Clinical researchers dedicate their lives and careers to discovering breakthrough treatments and therapeutics that could go on to save and enhance the lives of many people. However, bound up in those breakthroughs is the necessity for clinical trials research and testing to be carried out on human subjects. This brings up an array of clinical research regulations and ethics that clinical trials professionals (CTPs) must be aware of.
Meeting the ethical and legal standards in clinical research means more than technical proficiency. It means CTPs are also confident and responsible with how they manage participants’ personal data, their interpersonal relationships with participants and how they influence decision making. The efficacy of clinical trials rests heavily on how ethics and compliance are handled, which is why it is so important CTPs are trained to the highest level of responsible practice.
Overview
In February, as part of Black History Month, we explored histories concerning the unethical treatment of Black people in clinical and healthcare research. When we discover the legacy of clinical trials such as the Tuskegee Syphilis Study, it's easy for us to understand why ethics and clinical research guidelines are of paramount importance.
When human subjects have their trust, autonomy and safety compromised, it can have a profound impact on more than just one clinical trial. It can sow distrust between researchers and prospective communities of research candidates, demonstrated by the Tuskegee Syphilis Study, which has left a lasting legacy of mistrust.
CTPs have a responsibility to ensure the safety of participants and that the standards of the Research Ethics Committee are met. Misconduct, neglect or breach of clinical research ethics and guidelines could lead to the termination of your trial or the withdrawal of funding from external stakeholders.
Not only do legal and ethical standards keep participants safe, they also ensure the integrity of test results. Clinical research is already a long and costly process, which is why it is so beneficial to CTPs and research companies that their clinical trials are designed with compliance at the forefront and everyone is trained to the highest level of responsible practice.
Whether you’re a graduate, career-changer or you’re already working as a CTP, everyone in the field should be aware of the ethical guidelines and principles for clinical research. As you advance in your career, these principles will become even more prevalent as you design and manage your own trials.
Some of these principles include:
When CTPs are engaging with these principles, they may encounter conflicts and challenges they’ll be responsible for managing; for example, if a participant needs to be withdrawn from a trial for their own wellbeing and benefit, but does not wish to.
However, upholding these principles can manifest in more subtle ways. For example, when CTPs are responsible for managing patient data, if they accidentally send this data to a third party without the participants’ consent or they lose this data, they can breach the principle of confidentiality. A small mistake to make, but one that can have huge consequences for the success of your clinical trial.
With so many developments happening in the field, from artificial intelligence (AI) to stem cell research and human gene editing, it’s never been a more exciting time to work in clinical trials. However, all of these clinical trials bring their own set of ethical considerations.
If the next generation of CTPs are going to deliver these trials and their potential treatments, they need to be confident with ethical decision making in research. This is where CGX is prepared to deliver.
Our hands-on courses are built to simulate real-world situations CTPs will face in their careers, from entry level Clinical Trials Administrators to Clinical Project Managers and beyond. Because we use a mixture of case studies and documentation you can expect to use on the job, you’ll get first-hand exposure to the kind of ethical skills the job demands.
In addition to our courses, we partner with corporate entities such as pharmaceutical companies, biotechs, CROs and the NHS to provide bespoke training and consultancy when they are designing clinical trials or need to upskill their staff. With our industry knowledge and interactive courses, we can ensure that practitioners are trained responsibly and to the highest standards. This means they’re ready to tackle the ethical demands needed for the future of ambitious clinical research.
If you’d like to find out more about our training opportunities, then don’t hesitate to contact us today.
