Clinical trials are pivotal in advancing medical research, offering new treatments and insights into various health conditions. However, alongside innovation comes the critical responsibility of ensuring ethical conduct, particularly in safeguarding the wellbeing and rights of clinical trial participants. To protect the rights and welfare of clinical trial participants and ensure their safety, Ethics committees, also known as Institutional Review Boards (IRBs) or Research Ethics Boards (REBs), are indispensable in this process. They are independent bodies mandated to review and approve all aspects of a clinical trial protocol before it commences. Their primary goal is to protect the rights, safety, and welfare of trial participants, ensuring that the potential benefits of the research outweigh any risks.

The committee conducts regular and independent reviews to protect the health, rights, and welfare of participants. Federal regulations in the U.S. and other countries require that research projects involving human participants obtain IRB approval to continue. The ethics committee has the authority to approve, disapprove, require modifications (to be approved), monitor, and exempt studies. Read on to learn more about the pivotal role of ethics committees and how they keep clinical trial participants safe. 

 

Purpose of Ethics Committees 

Research Ethics Committees (EC), or Institutional Review Board (IRB), as designated by the U.S. Food and Drug Administration (FDA), are administrative bodies established to protect the health, human rights, and safety of patients recruited to participate in clinical research activities. 

The purpose of EC review, both in advance of a study and periodic review, is to ensure that steps are taken to protect the rights and safety of human participants. To this end, ECs use a group process to review and approve study protocols and related materials, e.g., informed consent documents, and to monitor ongoing research to continuously protect human volunteers, human rights, autonomy, confidentiality, and welfare of participants. According to FDA regulations, IRBs can approve, require modifications (to secure approval), or disapprove research. An independent body comprising members with expertise in both scientific and non-scientific areas, ECs operate based on six basic principles of autonomy, justice, beneficence, nonmaleficence, confidentiality, and honesty.  

 

Importance of Ethics Committees 

Ethics Committees play an essential role in reviewing and determining the validity of studies by comprehensively examining them for ethical issues1. They are integral in regulating research and ensuring patient safety. ECs have demonstrated their contribution to ensuring safe study designs, protecting the safety of human subjects, and protecting researchers from before study initiation to study completion and post-approval monitoring. For larger multi-region complex trials, data safety and monitoring boards (DSMBs) complement EC reviews for continuous monitoring and better protection of research subjects. 

 

Continuously upholding ethical standards  

The EC review process is continuous and is needed before study initiation, for monitoring adverse events (AEs), and until the completion of all data collection and analysis. The Good Clinical Practice (GCP) guidelines recommend that ECs review ongoing research as appropriate to the risks involved (at least once a year) by monitoring whether they abide by ethical regulations and adhere to the approved protocol.  

 

Ethically contributing to scientific knowledge 

ECs assess the risks and benefits of the proposed research and determine if a study is adequately designed to add to the scientific knowledge base while maintaining patient safety. In addition to aligning with GCP guidelines, the study design must be scientifically sound and conducted ethically to include participants with voluntary informed consent.  

 

Ensuring Patient Safety

1. Research methodology and risk

ECs are responsible for assessing research methodology and risk and determining if the proposed research is justified to avoid wasting the time and resources of participants and researchers alike. The EC monitors research protocols and related materials, e.g., informed consent documents, and the safety of study volunteers at the local level.  

 

2. Minimize risks for participants

ECs minimize the risk to the participant by reviewing the eligibility criteria, monitoring participants, checking whether proposed procedures are well justified, ensuring that research personnel are qualified, and checking whether there are standard operating procedures (SOPs) for the exclusion of participants. 

 

3. Ensuring privacy and confidentiality

Privacy and confidentiality must be maintained to help build trust, reduce participant anxiety, and preserve dignity. In addition to reviewing the consent document and process, the EC reviews measures taken to maintain participants’ privacy (particularly for multicenter projects), among other things. 

 

4. Monitoring data and maintaining oversight

Establishing data safety monitoring protocols includes monitoring and reporting adverse events (AEs). Complex clinical trials and multicenter, randomized controlled trials (RCTs) may require additional protection through a Data Safety Monitoring Board (DSMB). The functions of a DSMB include upholding participant safety, ensuring the integrity of the trial for future participants, ensuring the timely conclusion of the study so that the results can be disseminated, identifying protocol violations, if any, and identifying unexpectedly high dropouts.

During the trial, ethics committees oversee the systematic recording and reporting of adverse effects experienced by participants. They require investigators to document all adverse events, regardless of severity, and to report them promptly to ensure transparency and participant safety. ECs provide ongoing oversight throughout the trial’s duration. They review any amendments to the protocol, assess participant enrollment and withdrawal criteria, and monitor compliance with ethical guidelines and regulatory requirements. This continuous oversight is crucial for maintaining the integrity of the trial and safeguarding participant welfare.

 

5. Post-approval monitoring

ECs are responsible for conducting both pre- and post-approval oversight. Post-approval follow-up by ECs is a valuable resource and opportunity for early detection and resolution of protocol violations. Post-approval monitoring aims to ensure compliance with approved protocols, preserve research integrity, manage institutional risks, provide advisory/educational support to researchers, recommend corrective actions for identified issues, and ultimately protect the safety, rights, and well-being of participants.  

 

New and Evolving Ethical Considerations 

As clinical research evolves, so too do the ethical considerations faced by ethics committees. Advances in technology, changes in societal values, and the globalization of clinical trials have introduced new complexities that require careful consideration to ensure ethical conduct and participant safety.

1. Integration of digital health technologies

The integration of digital health technologies, such as wearable devices and remote monitoring tools, presents both opportunities and challenges for ethics committees. While these technologies can enhance data collection and participant monitoring, they also raise concerns about data privacy, informed consent in digital environments, and the equitable access to technology among diverse participant groups.

 

2. Inclusion and diversity

Ethics committees are increasingly focused on ensuring the inclusion and diversity of trial participants. This includes addressing barriers to participation faced by underrepresented populations, such as minorities, elderly individuals, and those with disabilities. Ensuring equitable access to clinical trials and considering cultural sensitivities in research protocols are essential aspects of promoting ethical conduct.

 

3. Globalization and cultural sensitivities

The globalization of clinical trials has expanded research opportunities but also necessitates heightened awareness of cultural differences and regulatory variations across different regions. Ethics committees must navigate these differences to ensure that research protocols respect local norms, values, and regulatory requirements while upholding universal ethical principles.

 

4. Emerging issues in gene therapy and biotechnology

Advancements in gene therapy and biotechnology present unique ethical challenges related to informed consent, long-term follow-up of participants, and the potential for unforeseen genetic consequences. Ethics committees play a critical role in evaluating the ethical implications of these cutting-edge therapies, balancing potential benefits with risks, and ensuring comprehensive risk communication to participants.

 

5. Ethical oversight in big data and artificial intelligence (AI)

The use of big data analytics and artificial intelligence (AI) in clinical research raises concerns about data privacy, algorithmic bias, and the interpretability of AI-driven insights. Ethics committees are tasked with evaluating the ethical implications of these technologies, ensuring transparency in data usage, and protecting participant confidentiality in the era of digital healthcare innovation.

A Swiss study highlighted gaps in the oversight mechanism of ECs in the face of big data, which may negatively impact patient safety and well-being. These gaps include limited experience with reviewing big data research, lack of expertise in data science, and uncertainty about big data research risk mitigation due to the computational complexity, methodological novelty, and limited auditability of big data approaches.

Furthermore, a recent paper on challenges posed by AI on research ethics highlighted the lack of knowledge and tools of ECs when conducting the ethical assessment of projects in AI research. To address these challenges, researchers recommend developing standard guidelines and mechanisms of oversight to adequately evaluate AI research ethics.  

 

6. Adapting ethical guidelines and standards

In response to these evolving challenges, ethics committees continuously adapt ethical guidelines and standards to reflect current scientific knowledge, societal expectations, and regulatory requirements. Collaborative efforts among researchers, ethicists, regulators, and patient advocates are essential for developing robust ethical frameworks that uphold participant rights and promote responsible research conduct.

 

7. Community-engaged research proposals

Investigators conducting community-engaged research are often met with challenges when seeking IRB approval. These challenges include community partners not being recognized as research partners, gaps in cultural competence, language of consent forms, and literacy level of partners, amongst others. To fulfill their mandate and protect patient safety, the authors’ recommendations include training IRBs to understand community-engaged research principles, requirements, and methodologies.

 

Conclusion

In conclusion, ethics committees play an indispensable role in clinical trials by safeguarding patient safety, upholding ethical standards, and ensuring the responsible conduct of research. Through rigorous review, monitoring, and oversight, these committees contribute to the ethical advancement of medical knowledge while prioritizing the well-being of trial participants. Their diligence and commitment are essential for maintaining public trust in clinical research and advancing healthcare innovation responsibly.

 

TFS HealthScience: Prioritizing Patient Safety and Well-being 

The guiding principles and practices at TFS HealthScience prioritize patient rights, patient safety, and data integrity. TFS is a global contract research organization (CRO) committed to protecting its patients, ethics, and integrity and conducting clinical trials transparently. To this end, TFS invests in systems and technologies that enable us to improve trial efficiency while remaining patient-centric and prioritizing patient rights and safety.    

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