The need for institutional review boards (IRBs).

Full Answer Section

• Upholding Ethical Principles: IRBs are guided by established ethical principles such as respect for persons (autonomy and protection of vulnerable individuals), beneficence (maximizing benefits and minimizing harm), and justice (fair selection of participants and equitable distribution of research burdens and benefits).
• Ensuring Informed Consent: A crucial function of the IRB is to review the informed consent process and documentation to ensure that participants are provided with adequate information about the research, understand the risks and benefits, and voluntarily agree to participate without coercion or undue influence.
• Maintaining Public Trust: By ensuring ethical conduct in research, IRBs contribute to maintaining public trust in the research process and the institutions that conduct it. This trust is essential for the continued participation of individuals in research that can lead to advancements in health and knowledge.
• Complying with Regulations: In many countries, including Kenya, research involving human subjects is subject to national and international regulations and guidelines. IRBs play a vital role in ensuring that research protocols comply with these legal and ethical frameworks.

Potential Effects and Impacts of IRBs on a Study:

While IRBs are essential for ethical research, their review process can potentially affect or impact a study in several ways:

1. Study Design Modifications and Enhancements:

   • Positive Impact: IRBs often provide valuable feedback on study protocols, leading to improvements in the research design. They may identify potential ethical concerns that researchers had not considered, suggest modifications to minimize risks, or recommend more robust procedures for obtaining informed consent or protecting vulnerable populations. For example, an IRB might suggest adding specific measures to protect the privacy of participants sharing sensitive health information or recommend a more culturally appropriate method for obtaining consent in a particular community in Kenya.
   • Potential Delay: The review process itself can take time, potentially delaying the start of a study. Researchers need to factor in the IRB review timeline when planning their research projects.

2. Constraints on Recruitment and Data Collection Methods:

   • Potential Limitation: IRBs may impose restrictions on recruitment strategies to ensure fairness and avoid coercion. For instance, they might disallow offering excessively large incentives for participation or restrict recruitment in settings where individuals may feel pressured to participate. Similarly, they may require modifications to data collection methods to minimize potential psychological distress or protect confidentiality. For example, an IRB might require researchers to anonymize data more thoroughly or to provide participants with access to mental health support if the research involves sensitive topics.
   • Ensuring Ethical Practice: These constraints, while potentially requiring adjustments to the research plan, are crucial for upholding ethical principles and protecting participants from harm or exploitation.

3. Increased Rigor in Informed Consent and Participant Protection:

   • Positive Impact: IRBs mandate a thorough and understandable informed consent process. This often leads to researchers providing more comprehensive information to potential participants, ensuring they are truly aware of the study's purpose, procedures, risks, and benefits. IRBs also require researchers to outline clear procedures for protecting participant confidentiality, managing data security, and addressing any potential adverse events. This enhances the ethical rigor of the study and safeguards the well-being of participants. For example, an IRB might require consent forms to be translated into local languages in Kenya and to include specific information about available compensation for research-related injuries.
   • Increased Administrative Burden: The process of preparing detailed consent forms, responding to IRB queries, and documenting the consent process can add to the administrative burden of the research team.

In summary, IRBs are a critical component of the research ecosystem, ensuring the ethical conduct of studies involving human subjects. While their review process can sometimes lead to modifications or delays, these impacts are generally outweighed by the benefits of enhanced ethical rigor, improved study design, and the protection of participant rights and welfare, ultimately contributing to more trustworthy and impactful research.

Sample Answer

The Need for Institutional Review Boards (IRBs)

Institutional Review Boards (IRBs), also known as Research Ethics Boards (REBs) in some regions, are committees established to review and approve research involving human subjects. Their existence is predicated on the fundamental ethical principle of protecting the welfare and rights of individuals who participate in research. The need for IRBs arises from a history of unethical research practices that have caused harm and violated the dignity of human beings.

The core justifications for IRBs include:

• Protecting Human Subjects: The primary mandate of an IRB is to ensure that research protocols are ethically sound and minimize risks to participants. This involves assessing the potential physical, psychological, social, and economic harms against the anticipated benefits of the research.