Ethical Considerations in

Research
 Learning Outcomes –
By the end of the lesson the students will be able to:

Recognise the importance of ethics in

Recognise
research.

Identify the ethical issues to be

Identify
considered in the research.

Understand the ethical responsibilities

Understand
of the researcher.
 Universal Declaration of Human
Rights – December 1948
https://www.un.org/en/about-us/universal-declaration-of-human-rights

‘All human beings are born free and

equal in dignity and rights’
United Nations:
https://www.un.org/en/about-us/universal-declaration-of-human-rights
 • Nuremberg Code (1940) – written principles for human
experimentation: voluntary consent essential.

• World Medical Association (WMA) Declaration Of Helsinki 1964

Background: (Last Updated 2013) – Ethical Principles For Medical Research
Involving Human Subjects.
• https://www.wma.net/policies-post/wma-declaration-of-helsinki-
ethical-principles-for-medical-research-involving-human-subjec
ts/

It is the duty of those involved in medical research to protect

the life, health, dignity, integrity, right to self-determination,
privacy, and confidentiality of personal information of research
 • Ethic: A moral principle or set of moral
What are values held by an individual or group.
Ethics?
• Ethical: In accordance with principles of
conduct that are considered correct,
especially those of a given profession or
group.

• Ethical situation: Individual or group

decisions and actions whether something
should or should not be done.
Biomedical
Ethical Principles
• Respect for Autonomy
• Beneficence
• Non-maleficence
• Justice

(Beauchamp & Childress, 1994)

Research Ethics

Researchers need to
demonstrate that their work is
conducted to high ethical
standards and is explained
clearly.
The stipulation that researchers
seek consent after providing
appropriate information is
central to the principles of
research ethics
 The public supports
research and wishes it
Research and to continue, but this is
Ethics not an unquestioning
acceptance.

Researchers need to
demonstrate that their
work is conducted to
high ethical standards
and is explained clearly.

The stipulation that

researchers seek
consent after providing
appropriate information
is central to research
ethics.
 Public involvement in research:

Why people want to be involved:

https://www.youtube.com/watch?v=_wDcyt0keJE
Ethical principles to apply to research

Beneficence- should benefit individual and society i.e. contributing

to knowledge

Non-maleficence- cause no harm

Fidelity-building of trust between participant and researcher

Justice-being fair

Veracity-tell the truth (even if this might mean non-participation or

withdrawal from study)

Confidentiality- of information gained, participant not identifiable

Rights of subjects
participating in
research

• Right not to be harmed

• Right to full disclosure
• Right of self-determination
(right to participate or
withdraw)
• Right of privacy, anonymity
and confidentiality
 •
Ethical Benefits to individuals
• Benefits to society
Motives for • Effectiveness of care
Research • Evidence based practice
 Non Ethical
Motives

• Direct financial gain (e.g. some

activities of pharmaceutical
companies)

• Indirect financial gain (e.g.

purely for career development)

• Personal interest or
satisfaction that is not in the
interests of others
What might
participants
consider before If you were invited to be part of a research
volunteering to study, as a participant, what would you want
participate in a to consider before agreeing?
research
project?
So… how do you
think
researchers can
ensure these
principles are
embedded?
 • Integral to whole research process
• Choice of topic
• Selection of methodology
Ethical •
•
Selection of participants
Data collection methods
implications • Data analysis methods
for research •
•
Publication of findings
Permission for study from REC?

Ethical considerations are essential throughout a

research project from the outset, through to
dissemination of findings and publication.
 Participants must be capable of
giving informed consent - if not,
consent must be gained via proxy
• e.g. Mental Capacity Act (2005) considerations,
children and young people, vulnerable adults,
people with learning disability

Consent Consent should be freely given-

participants must not be put under
pressure to give consent
• Inducements or other pressures

Consent may need to be acquired on

more than one occasion i.e. in a
longitudinal study
 • Data collection
• Data storage
• Writing up stage
Confidentiality
• Following completion of study
• To assure confidentiality- individuals and
organisations information is anonymised
Let’s discuss

Can you think of any

differences for ethical
considerations between
quantitative and
qualitative research
studies?
 Qualitative Quantitative

• Do not always know how an • Informed consent can be given

interview will progess so before start as data collection
researcher cannot predict what tools unlikely to change
questions participants may • Some deception with clinical
ask in advance trials when ‘blinded’
• Informed consent is a process • Surveys may bring back
not one off traumatic events
• Potential • Less likely to be identifiable
risks-anxiety/distress, • Nurse researchers may need
exploitation, to intervene if participants’
misrepresentation, identifiable condition worsens in a clinical
in published study trial
 Research ethics
committee (REC)

• Exist to examine the ethical

implications of a study

• Required to be independent when for

mulating advice
on the ethics of the proposed researc
h.

• Give approval for study to be

undertaken

• Made up of a range of people-

registered professionals, clinical
trials statisticians, lay people, other
experts in research (NHS/University)
USEFUL LINKS for Research (Ethics) Information:
(think about your assignments!)

NHS Research Authority

https://www.hra.nhs.uk/about-us/committees-and-services/res-
and-recs/

UK Research and Innovation:

https://www.ukri.org/councils/esrc/guidance-for-applicants/res
earch-ethics-guidance/

Integrated Research Application System (IRAS)

https://www.myresearchproject.org.uk/
 Studies needing IRAS approval

• NHS research uses the Integrated Research

Application System (IRAS)
• Studies involving patients
• Studies involving relatives or carers of patients
• Studies involving staff
• Studies involving access to data, bodily
materials of past or present patients
• Studies involving foetal material
• Recently dead
• Studies which will involve the use of or access
to NHS premises and equipment
Questionable Practices in Research

• Involving people without their knowledge or consent

• Coercing them to participate
• Withholding information about the true nature of the
research
• Otherwise deceiving the participant
• Inducing participants to commit acts diminishing
their self esteem
• Violating rights of self-determination
• Exposing participants to physical or mental stress
• Invading privacy
• Withholding benefits from some participants
• Not treating participants fairly, or with consideration,
or with respect
 Unethical studies:

https://www.youtube.com/watch?v=zZ3l1jgmYrY
 More about Milgram….

https://youtu.be/Xxq4QtK3j0Y?feature=shared
 Studies needing
ethical approval

• Studies involving patients/service users

• Studies involving relatives or carers
• Studies involving staff
• Studies involving access to data, bodily materials of past or present
patients
• Studies involving foetal material
• Recently dead
• Studies which will involve the use of or access to NHS premises and
equipment
Application for • National REC application form
ethical • Study protocol
approval • Details of indemnity arrangements
• Details of funding
• CV of investigator
• Participant information sheet
• Consent form
• Any other relevant documents e.g. questionnaire
What is the REC looking for?

• A full application :
• Can the protocol achieve the results
expected?
• Do the benefits outweigh the risks?
• Will confidentiality be maintained?
• What special arrangements are in place for
vulnerable groups?
• What on-going review procedures are in
place?
• Will the sample be enough to give
meaningful results?
• Are proposed drug doses appropriate?
What is the REC looking for?

Participant Information sheet: Does it?...

• make clear what is routine and what is experimental?

• make clear what the subject will need to do?
• make the time commitment clear?
• detail potential risks and benefits?
• make clear what will happen at the end of the study
period?
• explain why the participant has been approached?
• detail expenses / compensation payable?
• make it clear the subject can withdraw at any time
with no detrimental effect on future care?
• detail what happens if harm is caused?
• have a contact number for questions?
Participant Information Sheets

Length should be dictated by the complexity and risk of the

research.

Part one: clear information on the study, the voluntary nature

of involvement, withholding of treatment, the potential risks,
benefits, restrictions.

Part two: additional information including confidentiality,

data protection, indemnity, and publication.

It should be read and understood prior to participation.

What • Favourable
decisions can • Provisional Favourable
the REC • Unfavourable
make? • No decision
 • Became law in May 2004
• Enhances ethical and scientific
quality.
• Promotes good practice.
• Reduces adverse incidents and
ensures lessons are learned.
• Prevents poor performance and
misconduct.
Research • Ensures the dignity, rights, safety and
Governance wellbeing of participants is the
Framework primary consideration through ethical
approval.
• Ethics protect researchers/evaluators
from harm (e.g. allegations of
malpractice)
LINK: • Ethics protect the integrity of services
https://s3.eu-west-2.amazonaws.com/www.hra.nhs.uk/
media/documents/Final_Accessibility_uk-policy-framew
ork-health-social-care-research_.pdf
 What the Research Governance Framework
means for participants

=
National standards
Research
Governance
Clear national
standards for
health and social
Framework care research

Effective Continuing
Participants Management Training and
Learning Dependable
& Research of Research to Education in
networks local delivery
Partners National Research of research
Standards Management

Monitoring of
Research Standards- Monitored
based Assessment
=
research
Statutory Inspection standards
Adverse Event
Reporting
 Watch this
TED talk and
jot down your
thoughts https://www.ted.com/talks/boghuma_kabisen_tit
anji_ethical_riddles_in_hiv_research/transcript
about the
ethical
implications in
this study
In summary:
• Respect for participants
Key Elements of dignity, rights, safety and
Ethical Research well being
• Value of the diversity of
society
• Personal and scientific
integrity of researcher/s
• Leadership
• Honesty
• Accountability
• Openness and transparency
 Acknowledgements to
Rhiannon Griffiths-Williams,
Chris O’Grady, Karen
Griffiths and Helen Coleman
for contributions to the
presentation.