Ethical issues surrounding clinical and basic science research

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Introduction

Throughout history, the behavior of researchers has been a subject of debate. Some regulations have been set up to form a framework in which researchers can practice their much-needed work while protecting the subjects used in these studies. Every profession is guided by ethics, and clinical and basic research are not exemptions. Ethics in research are like the morals which differentiate what is right and what is wrong behavior.  Ethical lapses in clinical research can significantly hurt an animal or a human subject or worse off kill them. Also, besides harming the subjects, ethical lapses can cause wrong results of clinical trials. It is therefore imperative that ethical regulations are set up.  Researchers should abide by set ethical regulations and guidelines all the time when conducting studies. The purpose of this report is to explore bench to bedside translational research while discussing ethical issues and importance of both clinical and basic research in humans and animals.

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From Bench to Bedside

Research can be categorized into either basic research or applied research. For this report,  applied research will be referred to as clinical research. Often, basic research gives a further understanding of two states; normal state, and disease state. Basic research does not go beyond pure understanding, in fact, it fails to translate the gained knowledge for clinical applications (Goldblatt & Lee, 2010).  This shortcoming is where translational research comes in handy. The key objective of translational research is to incorporate developments in biological science with clinical trials taking research from the bench to bedside. The term “bench to bedside” is commonly used to refer to the procedure in which findings of investigations done in a laboratory environment are used to formulate new methods of treating patients directly (Hart, 2014). In other words, bedside to bench creates a repetitive loop of healthcare that is based on research findings where observations in clinical trials trigger research (bench) leading back to the bedside for implementation and more findings.

In a bid to enhance our health, scientists who discover important concepts need the translation of their finding into applications of real-life scenarios. These findings typically start at the bench with basic scientific research. At the bench, researchers study the pathogenesis of an illness and the mechanisms involved at the molecular level. After obtaining the findings at the bench, they are translated to clinical levels for application at the patient’s bedside hence the term bench to bedside. Basic science is involved in establishing answers to critical questions that assist in laying the ground for future research. For instance, at the molecular level, basic science can help identify key elements and behavior of molecules specific to a disease or a drug and later formulate precise target pathways to achieve an objective (Beckett et al., 2011).

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On the other hand, clinical science is concerned with human subjects with its main target being to understand the history of an illness together with the probable options of its diagnostic tools and management. To patients, clinical science may look more important and obvious, but it would be very wrong to downplay the significance of basic science. Clinicians make new observations about the progress and effect of a disease or drug to patients; these novel findings further trigger more basic research back at the bench. The clinical findings and data collected at the bedside are usually transmitted back to the basic researchers to see if further developments are required (Beckett et al., 2011).

The process for developing new treatments or drugs is clearly defined by the FDA (Food and Drug Administration). The process starts at the pharmaceutical company or physician level who are interested introducing a treatment into the market. The pharmaceutical company will begin by submitting in an IND (Investigational New Drug Application) to FDA and any other relevant authority. During this initial phase, the involved stakeholders must submit findings of laboratory animal preclinical trials to FDA and other applicable authority. Animal studies are necessary at this stage to give preclinical results. From the presented preclinical results, FDA determines if it is rationally safe to proceed to test the treatment in human beings. The second process of developing the treatment includes the review of submitted IND by a panel of scientist and non-scientists in hospitals, authorities that oversee clinical research and FDA themselves. After the IND is approved, the committee and FDA define the clinical trial protocols. The third process is where phase 1 studies are conducted to determine possible side effects on healthy volunteers. The fourth process is the Phase 2 studies which are focused on testing the effectiveness of the drug. The fifth process is phase 3 testing which gathers more on efficacy and safety of the treatment. The sixth, seventh, eighth, and ninth all the way to the twelfth process are about reviewing, submitting the new drug application, inspecting production of the drug and finally approving the new drug application and releasing it to the market (Meadows, 2002).

Clinical Research Ethics; The Use of Humans in Research

Over the years, researchers have on several occasions violated ethics in conducting their clinical research. These violations led to grave problems to human health triggering the creation of laws to safeguard human subjects in research. One well-known, such violation happened in 1946 where German researchers performed experimental treatment on prisoners without their consent. Many of the subjects died, and others become crippled. This event led to the creation of the Nuremberg Code in 1948 which requires voluntary consent of human participants (CGU Institutional Review Board, 2016). The other historical event in regards to violation of ethics happened in the 1950s. Thalidomide, an approved sedative in Europe, caused severe abnormalities in newborn babies. FDA had not authorized the use of Thalidomide in the U.S. and people took it without giving their informed consent. The Kefauver Amendments were done after this event on FDA act requiring manufacturers to prove the effectiveness of their drugs before selling them. In 1964, the Declaration of Helsinki was made by World Medical Association giving guidelines on the involvement of human subjects in medical research. In 1974, the National Research Act was enacted to protect human subjects in both medical and behavioral research (CGU Institutional Review Board, 2016).

In research, human subjects are required to give an informed consent before participating. Informed consent is simply a declaration by the participant that they understand the risk they are getting into when becoming subjects to an experiment. Informed consent protects the health welfare of participants as well as overenthusiastic efforts by researchers to advance their careers behind participants’ back. On the other hand, the consent protects the researchers from litigations that may arise if the study went wrong. Informed consents give both the researcher and the participant the autonomy and prevent any abusive conduct from either side. Informed consent has four components; one must have the capacity to make a decision, the researcher must disclose every detail of the research, the participant must understand key information, and subject must voluntarily give the consent. Informed consent can be considered invalid in cases where there was coercion, undue inducement or in a situation of where no choices were given.

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The Institutional Review Board (IRB) evaluates and authorizes all research that involves human participants at universities. Any research reviewed and approved by IRB contains identifiable private information on 45 CFR 46, the code of federal regulation guiding the research and protection of human research subjects. Any article with IRB approved research should also have some accompanying notes of that particular IRB’s approval letter.

Basics Research Ethics on The Use of Animals

Research that involves animals has a lot of benefits to human and animals too. However, just like human subjects, animals have undergone violations in the name of research. An example of violation ethics in animal studies is when Harvard Medical School researchers failed to repair a broken-down watering system leading to severe dehydration of the monkeys, and one died in the process (Grant, 2013). Another example is when three dogs were forced to swallow a test drug daily for a week at Charles River Laboratories. The test dogs experienced breathing difficulties, increased heartbeat, and they became cold. One dog died (Humanesociety, 2015).

In the U.S., the Animal Welfare Act (7 U.S.C. § 2131) regulates the use of animals in testing, research, and teaching. The federal government has a well-respected Guide for the Care and Use of Laboratory Animals that is published and reviewed by the Institute for Laboratory Animal Research (American Physiological Society, 2017).  The Institutional Animal Care and Use Committee (IACUC) is established in every university to oversee research involving animals. The Public Responsibility in Medicine and Research (PRIM&R) oversees the operations of IACUC and inspects testing facilities regularly. It is unethical to conduct research on animals without appropriate approvals.

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One common misconception about the use of animals in research is that research in animals is irrelevant because people and animals are different. Some people think that experimentation with animals is selfish and cruel torture on animals. Others say that it serves as research for cosmetic purpose and purely benefits humans. Another usual misconception is that researchers mostly use household animals for research (Proanimaltesting, 2013). Despite these and many more misconceptions, research on animal has provided highly valued information and breakthroughs in medical science and advancements in human health.

In 2016, FDA approved Targeting Aging with Metformin (TAME) study after animal’s results were very compelling on anti-aging elements. Metformin has been found to stall the aging process which is a major scientific breakthrough. Non-human primates have been integral in understanding the Hepatitis C virus. In 2013, Sovaldi, the treatment of this chronic hepatitis was approved after major discoveries in non-human primates were made (Foundation for Biomedical Research, 2018).

Conclusion

Issues surrounding clinical and basic research are guided by ethics right from the bench to the bedside. Clinicians need basic science and scientists depend on clinicians to get feedback on the effectiveness of their discoveries. Several laws have been set in place to regulate the use of human subjects in research. For instance, human participants must provide informed consent before their participation. Likewise, the Animal Welfare Act is the primary law guiding the use of animals in research. Besides the law, universities are supposed to have committees that oversee the use of both human and animal subjects in research. Use of animals in research has been of tremendous success in both human and animal healthcare. From this report, I have gained new insights on various issues. One very important thing that I learned is the importance of bench to bedside concept.

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  1. American Physiological Society. (2017). Regulation of Animal Research in the U.S.
  2. Beckett, M., Quiter, E., Ryan, G., Berrebi, C., Taylor, S., Cho, M., … & Kahn, K. (2011). Bridging the gap between basic science and clinical practice: the role of organizations in addressing clinician barriers. Implementation Science6(1), 35.
  3. CGU Institutional Review Board. (2016). Background: History of Ethics.
  4. Foundation for Biomedical Research. (2018). Animal research achievements medical scientific milestones.
  5. Goldblatt, E. M., & Lee, W.-H. (2010). From bench to bedside: the growing use of translational research in cancer medicine. American Journal of Translational Research2(1), 1–18.
  6. Grant, B. (2013). Harvard Fined for Animal Welfare Violations.
  7. Hart, D. (2014). From Bench to Bedside and Beyond.
  8. Humanesociety. (2015). Examples of Severe Animal Suffering in Laboratories.
  9. Meadows, M. (2002). The FDA’s drug review process: ensuring drugs are safe and effective. FDA consumer36(4), 19-24.
  10. Proanimaltesting. (2013). Common Misconceptions.
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