Ethical and Legal Framework for Healthcare Research in Saudi Arabia

This report provides a comprehensive overview of ethics in healthcare research, focusing on ethical and legal considerations, especially within the context of Saudi Arabia. It defines research ethics, emphasizing the importance of norms, regulations, and values guiding scientific experiments. The report covers critical ethical concerns such as participant confidentiality, informed consent, and adherence to human rights and Islamic principles. It also outlines legal concerns, including compliance with the Law of Ethics of Research on Living Creatures and guidelines from the National Commission of Bioethics (NCBE) and the Saudi Food and Drug Authority. The report details best practices for informed consent, emphasizing clear communication and creating a safe environment. It also discusses the ethical and legal implications of non-compliance with research ethics, such as the cancellation of funding or legal suits. The conclusion highlights the importance of research ethics in maintaining trust, accountability, and protecting participants' interests. The report includes references to relevant literature on research ethics and legal frameworks.

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
(Source: Pinterest,2019)

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?
fileName=AAHRPP%20Addendum%20-%20Saudi%20Arabia%202016-10-03.pdf [Accessed 12 Sep.
2019].
Alahmad, G. (2017). The Saudi Law of Ethics of Research on Living Creatures and its implementing
regulations. Developing world bioethics, 17(2), 63-69.
Haggerty, K. (2016). Ethics creep: Governing social science research in the name of ethics. In Engaging
with Ethics in International Criminological Research (pp. 29-51). Routledge. P.88
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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