Clinical research has the purpose to ensure the effectiveness and safety of newly developed medications for human consumption. Crucially, researches are envisioned as the practices which can largely contribute to, form and promise better integrity of health knowledge, improved health of people worldwide and more efficient ways to treat patients and prevent diseases. All of this should be done in consistence with Good Clinical Practice (GCP) regulations, FDA requirements and others. However, to perform clinical research, there is a need of trialists – people who voluntarily participate in clinical studies. Even though their decision whether to participate or not is made entirely on their own without any external influence, patients must be informed not only about the benefits of the trial but the risks that come with it as well. In this sense, while the primary goal of clinical studies is to generate advanced knowledge and enhance interventions, there is another goal which is just as integral as the formal one. Precisely, the other goal involves making sure that all ethical principles in clinical research are kept and followed, without violating patients’ rights.
In clinical studies, most processes include different risks, complications, as well as anticipated and unanticipated reactions. And this is something usual. The smoothness of processes can quickly turn into difficulties and obstacles. Yet, this should not be perceived as a recipe for failure, unless there are serious discrepancies, incompliances and cases of intended misleading. Simply, the research environment can be viewed as ever-shifting and vulnerable to many factors from the outside, which is the reason why complications do occur. Most importantly however, trials which are closely linked to and dependent on human subjects may be performed only when the wellbeing of participants outweighs any possible risks. This is to say that the welfare and life of individuals should be placed before anything else. Therefore, clinical researchers are expected to conform all ethical principles and rules so that no other person is put at severe, inappropriate and life-threatening situations.
The World Medical Association (WMA) has created the Declaration of Helsinki as a policy-statement of the ethical principles related to drug-testing on humans. Such principles in clinical research aim to protect patients and to preserve the quality of the study itself. They include:
- Adequate selection of trial participants
People should be selected in a manner that eliminates risks and maximises benefits. Any bias in the recruitment of subjects should be minimised down to zero. All volunteers should be presented in the appropriate mental condition so that they can demonstrate complete comprehension of the treatment along with its advantages and disadvantages.
- Regular risk-assessment
All physicians involved in the trial have the duty to evaluate the risk on a regular basis. In this regard, the risk must be monitored and documented continuously in order to be managed on time, thus avoiding potential threats. When risk is discovered, researchers have the ethical responsibility to measure whether or not it endangers the life of patients and if so whether to modify or terminate the study immediately.
- Preparing research protocol
In order to avoid possible conflicts researchers are bound to write a research protocol which contains a thorough outline of the design and the conduct of each study involving human subjects. The protocol should also address how the principles stated in the Declaration of Helsinki are being acknowledged and taken into consideration.
- Ensuring validity
Guaranteeing for the scientific validity of the research is one of the key ethical principles that need to be kept. This includes ensuring that the scientific methods of the study are relevant, doable and easy to understand by trialists. Moreover, trial performers are expected to make sure that the trial design is valid too and points out plain objectives with reliable tactics and answerable questions.
- Respect human lives
It is the duty of the healthcare team to respect and protect the rights, life, privacy, confidentiality and health of research subjects. Safeguarding participants is rule number one when performing a trial. Good Clinical and Good Research Practices (GRPs) state that physicians are responsible for the wellbeing of volunteers during the research procedures and they must listen, inform and talk to the patients with the upmost care.
In conclusion, the realization of every trial depends on the subjects involved in it. The progress of the trial, on the other hand, rests within the responsibilities of researchers and the ways in which they carry them out. As part of GCPs and GRPs, physicians should follow certain ethical principles in order to promise integrity of science and wellbeing of subjects. Failures to do so can have consequences such as restarting of the research and sometimes they can even lead to complete cancelation.
Acknowledging how vital following ethical principles is, we at Astra Nova are preparing a free course on the subject matter which will be available very soon. So stay around.
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