Research Ethics and Methods

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Questions and Answers

Why do custom-built, homegrown, and/or investigational technologies pose the greatest risk to research participants?

Researchers cannot know all the potential risks until participants have used the technology in practice (correct)

They are not available to purchase

Their use is considered deceptive

Their use is considered limited

What is the primary purpose of data lifecycle management in research?

The destruction plan for all research data collected during a study

Ongoing oversight of research data by the researchers for the study’s duration (correct)

Review of all the data when the study has concluded

Creation of named file coding in preparation for data collection

What is the primary purpose of a data safety monitoring plan (DSMP) in research?

A report submitted to the IRB when a breach of confidentiality occurs

A plan written by the researcher to ensure participant safety and protect study data integrity (correct)

A document listing all technologies in the study and describing their safety

A living document that changes based on serious adverse events reported to the sponsor

When would an Institutional Review Board (IRB) consider the risks of a study to be controlled?

When there is an appropriate risk mitigation and management plan in place Signup and view all the answers

What should a robust data security plan specify instead of 'data will be stored on the researcher’s computer'?

Data will be stored on an encrypted computer with a strong password known only to the researcher Signup and view all the answers

Why are custom-built, homegrown, and/or investigational technologies used in research?

Because researchers cannot find suitable commercial products Signup and view all the answers

What is the primary goal of a data safety monitoring plan (DSMP) in research?

To ensure participant safety and protect study data integrity Signup and view all the answers

What is the main benefit of having a robust data lifecycle management plan in research?

It provides ongoing oversight of research data Signup and view all the answers

Which principle is applied when ensuring that persons with diminished autonomy are protected in a study?

Respect for Persons Signup and view all the answers

What is the primary goal of incorporating the principle of beneficence in a study?

To maximize benefits and minimize risks Signup and view all the answers

Which of the following is NOT one of the three principles discussed in the Belmont Report?

Informed Consent Signup and view all the answers

What is the main objective of incorporating the principle of respect for persons in a study?

To protect individuals with diminished autonomy Signup and view all the answers

Which of the following is an example of the principle of justice in a study?

Selecting subjects from diverse populations Signup and view all the answers

What is the primary goal of incorporating the principle of beneficence in a study employing human subjects?

To maximize benefits and minimize risks Signup and view all the answers

Study Notes

Research Risks and Data Management

Custom-Built Technologies and Research Risks

Custom-built, homegrown, and/or investigational technologies pose the greatest risk to research participants because their use is not well-established and potential risks are unknown until participants use them in practice.

Data Lifecycle Management

Data lifecycle management refers to the ongoing oversight of research data by researchers throughout the study's duration.

Data Safety Monitoring Plan (DSMP)

A DSMP is a plan written by the researcher to ensure participant safety and protect study data integrity.
It is a living document that changes based on serious adverse events reported to the sponsor.

Institutional Review Board (IRB) and Risk Assessment

An IRB considers the risks of a study to be controlled when there is an appropriate risk mitigation and management plan in place.
IRB does not consider risks acceptable when they are unacceptable or when risk mitigation strategies only consider harms encountered in daily life.

Data Security Plan

A robust data security plan should state that data will be stored on an encrypted computer with a strong password known only to the researcher.
It should avoid stating general or insecure storage methods, such as storing data on the researcher's computer without encryption or in an unsecured location.

Principle of Beneficence

Ensuring that persons with diminished autonomy are protected is an example of applying the principle of beneficence to a study employing human subjects.
Beneficence involves maximizing benefits and minimizing risks in a study.

Belmont Report

The Belmont Report discusses three principles: Respect for Persons, Beneficence, and Justice.
Respect for Persons incorporates two ethical convictions:
- Individuals should be treated as autonomous agents.
- Persons with diminished autonomy are entitled to protection.
The Belmont Report does not mention principles such as Informed Consent, Institutional Assurance, Researcher Responsibility, Privacy, Confidentiality, Equitable Selection of Subjects, IRB Review, Federal Regulations, or Declaration of Helsinki.

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Description

This quiz covers important concepts in research ethics, including participant risks and data lifecycle management in research studies.