Which principles are outlined in the Belmont Report?

Respect for Persons Signup and view all the answers

What does the principle of beneficence in the Belmont Report entail?

Maximization of benefits and minimization of risks. Signup and view all the answers

The Belmont Report indicates it is necessary to rigorously avoid conflicts of interest.

True Signup and view all the answers

What does the Belmont Report require under respect for persons?

Voluntariness and informed consent. Signup and view all the answers

What two terms does the Belmont Report define and delineate?

Practice and Research. Signup and view all the answers

What does the principle of justice in the Belmont Report involve?

Fair distribution of research benefits and burdens. Signup and view all the answers

The Belmont Report describes the necessity to effectively manage conflicts of interest.

False Signup and view all the answers

What historical document initiated the regulations for ethical treatment of human subjects in research?

Nuremberg Code. Signup and view all the answers

What year was the Nuremberg Code established?

<ol start="1949"> <li></li> </ol> Signup and view all the answers

What element must be included in informed consent?

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

Which type of IRB review requires a determination by the IRB but does not require full approval?

Exemption. Signup and view all the answers

What is another name for the 'Exempt' status?

The Common Rule. Signup and view all the answers

How can faculty researchers avoid coercion of student subjects?

By avoiding using their own students in their research. Signup and view all the answers

What is the definition of Exempt Review category 2?

Research study that involves the use of educational tests, surveys, interviews, or observations of public behavior without identifiable information. Signup and view all the answers

What is a Full Board Review?

A study involving data that could impact the subjects' careers and includes identifiers. Signup and view all the answers

What qualifies as an Expedited Review?

No identification of subjects or responses that would place them at risk. Signup and view all the answers

What does 'Not Human Subjects' mean in research?

Data collected does not involve living individuals. Signup and view all the answers

What components define human subjects as per federal regulations?

Data through intervention or interaction and identifiable private information. Signup and view all the answers

What are the three main responsibilities of the IRB?

Protecting rights and welfare of subjects, ensuring compliance with regulations, and reviewing recruitment strategies. Signup and view all the answers

IRBs investigate scientific misconduct.

False Signup and view all the answers

IRBs do not review manuscripts prior to submission for publication.

True Signup and view all the answers

What organizations do IRBs review for current policies?

Department of Health and Human Services and Food and Drug Administration. Signup and view all the answers

Which study is linked to the establishment of the National Research Act?

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

Which Belmont principle is associated with the Tuskegee Study?

Beneficence. Signup and view all the answers

Which principle was violated when Humphreys collected data under false pretenses?

Respect for persons. Signup and view all the answers

According to the Belmont Report, what does justice in research entail?

Fair outcomes in the selection of research subjects. Signup and view all the answers

How is beneficence applied to studies involving human subjects?

By ensuring risks are reasonable related to anticipated benefits. Signup and view all the answers

The study on developmental psychologist interactions is considered human subjects research.

True Signup and view all the answers

A study of a list with deceased passengers qualifies as human subjects research.

False Signup and view all the answers

Questioning individuals to acquire data about newly diagnosed HIV cases qualifies as human subjects research.

False Signup and view all the answers

A study with linguistic analysis of comments on a public blog qualifies as human subjects research.

False Signup and view all the answers

A research proposal involving interactions with living individuals counts as human subjects research.

True Signup and view all the answers

An economic feasibility study is considered human subjects research.

False Signup and view all the answers

What additional protections does Subpart D of DHHS regulations provide?

Pregnant women, fetuses, neonates, and prisoners. Signup and view all the answers

What does the expedited review process require?

Studies pose no more than minimal risk. Signup and view all the answers

Continuing review of an approved protocol must occur within 12 months.

True Signup and view all the answers

What must the continuing review process include?

Unanticipated problems, number of subjects accrued, relevant literature, and consent form copy. Signup and view all the answers

Officials of the institution may overrule an IRB approval.

True Signup and view all the answers

What is a potential risk in a study about abuse survivors?

Emotional or psychological distress. Signup and view all the answers

What is the primary purpose of a Certificate of Confidentiality?

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

Data must be evaluated solely based on the severity of expected harm.

False Signup and view all the answers

What must researchers ensure regarding participation in studies?

That participation decision does not affect future care. Signup and view all the answers

School authority's permission replaces the need for parental permission.

False Signup and view all the answers

Children's right to choose cannot be overridden for community interest.

True Signup and view all the answers

What is an appropriate criterion for waiving informed consent?

Participants were assigned to a study based on negative physical characteristics. Signup and view all the answers

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

When the consent document is the only link and the primary risk is confidentiality breach. Signup and view all the answers

What do federal regulations require of researchers during the consent process?

Provide information at an appropriate reading comprehension level. Signup and view all the answers

How is data made anonymous?

By destroying all identifiers connected to the data. Signup and view all the answers

What confidentiality procedure protects against compelled disclosure in a longitudinal study?

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

What is true regarding confidentiality when discussing sensitive topics in focus groups?

The researcher cannot control what participants share outside the group. Signup and view all the answers

Leaving research files in the car poses a risk of breaching confidentiality.

False Signup and view all the answers

Making identifiable data about sexual behavior available to students is both a breach of confidentiality and a violation of privacy.

True Signup and view all the answers

What must the IRB ensure in studies examining health statuses of prisoners?

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

What is true about conducting research in prisons?

Researchers may study the effects of privilege upgrades awarded by the prison. Signup and view all the answers

If toys are given to children during visits, what must the IRB assess?

That the toys are not an excessive incentive. Signup and view all the answers

Should the IRB approve a research project where the graduate student uses a local prison as a convenience sample?

No, it should not be approved. Signup and view all the answers

Documentation of minors' assent is mandatory.

False Signup and view all the answers

What research activities with children qualify for exemption under Subpart D?

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

Under what condition can an IRB waive parental permission in research involving children?

When the research poses no more than minimal risk. Signup and view all the answers

What should be considered in the review of a revised protocol adding adolescents to a study?

The level of risk to adolescents must not exceed minimal risk. Signup and view all the answers

When is parental notification allowed instead of active parental permission?

When an IRB has approved a waiver of parental permission. Signup and view all the answers

Study Notes

Belmont Report Principles

Three core principles: Respect for Persons, Beneficence, Justice.
Respect for Persons emphasizes voluntary participation and informed consent.
Beneficence focuses on maximizing benefits while minimizing risks in research.

Ethics in Research

The Belmont Report indicates the necessity to avoid conflicts of interest rigorously.
Must clearly inform subjects of all foreseeable risks and discomforts in the consent process.
Conflicts of interest must be managed effectively to protect research integrity.

Historical Context

The historical foundation for ethical regulations in human subjects research began with the Nuremberg Code in 1949.
The Tuskegee Study significantly impacted the establishment of the National Research Act and the Belmont Report, emphasizing ethical conduct in research.

Essential components of informed consent include detailing potential risks.
Waivers for documentation of consent can be granted if confidentiality is a primary concern.

IRB Responsibilities

The Institutional Review Board (IRB) is responsible for protecting human subjects, ensuring compliance with regulations, and reviewing recruitment materials.
The IRB does not investigate scientific misconduct or review manuscripts before publication.

Types of IRB Review

Exempt review is for studies with minimal risk and specific criteria, while expedited review is for studies that pose no more than minimal risk and fall within predefined categories.
Full Board Review is necessary for studies involving identifiable data that could impact subjects' lives.

Vulnerable Populations

DHHS regulations provide additional protections for pregnant women, fetuses, neonates, and prisoners.
No extra protections are provided for populations such as the elderly, students, or those with impaired decision-making capabilities.

Confidentiality and Privacy

Certificates of Confidentiality protect identifiable information from compelled disclosure.
Breach of confidentiality occurs when identifiable information is disclosed contrary to initial agreements with subjects.

Special Considerations in Research

Researchers must avoid using their own students in studies to prevent coercion.
Emotional or psychological distress is a potential risk in studies involving sensitive topics.
In international research, local laws and customs determine age of majority.

Online Research Ethics

Online research poses unique risks, including potential inadvertent sharing of personal information by subjects.
Researchers must maintain respect for autonomy when conducting online studies, particularly when disguising one’s identity in sensitive contexts.

Children in Research

Studies involving children need additional ethical considerations, such as obtaining parental permission and child assent.
Research about educational tests using minors may qualify for exemption under federal regulations.

Continuing Review and Oversight

The IRB must conduct continuing reviews at least annually to ensure ongoing adherence to ethical standards.
Unanticipated problems, subject accrual data, and current consent forms must be reviewed in continuing processes.

Conclusion

Ethical research practices are crucial in protecting human subjects and maintaining research integrity, with guidelines established by foundational reports like the Belmont Report and legislative acts.### Survey Design
Surveys should allow subjects to move between questions without forced sequencing.
Avoid collecting direct or indirect identifiers to minimize risks of harm in online surveys.

Research with Human Subjects

Online focus groups that include cancer survivors and their significant others qualify as research involving human subjects.

HIPAA Authorization

Must use "plain language" understood by data subjects, similar to informed consent documents.

HIPAA Disclosure Accounting

More detailed information is required for disclosures involving fewer than 50 subject records.

Consultation for HIPAA Issues

Consult an organizational Institutional Review Board (IRB), Privacy Board, or designated privacy/security officials for HIPAA-related inquiries.

Recruiting for Research

Initial contact with prospective research subjects may be preparatory to research, provided data remains within the covered entity.

HIPAA Protections

HIPAA safeguards health information utilized for research, complementing protections of the Common Rule and FDA regulations.

Understanding HIPAA

HIPAA governs the use of identifiable health data, emphasizing the need for authorization unless alternative permissions apply.

Minimum Necessary Standards

Researchers must comprehend minimum necessary standards, disclosure accounting, and authorization characteristics when dealing with HIPAA.

Identifiers Defined by HIPAA

Specific identifiers that must be protected include names, geographic subdivisions, dates, contact numbers, medical and account numbers, biometric data, and more.

Vulnerable Persons

Vulnerable populations are those less capable of self-protection in particular situations, necessitating special considerations in research contexts.

Common Rule Protections

The Common Rule outlines specific protections for vulnerable groups, including pregnant women, prisoners, and children, under designated subparts.

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Description

This quiz covers the essential principles outlined in the Belmont Report, including respect for persons, beneficence, and justice. Test your knowledge on the significance of these principles and their implications in research ethics. Ideal for those involved in research and ethics training.