Research ethics

Jan DeckersSchool of Medical Sciences Education

DevelopmentEmail: jan.deckers@ncl.ac.uk

Objectives

• To think about the ethical issues associated with research ethics committee applications

• To reflect on frequently identified problems• To develop good practice in making

applications to research ethics committees

What is ethics?

Why do we need ethics?

• Many (or all?) people feel the need to justify their behaviour – to explain why their behaviour is (un)acceptable = subjective aspect

• Many (or all?) things deserve moral consideration = objective aspect

Why is ethics important?

• Realisation that “not everything goes”• The need for justification

Two dimensions

• Law and professional guidelines• Reflection

How does it work?

• Establishing knowledge of the relevant legal and professional guidelines

• Exercise your ability to reflect........How?

The tools of the trade

• Principle of non-contradiction• Analogies

Principle of non-contradiction/consistency

• Example:A researcher who carries out research on patients with advanced dementia says the following:“I believe that researchers who want to carry out research on patients should only proceed if patients give their voluntary, informed consent to taking part in the research.”

Analogies

• Example:- When a research project is likely to kill human

subjects, research should not proceed- When a research project is likely to kill non-

human subjects, research should not proceed

Is this a valid analogy?

Some ethical theories

• Consequentialism• Deontology• Principlism

Consequentialism

• Focus on consequencesExample:

Utilitarianism: consequences are measured in terms of whether or not they produce happiness

Deontology

• Focus on rules and motives

PrinciplismThe ‘four principles’ approach:

1. Autonomy2. Beneficence3. Non-maleficence4. Justice

1&4 are deontological; 2&3 are consequentialist

= a very popular approach in bioethics

Practical tips on making research ethics applications

Accuracy and clarity of the information

• Have spelling and grammatical problems been avoided? Particularly in the consent and/or participant information sheets

• Is the information consistent across the whole application? E.g. the consent sheet and application text

• Will potential participants understand the aims and methods of the study?

• Is unnecessary jargon and technical detail used? Or, have they been explained?

Confidentiality and data sharing

Is there an appropriate balance between:• Confidentiality and data protection (right to

privacy)• Data sharing

The right to withdraw

• Have participants been informed of their right to withdraw?

• Should they be allowed to withdraw? Concerns about sample size!

Deception

• Is deception ever acceptable?• If so, participants could be told:

“The experiments you will be participating in will also be used to examine something that we will not tell you about yet as this may affect the outcomes. We will tell you about this aspect of our study later on.”

(or something similar)

Incentives

• Is it acceptable to provide financial or other incentives to potential research participants?

• If so, might this impair the ability of the participants to give voluntary consent?

The “How would you feel....” test(Or “don’t do unto others what you would not want others to do unto you”)

Example:Offering a financial incentive to encourage participation, and then not giving it at the end of the activity

Healthy scepticism

• Absence of evidence of reasons to think the research might cause distress/risk should not be construed as evidence of absence that it might cause distress/risk

• It is not because the Government recommends something that it should be recommended.

• …

Research duplication

• Why is this an issue?

Information about funding source

• Disclose the funding source of the study to (potential) participants