By: Inclduovate Team
As researchers in the development space, we’re all too familiar with the critical role that ethical considerations play in our work. Whether you’re conducting clinical trials, interviews, surveys, or behavioural studies, navigating the landscape of Human Research Ethics Committees (HRECs) and Institutional Review Boards (IRBs) is an essential part of our research process. Let’s delve into the key aspects of these approval processes that every researcher should understand.
Purpose of HREC/IRB
At their core, HRECs/IRBs serve as guardians of ethical research practices. These committees ensure that our studies involving human participants adhere to ethical standards and comply with reglatory requirements. Their primary focus is safeguarding the rights, dignity, and well-being of research participants – a responsibility we all share as ethical researchers.
Key Differences Between HREC and IRB
While HRECs and IRBs serve similar functions, it’s crucial to understand their regional differences, especially for those of us engaged in global research. HRECs are typically found in Australia and some other regions, while IRBs are more common in the United States and various international contexts. The terminology may differ, but the underlying principles remain consistent.
Types of Research Requiring Review
It’s a common misconception that only high-risk studies require ethical review. In reality, any research involving human participants must undergo this process. This includes clinical trials, interviews, surveys, focus groups and behavioural studies. Even if we perceive the risks as minimal, it’s our responsibility to submit our work for review.
Common Ethical Concerns Addressed
When preparing submissions, it’s helpful to understand the key ethical concerns that review committees typically focus on:
(1) Informed Consent and Participant Autonomy: Ensuring participants are fully aware of the study’s purpose, procedures, risks, and benefits before they agree to participate. This includes clear communication about their right to withdraw at any time without consequences, and ensuring consent is given without coercion. For research involving vulnerable populations or cross-cultural contexts, this may require additional considerations such as translated materials or culturally appropriate consent processes.
(2) Privacy and Confidentiality of Data: Implementing robust measures to protect participant privacy and maintain data confidentiality throughout the research process. This encompasses secure data storage protocols, clear procedures for handling sensitive information, methods for de-identifying data, and specific plans for data sharing and disposal. Particularly crucial in today’s digital research environment, this also includes considerations for cybersecurity and digital data protection.
(3) Minimisation of Risks and Ensuring Participant Welfare: Carefully identifying potential physical, psychological, social, or economic risks to participants and implementing specific strategies to minimise these risks. This includes having clear protocols for handling adverse events, providing appropriate support services when needed, and ensuring the research benefits outweigh any potential risks. Regular monitoring of participant welfare throughout the study is essential.
(4) Fair Recruitment Practices and Equitable Distribution of Benefits: Ensuring research participant selection is equitable and based on sound scientific criteria rather than convenience or vulnerability. This includes justifying any inclusion/exclusion criteria, avoiding exploitation of vulnerable populations, and ensuring that the benefits and burdens of research are distributed fairly.
Addressing these concerns thoroughly in our proposals can significantly streamline the review process.
Steps in the Approval Process
The approval process typically follows these steps:
(1) Ensure clear and detailed informed consent forms
(2) Ensure all research tools for data collection have been submitted for review
(3) Be transparent about potential risks and how they will be mitigated
(4) Involve local partners or experts, especially in cross-cultural research, to ensure ethical relevance
Timelines and Expectations
One of the most common questions among our peers is, “How long does approval take?” The honest answer is that it varies. Approval can take anywhere from a few weeks to several months, depending on the complexity of the study and the committee’s workload. As seasoned researchers, we know that early planning is crucial to avoid delays that could impact our project timelines.
Post-Approval Monitoring
Our ethical responsibility doesn’t end with initial approval. HREC/IRBs continue to monitor ongoing studies to ensure ethical standards are maintained. This often involves submitting periodic reports and potentially undergoing audits, particularly for long-term or high-risk research. It’s an ongoing process that helps maintain the integrity of our work.
Remember, the ethical review process isn’t just a bureaucratic hurdle. It’s an opportunity to refine our research designs, consider potential impacts more deeply, and ultimately produce more robust, ethical, and impactful research.
As we continue to push the boundaries of knowledge in our respective fields, let’s view ethical review as an integral part of our research process. By doing so, we not only protect our participants but also enhance the quality and credibility of our work in the global research community.
You can learn more about the HREC and IRB process Here
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