Week 2: Research Ethics, PICO(T), FINER, SMART, and Belmont Principles in Human Subjects Research

What is PICO(T) used for?

Structuring a research/clinical question.

What does PICO(T) stand for?

Population/Patient/Problem, Intervention, Comparison, Outcome, Time (optional).

What is FINER used for?

Evaluating the quality of a research question and whether it is worth pursuing.

What does FINER stand for?

Feasible, Interesting, Novel, Ethical, Relevant.

What is SMART used for?

Defining objectives or goals.

What does SMART stand for?

Specific, Measurable, Achievable, Relevant, Time-bound.

What is human subjects research?

Research involving living individuals through interaction, intervention, or identifiable private information.

What are the four key safeguards for human subjects listed in the slides?

Informed consent, privacy/confidentiality protections, risk-benefit analysis, and ongoing oversight/monitoring.

What are the four essentials of informed consent?

Voluntary participation; clear explanation of purposes, risks, and benefits; participant comprehension; and ability to withdraw at any time.

Is signing a consent form enough if the participant doesn't understand the study?

No. Comprehension is an essential part of informed consent.

Can a research participant withdraw after agreeing to participate?

Yes. Participants must have the ability to withdraw at any time.

What information must be clearly explained during informed consent according to the slide?

The study's purposes, risks, and benefits.

What are the 3 Belmont Report principles?

Respect for Persons, Beneficence, and Justice.

What does Respect for Persons mean?

Autonomy and informed consent.

What does Beneficence mean?

Maximize benefits and minimize harms.

What does Justice mean?

Fair distribution of research burdens and benefits.

A participant is pressured into joining a study. Which Belmont principle is violated?

Respect for Persons.

Researchers fail to minimize unnecessary risks to participants. Which Belmont principle is violated?

Beneficence.

One group bears an unfair amount of research risk while another group receives the benefits. Which Belmont principle is violated?

Justice.

What is the purpose of an IRB?

To review research protocols, ensure participant protections, and require ongoing review/reporting.

What does IRB stand for?

Institutional Review Board.

What major ethical problem occurred in the Tuskegee study?

Participants lacked informed consent, were misled, and were denied effective treatment.

What major research ethics document did the Tuskegee study help lead to?

The Belmont Report.