Ethical Principles in Biomedical Research
Biomedical research is a field of medical research which is used to assist and support the body of knowledge that is available in the field of medicine. It is divided into two major categories. The first is the evaluation of new treatments for both their efficacy and safety in what are known as clinical trials. This kind of research contributes in the development of new forms of treatment. The second category is the preclinical research which is conducted to specifically elaborate on the knowledge available in order to develop new therapeutic strategies.
Role and impact of government regulatory agencies
Biomedical research is a highly regulated field. This is because it can directly or indirectly because of several reasons. The first is that it uses human subjects. Second is that it can cause serious harm, directly and indirectly, to the human subjects under test. National regulatory authorities have a role to supervise and monitor all biomedical research being carried out. In the U.S., this is the role of the Food and Drug Administration (FDA) which oversees the development of new drugs and forms of treatment. In Europe, there is the European Medicines Agency which does the same work as the FDA. In Japan, it is the work of the as the Ministry of Health Bosk & Vries, 2004()
There are also other agencies that deal with regulation of biomedical research. The World Medical Association is tasked with the development of ethical standards for biomedical research. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) deals with the development of rules and guidelines for developing new forms of medication such as the Good Clinical Practice (GCP). All ideas for the regulation of biomedical research are usually based on the country’s ethical code of standards. This is the reason why a certain drug or form of treatment may be acceptable in one country but not in another one Bosk & Vries, 2004()
Major principles of ethics and their application in biomedical research
There are four major principles of ethics which are generally accepted in health practice. The first principle is the principle of respect for autonomy. Respect for autonomy is whereby the patient is allowed to act in any way they would like. It means that the patient has the capacity to act in their own intention with their own understanding and without the control of any influences that would prevent them from taking a voluntary and free action. This principle is also the basis of the common health practice of informed consent. This is where the patient is supplied with as much information as possible on the procedure or treatment to be undertaken including advantages, disadvantages, alternatives, possible complications, etc. And then the patient makes their decision based on the provided information. In biomedical research, this simply means that the patient or research participant has the freedom to make their own decisions Emanuel, Wendler, Killen, & Grady, 2004()
The research participant should also be allowed to make their choice based on the principle of informed consent. The patient should be informed of the pertinent information regarding the research study being done including what the results will be used for, confidentiality, possible complications, research methodology, researcher(s), and etc. The patient will then be able to decide on whether they should join the study or not Fadare & Porteri, 2010()
The second principle is the principle of non-maleficence. This is whereby the medical practitioners are required to take actions which do not harm or injure the patient in any way either through the action of omission or commission. This is simply the avoidance of negligence and providing a high standard of care in order to avoid and minimize risks arising to the patient. Negligence, under the legal criteria, is determined by four major things. These are as below:
1. The medical professional must have a duty or role to play to the party that is affected.
2. The medical professional must be in breach of that particular duty.
3. The party that is affected must experience a kind of harm for the breach of the duty by the medical professional.
4. The harm that is experienced by the affected party must be caused by the breach of this duty by the medical professional. Emanuel et al., 2004()
The principle of non-maleficence accepts that there is a need for medical professionals to be competent and to work with due diligence. It becomes very clear that mistakes of a medical nature can occur, however, this principle states that the health care professionals have a fundamental commitment to protect the patients who they have a duty towards from any such harm Emanuel et al., 2004()
In biomedical research, this principle can be applied in that the health care professionals need to take due diligence and care to prevent any harm from happening to the patients. For example, in a clinical research, if it is realized that there is a potential complication that is occurring in the patients, the study should be stopped for a while until the source of the complication is identified and removed. Similarly, in a preclinical research, the researchers should work hard to protect any harm from arising to their patients including taking care in the carrying out of any procedures.
The third principle is the principle of beneficence. This principle simple implies that the medical practitioners should be of some benefit to the patient. They should take the necessary positive steps towards the prevention and removal of any harm or potential source of harm to the patient. These duties of the medical professionals are viewed as being self-evident and they are generally accepted as the part of the goals of medicine. These goals are applied both to the patients individually and for the good of the society as a whole. This principle of beneficence is a goal of medicine since, for example, it is a goal of medicine to achieve the good health of patients and to prevent diseases through the activities of research, vaccination and immunization Emanuel et al., 2004()
Scholars in the medicine world state that non-maleficence is a constant duty for health care professionals in general whereas beneficence is a limited duty. The medical professional has a duty to seek the benefit of their patients. However, the professional has a choice of whom they can admit to their practice which is not a strict duty. The duty becomes complex if two or more patients appeal to be treated at the same time. The professional needs to make their own criteria of urgency which they use to decide on whom to help first DuBois, 2009()
This principle can be applied in biomedical research where the researchers have a duty to ensure they benefit the research study participants. This is achieved through having the betterment of lives as one of the objectives of the study.
The last principle is the principle of justice. Justice in health care simply refers to fairness. As stated by Aristotle, fairness is ‘giving to each that which is due.’ It implies fairness in the distribution of health care professionals and supplies. Therefore, there must be some form of fairness in the allocation of scarce medical resources to the patients. In the field of medicine, it is generally accepted that the people who are equals should also qualify for equal treatment. There are certain factors that are implied in the criteria for distributive justice. This criteria is that to each person, an equal share is given according to their need, effort, contribution, merit and free-market exchanges Emanuel et al., 2004()
In biomedical research, this principle means that all subjects should be treated fairly and as equals. For example, in a clinical research, there are those participants in the control condition who receive a placebo of the drug and those in the experimental condition who receive the drug itself. All participants in the control should be treated as equals. Same goes for those participants in the experimental condition.
Conclusion
Biomedical research is an important field of medicine which adds to the knowledge that is available in the particular field. Since the field usually deals directly with human subjects and it is expected that there can be some harm caused to the patients, the field needs to be highly regulated and this is where the government regulatory authorities come in. Medical professionals involved in biomedical research also need to apply the four major ethical principles to make sure the research is conducted in an ethical manner.
References
Bosk, C.L., & Vries, R.G. d. (2004). Bureaucracies of Mass Deception: Institutional Review Boards and the Ethics of Ethnographic Research. Annals of the American Academy of Political and Social Science, 595, 249-263.
DuBois, J.M. (2009). The Biomedical Ethics Ontology Proposal: Excellent Aims, Questionable Methods. Journal of Empirical Research on Human Research Ethics: An International Journal, 4(1), 59-62.
Emanuel, E.J., Wendler, D., Killen, J., & Grady, C. (2004). What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research. The Journal of Infectious Diseases, 189(5), 930-937.
Fadare, J.O., & Porteri, C. (2010). Informed Consent in Human Subject Research: A Comparison of Current International and Nigerian Guidelines. Journal of Empirical Research on Human Research Ethics: An International Journal, 5(1), 67-74.
Get Professional Assignment Help Cheaply
Are you busy and do not have time to handle your assignment? Are you scared that your paper will not make the grade? Do you have responsibilities that may hinder you from turning in your assignment on time? Are you tired and can barely handle your assignment? Are your grades inconsistent?
Whichever your reason is, it is valid! You can get professional academic help from our service at affordable rates. We have a team of professional academic writers who can handle all your assignments.
Why Choose Our Academic Writing Service?
- Plagiarism free papers
- Timely delivery
- Any deadline
- Skilled, Experienced Native English Writers
- Subject-relevant academic writer
- Adherence to paper instructions
- Ability to tackle bulk assignments
- Reasonable prices
- 24/7 Customer Support
- Get superb grades consistently
Online Academic Help With Different Subjects
Literature
Students barely have time to read. We got you! Have your literature essay or book review written without having the hassle of reading the book. You can get your literature paper custom-written for you by our literature specialists.
Finance
Do you struggle with finance? No need to torture yourself if finance is not your cup of tea. You can order your finance paper from our academic writing service and get 100% original work from competent finance experts.
Computer science
Computer science is a tough subject. Fortunately, our computer science experts are up to the match. No need to stress and have sleepless nights. Our academic writers will tackle all your computer science assignments and deliver them on time. Let us handle all your python, java, ruby, JavaScript, php , C+ assignments!
Psychology
While psychology may be an interesting subject, you may lack sufficient time to handle your assignments. Don’t despair; by using our academic writing service, you can be assured of perfect grades. Moreover, your grades will be consistent.
Engineering
Engineering is quite a demanding subject. Students face a lot of pressure and barely have enough time to do what they love to do. Our academic writing service got you covered! Our engineering specialists follow the paper instructions and ensure timely delivery of the paper.
Nursing
In the nursing course, you may have difficulties with literature reviews, annotated bibliographies, critical essays, and other assignments. Our nursing assignment writers will offer you professional nursing paper help at low prices.
Sociology
Truth be told, sociology papers can be quite exhausting. Our academic writing service relieves you of fatigue, pressure, and stress. You can relax and have peace of mind as our academic writers handle your sociology assignment.
Business
We take pride in having some of the best business writers in the industry. Our business writers have a lot of experience in the field. They are reliable, and you can be assured of a high-grade paper. They are able to handle business papers of any subject, length, deadline, and difficulty!
Statistics
We boast of having some of the most experienced statistics experts in the industry. Our statistics experts have diverse skills, expertise, and knowledge to handle any kind of assignment. They have access to all kinds of software to get your assignment done.
Law
Writing a law essay may prove to be an insurmountable obstacle, especially when you need to know the peculiarities of the legislative framework. Take advantage of our top-notch law specialists and get superb grades and 100% satisfaction.
What discipline/subjects do you deal in?
We have highlighted some of the most popular subjects we handle above. Those are just a tip of the iceberg. We deal in all academic disciplines since our writers are as diverse. They have been drawn from across all disciplines, and orders are assigned to those writers believed to be the best in the field. In a nutshell, there is no task we cannot handle; all you need to do is place your order with us. As long as your instructions are clear, just trust we shall deliver irrespective of the discipline.
Are your writers competent enough to handle my paper?
Our essay writers are graduates with bachelor's, masters, Ph.D., and doctorate degrees in various subjects. The minimum requirement to be an essay writer with our essay writing service is to have a college degree. All our academic writers have a minimum of two years of academic writing. We have a stringent recruitment process to ensure that we get only the most competent essay writers in the industry. We also ensure that the writers are handsomely compensated for their value. The majority of our writers are native English speakers. As such, the fluency of language and grammar is impeccable.
What if I don’t like the paper?
There is a very low likelihood that you won’t like the paper.
Reasons being:
- When assigning your order, we match the paper’s discipline with the writer’s field/specialization. Since all our writers are graduates, we match the paper’s subject with the field the writer studied. For instance, if it’s a nursing paper, only a nursing graduate and writer will handle it. Furthermore, all our writers have academic writing experience and top-notch research skills.
- We have a quality assurance that reviews the paper before it gets to you. As such, we ensure that you get a paper that meets the required standard and will most definitely make the grade.
In the event that you don’t like your paper:
- The writer will revise the paper up to your pleasing. You have unlimited revisions. You simply need to highlight what specifically you don’t like about the paper, and the writer will make the amendments. The paper will be revised until you are satisfied. Revisions are free of charge
- We will have a different writer write the paper from scratch.
- Last resort, if the above does not work, we will refund your money.
Will the professor find out I didn’t write the paper myself?
Not at all. All papers are written from scratch. There is no way your tutor or instructor will realize that you did not write the paper yourself. In fact, we recommend using our assignment help services for consistent results.
What if the paper is plagiarized?
We check all papers for plagiarism before we submit them. We use powerful plagiarism checking software such as SafeAssign, LopesWrite, and Turnitin. We also upload the plagiarism report so that you can review it. We understand that plagiarism is academic suicide. We would not take the risk of submitting plagiarized work and jeopardize your academic journey. Furthermore, we do not sell or use prewritten papers, and each paper is written from scratch.
When will I get my paper?
You determine when you get the paper by setting the deadline when placing the order. All papers are delivered within the deadline. We are well aware that we operate in a time-sensitive industry. As such, we have laid out strategies to ensure that the client receives the paper on time and they never miss the deadline. We understand that papers that are submitted late have some points deducted. We do not want you to miss any points due to late submission. We work on beating deadlines by huge margins in order to ensure that you have ample time to review the paper before you submit it.
Will anyone find out that I used your services?
We have a privacy and confidentiality policy that guides our work. We NEVER share any customer information with third parties. Noone will ever know that you used our assignment help services. It’s only between you and us. We are bound by our policies to protect the customer’s identity and information. All your information, such as your names, phone number, email, order information, and so on, are protected. We have robust security systems that ensure that your data is protected. Hacking our systems is close to impossible, and it has never happened.
How our Assignment Help Service Works
1. Place an order
You fill all the paper instructions in the order form. Make sure you include all the helpful materials so that our academic writers can deliver the perfect paper. It will also help to eliminate unnecessary revisions.
2. Pay for the order
Proceed to pay for the paper so that it can be assigned to one of our expert academic writers. The paper subject is matched with the writer’s area of specialization.
3. Track the progress
You communicate with the writer and know about the progress of the paper. The client can ask the writer for drafts of the paper. The client can upload extra material and include additional instructions from the lecturer. Receive a paper.
4. Download the paper
The paper is sent to your email and uploaded to your personal account. You also get a plagiarism report attached to your paper.
PLACE THIS ORDER OR A SIMILAR ORDER WITH US TODAY AND GET A PERFECT SCORE!!!
