1-IRB is an important step in research. State the required components one should look for in a project to determine if IRB submission is needed? 2-Think back on your National Institute of Health (NIH) training and share what you learned. How will this apply to having an IRB form completed and why?
1- The IRB, or Institutional Review Board, plays a crucial role in ensuring the ethical conduct of research involving human subjects. To determine if IRB submission is needed for a project, several components need to be considered. These components include the involvement of human subjects, the nature of the research, the potential risks and benefits, and the funding source.
The first component to consider is whether the project involves human subjects. According to the regulations set forth by the Department of Health and Human Services (DHHS), human subjects are defined as living individuals about whom an investigator (or team member) conducting research obtains data through intervention or interaction with the individual or identifiable private information. If a project involves interactions with individuals or the collection of identifiable information, it is likely to meet the definition of human subjects research and would require IRB review.
The nature of the research is another critical component. Some types of research are exempt from full IRB review because they involve minimal risk to subjects or do not involve interventions or data collection under certain conditions. The DHHS provides a list of exempt research categories, such as research involving surveys, interviews, observation of public behavior, or existing data, under specific circumstances. However, even if a project qualifies for exemption, it is still important to document the exemption status and ensure compliance with applicable regulations and ethical principles.
The potential risks and benefits associated with the research are also important considerations. The IRB evaluates if the risks to participants are minimized and reasonable in relation to the potential benefits. Risks can be physical, psychological, legal, or social, while benefits can include knowledge gained, improvement in participant understanding or well-being, or societal benefits. If a project poses more than minimal risks to participants, or if there are potential benefits to participants or society, IRB review is typically required.
Finally, the funding source can be an indicator of whether IRB submission is needed. Most funding agencies, such as the National Institute of Health (NIH), require research projects they fund to undergo IRB review. This is because funding agencies want to ensure that their resources are being used in an ethical manner and that the rights and welfare of research participants are protected.
2- The National Institutes of Health (NIH) provides valuable training and resources for researchers to enhance their knowledge of ethical considerations in human subjects research. Understanding the content covered in NIH training can greatly assist in completing an IRB form and ensuring ethical compliance.
One key aspect of NIH training is the reinforcement of the importance of protecting the rights and welfare of research participants. The training familiarizes researchers with the ethical principles that should guide their work, such as autonomy, beneficence, and justice. This knowledge can be directly applied to completing an IRB form by ensuring that the research design and procedures adhere to these principles. For example, researchers can consider how they will obtain informed consent from participants, how they will maintain participant privacy and confidentiality, or how they will address any potential conflicts of interest within the study.
Furthermore, NIH training emphasizes the significance of conducting risk assessments and mitigating potential harm to participants. Researchers are encouraged to evaluate and minimize risks, both physical and psychological, through careful study design and implementation. This knowledge can be applied to the completion of an IRB form by accurately describing the potential risks to participants and detailing the steps the research team plans to take to minimize these risks. Additionally, researchers can address any potential vulnerabilities of specific populations and ensure appropriate measures are in place to protect their well-being.
Lastly, NIH training emphasizes the importance of incorporating diverse perspectives and promoting the equitable inclusion of populations in research. Researchers are encouraged to consider how their research may impact different population groups and strive for inclusivity in study design and recruitment. This emphasis on diversity and inclusion can be applied to the completion of an IRB form by considering if the research sample adequately represents the target population and if there are any potential disparities in access to participation.
In conclusion, the knowledge gained from NIH training on ethical considerations in research can greatly assist in completing an IRB form. The training reinforces the importance of protecting participants’ rights and welfare, conducting risk assessments, and promoting diversity and inclusion in research. By integrating these principles into the IRB form, researchers can help ensure ethical compliance and contribute to the responsible conduct of human subjects research.