Ethics in Healthcare Research: Importance, Concerns, and Implications

This presentation discusses the importance of ethics in healthcare research, ethical and legal concerns of conducting research in Saudi Arabia, best practices for informed consent, and the implications of non-compliance with research ethics.

ETHICS IN
HEALTHCARE
RESEARCH
Submitted by:

DEFINING ETHICS:
Research ethics can be defined as the
consideration of the set of norms,
institutional regulations as well as
values that direct a scientific experiment
or a research activity.
(Source: Pinterest, 2019)

INTRODUCTION:
 The word ‘ETHICS’ is derived from
the Greek Word ‘Ethos’ which refers
to custom or the spirit of community
 Research ethics refer to the moral
values that guide a research activity
 Ethical concerns include:
 Professional issues
 Relationship between science and
society
 Consideration of research
participants
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ETHICAL CONCERNS OF CONDUCTING
A RESEARCH IN SAUDI ARABIA:
 Protection of participant
confidentiality
 Ensuring informed consent
 Obtaining approval from concerned
ethical committees
 Non violation of human rights
 Non violation of research guidelines
and Islamic principles which is the
official religion of the Kingdom of
Saudi Arabia

LEGAL CONCERNS OF
CONDUCTING RESEARCH IN
SAUDI ARABIA:
 Research must be aligned to the regulations of the
Law of Ethics of Research on Living Creatures,
Royal Decree no. M/59, Dated 14/9/1431H-
24/8/2010
 Research complies with informed consent
requirements propounded by the National
Commission of Bioethics (NCBE)
 Compliant with National Commission of Bioethics
(NCBE)
 Compliant with Guidelines for Investigational New
Drugs, Version 1.1, Saudi Food and Drug Authority
 Compliant with Medical Device Interim Regulations,
Decree number 1-8-1429, Saudi Food and Drug
Authority.

ETHICS AND PROTECTION OF
HUMAN SUBJECTS:
 The IRB or the EC under the
standard II-2 can exercise the
regulation to conduct evaluation
of the research protocol in order
to ensure privacy and protection
of human subjects
 The standard has policies in place
to evaluate unanticipated
outcomes and issue legal action
ranging from imposing penalty in
the form of fine to cancellation of
research affiliation.

BEST PRACTICES FOR
INFORMED CONSENT:
 Consent form should be sent in advance
 Integrate teach back moments to assess the level of
comprehension while moving forward with the research
 Instil a non-judgmental and safe clinical environment
 Observe the subjects
 Integrate a ‘post-test’

UNDERSTANDING THE
SIGNIFICANCE OF CONSENT:
 Ensures autonomy
 Maintenance of beneficence/non maleficence
 Protects participant’s interests

EXAMPLE OF INFORMED
CONSENT:
 The following components must be included in the
consent form:
 Name and purpose of study
 Timeframe of study and subject involvement
 Statement of protocol mentioning informed consent
was evaluated with the participant and risk was
identified
 Discussion on alternative treatment measures
 Maintenance of confidentiality record
 Elaborate description of the decision of participants
 Contact and remuneration details
 Attested copy of ICF
 Use of simple and lucid language
(Source: As created by Author)

ETHICAL AND LEGAL IMPLICATION OF
NON-COMPLIANCE WITH RESEARCH
ETHICS:
Non compliance with research ethics
can lead to:
 Cancellation of research funding
 Cancellation of research approval
 Filing of legal suite
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CONCLUSION:
 Research ethics help to sustain values of trust, accountability
and mutual respect
 Protect patient confidentiality
 Act in the best interest of the human subjects
 Ensures credibility of the research

REFERENCES:
Aahrpp.org (2019). [online] Aahrpp.org. Available at: http://www.aahrpp.org/TipSheetDownload.ashx?
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2019].
Alahmad, G. (2017). The Saudi Law of Ethics of Research on Living Creatures and its implementing
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Haggerty, K. (2016). Ethics creep: Governing social science research in the name of ethics. In Engaging
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Hedgecoe, A. (2016). Reputational risk, academic freedom and research ethics review. Sociology, 50(3),
486-501.
Kara, H., & Pickering, L. (2017). New directions in qualitative research ethics.P.90
McConville, M. (Ed.). (2017). Research methods for law. Edinburgh University Press.P 67.68
Pinterest (2019). Introduction to Research Ethics | Ethics | Research writing, Research proposal,
Research methods. [online] Pinterest. Available at:
https://www.pinterest.com/pin/304415256038764113/ [Accessed 13 Sep. 2019].
Ryen, A. (2016). Research ethics and qualitative research. Qualitative research, 31-46.
Walliman, N. (2017). Research methods: The basics. Routledge.P.57

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