As more treatments arrive on the market, clinical research ensures they have been proven safe and effective for public use. Today, it’s not just the treatment that comes under scrutiny but the research process itself. Any clinical research that involves human subjects must comply with ethical standards.
A big part of ethical research is getting the informed consent of participants. But many people think that informed consent is what makes clinical research ethical. In reality, informed consent is not the only mark of ethical research. Similarly, there’s a belief that informed consent simply means getting a signature. In fact, a big ethical concern around consent is whether participants are fully informed about the risks of a trial.
Students in the Clinical Research program at AAPS will understand the importance of upholding ethics in clinical research, along with the power–and limitations–of informed consent. Below, we’ll break down what it all means.
The Principles of Ethical Research
Ethical guidelines for clinical research are put in place to ensure the integrity of the research results and to protect the safety of patients who volunteer to participate. These standards must be considered during the planning, implementation, and evaluation of studies.
According to the NIH Clinical Center, there are seven key principles behind ethical research:
- Social and clinical value: there should be a good reason for conducting the study
- Scientific validity: the study should give a clear answer to an important research question
- Fair subject selection: participants should be chosen based solely on the goals of the study
- Favourable risk-benefit ratio: the benefits should be proportionate to or outweigh the risks
- Independent review: an independent panel should review and monitor the study
- Informed consent: patients must be informed about the research and make their own decision to participate
- Respect for potential and enrolled subjects
After clinical research training, you’ll need to keep these principles in mind when designing and carrying out studies. Continued respect for these ethical requirements is crucial to ensure that clinical trials remain valid and moral while advancing the public interest.
What Does Informed Consent Involve?
Many clinical trials rely on the participation of human subjects. Informed consent is a requirement designed to keep that process ethical and transparent. The main components of informed consent are:
- The patient must be accurately informed of the research’s purpose, methods, risks, benefits, and alternatives
- The patient must understand this information and how it relates to their own clinical situation
- The patient must make a voluntary decision about whether to participate
As you can see, obtaining a participant’s verbal or written consent is only part of the process. The FDA goes into even greater detail on the requirements of informed consent. For example, you must give an appropriate amount of time for the patient to decide whether to participate. This includes allowing sufficient time for the patient to ask questions, have those questions answered, and discuss the research protocol with family and friends.
What to Expect from Clinical Research Training
Given the importance of ethical standards in studies today, good clinical research training should highlight the expectations and challenges around ethical research and informed consent. Clinical research courses at AAPS take a unique approach that uses practical and current real cases to give students a working knowledge of ethical requirements. You’ll learn how to ensure clinical trial data is credible and that the rights, integrity, and confidentiality of trial subjects are protected. More specific topics cover a review of the key regulatory agencies, guidelines for regulatory application, required documentation, and protection of human subjects.
A knowledgeable Clinical Research and Pharmacovigilance professional plays a vital role in protecting the study participant and the general population for marketed drugs. With the right training, you can help to advance the ethical standards of the clinical research industry today.
Ready to earn your clinical research diploma?
Contact AAPS today to learn more!