Podcast
Questions and Answers
What is the purpose of the Family Educational Rights and Privacy Act (FERPA)?
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?
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?
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?
How is the age of majority in international research determined?
Which activities constitute engagement in research?
Which activities constitute engagement in research?
What is one potential risk of harm in internet-based research?
What is one potential risk of harm in internet-based research?
Which of the following online research strategies raises the most concerns regarding ethical principles?
Which of the following online research strategies raises the most concerns regarding ethical principles?
What strategy helps ensure participation in a survey about a sensitive personal topic remains voluntary?
What strategy helps ensure participation in a survey about a sensitive personal topic remains voluntary?
How can a researcher minimize potential risks of harm when conducting an online survey?
How can a researcher minimize potential risks of harm when conducting an online survey?
Which example of using the Internet to conduct research meets the federal definition of research with human subjects?
Which example of using the Internet to conduct research meets the federal definition of research with human subjects?
What characteristics does a HIPAA authorization have?
What characteristics does a HIPAA authorization have?
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.
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.
Who can you usually consult with if unsure about HIPAA research requirements?
Who can you usually consult with if unsure about HIPAA research requirements?
Recruiting into research can qualify as an activity 'preparatory to research,' but data should not leave the covered entity. True or False?
Recruiting into research can qualify as an activity 'preparatory to research,' but data should not leave the covered entity. True or False?
What do HIPAA's protections for health information used for research purposes do?
What do HIPAA's protections for health information used for research purposes do?
What does HIPAA stand for?
What does HIPAA stand for?
HIPAA privacy protections supplement those of which regulations?
HIPAA privacy protections supplement those of which regulations?
What does HIPAA protect?
What does HIPAA protect?
Under HIPAA, research activity using PHI generally requires what?
Under HIPAA, research activity using PHI generally requires what?
What must researchers understand when HIPAA applies?
What must researchers understand when HIPAA applies?
If unsure about particulars at your organization regarding HIPAA, what should you do?
If unsure about particulars at your organization regarding HIPAA, what should you do?
What are specified identifiers under HIPAA?
What are specified identifiers under HIPAA?
Who are considered vulnerable persons?
Who are considered vulnerable persons?
What are some of the vulnerable populations identified in the Common Rule (45 CFR 46)?
What are some of the vulnerable populations identified in the Common Rule (45 CFR 46)?
Which principles are outlined in the Belmont Report?
Which principles are outlined in the Belmont Report?
What does the principle of beneficence in the Belmont Report entail?
What does the principle of beneficence in the Belmont Report entail?
The Belmont Report indicates it is necessary to rigorously avoid conflicts of interest.
The Belmont Report indicates it is necessary to rigorously avoid conflicts of interest.
What does the Belmont Report require under respect for persons?
What does the Belmont Report require under respect for persons?
What two terms does the Belmont Report define and delineate?
What two terms does the Belmont Report define and delineate?
What does the principle of justice in the Belmont Report involve?
What does the principle of justice in the Belmont Report involve?
The Belmont Report describes the necessity to effectively manage conflicts of interest.
The Belmont Report describes the necessity to effectively manage conflicts of interest.
What historical document initiated the regulations for ethical treatment of human subjects in research?
What historical document initiated the regulations for ethical treatment of human subjects in research?
What year was the Nuremberg Code established?
What year was the Nuremberg Code established?
What element must be included in informed consent?
What element must be included in informed consent?
Which type of IRB review requires a determination by the IRB but does not require full approval?
Which type of IRB review requires a determination by the IRB but does not require full approval?
What is another name for the 'Exempt' status?
What is another name for the 'Exempt' status?
How can faculty researchers avoid coercion of student subjects?
How can faculty researchers avoid coercion of student subjects?
What is the definition of Exempt Review category 2?
What is the definition of Exempt Review category 2?
What is a Full Board Review?
What is a Full Board Review?
What qualifies as an Expedited Review?
What qualifies as an Expedited Review?
What does 'Not Human Subjects' mean in research?
What does 'Not Human Subjects' mean in research?
What components define human subjects as per federal regulations?
What components define human subjects as per federal regulations?
What are the three main responsibilities of the IRB?
What are the three main responsibilities of the IRB?
IRBs investigate scientific misconduct.
IRBs investigate scientific misconduct.
IRBs do not review manuscripts prior to submission for publication.
IRBs do not review manuscripts prior to submission for publication.
What organizations do IRBs review for current policies?
What organizations do IRBs review for current policies?
Which study is linked to the establishment of the National Research Act?
Which study is linked to the establishment of the National Research Act?
Which Belmont principle is associated with the Tuskegee Study?
Which Belmont principle is associated with the Tuskegee Study?
Which principle was violated when Humphreys collected data under false pretenses?
Which principle was violated when Humphreys collected data under false pretenses?
According to the Belmont Report, what does justice in research entail?
According to the Belmont Report, what does justice in research entail?
How is beneficence applied to studies involving human subjects?
How is beneficence applied to studies involving human subjects?
The study on developmental psychologist interactions is considered human subjects research.
The study on developmental psychologist interactions is considered human subjects research.
A study of a list with deceased passengers qualifies as human subjects research.
A study of a list with deceased passengers qualifies as human subjects research.
Questioning individuals to acquire data about newly diagnosed HIV cases qualifies as human subjects research.
Questioning individuals to acquire data about newly diagnosed HIV cases qualifies as human subjects research.
A study with linguistic analysis of comments on a public blog qualifies as human subjects research.
A study with linguistic analysis of comments on a public blog qualifies as human subjects research.
A research proposal involving interactions with living individuals counts as human subjects research.
A research proposal involving interactions with living individuals counts as human subjects research.
An economic feasibility study is considered human subjects research.
An economic feasibility study is considered human subjects research.
What additional protections does Subpart D of DHHS regulations provide?
What additional protections does Subpart D of DHHS regulations provide?
What does the expedited review process require?
What does the expedited review process require?
Continuing review of an approved protocol must occur within 12 months.
Continuing review of an approved protocol must occur within 12 months.
What must the continuing review process include?
What must the continuing review process include?
Officials of the institution may overrule an IRB approval.
Officials of the institution may overrule an IRB approval.
What is a potential risk in a study about abuse survivors?
What is a potential risk in a study about abuse survivors?
What is the primary purpose of a Certificate of Confidentiality?
What is the primary purpose of a Certificate of Confidentiality?
Data must be evaluated solely based on the severity of expected harm.
Data must be evaluated solely based on the severity of expected harm.
What must researchers ensure regarding participation in studies?
What must researchers ensure regarding participation in studies?
School authority's permission replaces the need for parental permission.
School authority's permission replaces the need for parental permission.
Children's right to choose cannot be overridden for community interest.
Children's right to choose cannot be overridden for community interest.
What is an appropriate criterion for waiving informed consent?
What is an appropriate criterion for waiving informed consent?
When can a waiver of documentation for informed consent be granted?
When can a waiver of documentation for informed consent be granted?
What do federal regulations require of researchers during the consent process?
What do federal regulations require of researchers during the consent process?
How is data made anonymous?
How is data made anonymous?
What confidentiality procedure protects against compelled disclosure in a longitudinal study?
What confidentiality procedure protects against compelled disclosure in a longitudinal study?
What is true regarding confidentiality when discussing sensitive topics in focus groups?
What is true regarding confidentiality when discussing sensitive topics in focus groups?
Leaving research files in the car poses a risk of breaching confidentiality.
Leaving research files in the car poses a risk of breaching confidentiality.
Making identifiable data about sexual behavior available to students is both a breach of confidentiality and a violation of privacy.
Making identifiable data about sexual behavior available to students is both a breach of confidentiality and a violation of privacy.
What must the IRB ensure in studies examining health statuses of prisoners?
What must the IRB ensure in studies examining health statuses of prisoners?
What is true about conducting research in prisons?
What is true about conducting research in prisons?
If toys are given to children during visits, what must the IRB assess?
If toys are given to children during visits, what must the IRB assess?
Should the IRB approve a research project where the graduate student uses a local prison as a convenience sample?
Should the IRB approve a research project where the graduate student uses a local prison as a convenience sample?
Documentation of minors' assent is mandatory.
Documentation of minors' assent is mandatory.
What research activities with children qualify for exemption under Subpart D?
What research activities with children qualify for exemption under Subpart D?
Under what condition can an IRB waive parental permission in research involving children?
Under what condition can an IRB waive parental permission in research involving children?
What should be considered in the review of a revised protocol adding adolescents to a study?
What should be considered in the review of a revised protocol adding adolescents to a study?
When is parental notification allowed instead of active parental permission?
When is parental notification allowed instead of active parental permission?
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.
Informed Consent
- 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.
Studying That Suits You
Use AI to generate personalized quizzes and flashcards to suit your learning preferences.
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.
