BIOET - Basic Elements of Research Ethics

Social value

What is the primary requirement for health research to be ethically permissible?

Quality, relevance, contribution

What are the three factors grounding the social value of research?

False

T/F: Research participation is justified even without social value.

Protocol section

What should reflect the significance and rigor of a study?

Participants’ rights

The goal of research should never override whose rights?

True

T/F: Social value is realized only if research is scientifically valid.

Research protocol

What document ensures that research is described and justified in detail?

Informed consent

What element shows respect and concern for participants’ rights?

False

T/F: Informed consent is a one-time event before study enrollment.

Research Ethics Committee (REC)

Who can approve a waiver of informed consent?

Minimal risk

One condition required for a waiver of informed consent.

Important social value

Another condition required for waiver approval.

Not feasible without waiver

Final condition required for waiver approval.

Before research

When must consent be sought and obtained?

Adequate understanding

What must researchers ensure participants have before deciding?

Signed formed

What form serves as evidence of informed consent?

False

T/F: Researchers may withhold relevant information if it benefits the study.

Voluntariness

What essential element must participation always have?

Legally authorized representative

Who gives consent for participants incapable of deciding?

False

T/F: Family or community approval can replace informed consent for capable adults.

Specific protections

What must be ensured when recruiting vulnerable groups?

Consent, hierarchy, institutionalized, women, pregnant, others

What are the six characteristics of vulnerable populations?

Undue influence

What may influence voluntariness in hierarchical settings?

False

T/F: Subordinates in research are free from pressure or bias.

Prison

What setting makes residents vulnerable due to confinement?

False

T/F: Institutionalized individuals always have full freedom of consent.

No

Are all women automatically considered vulnerable in research?

Trafficking (Intimate partner violence)

One context that makes women vulnerable.

No

Are pregnant women always considered vulnerable?

Fetal risk

What factor requires special protection in pregnancy research?

Frail elderly

Vulnerable group due to physical condition.

True

T/F: Research with vulnerable groups is justified only if it addresses their health needs.

Each intervention, entire study

What are the two steps of risk-benefit evaluation?

False

T/F: Risks are acceptable even without potential benefits.

Minimal risk

Acceptable risk level for interventions without direct benefit.

Effective intervention

What must control group participants usually receive?

Research Ethics Committee

Who assesses total study risk and benefits?

False

T/F: Studies may proceed even if risks outweigh objectives.

Accountability

Principle that governs data collection and storage.

Protect confidentiality

Main duty of investigators regarding data.

False

T/F: Participants themselves are responsible for protecting their privacy.

Leakage, linkage, legal disclosure

Three main limits to confidentiality.

Limitations

What should participants be informed about regarding privacy?

Justice

Principle ensuring fair and equal treatment.

False

T/F: Justice allows unfair treatment of vulnerable groups.

Benefits, burdens

What are the two focuses of distributive justice in research?

Researchers and sponsors

Who must ensure public accountability for research benefits?

Limited class

Research should address diverse health needs, not just a ______.

Disadvantaged groups

What population must not be overrepresented in research?

Concentrates risk

Why is targeting marginalized groups unjust?

True

T/F: Broad inclusion of groups promotes ethical acceptability.

Transparency

What enhances public and professional trust in research?

Register studies

What is the first step in ensuring public accountability?

Publish results

Second step in promoting transparency.

Share data

Third step to ensure transparency.

Negative findings

What must be published besides positive results?

True

T/F: Sharing clinical trial data serves the public interest.