Key 5 Ethical Considerations in Clinical Research: Maintaining Trust and Integrity
Clinical research and clinical trials are the important factors for innovation and for conducting various biomedical studies with human participants. This is an essential yet complicated process. Good clinical research practice is necessary for the advancement of healthcare and medical innovations. Ethical Considerations in Clinical Research and ethical guidelines are established for clinical research to protect the rights of research participants. For every clinical research study, there is an important question that has to be solved and the answer should be important enough to justify volunteers or participants to accept some risk or inconvenience for others.
If we study deep, there are numerous intertwined considerations related to research ethics, informed consent, confidentiality and data protection; which focuses on integrity, trust, confidentiality and data protection in research and clinical trials. Scroll down to know and explore more about Informed consent, confidentiality and data protection and how to protect the rights of research participants.
The Importance of Ethical Considerations in Clinical Research
Before understanding ethical considerations in clinical research, the first question that came to our mind is why do people participate in clinical trials? The answer is, by participating in a clinical trial, you are contributing to doctors and researchers' ability to better understand diseases to improve future health care systems. As Dr. Christine Grady, chief of the NIH rightly said “When people are invited to participate in research, there is a strong belief that it should be their choice based on their understanding of what the study is about, and what the risks and benefits of the study are.”
Ethics in clinical research is not just a protocol, it represents human rights to protect the rights of research participants. These are the roots of all studies and trials and guide organizations to take decisions from protocol to innovation. National Institutes of Health Clinical Center researchers mentioned about 7 main principles to guide the conduct of ethical research, which as as follows:
- Informed consent
- Scientific validity
- Favorable risk-benefit ratio
- Fair subject selection
- Respect for potential and enrolled subjects
- Social and clinical value
- Independent review
Ethical Considerations in Clinical Research: The History
The horrific experiments during World War II conducted by 20 physicians and medical assistants in Germany under the direction of the Nazis in humans, where individuals were forced to participate in high altitude experiments, without oxygen. Nazi doctors were removing sections of bone, muscle, and nerves, including whole legs from volunteers' bodies, artificial wounding of two limbs and treatment of one with sulfanamide antibiotics.
The field of clinical research has not lacked ethical controversies in its history. So, if anyone asks the importance of Ethical Considerations in Clinical Research, Informed consent, Confidentiality and data protection, and why to protect the rights of research participants. The answer is very simple, every life matters and for participating in any trial Informed consent is essential. As we are in this clinical research domain, we are aware of clinical studies now and yet patients are being subjected to experimentation that puts them at great risk. Thus we should be aware of what's going on, what's ethical and what is not!
5 Ethical Considerations in Clinical Research
1. Informed Consent
One of the primary principles of clinical research is consent. Potential participants should make their own decision about whether they want to participate or continue participating in research. Participants should understand the purpose of the study, through procedures, the potential risks involved, and the possible benefit of the study. Most importantly individuals should be accurately informed about the purpose, methods, not otherwise. In case of minor participants, obtaining parental consent is important.
2. Scientific validity and integrity
The scientific answer researchers are looking for through the study should be understandable and it should include valid and feasible research methods, The ethical clinical research must be carried out with honesty and openness with acceptable principles, clear methods, and reliable practices. Invalid methods are unethical leading to data manipulation, or resource wastage.
3. Favorable risk-benefit ratio
Uncertainty about degree of risk is inherent, which may include long time risk as well. Research study should be done in such a way to minimize the risk factor, so that it can be justifiable, and the potential benefits of participation are proportionate to, or outweigh, the trial risks.
4. Fair Participant Selection
Selection of human subjects must be driven by scientific principles and not by convenience, discrimination or privilege, or other unrelated factors. Confidentiality and Data Protection is of utmost importance. Certain groups like minor or women participant’s requirements or exclusion should be scientifically backed.
5. Respect for prospective and enrolled subjects
Along with confidentiality and data protection, and scientific validity and integrity, respect for prospective and enrolled subjects is also a key ethical principle in clinical research. Scientists need to also respect privacy and confidentiality by protecting subjects' individual identifiable information. Respecting prospective and enrolled subjects means protecting the rights, dignity, and welfare of each participant.
Moreover, scientists and researchers have the duty to communicate with utmost transparency so that participants are aware of any pertinent findings and risks related to the study. In a clinical trial, scientific validity and integrity and informed consent is very important, which leads us to the next big factor about participants' rights is that the participants have every right to withdraw their participation from the trial at any time without any consequence.
Ethical Considerations in Clinical Research: Key Issues in Global Clinical Trials
The key issues in global clinical studies are bioethical and cultural challenges scientists face during conducting global clinical trials. While planning and conducting trials, organizers or managers need to consider ethnic background, cultural differences, healthcare access and cultural norms and values.
Exploitation in the name of clinical research is not acceptable and it must not exploit individuals or groups of people with limited options for healthcare. Trial participants must know and should be able to access study benefits following a clinical trial.
Conclusion
In the ever-changing landscape of clinical research, and with the growing need for discovering new drugs, devices and vaccines, ethical guidelines are crucial to protect the rights of research participants. Let all of us strive to maintain the highest ethical standards. As a part of the clinical research domain we invite our students and anyone interested in the clinical research field to learn, understand, and be aware of ethical considerations and spread your knowledge.
Some Emerging Ethical Issues in Clinical Research include Artificial Intelligence-led research which can introduce bias and data security risks. Patient-centric trials enabled by digital health tools and decentralized studies may lead to less oversight and data security. To learn more about ethical guidelines and technical expertise in clinical research, visit Cliniwave today. Enroll for our Advanced Diploma in Clinical Research Program to understand these complex topics.
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