Untitled Quiz

Belmont Report Principles

• Respect for Persons: Individuals should be treated as autonomous agents; those with diminished autonomy require protection.
• Beneficence: Emphasizes maximizing benefits and minimizing risks in research.
• Justice: Ensures fair outcomes in the selection of research subjects.

Ethical Violations in Research

• The "Tastes, Ties, and Time (T3)" study exemplified failure to protect subjects from deductive disclosure.
• Humphreys' Tearoom Trade study violated respect for persons by collecting data under false pretenses.

Human Subjects Research Criteria

• Human subjects are defined as living individuals from whom information is collected via interaction or identifiable private information.
• Studies that involve systematic variation of teaching times or gender-related stereotypes in performance qualify as research with human subjects under federal regulations.

Regulatory Exemptions and Reviews

• Research qualifies for exemption if it falls under one of eight specified categories by federal regulations.
• For studies posing minimal risk and in compliance with specific guidelines, an expedited review process may apply.

Special Populations and Additional Protections

• Additional protections apply to vulnerable groups such as prisoners, fetuses, and neonates under HHS regulations.
• Research with children requires adherence to Subpart D, which offers further safeguards.

Informed Consent

• Informed consent cannot include exculpatory language that waives legal rights of subjects.
• Waivers for documentation of consent can occur when the only record linking subjects to research is the consent document.

Data Privacy and Confidentiality

• Data anonymity is achieved by destroying all identifiers connected to the data.
• Confidentiality breaches occur when identifiable data is disclosed contrary to agreements made with participants.

International Research Considerations

• In international settings, local laws determine the age of majority for research participants.
• Studies qualifying for exemption from federal regulations do not require local institutional review if determined exempt by institutional policy.

Online Research Ethics

• Researchers should design online surveys to avoid collecting identifiable information and ensure participation remains voluntary.
• Risks unique to online research must be acknowledged, such as potential inadvertent sharing of private information.

Reporting Obligations

• Unanticipated problems posing risks to research subjects must be reported directly to the IRB.
• Problems are classified as unanticipated when they are unexpected or increase risk related to the research.

Specific Case Scenarios

• Researcher access to prisoners must avoid coercion or influence by prison staff to ensure voluntary participation.
• Reports to the IRB are unnecessary for health events unrelated to research participation.

Conclusion

• Adhering to ethical principles and regulatory standards is vital for the protection of human subjects in research.
• Continuous education and awareness of these principles support responsible research practices and the integrity of the research process.### Unanticipated Problems in Research
• Unanticipated problems related to research must be reported due to factors including unexpected incidents and increased risks of harm.
• According to OHRP, these reports must be submitted to the IRB promptly.

Medical Vulnerability

• Individuals with serious illnesses are at risk for exploitation, driven by desperation for cures.

Cognitive or Communicative Vulnerability

• Cognitive or communicative vulnerability affects prospective subjects unable to understand, deliberate, and decide on study participation due to limitations in comprehension or communication.

Economic Vulnerability

• Economic vulnerability occurs when subjects engage in studies because of treatment that is affordable only through research participation.

Common Abuses Leading to Vulnerability

• Common abuses that increase vulnerability include physical control, coercion, undue influence, and manipulation.

Situational Cognitive Vulnerability

• Situational cognitive vulnerability considers that seriously ill individuals may be at higher risk for psychological harm when making decisions about participation.

Financial Conflict of Interest Regulations

• PHS regulations mandate that researchers disclose significant financial conflicts of interest.

Individual Financial Conflict of Interest Example

• An example includes situations where a researcher's family member has stakes in a pharmaceutical company sponsoring the researcher’s study.

Advisory Board Membership and COI

• A researcher's role on an advisory board for a sponsoring organization can complicate perceptions of neutrality regarding research outcomes.

FDA Regulations on COI Disclosure

• FDA regulations require transparency about financial conflicts involving researchers in clinical studies during marketing application submissions.

IRB Member Conflict of Interest

• During IRB meetings, members aware of potential conflicts must disclose and recuse themselves from voting on related studies.

Vulnerable Populations under Common Rule

• Vulnerable populations are legally recognized as requiring additional protections except for workers, who do not have specific requirements under the Common Rule.

Employment-Related Vulnerabilities

• Workers may face pressures related to management expectations, implications for pay or benefits, and union influences when approached to participate in studies.

Safeguards for Workers in Research

• Research involving workers must employ safeguards, clarifying data access, confidentiality measures, and the handling of personal identifiers.

Biological Samples in Research

• Comprehensive explanations regarding the future use of biological samples and associated data are essential for informed consent.

Considerations for Non-English Speaking Subjects

• Cultural differences must be accounted for when researching subjects who do not speak English.

Importance of Certified Interpreters

• Using certified interpreters enhances communication; researchers should pre-meet with interpreters to ensure understanding of key concepts.

Enhancing Informed Consent for Non-English Speakers

• Providing interpreters and discussion time during the consent process significantly aids understanding for non-English speaking subjects.

Risks of Using Family Members to Interpret

• Family members may misinterpret due to various factors, making it risky to rely on them for the consent process.

Definition of "Eligible Student"

• An eligible student is defined as one who turns 18 or enrolls in a postsecondary institution.

Gonzaga v. Doe Ruling

• The U.S. Supreme Court ruled that no private cause of action exists against educational institutions for FERPA non-compliance.

Oversight of FERPA

• The Family Policy Compliance Office (FPCO) enforces compliance with FERPA regulations.

Initial Opposition to FERPA

• Initial opposition to FERPA came from school counselors and university administrators.

Response Time for Educational Record Requests

• Educational institutions must respond to requests for educational records from eligible students or parents within 45 days.

Disclosure of Educational Records

• A student's educational record cannot be disclosed when a professor is collecting data for personal research.

Directory Information Definition

• Schools can define what constitutes directory information within specific regulatory guidelines.

Risk of Disclosure in Small Cell Data

• Small cell size in data reporting poses a risk of inadvertently disclosing individual students' information.

Non-FERPA Protected Online Tool Content

• Metadata from online educational tools, not linked to identifiable information, is not subject to FERPA protections.

Resources for IRB Approval Process

• Additional resources for students regarding the IRB approval include Faculty Advisors and the IRB Office.

Types of IRB Review

• Studies involving identifiers and sensitive information typically require Full Board Review, while studies without identifiable information may qualify for Exempt Review.

Institutional Review Board Responsibilities

• The IRB is responsible for protecting human subjects' rights and welfare, ensuring compliance with regulations, and reviewing recruitment strategies and materials.

Informed Consent Document Requirements

• Informed consent documents must include descriptions of all foreseeable risks and discomforts associated with participation.