Clinical Trials Ethics: What You Need to Know

The goal of clinical trial ethics guidelines is to protect patient volunteers while still maintaining scientific integrity.

Clinical research aims to produce generalisable knowledge that benefits human health or expands our understanding of human biology. Trial participants make it feasible to preserve such knowledge. Companies such as ObvioHealth (https://www.obviohealth.com/) are making clinical trials more widely available to researchers.

Testing a novel drug or treatment on patient volunteers, for example, is one way to determine whether it is safe or effective. But clinical research can exploit patient volunteers by putting some people in danger for the benefit of others.

This post will look at some of the ethical issues faced when conducting clinical trials and common ethical guidelines.

Common Ethical Issues Faced when Conducting Clinical Trials

• Clinical trial participants may be put at risk for the benefit of others.
• The risks may outweigh the potential benefits to each participant while still benefitting a more significant number of people.
• Researchers have a responsibility to protect the rights and welfare of participant volunteers by avoiding undue harm or breach of trust.
• The distinction between therapeutic and non-therapeutic trials may benefit some trial volunteers by avoiding undue harm or breach of trust.
• Financial incentives such as providing insurance coverage, paying for expenses may create conflicts of interest that endanger the welfare or rights of patient volunteers.
• Trial participants may face a high likelihood of breach of trust.
• The risks to trial participants may outweigh the benefits to researcher scientists.

The Role of Ethics in Clinical Trials

1. Protect Against Abuse and Exploitation of Clinical Trial Participants

Ethics protect trial patients against exploitation or harm. It ensures that patients get proper oversight of their trial activities. Research participants may be exploited, for example, if they lack the capacity for rational judgment. This may occur if they are children or mentally handicapped.

Research participants in some studies may also be exploited if they are hospitalised as patients with a particular disease. The interests of fellow patients or their self-interests take precedence over scientific aims.

2. Promote Fairness

Clinical trial ethics promote fairness by ensuring that participant volunteers are fairly compensated for their time and effort and appropriately protected from research risks.

Patient advocates have raised concerns about medical research on human subjects being conducted without consent or compensation in recent years.

3. Promote Principled Conduct

This role of ethics is to promote scientific integrity by ensuring appropriate oversight of trial activities that aim to protect patient volunteers from undue harm or breach of trust.

The initial phase of clinical trial ethics focuses on ethical regulation, while scientific integrity is promoted during the administrative review process and clinical trial data.

4. Promote Productive Collaborations among Researchers

Ethics promote productive collaborations among researchers by providing guidance that supports the sharing of resources and information so that research can benefit the greatest number of people.

5. Promote Responsible Use of Trial Results

Clinical trial ethics promote responsible use of trial results by ensuring that scientific knowledge and data are shared to maximise public health benefits.

Top 5 Ethical Considerations in Clinical Trials

1. Minimise the harm and maximise the benefits

The goal should be to maximise net benefits for patients while minimising risks. This requires a delicate balancing act, but it is crucial to understand the risks to make informed decisions.

2. Know the Limits on Risk

It is important to note that while there are limits on risk and harm in a clinical trial, there are also little-to-no guarantees of safety. It can be difficult or impossible to anticipate all potential side effects or harms. For this reason, you must understand the risks posed by the treatment you are testing.

3. Let the Patient Volunteers know the Potential Side Effects

Patient volunteers should have a basic knowledge of the potential side effects or risks associated with clinical trial participation, and they should be comfortable with those risks.

If you are not mentally prepared to deal with harm or danger, it may be wise to forego clinical research altogether.

4. Respect for All the Clinical Trial Participants

Respect will vary from person to person, but it is crucial that your study participants feel as respected and valuable as possible. A lack of respect can lead to a breach of trust on the part of the patient volunteers. This can endanger the safety of your participants and lead to insufficient or inaccurate data for you to analyse.

5. Responsible Recruitment of Patients

The process of recruiting participants should be done responsibly as well. You must recruit volunteers who can make informed decisions and who want to participate in clinical trial research.

You should not recruit participants if you believe they are coerced or forced into participating in your study.

Clinical Trials Ethics Final Thoughts

Clinical trials are an essential part of the medical process. They help the world develop top-notch quality drugs and treatments to improve human health. However, ethics must be followed to ensure fairness and justice for researchers and patient volunteers who participate in clinical research studies. Ethics form a baseline for great clinical trials with solid oversight from regulatory agencies to protect everyone.