Ethical & Legal Concerns About Medical Research Presentation

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This week we are learning about the various types of studies that can be used in researching a population for risk factors, controls versus experimental treatment, and the Framingham Heart Study is introduced. Please read the following study: Alanzi, T., & Al-Habib, D. K. (2020). The Use of Social Media by Healthcare Quality Personnel in Saudi Arabia. Journal of Environmental & Public Health, 1–9.

https://doi.org/10.1155/2020/1417478 When considering research from the perspective of ethical and legal concerns around research in the Kingdom of Saudi Arabia. What aspects of this research protected the participants? What are the best practices of creating an informed consent? Finally, discuss the informed consent and the components that you have found are necessary to protect the patient. Please use one of your references.

Your well-written presentation should meet the following requirements: -Be 7-8 slides in length, not counting the title, introduction, and reference slides. -Presentation notes (100-150 words) are required for each slide. Notes must draw from and cite relevant reference materials. Add notes to the speaker’s notes section of the PowerPoint -presentation. Submit the document in PowerPoint format so that speaker’s notes can be viewed by the instructor. -Provide support for your statements with in-text citations from a minimum of four scholarly articles in the speaker notes as well as the references slide. Two of these sources may be from the class readings, textbook, or lectures, but two must be external. The Saudi Digital Library is a good place to find these sources and should be your primary resource for conducting research. -Follow APA 7th edition.

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Abstract
Legal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (The Declaration of Helsinki, Belmont Report, Council for International Organisations of Medical Sciences/World Health Organisation International Guidelines for Biomedical Research Involving Human Subjects, World Association of Medical Editors Recommendations on Publication Ethics Policies, International Committee of Medical Journal Editors, CoSE White Paper, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use-Good Clinical Practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Researchers should note the major international guidelines and regional differences in legislation. Hence, specific ethical advice should be sought at local Ethics Review Committees.

Key words: Confidentiality, ethics, informed consent, legal issues, plagiarism, professional misconduct
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INTRODUCTION
The ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. The Declaration of Helsinki established ethical principles applied to clinical research involving human participants. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. Therefore, it is important to be familiar with Good Clinical Practice (GCP), an international quality standard that is provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),[1] or the local version, GCP of the Central Drugs Standard Control Organization (India’s equivalent of US Food and Drug Administration)[2] and local regulatory policy to ensure that the research is conducted both ethically and legally. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Some of the core principles of GCP in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.