If you or a loved one has a serious health condition for which traditional treatment is not working, you may consider enrolling in a clinical trial. As you may know, clinical trials evaluate the safety and effectiveness of new patient care advances, such as new medications and medical devices. Importantly, participating in any type of clinical trial comes with a degree of risk. What steps do the researchers take to protect participants? Could researchers put their own scientific or financial interests above patient concerns? What about your privacy? Certainly, before deciding on your next steps, it’s worth taking the time to learn about ethics in clinical trials.
The importance of ethics in clinical trials.
Generally, ethics dictate that healthcare professionals treat patients with dignity, respect, fairness, and justice in all healthcare encounters. Simply put, ethical guidelines ensure that healthcare providers act in patients’ best interests.
There is a long history of ethics in healthcare, starting in ancient Greece with the Hippocratic oath. Interestingly, the horrors inflicted by Nazi scientists conducting unethical medical trials led to the 1947 creation of The Nuremberg Code – a widely accepted standard for ethics in clinical trials.
The Nuremberg code recognizes 10 standards, including:
- Participants must voluntarily give their consent.
- The risk must be weighed against the expected benefit.
- Unnecessary pain and suffering must be avoided.
- Doctors should avoid actions that injure human patients.
Not all researchers maintain ethical standards.
In addition to the horrible Nazi experiments, there have been many other examples of unethical studies where participants were either forced or coerced under false pretenses, often on vulnerable populations. Familiar examples of unethical studies include the Tuskegee syphilis study, the Stanford Prison Experiment, and the CIA’s LSD studies. Surprisingly, many of these unethical experiments were conducted after informed consent was introduced in the 1950s.
Although some of these studies led to scientific advances, they brought harm and pain on unknowing participants.
Hopefully, the core ethical principles involved with clinical trials today will keep participants informed and free of unnecessary harm. With this in mind, continue reading to learn more about ethics in clinical trials in the present time.
Institutional Review Boards evaluate ethics in clinical trials.
Generally speaking, an institutional review board (IRB) at each participating hospital must assess the ethics and safety of research studies involving human participants. In short, IRBs make sure researchers take the appropriate steps to protect the rights and welfare of participants.
How? Institutional review boards (IRBs) – also called research ethics committees – protect human research participants by independently reviewing the ethical acceptability of a research project before it starts and periodically during the time of the trial. Importantly, IRBs check for any potential biases among the researchers, and evaluate compliance with regulations and laws designed to protect human participants.
Moreover, IRBs are made up of a group of diverse professionals with varying backgrounds – including doctors, statisticians, and community advocates – which provides a breadth of experience, knowledge, and viewpoints.
When assessing clinical trials, the group reviews research protocols and related materials (e.g., informed consent documents and investigator brochures). During an evaluation, an IRB will determine if:
- Risks are minimized.
- Risks are reasonable in relation to anticipated benefits, if any, and the importance of the expected knowledge gained from the trial.
- Subject selection is equitable, including inclusion of vulnerable populations.
- Informed consent will be sought and documented.
- The study includes adequate provisions for monitoring subjects and progress.
- The study includes adequate provisions to protect participant’s confidentiality.
- Additional safeguards are included to protect vulnerable people against coercion or undue influence.
Importantly, IRBs have the authority to approve, require modifications (in order to secure approval), or disapprove research – before the research starts or during an ongoing trial if issues arise.
Ethics in clinical trials requires informed consent.
You can’t have ethics in clinical trials without informed consent, an important requirement for all US clinical trials with human subjects.
Importantly, you have the right to control your own body, which includes understanding the risks and benefits of participating in a trial, as well as learning about other available treatment options.
Because informed consent is so important, doctors and/or the researchers must make sure you understand the information provided and can competently make decisions. It’s not enough to simply present the information. And they must document the informed consent process.
Although you provide informed consent to participate, it’s important you understand you can withdraw from a trial at any time – without consequences.
What can you expect during an informed consent process?
Most importantly, researchers should explain everything you need to know to make an informed decision about your participation.
Generally, an informed consent process should include these elements:
- Ensuring your privacy during the process.
- Providing you with clear study details using language you can understand.
- Giving you an opportunity to consider other treatment options.
- Sharing consent documents with you.
- Addressing your questions and concerns.
- Providing necessary information as needed.
- Ensuring you understand the information provided.
- Getting your consent to participate.
- Properly documenting your consent.
Importantly, regulations require researchers to provide the following information:
- Explanation of the purpose of the research, the expected duration of your participation, a description of the procedures involved, and the identification of any procedures which are experimental.
- Description of any reasonably foreseeable risks or discomforts you may experience.
- Description of any benefits you may reasonably expect from the research.
- Disclosure of other treatment options, if any, that might help you.
- Description of the extent, if any, to which they will maintain the confidentiality of your records.
- For research involving more than minimal risk, an explanation regarding medical treatment that may be available if you are injured.
- Explanation of whom to contact for answers to pertinent questions about the research and your rights, and whom to contact in the event of a research-related injury.
- Statement that your participation is voluntary, and refusal to participate will involve no penalty or loss of benefits to which you are otherwise entitled. Additionally, you may drop out of the trial at any time without penalty or loss of benefits to which you are otherwise entitled.
Ethics in clinical trials dictates respect for patient autonomy.
Like informed consent, respect for autonomy means letting patients decide their own healthcare interventions, a key ethical component in clinical trials.
You must feel empowered to make your own healthcare decisions. Therefore, your doctor(s) must involve you in discussions and decisions regarding your treatment options and must provide information that you can understand.
And doctors should never pressure you to participate in a trial. Importantly, don’t feel obligated to participate in a trial. It is your life and your decision.
Ethics in clinical trials dictates transparency and accountability.
Open and honest communication between you and your doctors is vital for ethical clinical trials. Not only should you understand your options and have an opportunity to ask questions, but your doctors should also disclose any potential conflicts of interest. For instance, is your doctor or hospital steering you towards a particular clinical trial because they are receiving payments from a pharmaceutical or medical device company? Could they be putting their own financial gains ahead of patients’ needs and safety?
Importantly, pharmaceutical and medical device companies must release details of payments made to doctors and US teaching hospitals, including payments for research.
Therefore, if you have concerns, you can use the following websites to search for payments made to doctors and hospitals by pharmaceutical and medical device companies:
Ethics in clinical trials dictates safeguarding patient privacy.
Certainly, researchers must safeguard the personal and health information of patients enrolled in clinical trials. Importantly, US laws require healthcare organizations to secure protected health information (PHI).
Fortunately, the same rules and regulations that protect the privacy of our health information when receiving healthcare services also protect our privacy when participating in clinical trials. This protection even extends to the publication of the trial results in scientific and clinical publications. For instance, no one should ever publish your identifiable personal information without your consent.
Moreover, when you share personal information with researchers, you are granting access, but you are not waiving all your rights. You can, and should, ask your doctor(s) what steps the researchers take to keep your information secure and private.
The US government has 2 laws that cover patient privacy and data security: HIPAA and HITECH regulations.
Firstly, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.
HIPAA applies to patients receiving standard care and to participants in clinical trials.
Expanding on HIPAA, the Health Information Technology for Economic and Clinical Health Act, (HITECH) was signed into law in 2009. This expansion of HIPAA focuses on the implementation and use of health information technology, with a particular emphasis on privacy and security.
The five HITECH Act goals below align with the goals of the US healthcare system:
- Improve healthcare quality, safety, and efficiency.
- Engage patients in their care.
- Increase coordination of care.
- Improve the health status of the population.
- Ensure privacy and security.
To achieve these goals, HITECH:
- Incentivizes the adoption and use of health information technology,
- Enables patients to take a proactive interest in their health.
- Paves the way for the expansion of Health Information Exchanges.
- Strengthens the privacy and security provisions of the HIPAA.
Healthcare providers and their business associates – including clinical trial researchers – must safeguard your protected health information with encryption, access controls, and more under these laws. Furthermore, if they don’t safeguard your information, and a security breach occurs, the institution can receive hefty fines.
Indeed, clinical research is important for medical knowledge and patient care. Fortunately, laws and regulations discourage unethical practices during clinical trials. Additionally, Institutional Review Boards play an integral part in assuring patient safety and ethical standards.
However, as with any other medical decision, before enrolling in a clinical trial you should do your homework and ask as many questions as you need. Moreover, speak up at any time if you have concerns!
Certainly, deciding to enroll in a clinical trial is a big decision. Therefore, I suggest you read the following posts for more information:
- Are Clinical Trials Safe?
- What You Need to Know About Clinical Trials Before You Sign the Dotted Line.
I wrote this article in collaboration with Lindsey Lee, a highly accomplished healthcare professional with over 9 years of experience in healthcare administration, medical billing and coding, and compliance. She holds several AAPC specialty certifications and has a bachelor’s degree in Health Administration. Lindsey currently works for Medcare MSO in the ICD-10 Editorial Department, writing articles about medical billing services. She has authored many articles for healthcare publications and has been a featured speaker at workshops and coding conferences across the country.