Instruction:41bc2a1d-26f7-49f9-8bf7-9fc6b4ecf10c

Instructions

03 - Four Quadrant Approach: A Method for Analysing Cases in Research Ethics and Research Integrity

Instructions for:TraineeTrainer

Goal

Members of The Embassy of Good Science have developed a set of six user-friendly, accessible methods for analysing research ethics and research integrity cases.

These methods have been identified, adapted and presented so that they can be appropriated by all users, without prior philosophical knowledge, in local contexts.

Requirements

The key aim for the case analysis method described here is that it can be appropriated by all users, without prior philosophical knowledge, in local contexts.

In order to apply this method in the analysis of specific cases, it is advised that RECs, RIOs and IRBs engage with the regulatory frameworks and normative standards that apply to their respective organizations in the form of codes of ethics, codes of conduct, funding body standards and, if applicable, broader national and international research ethics and research integrity regulatory documents.

Duration (hours)

2

For whom is this important?

ResearchersEthics committee membersResearch Integrity OfficersResearch integrity trainers

Steps

1STAGE 1: Initial Perception

2STAGE 2: The Four Quadrant Analysis

3STAGE 3: Casuistic Reasoning and Justification

What is this about?

In a collaborative effort, three clinical ethicists, a philosopher, Jonsen, a physician, Siegler, and a lawyer, Winslade, developed the ‘four quadrant approach’ (‘4QA’) for dealing with difficult cases in clinical settings.^[1] The process can be viewed as an “ethics workup,” similar to the “History and Physical” skills that all medical students come to use when learning how to “workup” a patient’s primary complaints.

The full procedure of the 4QA involves three stages and a list of distinctive steps:

1. The first stage identifies and describes our initial perception of the case;
2. The second involves the four quadrants (medical indications, patient preferences, quality of life, contextual features) and the identification of information relevant to a given quadrant;
3. The third involves the application of case-based reasoning to identify and justify the best course of action.

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^[1] Jonsen A, Siegler M, Winslade W. Clinical ethics: a practical approach to ethical decisions in clinical medicine. Mc-Graw Hill, 6th edition, 2010. ^[2] http://depts.washington.edu/bioethx/tools/cesumm.html

Why is this important?

While this method has deep philosophical roots, what clinicians like about it is the ease with which it fits with how we normally think about tough medical cases.^[1]

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^[1] http://depts.washington.edu/bioethx/tools/cesumm.html

Practical Tips

The original version of the 4QA was developed to deal with clinical decisions involving patients and dilemmas or conflicts within the doctor-patient relationship.^[1] Therefore, there is little room for developing, altering or adapting the method even in clinical settings.^[2] Moreover, the four quadrants are said to be responsive to the four principles of biomedical ethics, specifically, autonomy, beneficence, non-maleficence and justice. This is a normative framework originally developed for biomedicine.

Here, we have adapted the “original version” to test its applicability in different research ethics and research integrity scenarios.

The basic structure and the general decision-making procedure embedded in the 4QA approach seem to be adaptable to any cases where various options for decision-making need to be assessed and clarified.

In adapting the 4QA, the aim is to enable a focused discussion around normative standards pertinent to research ethics and research integrity, leading to the application of case-based reasoning to the facts of the particular case at hand.

Consequently, the four quadrants of the procedure have been revised so that they not only are responsive to the regulatory frameworks and normative standards that apply to a user’s respective organization in the form of codes of ethics, codes of conduct, and, if applicable, broader national and international research ethics and research integrity codes, but can be applied to non-clinical settings to deal with cases in research ethics and research integrity.

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^[1] Sokol DK. The “four quadrants” approach to clinical ethics case analysis; an application and review. J Med Ethics. 2008;34(7):513-516. ^[2] Schumann JH, Alfandre D. Clinical ethical decision making: the four topics approach. Semin Med Pract 2008;11:36–42.

1

STAGE 1: Initial Perception

The user should attend to some general questions in order to identify relevant aspects and major characteristics of the situation:

• What are the morally relevant facts?
• What are the ethical or moral issues at stake in this case?
• Who are the stakeholders?
• What particular normative standards in pertinent regulatory documents apply to the case?
• What possible courses of action are available?
• What are the predictable effects of each action?
• Which set of possible outcomes seem to be better?

2

STAGE 2: The Four Quadrant Analysis

#Relevant Facts: What are the most relevant facts concerning the situation?

1. Uncertainties: Which features of the situation are uncertain, lacking in clarity, or controversial?
2. Courses of Action: What are the practically available options for providing a solution to the case?
3. Contextual Features: What legal, financial and institutional policies and regulations apply to the case?

3

STAGE 3: Casuistic Reasoning and Justification

Once the details of a case have been outlined according to the four quadrants, there are a series of questions that should be considered:

• What is at issue? Try to list what is the major ethical issue at the case, e.g researchers’ dishonesty, negligent conduct, informed consent, rules of data collection etc.)
• Where is the conflict? Is there a conflict between principles of research or principles of research integrity? (e.g. autonomy, justice, beneficence or between honesty, reliability and respect for colleagues)
• What is this a case of? Does it sound like other cases you may have encountered? (e.g. Is it a case of "self-plagiarism", “fabrication of data in a grant application” or “low risk research involving humans without a valid informed consent”?)
• What do we know about other cases like this one? Is there clear precedent? If so, we call this a paradigm case. A paradigm case is one in which the facts of the case are very clear cut and there has been much professional and/or public agreement about resolution of the case.
• How is the present case similar to the paradigm case? How is it different? Is it similar (or different) in significant ways?

Steps

Other information

Virtues & Values

• Accountability
• Honesty
• Transparency
• Fairness
• Respect