2.3. Describe the role of the research ethics committee

This guide will help you answer 2.3. Describe the role of the research ethics committee.

The research ethics committee (REC) plays a critical part in overseeing ethical standards in research. Its role prioritises protecting the rights, dignity, and welfare of individuals participating in research. This applies particularly to studies involving human subjects. The committee ensures researchers conduct their studies responsibly and ethically, safeguarding both participants and the quality of the research itself.

Overview of the REC

The REC is an independent body. It reviews and monitors research projects, ensuring they comply with ethical principles and legal regulations. These principles help in building trust between researchers and participants by fostering transparency and integrity.

The REC typically includes professionals from different disciplines, such as healthcare experts, legal advisors, and laypeople (non-specialists). The lay members represent the general public’s perspective, while professionals bring specialised knowledge. This combination ensures a balanced approach when reviewing research proposals.

Protecting Research Participants

One of the main functions of the REC is protecting participants involved in a study. This involves ensuring that:

• Participants are treated with respect at all times.
• Risks to participants are minimised.
• Appropriate support is available in case participants face harm or distress.

For example, a REC may request a mental health support plan for studies involving sensitive topics, such as bereavement or trauma.

Informed Consent
The REC ensures that researchers obtain informed consent before participants take part in a study. Informed consent means participants fully understand what the research involves, including its purpose, duration, potential risks, and benefits.

An REC might ask researchers to:

• Use simple, non-technical language in consent forms.
• Provide opportunities for participants to ask questions.
• Allow participants to withdraw at any time without facing negative consequences.

Ensuring Ethical Research Design

The REC thoroughly examines each research proposal to check its ethical validity. This means considering whether the study methods align with ethical guidelines. The committee may assess:

• The balance of risks versus benefits – Is the potential benefit worth any possible risks participants might face?
• The necessity of the research – Is the study essential, or could its aims be achieved through other means?

For example, if invasive procedures are proposed for a study, the REC may challenge whether these are truly necessary or if a less invasive method can be used. Similarly, they will assess if data collection respects privacy and confidentiality.

Protecting Vulnerable Groups

Certain groups may be considered more vulnerable in research settings. These can include:

• Children and young people
• Pregnant women
• Older adults
• Those living with disabilities or serious health conditions

The REC closely examines studies involving such groups to ensure they are not exploited or exposed to unnecessary harm. For instance, research involving children might require additional parental or legal guardian consent forms.

Safeguarding Data Privacy and Confidentiality

The REC ensures researchers adopt secure methods for handling participants’ sensitive information. This includes ensuring data is anonymised wherever possible, and access is limited to authorised personnel only.

A key concern is compliance with UK data protection laws, such as the Data Protection Act 2018. If a research project plans to share personal or health data, the REC checks that researchers have valid reasons for doing so and have taken appropriate steps to secure it.

Maintaining Fair Treatment

As part of its role, the REC ensures research studies treat all participants fairly. This means avoiding bias or discrimination based on race, gender, disability, or other characteristics protected under the Equality Act 2010.

For instance, if a study excludes certain groups without valid justification (e.g., only recruiting male participants for a general health study), the REC would likely raise concerns.

Legal and Regulatory Compliance

RECs ensure that research complies with relevant laws and regulations. In healthcare research, this may include meeting the standards set out by:

• The Medical Research Council (MRC)
• The NHS Health Research Authority (HRA)

Competitive international research may also require adherence to global ethical guidelines, such as the Declaration of Helsinki. The REC is responsible for aligning local research practices with these standards.

Ongoing Monitoring of Research

An REC’s role doesn’t end once it approves a research study. It often monitors projects throughout their duration to ensure they continue meeting ethical standards. Researchers may be required to submit progress reports or notify the REC of any significant changes to their study protocols.

If a participant is harmed during a study, the REC may intervene to assess whether the research can continue safely.

Promoting Public Trust in Research

By ensuring ethical standards are met, the REC promotes public confidence in the research process. People are more likely to participate in studies and benefit from their findings when they trust the research is carried out responsibly.

The REC acts as a bridge between researchers and society, advocating for participant welfare while supporting meaningful scientific progress.

Encouraging Transparency

Transparency is another priority for RECs. This involves ensuring all information shared with participants or the public is clear and accurate. Researchers are expected to provide honest reports of their study’s findings, whether these are positive, negative, or inconclusive.

For example, if a drug trial reveals no beneficial effect, the REC would expect the researchers to report this rather than withholding the results.

Addressing Ethical Dilemmas

Research often involves complex ethical challenges. The REC provides a forum for discussing and resolving such issues. By drawing on diverse expertise, members contribute to balanced, informed decisions.

For example, research involving artificial intelligence (AI) may raise ethical questions about privacy or bias. The REC ensures these are addressed before the research begins.

Training and Support for Researchers

The REC also serves as an educational resource. It helps researchers understand their ethical responsibilities by offering guidance and recommendations. This support can help ensure future research project proposals are ethically sound from the outset.

For example, the REC might suggest how researchers could improve participant information sheets to make them clearer and more accessible.

Conclusion

The research ethics committee plays a vital role in maintaining high ethical standards across research projects. Its responsibilities include protecting participants, ensuring informed consent, safeguarding privacy, and promoting fairness. By fulfilling these functions, the REC not only facilitates valuable research but also ensures it respects the rights and welfare of those involved.