Ethics in Medical Research

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Questions and Answers

What major ethical framework was developed in response to the Tuskegee Syphilis Study?

The Declaration of Helsinki

The National Research Act

The Nuremberg Code

The Belmont Report (correct)

Which principle of the Belmont Report focuses on treating individuals as autonomous and independent?

Respect for persons (correct)

Informed consent

Justice

Beneficence

What does the principle of beneficence in research ethics primarily address?

Maximizing benefits and minimizing harm (correct)

Fair distribution of research benefits

Ensuring independence of participants

Protecting vulnerable populations

What is a key requirement under the principle of justice in human subjects research?

Participation should be based on fairness Signup and view all the answers

Which legislation established a national commission for human subjects research in 1974?

The National Research Act Signup and view all the answers

What is a critical factor to consider when placing questions in a survey?

The sequence of questions Signup and view all the answers

Which guideline should be followed when crafting opening questions in a survey?

They should be nonthreatening and easy to answer. Signup and view all the answers

How should sensitive questions be positioned within a survey?

They should be placed towards the end after building trust. Signup and view all the answers

What should be avoided when starting a mail survey?

Asking open-ended questions as the first item. Signup and view all the answers

Which action is essential for an interviewer during a study?

To clarify any confusion or concerns from respondents. Signup and view all the answers

What is the purpose of a codebook in statistical programs?

To describe each variable and indicate how it can be accessed Signup and view all the answers

What does the double entry method achieve in data entry?

It increases the likelihood of entering more accurate data Signup and view all the answers

Which characteristic does NOT typically describe a variable in descriptive statistics?

Confidence intervals Signup and view all the answers

What is one risk associated with summarizing large datasets with a single indicator?

It can simplify the data excessively and omit important details Signup and view all the answers

Which of the following is a method of data transformation?

Expressing variables in logarithm form Signup and view all the answers

Which response format involves respondents choosing between two possible answers?

Dichotomous response format Signup and view all the answers

What is a characteristic of the nominal response format?

Responses are distinguished by numbers that act only as placeholders. Signup and view all the answers

Which type of response format uses numbers spaced at equal intervals?

Interval level response format Signup and view all the answers

Which type of question is best to determine if a respondent qualifies to answer subsequent questions?

Contingency question Signup and view all the answers

Which of the following is NOT a recommendation for structured question content?

Ensure the question is biased. Signup and view all the answers

What defines a Likert-type response scale?

Responses are gathered using numbers spaced at equal intervals. Signup and view all the answers

Which of the following is an example of an unstructured response format?

Open-ended question Signup and view all the answers

What is a significant drawback of using a double-barreled question?

It forces the respondent to choose a single answer for multiple issues. Signup and view all the answers

What is one of the main advantages of factorial designs in research?

They efficiently combine studies into one. Signup and view all the answers

What is a limitation of using factorial designs?

They involve more planning and require more participants. Signup and view all the answers

What characterizes an incomplete factorial design?

Some cells from a fully crossed design are intentionally left empty. Signup and view all the answers

What is the purpose of blocking in a randomized block design?

To reduce noise or variance in the data. Signup and view all the answers

In Analysis of Covariance Design (ANCOVA), what is a covariate?

A variable correlated with the dependent variable. Signup and view all the answers

Which of the following accurately describes a switching-replications design?

It involves two distinct phases with repeated measures. Signup and view all the answers

What is a key benefit of covariate inclusion in ANCOVA?

It helps in adjusting for initial differences among subjects. Signup and view all the answers

What is a challenge associated with factorial designs when a large number of groups are present?

Increased complexity in data analysis. Signup and view all the answers

Study Notes

Declaration of Helsinki

Adopted in 1964 by the World Medical Association.
Outlines principles for ethical medical research.

The Tuskegee Syphilis Study

A 40-year observational study on the impact of untreated syphilis on men.
Involved low-income African American men who were falsely led to believe they were receiving treatment.
A major catalyst for the development of the Belmont Report.

Evolution of a Modern System of Research Ethics

Pre-1970s: no comprehensive guidelines existed in the US for ethical research involving human subjects.
The Tuskegee Syphilis Study revelation in 1972 prompted the development of a broader ethical framework.

National Research Act (1974)

Established a national commission to develop guidelines for human subjects research.
Regulates human experimentation in medicine.

The Belmont Report

Outlines basic standards for ethical conduct in biomedical and behavioral research involving human participants.
Emphasizes universal principles regardless of time or technology.

Three Core Principles of the Belmont Report

Respect for Persons: People are to be treated as independent individuals, with autonomy.
- Vulnerable Populations: Individuals who might not be fully in control of their decision-making.
- Assent: A child's affirmative agreement to participate in research.
- Informed Consent: Providing research participants with clear information about procedures and risks.
- Voluntary Participation: Individuals freely choose to participate in research.
Beneficence: Research should strive to maximize potential benefits and minimize risks to participants.
Justice: Participation in research should be fair and equitable, not based on researcher convenience or control over specific populations.

Structured Questioning

Dichotomous Response Format: Respondents choose between two options (e.g., yes/no, male/female).
Questions Based on Level of Measurement:
- Nominal Response Format: Numbers used as placeholders for responses, with no inherent numerical meaning (e.g., occupational class).
- Ordinal Response Format: Respondents rank answers in order of preference.
- Interval Level Response Format: Numbers represent equal intervals, with meaningful differences between values (e.g., 1-5 scale).
- Likert-type Response Scale: Respondents use numbers spaced at equal intervals to indicate agreement or disagreement (e.g., 1 = strongly agree, 5 = strongly disagree).
Filter or Contingency Questions: Determine participant qualification or experience to answer subsequent questions.

Question Content

Necessity and Usefulness: Ensure each question is relevant and contributes to the research objectives.
Multiple Questions: Avoid double-barreled questions that ask about two separate issues with a single answer.
Respondent Information: Verify that respondents have the needed information to answer accurately.
Specificity and Generality: Ensure questions are specific enough for clarity, while maintaining appropriate generality.
Bias and Loaded Wording: Avoid questions that are slanted or leading.
Truthfulness of Response: Consider factors that might influence the respondent's honesty.

Response Format

Structured Response Format: Predefined options for respondents to choose from.
- Fill-in-the-Blank: Respondents provide textual answers.
- Check the Answer: Respondents mark options with an "X," allowing for multiple selections.
  - Multi-option or Multiple-Response Variable: Respondents can select multiple choices from a list.
  - Single-Option Variable: Respondents select only one option.
- Circle-the-Answer: Respondents circle the chosen response.
Unstructured Response Format: Open-ended questions allow flexible response options and individual interpretation.

Question Wording

Clarity and Avoid Misunderstandings: Write questions in a way that eliminates ambiguity.
Assumptions: Ensure questions don't make unstated assumptions.
Time Frame: Clearly specify the time frame for the question.
Personal Wording: Use language that is appropriate for the topic and the respondent.
Directness of Wording: Consider the impact of overly direct phrasing.

Question Placement

Influence of Previous Questions: Be mindful of how earlier questions might affect subsequent responses.
Timing of Questions: Place questions strategically to maximize interest and engagement.
Attention and Impact: Ensure questions receive sufficient attention, considering surrounding questions.

Opening Questions

Crucial for setting the survey tone.
Begin with easy and non-threatening questions to establish comfort.

Sensitive Questions

Difficult or uncomfortable topics require careful handling.
Build trust before introducing these questions.
Use easier questions as a warm-up, and explain the research purpose in advance.

Question Placement Guidelines

Start with easy, non-threatening questions.
Place more difficult or sensitive questions toward the end.
Avoid starting mail surveys with open-ended questions.
In historical demographic sections, follow chronological order.
Focus on one topic at a time.
Use transitions when shifting topics.
Reduce response set for clarity.
Create flowcharts for filter or contingency questions.

The Golden Rule of Survey Design

Express gratitude to the respondent at the beginning.
Keep the survey concise.
Be sensitive to the respondent's needs and feelings.
Be alert to signs of discomfort.
Thank the respondent at the end.
Offer to share the final results with participants.

Interviews

Challenging but rewarding forms of measurement.
Require personal sensitivity, adaptability, and adherence to protocols.

Role of the Interviewer

Locate and engage respondents.
Motivate respondents to participate fully.
Clarify any confusion or concerns.
Observe the quality of responses.
Conduct a well-structured interview.

Benefits of Factorial Designs

Flexibility in exploring or enhancing research signals.
Efficiency by combining multiple studies into one.
The only effective way to examine interaction effects.

Limitations of Factorial Designs

More planning and setup required.
Need larger sample sizes.
Can be problematic with a large number of groups.

Incomplete Factorial Design

Not all combinations of factor levels are included in the design.
Some combinations may not be relevant to research objectives.
Enables selective pairing of factor levels.
Example: Using a control or placebo group that receives no treatment.

Noise-Reducing Designs: Randomized Block Designs

Groups are divided into homogeneous subgroups or blocks, within which the experiment is replicated.
Reduces noise and variance in data.
Similar to stratified random sampling.

Noise-Reducing Designs: Covariance Designs

Analysis of Covariance Design (ANCOVA): Estimates the differences between groups on a post-test, adjusted for pre-test differences.
Covariate: A variable correlated with the dependent variable.
Covariates are adjusted for in analysis to obtain a more precise estimate of the relationship between independent and dependent variables.

Hybrid Designs: Switching-Replications Experimental Designs

Two-group design with two phases and three waves of measurement.
Treatment implementation is repeated in both phases.
Groups switch roles: original control becomes treatment, and original treatment becomes control.
All participants receive treatment by the end.

Statistical Programs

Codebook: Defines each variable in the data, including its name, description, format, source, collection date, respondent/group, location, and notes.
Data Entry:
- Double Entry: A method for checking data entry accuracy by entering data twice and resolving discrepancies.
Data Transformations: Transforming data into more usable variables.
- Missing Values: Address missing data entries.
- Item Reversals: Reverse ratings to align with other items.
- Scale and Subscale Totals: Calculate totals for multiple items.
- Categories: Combine data points into meaningful categories.
- Variable Transformations: Express variables in logarithms or square-root form.

Descriptive Statistics

Statistics used to describe basic features of data in a study.
Provide concise summaries of large datasets.
Risks distorting data or losing important detail when using only one indicator.

Characteristics of a Variable

Distribution: How a variable takes on different values in the data.
- Frequency Distribution: Summarizes the frequency of values or ranges of values.
- Percentages: Represent data portion relative to the whole.
Central Tendency: Estimates the center of the distribution of values.
- Mean: The arithmetic average of values.
Dispersion/Variability: Indicates spread or variability of values.
- Range: The difference between the highest and lowest values.
- Variance: A measure of how far values are spread from the mean.
- Standard Deviation: The square root of variance, providing a more interpretable measure of dispersion.

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Description

This quiz explores key milestones in the ethical guidelines for medical research, such as the Declaration of Helsinki and the Belmont Report. It examines historical studies like the Tuskegee Syphilis Study and the evolution of research ethics in the United States. Test your knowledge of these crucial developments in research ethics.