Medical research relies heavily on human clinical trials to test medication. Before a new medication can be used in clinical settings or pharmacies, it needs to go through a clinical trial phase to ensure safety. Human clinical trials serve as rigorous scientific investigations and will test new drugs’ safety, efficacy, and tolerability. Because these trials involve potential side effects, the trials are volunteer-based, and there is often debate over the most ethical way to proceed. Here is a guide to ethical considerations for potential clinical trial patients to consider here at Altus Research.
Guiding Principles for Ethical Research
When it comes to creating clinical trials, researchers begin with a set of guiding principles to follow to ensure that their research is ethical. These principles typically include the following: clinical value, scientific validity, informed consent, anonymity and confidentiality, providing the right to withdraw, and fair subject selection. An independent review by an outside committee might be involved to help keep research on an ethical track. Let’s look at these more in detail.
Clinical Value
Research needs to exist for a reason. It must seek to answer a question that is important enough to test. This is particularly important in medical research where trial participants take new medication and risk their health.
Scientific Validity
Studies should be well-designed and thought out from a scientific perspective. This comes back to purpose: ethical research involves risk for participants, but that risk is designed to learn something new that is useful and helpful to the community at large. Therefore, the scientific study needs to be valid in its design, ensuring that the methodology is robust and capable of generating reliable data.
Informed Consent
Ethical research involves informed consent where participants not only know that they are taking part in research, but they understand fully what the research requires of them. This includes sharing information about the methods that will be used, the possible outcomes from the research, and the full list of risks that the participants may deal with during or after the trial. It’s important to ensure no information that might influence someone to withdraw consent is left out. Participants must be given all of the trial details upfront.
Anonymity and Confidentiality
One of the most well-known ethical practices in clinical trials is that the anonymity and confidentiality of all participants must be protected. This comes down to the way the data is collected and stored, as well as who has access to it.
Providing the Right to Withdraw
Participants must have the right to withdraw from the study at any time – this includes for any reason. Participants must not be prevented from withdrawing or in any way penalized from withdrawing early from a study.
Fair Subject Selection
Selecting subjects must be done fairly, meaning participants are not chosen based on their privilege, vulnerability, or another specific factor. Avoiding discrimination of any kind in participant’s election ensures that research benefits and burdens are distributed equitably across diverse demographics.
Consult with Us
If you are interested in learning more about ethical clinical research, reach out to us. Located in Lake Worth, FL, we specialize in clinical trials in a variety of fields. To learn more about our participating trials and what you can expect, contact us today.
