The goal of clinical research is to improve human health and the aim of ethical guidelines in clinical research is to protect patient volunteers from exploitation and malpractices.
Importance of Ethics
A set ofethicsrequired during clinical trials are called Clinical Research Ethics. On discovery of inhumane behaviour and abuse associated with participants of a clinical research experiment in the past, ethical guidelines were formulated.The main principles of ethical research are: non-exploitation; privacy and confidentiality; professional competence; enhance social and clinical value; improve scientific validity; unbiased subject selection; high accountability and transparency; precaution and risk minimization; informed consents from patients; respect towards potential and enrolled subjects.
The requirements for clinical research to be ethical are: study design and protocol are properly designed and approved by ethical committee, subjects selected without bias, respect the rights of the subject, treat patients as autonomous individuals whose welfare and rights need to be respected, investigators need to increase benefits and minimise risks towards study population. Every ethical research needs an informed consent from the prospective participant or a legal guardian, if the individual is unable to give consent. Informed consents are well documented and needs to respect an individuals autonomy to participate or not.
Ethics in clinical study protects the rights, privacy and confidential information of participants. The participants should be able to assess risk and benefits before participating in the study. They can leave or withdraw from a study without penalty and need to be kept informed of any new information arising during the study that can influence their participation. The committee have to ensure that the investigators monitor welfare of the participants throughout the course of the study.
Ethics Committee (EC) / Institutional Review Board (IEC)
Clinical research ethics is overseen by local institutional review board that understands and acts as per the local and national law. Ethical committee consists of a minimum of five members having at least one clinician, one legal expert or retired judge and one medical scientist or doctor. The decision-making process of the committee should be free from institutional, professional and political influence. For the proper functioning of the committee standard operating procedures are enforced.
The ethical committee prevents therapeutic misconception of misinterpreting a research study as routine medical care and safeguards ethical rights of the subjects. The committee is also responsible to prevent exploitation of vulnerable populations enrolled in the clinical study. Any one carry out research needs to approach the committee for approval of the project, without ethical approval the proposed project cannot commence.
The ethical committee reviews the scientific design and study plan before the commencement of the proposed research. The responsibility of the committee is to safeguard the rights, safety, dignity and well-being of the participants by conducting competent, independent and timely review of the project proposals for clinical research. The aim of the study, the appropriateness of the study design and the statistical methods should be assessed with the smallest number of research participants. They also evaluate the qualifications of the principal investigator and supporting staff, informed consent process, infrastructure and facilities, maintenance of confidentiality, risk benefit ratio, post trial access and compensations. Along with evaluating new proposals, ongoing studies also need continuous monitoring.
Online Course in Clinical Research
James Lind Institute (JLI) provides online programs in Clinical Trial Management which provide a detailed understanding of the processes involved in clinical research, pharmacovigilance, medical writing and data management. JLI also provides an online course in Pharmaceutical Medicine which helps develop a robust understanding about the clinical trial enterprise and clinical drug development process.
For more information please visit: www.jliedu.com