REalistiC Decisions: A Method for Analysing Cases in Research Ethics and Research Integrity

From The Embassy of Good Science

REalistiC Decisions: 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

What is this about?

REalistiC Decisions is a case analysis method  proposed by Hugh Davies MB BS, Research Ethics Advisor for the Health Research Authority (‘HRA’) and former Consultant Paediatrician at Oxford University Hospitals.

Although intended to be a procedure for reviewing research ethics proposals, it is flexible enough to be used to analyse research integrity cases.[1]

  1. Davies H. REalistiC Decisions: making judgements in review (and design). [Online]. http://www.reviewingresearch.com/realistic-decisions-making-judgements-in-committee/. Accessed 10 March 2019.

Why is this important?

The method is founded on the idea that each member of a research ethics committee (‘REC’), research integrity office (‘RIO’) or institutional review board (‘IRB’) will deliberate based on their initial views and beliefs about a particular case.

The purpose is to move from individual opinions to the underlying reasons for those opinions in order turn ‘I think’ claims regarding a particular case into ‘We agree’ judgments.

REalistiC Decisions Case Analysis Diagram.png

This procedure is only part of the process of coming to decisions about individual cases. Although the procedure helps members of RECs, RIOs and IRBs to shape and share their deliberations, it cannot make the decision for them.[1][2][3]

  1. Davies H. How we can make better decisions in review and design of research using a simple ethics model. Journal of Medical Ethics: Blog. [Online]. https://blogs.bmj.com/medical-ethics/2018/10/11/how-we-can-make-better-decisions-in-review-and-design-of-research-using-a-simple-ethics-model/. Published 18 October 2019. Accessed 10 March 2019.
  2. Davies H. REalistiC Decisions: making judgements in review (and design). [Online]. http://www.reviewingresearch.com/realistic-decisions-making-judgements-in-committee/. Accessed 10 March 2019.
  3. Davies H. Moral engineering - how we can improve research review with a simple ethics decision making model. [Online]. http://www.reviewingresearch.com/wp-content/uploads/2018/08/A-model-to-help-resolve-differences180828forRR.pdf. Accessed 10 March 2019.

Practical Tips

By following the instructions, a user will be able to:


  • Analyse specific research ethics and research integrity cases;
  • Understand and explain the process by which they came to their judgment regarding a particular case;
  • Identity and explain their reasons for their judgment.

In addition, by following the instructions, a research ethics committee ('REC'), research integrity office ('RIO') or institutional review board ('IRB') will be able to:


  • Facilitate the analysis of research ethics and research integrity cases in accordance with an explicit procedure;
  • Involve its members in structured deliberation and debate regarding a particular case in accordance with an explicit procedure;
  • Generate a consensus regarding a specific case.
1
Identify and Clarify the Issue

Produce a synopsis of the case


  • Only include the facts of the case
  • If the issue is ambiguous, then attempt to clarify what issue or set of issues are at stake

2
Early View (‘What do I think?’)

Once an issue has been identified and clarified, the next step is to ask:


  • "What do I think?"

When formulating an Early View, I need to:


  • Know when I can and can’t rely on this Early View;
  • Ensure my view does not prejudice against diverging opinions.

3
What are My Reasons for Thinking This?

Once I have formed my Early View, the next step is to ask:


  • "What are my reasons for thinking this?"

When formulating these reasons, I need to:


  • Assess the strengths and weaknesses of the reasons for my view.

4
Communicate My Early View

Communicate my Early View and associated reasons to the rest of the committee

5
Listen to and Recognise the Early Views and Associated Reasons of All Other Members of the Committee

Is there disagreement between members of the committee?


  • On which issues and views do we disagree?
  • What reasons are given that either support or undermine my Early View?

6
Review My Early View

Review my Early View and associated reasons by addressing each of the following themes and  questions:

Normative Standards

"How do normative frameworks help us?"

In order to answer this question, we need:


  • A basic knowledge of the appropriate regulations that apply to the issue;
  • To be able to use these regulations to analyse our Early View;
  • To revise our Early View and to provide reasons for any revisions.

Experience

"How have we approached this issue before?"

In order to answer this question, we need:


  • To access past decisions;
  • To compare past cases and the current case and determine whether previous decisions are relevant;
  • To use disagreement to develop new standards for guiding future considerations;
  • To be able to explain why, if relevant, we haven’t followed such precedent.

Expertise

"What expertise has been applied to this before?"

To answer this question, we need to:


  • Access independent expert review;
  • Access an up-to-date library of authoritative guidance;
  • Balance guidance documents and judge the relative authority of guidance documents;
  • Provide reasons if our decisions run contrary to guidance.

Empathy

"What views and opinions do other parties have?"

We turn to the views of those with a legitimate interest in the case (for example, the accused, the complainant, individuals involved with the case, and the public).

To answer this question, we need to:


  • Identify all those with an interest in the case and see it ‘through their eyes’;
  • Recognize limitations to our empathy;
  • Confirm or refute any ‘empathy-based decisions’ using answers to the other questions listed above;

Evidence

"What evidence is there on this issue?"

We turn to any published research concerning similar cases. However, we need to be careful when forming prescriptive conclusions based on factual premises. After all, the quality of the evidence may be questionable and there may be significant normative and factual differences between the case in question and situations discussed in published research.

In order to answer this question, we need:


  • To locate, assess, and apply published evidence;
  • To recognize the proper place of facts when making judgments;
  • To encourage published research on research integrity and research ethics.

Expediency

"What is possible or realistic in the circumstances?"

We need to ensure that we have not interpreted the case against sets of unrealistic standards. Expediency is built on a realistic evaluation of research constraints and consequences and imposes proportionate and realistic conditions.

In order to answer this question, we need to:


  • Understand and accommodate realistic standards when assessing the case;
  • Judge when expediency is adequate justification;
  • Balance expediency and fair standards when forming a judgment about a case.

Escape

"How can we manage this problem of our disagreement?"

In order to answer this question, we might be required to:


  • Agree to disagree (if it will not affect the final judgment);
  • Seek elaboration on any of the answers to the questions listed above;
  • Vote on a set of judgments;
  • Consider alternatives.

7
Develop an Informed Judgment

Having addressed all the themes and associated questions in the previous step, I now need to come up with an Informed Judgment.

To come up with my Informed Judgment, I should be aware that:


  • Answering each question in the previous step leads to reasons to justify (or refute) a position;
  • No single answer can provide a firm base for judgment;
  • My Informed Judgment will involve balancing the answers to the different questions.

8
Reach a Consensus with Other Members of the Committee

In order for our committee to reach a consensus regarding a specific case:


  • I must share my Informed Judgment and associated reasons with the rest of the committee;
  • Listen to and recognise the Informed Judgments and associated reasons of all other members of the committee.

The final step is to deliberate and debate with our fellow committee members.


  • If we all agree, then the decision is made and little needs to be done, although, from time to time, we should critique our views;
  • If we fail to obtain a consensus, we can ask for further involvement from interested parties ("Empathy"), outside advice and deliberation ("Expertise") and/or new research ("Evidence").

Steps