Procedures and Ethical Standards

This article focuses on answering the questions or concerns many people face when considering joining a trial, such as how long it will last, legal issues, participant qualification and clinical trial ethical standards and procedures. While much of this will depend heavily on the individual trial being conducted, our goal at Clinical Trial Guide is to present information that we know to be true and consistent when it generally comes to how all clinical trials operate. This article details clinical trial procedures and ethical standards for clinical trials for patients and their caregivers.

What Are Some of the Legal Issues Involved?

There are many legal practices and laws put into place whenever it comes to clinical trials and research. This is due to errors in the past that resulted from a lack of knowledge and unethical behavior when safety and standard regulations were not put into place. The Federal Government has since established very strict rules that every clinical trial must follow in order to remain ethical, while also achieving scientific research and medical progress. There is much rigorous review and research conducted for a new drug before it reaches human trials.

Preclinical Trials and IND Applications

Before a clinical trial can be approved, the first step for a new drug or treatment is to go through preclinical testing. This involves studies and tests being conducted in labs with live cells, and with animals to determine if it is safe for humans. According to PhRMA, “The FDA requires extremely thorough preclinical testing before the candidate drug is allowed to be studied in humans” (Biopharmaceutical Research & Development). Once a drug has been through preclinical trial testing, the organization conducting the research must fill out and submit an IND (Investigational New Drug) application before it can be approved to begin research in human clinical trials.

The IND form is filed and submitted to the FDA for review and approval. This application includes the results of the new drug’s preclinical background, molecular structure, details on how it is presumed to work in the human body, and any presumed side effects. The IND also includes a plan for the clinical trial hoping to be conducted by mapping the how, why, where, and by whom the study being conducted involves (Biopharmaceutical Research & Development).

Institutional Review Boards

Following the preclinical and IND application, all clinical trials are required to be reviewed and approved by an institutional review board, or IRB, as well as an ethics committee. IRBs are composed of at least five members, which can be made up of doctors, scientists and lay people. Their responsibility is to review and approve clinical trials that take place in the respective jurisdiction they abide before a trial can begin in that area.

According to the National Cancer Institute, IRB board members “make sure that the risk or harms in the trial is low and that any harms are reasonable when compared to the possible benefits.” Additionally, IRBs closely monitor the progress of a trial approved, and may even require changes to certain protocols—or even disband the trial if necessary—in order to ensure the overall wellbeing of the volunteers that are participating (Scientific Review).

IRBs aim to protect the rights of the study volunteers and participants. If there are any risks indicated that are too great, the research will not be approved by the IRB, and the clinical trial may need to make adjustments before being considered any further.

Ethical Guidelines and Informed Consent

Ethical guidelines and procedures have long been integrated into the clinical trial review and practice requirements. This is to further ensure the safety of study subjects, as well as to keep researchers and trial conductors aware and accountable before, during, and after a clinical trial study. Ethical guidelines have been a wise requirement in addition to legal protocol for clinical trials in the United States.

Not only does the IRB review the overall safety of a new drug or treatment, but they also see who is conducting the trial and any persons or organizations that invest money into the trials. According to the FDA, the IRB “reviews how much money participants receive, and what those payments are for.” This is to make sure that any payment or financial investment in a clinical trial or to a clinical trial participant is ethical and does not possess any undue influence upon anyone’s decision to partake in the study.

Another mandatory ethical requirement is making sure that every participant in a clinical trial is receiving informed consent. The National Institutes of Health defines informed consent as: “the process of learning the key facts about a clinical trial before deciding to participate” (The Basics). This practice continues as participants advance throughout the study and as new information arises. The informed consent document should include information about the clinical trial and protocols, such as:

• Details about the study and its purpose
• The expected duration of the trial for each phase
• The required trial procedures
• Who to contact for numerous reasons or purposes
• Potential risks and benefits of the trial

We always want to emphasize that if there is ever a question or concern about your particular condition or anything involved with the clinical trial you are considering taking part in, please ask these questions before signing the informed consent document. Ask questions throughout the study as they arise, and if you are ever uncomfortable, you are free to leave at any time during the trial. Informed consent is a required ethical and legal practice as every participant has the right to know as much as they can about the things they will or may experience in these scientific studies.

FDA Approval and Continued Monitoring

Assuming that the FDA and IRBs have approved the clinical trial for study in humans and there are enough participants, the new trial is then authorized to legally operate and begin further research.

According to PhRMA, the “clinical trial research team, including the nurses and clinical investigators, continually monitor trial participants and collect data that will be carefully reviewed and tracked by the company supporting the research.” Even after a trial begins, the FDA, IRBs, and other necessary review boards will continue to monitor and receive updates on the trial to make sure that all safety protocols are being practiced at all times. They may also intervene if necessary upon the report of a participant having adverse reactions, therefore indicating the testing could be harmful to study subjects (Biopharmaceutical Research & Development).

The FDA or company overseeing the clinical trial has the legal authority and obligation to cease any trial deemed unsafe upon the discovery that the new treatment or drug could be harmful. In rare cases, trials are even cut shorter than usual if the candidate drug is performing phenomenally as it would be deemed unethical to withhold it from the patients in the trial that are not receiving it currently. This would help researchers fast-track the development and study of the new drug or treatment (Biopharmaceutical Research & Development).

Additional Trial Monitoring

During phase III of trials, Data Safety and Monitoring Boards (DSMBs) may also be incorporated into the overseeing process. As stated by the National Cancer Institute, “these boards review the progress of a clinical trial and monitor the safety of those taking part in the trial. They also review data on the effectiveness of the trial interventions.” These boards are typically made up of doctors, statisticians and independent people or parties from the organizations sponsoring or conducting the clinical trial taking place (Scientific Review).

Overall, there are many organizations involved in the legal and ethical process to ensure the safety and potential effectiveness of a new drug or treatment being developed for future use in patients. Once a clinical trial is complete, the FDA makes sure that the research from the trials is published and shared to the public at the appropriate time (Biopharmaceutical Research & Development). These practices and protocols hold all clinical trials to an ethical and legal standard and ensure that all findings and conclusions are fully disclosed to the public. Thanks to the regulations monitored by the FDA and many other organizations, clinical trials today have been able to remain a scientific practice while also maintaining good ethical applications, striving to operate as safely as possible.

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