Ethical Considerations & Compliance Flashcards

Why is informed consent important in research?

Answer: To comply with ethical standards and protect participants

Informed consent is a cornerstone of ethical research, ensuring that participants voluntarily agree to take part after fully understanding the study's purpose, procedures, risks, and benefits. It protects participants' autonomy and rights, and is a mandatory requirement for ethical approval of research involving human subjects.

What is the role of an Institutional Review Board (IRB)?

Answer: To oversee research safety and ethics

An Institutional Review Board (IRB) is a committee responsible for reviewing research involving human subjects to ensure it meets ethical guidelines and protects participants' rights and welfare. The IRB's primary role is to approve, monitor, and review biomedical and behavioral research to prevent harm and ensure ethical conduct.

Which of the following is a breach of research ethics?

Answer: Fabricating data

Fabricating data, which means making up data or results and recording or reporting them, is a severe breach of research ethics and scientific integrity. It undermines the trustworthiness of research, misleads the scientific community, and can have serious consequences for both the researcher and the public.

What does confidentiality mean in research?

Answer: Keeping participant data secure and private

Confidentiality in research is an ethical principle that requires protecting the identity and personal information of participants. It means keeping their data secure and private, ensuring that unauthorized individuals cannot access or link information back to specific individuals. This builds trust, respects privacy, and prevents potential harm or discrimination to those involved in the study.

Why should researchers avoid conflicts of interest?

Answer: To ensure transparency and objectivity

Researchers must avoid conflicts of interest to maintain the integrity and credibility of their work. A conflict of interest can arise when personal or financial considerations might unduly influence a researcher's professional judgment or actions. By avoiding such conflicts, researchers ensure transparency and objectivity, guaranteeing that their decisions are based solely on scientific merit and ethical considerations.

What is the Belmont Report known for?

Answer: Ethical guidelines for human research

The Belmont Report is a landmark document in research ethics, published in 1979. It is renowned for outlining three fundamental ethical principles for research involving human subjects: Respect for Persons, Beneficence, and Justice. These principles serve as the cornerstone for regulations and guidelines governing human research, particularly in the United States.

Which principle ensures fair treatment of research participants?

Answer: Justice

The principle of Justice ensures fair treatment of research participants by requiring an equitable distribution of the burdens and benefits of research. This means that no single group should bear an undue burden of participation while others disproportionately receive the benefits. It emphasizes fairness in participant selection, recruitment, and treatment throughout the study.

What is coercion in research ethics?

Answer: Forced participation or pressure

Coercion in research ethics refers to any situation where a participant is forced or unduly pressured to participate in a study against their free will. This undermines the crucial ethical principle of voluntary informed consent, which mandates that participation must be entirely free from threats or excessive inducements. Researchers must ensure that all consent is freely given.

Why must vulnerable populations receive extra protections in research?

Answer: To protect from potential harm or exploitation

Vulnerable populations, such as children, prisoners, or individuals with cognitive impairments, receive extra protections in research because they are at increased risk of harm or exploitation. They may have limited capacity to understand risks and benefits, or may be easily influenced. These additional safeguards ensure their rights and welfare are prioritized and protected from potential abuses.