Ethical considerations for clinical research

Introduction

Clinical research involves medical research conducted on people either in clinical trials or as observational studies. Clinical trials aim to evaluate medical related interventions to determine whether a new drug, treatment or device is safe and effective for its intended use. Observational studies on the other hand are research conducted in normal settings or during routine standard procedures to gather information, data and characteristics over a period in a selected group of individuals (National Institute on Aging, 2017).  There are different types of clinical research ranging from treatment, prevention, diagnostic, screening, quality of life, genetic studies and epidemiological studies depending on the aims of researchers. Clinical trials are carried out in four phases with a specific purpose to help answer different scientific questions (U.S Food and Drug Administration, 2018). The standards for conduct of scientific research are governed by research ethics which highlight principles to be adhered to in order to protect the dignity, rights and welfare of participants. Therefore, research involving human beings are required to be reviewed by an ethics committee to ensure that the appropriate standards are in place (World Health Organization, 2021). The current principles of ethics have been identified to surround main themes including informed consent, voluntary participation and no coercion, participant right to withdraw, specific permission required for recording, transparency and disclosure of funding, confidentiality of personal information, data protection and appropriate use of research methodology (Vanclay, Baines and Taylor, 2013). The aim of this report is to give an overview on the principles of ethical research and its implications.

Principles of ethics in research

Ethics applies to all aspects of organisational and personal and practice, the application of ethics often takes the form of an agreement, document or written code which stipulates the expectations and behaviours from a moral perspective. The goals of ethics and educating professionals have been considered around five core areas according to an article published in the context of impact assessments. The five areas captured focused on stimulating learning on associated moral issues, recognition of ethical issues, developing skills for analysis and gaining an understanding of obligations or responsibilities (Vanclay, Baines and Taylor, 2013).  Research studies before commencing should be approved by an Institutional Review Board or Ethics Committee and is a requirement for majority of funding agencies. There are several questions that guide the reviewing of research proposals prior to approval and include risks to human subjects in comparison to the benefits, study design, selection of participants, informed consent process, special considerations for vulnerable populations, protection of privacy, confidentiality of data, publication of results and transparency (Charlesworth Author Services, 2021). The ethics of scientific research varies by countries and disciplines traced to foundational frameworks and documents such as Nuremberg Code (1947), the Universal Declaration of Human Rights (1948), the Declaration of Helsinki (1968), the European Charter of Fundamental Rights (2000), and others. Ethics has been found to change and evolve due to significant events and advancements. The common themes which are universal across all scientific research (Weinbaum et al., 2019) are summarised as follows:

• Informed consent: Voluntary agreement from research participants without coercion based on financial gain and understanding of the research risks. For participants unable to give consent or vulnerable groups specific actions are required to protect them.
• Beneficence: The obligation of the researcher to act on the benefit of participants or patients supporting moral rules that protect and prevent harm.
• Non-maleficence: This is closely related to beneficence and assumes that no harm should come to the patient or research participant. However, it is difficult to estimate or monitor the exposure of harm to research participants. It may be physical, emotional, social or economic and the participant may be harmed without the researcher being aware (Gelling, 1999).
• Confidentiality: Protecting personal information and sensitive data to maintain confidentiality. The records include all details relating to participation in research.
• Integrity: This emphasises the need to demonstrate honesty and truthfulness, not falsify results, not fabricate data or exclude relevant data. It is expected that findings are reported fully, minimize or eliminate bias in methods, and disclose underlying assumptions to avoid misleading the public.
• Competency: Ensuring that researchers are qualified to perform their duties and participate in training and professional development programs to improve their skill sets. It includes choice of research methods, statistical methods, and sample sizes that are appropriate and would not cause misleading results.
• Conflict of interest: To minimize financial and other influences on their research and on research participants that could introduce bias in research results. This is more frequently directed at the researcher, but it may also involve the participants if they are provided with a financial or nonfinancial incentive to participate.
• Autonomy: Refers to an individual’s right of independence and freedom to make their own choices. The concept is most concerned with the ethical obligation of the researcher to respect their participant / patient right to make decisions about their own health (Open Learn Create, 2017).

Conclusion

Ethics is underpinned by the need to utilise moral standards in practice which is applicable to scientific research and other disciplines. Scientific research is governed by personal and organisational value which require ethical standards around work practices, the protection of welfare of subjects and the publication of the credible information and data from research. Researchers and professionals must develop an awareness of ethical issues and an effective framework to maintain them according to guidelines. Ethical principles in research are of high importance and underpin decision making in the research process. Ethical codes of practice have evolved over the years due to advancement in healthcare and the way research is conducted. Many guidelines have been produced globally to maintain the expected standards. With ethical requirements for clinical research in place it aims to minimize the possibility of misuse by ensuring that research participants are not merely participating but are treated with respect while they contribute to the good causes for research, and their rights and welfare are protected throughout the process of conducting research.

References

Charlesworth Author Services (2021). Key Principles of Ethical Research – Charlesworth Author Service. [online] www.cwauthors.com. Available at: https://www.cwauthors.com/article/Key-Principles-of-Ethical-Research [Accessed 12 Oct. 2021].

Gelling, L. (1999). Ethical principles in healthcare research. Nursing Standard, 13(36), pp.39–42.National Institute on Aging (2017). What Are Clinical Trials and Studies? [online]

National Institute on Aging. Available at: https://www.nia.nih.gov/health/what-are-clinical-trials-and-studies [Accessed 11 Oct. 2021].

Open Learn Create (2017). OLCreate: HEAT_HMER_ET_1.0 Health Management, Ethics and Research Module: 7.  Principles of Healthcare Ethics: 7.2.2  Autonomy. [online] www.open.edu. Available at: https://www.open.edu/openlearncreate/mod/oucontent/view.php?id=225§ion=1.4.2 [Accessed 12 Oct. 2021].

U.S Food and Drug Administration (2018). What Are the Different Types of Clinical Research? [online] FDA. Available at: https://www.fda.gov/patients/clinical-trials-what-patients-need-know/what-are-different-types-clinical-research [Accessed 12 Oct. 2021].

Vanclay, F., Baines, J.T. and Taylor, C.N. (2013). Principles for ethical research involving humans: ethical professional practice in impact assessment Part I. Impact Assessment and Project Appraisal, [online] 31(4), pp.243–253. Available at: https://www.tandfonline.com/doi/full/10.1080/14615517.2013.850307 [Accessed 12 Oct. 2021].

Weinbaum, C., Landree, E., Blumenthal, M., Piquado, T. and Ignacio Gutierrez, C. (2019). Ethics in Scientific Research An Examination of Ethical Principles and Emerging Topics. [online] Available at: https://www.rand.org/content/dam/rand/pubs/research_reports/RR2900/RR2912/RAND_RR2912.pdf [Accessed 12 Oct. 2021].

World Health Organization (2021). Ensuring ethical standards and procedures for research with human beings. [online] www.who.int. Available at: https://www.who.int/activities/ensuring-ethical-standards-and-procedures-for-research-with-human-beings [Accessed 12 Oct. 2021].