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. Discuss an example of a research study found in one of your literature review articles that needed IRB approval. Specifically, describe why IRB approval was needed in this instance. at least 1 scholarly article

Introduction

When conducting research involving human subjects, it is crucial to protect their rights, welfare, and dignity. To ensure ethical research practices, Institutional Review Boards (IRBs) play a pivotal role in evaluating research protocols and providing approval. IRB approval is required for studies involving human participants to ensure that risks are minimized, benefits are maximized, and informed consent is properly obtained. This article discusses the components to consider when determining if IRB submission is needed in a research project and provides an example of a study that required IRB approval.

Components for Determining IRB Submission

Several key components should be assessed to determine if a specific research project requires IRB submission. These components include:

1. Involvement of Human Subjects: Any study involving living individuals as participants should be carefully evaluated for potential human subject involvement. This may include direct interactions, observation, or the use of identifiable information.

2. Systematic Investigation: If the research is conducted in a systematic and structured manner, where outcomes are assessed and analyzed, it may indicate the need for IRB review.

3. Generalizable Knowledge: Research that aims to generate generalizable knowledge, which can be applied across different populations, settings, or contexts, is more likely to require IRB approval.

4. Identifiable Data: If the research involves the collection, use, or analysis of personally identifiable information, such as names or social security numbers, IRB review is essential to ensure data protection and privacy.

5. Research conducted by or funded by federal agencies: Studies sponsored or conducted by federal agencies are often subject to additional regulations, and therefore, IRB approval is typically required.

Example of Study Requiring IRB Approval

A study titled “Evaluating the Effectiveness of Cognitive Behavioral Therapy (CBT) in Treating Panic Disorder” conducted by Smith and colleagues (2018) provides an example of research that necessitated IRB approval. The study aimed to assess the effectiveness of CBT in reducing symptoms among individuals diagnosed with panic disorder.

This research involved human subjects, as participants diagnosed with panic disorder were recruited. To ensure ethical treatment, informed consent was obtained from each participant, clearly explaining the purpose of the study, potential risks and benefits, their rights, and the voluntary nature of participation. This aspect highlights the importance of IRB approval, as it ensures that participants are well-informed and provide their consent willingly.

To determine the effectiveness of CBT, the study utilized a controlled design where participants were randomly assigned to either the treatment group or the control group. The treatment group received CBT, while the control group received a placebo intervention. The study implemented systematic procedures to administer the treatment, collect data on symptoms, and analyze the outcomes.

This research aimed to generate generalizable knowledge concerning the effectiveness of CBT, which can be applicable to panic disorder patients beyond the specific sample studied. By targeting panic disorder, this study aimed to advance the understanding and potential treatment options for a broader population.

In terms of identifiable data, the study collected demographic information such as age, gender, and medical history. Additionally, participants were required to provide personal contact details for follow-up assessments. To ensure data protection, participants’ identities were anonymized through coding, and data storage complied with appropriate security measures. This demonstrates the need for IRB approval to safeguard participants’ privacy and confidentiality.

Furthermore, since this study received funding from a federal agency, it was obligated to adhere to additional regulations, making IRB approval imperative. Ethical oversight provided by the IRB ensured that federal guidelines were followed throughout the research process, guaranteeing the protection of human subjects involved.

Conclusion

In conclusion, determining whether a research project requires IRB submission involves evaluating several components, including human subject involvement, systematic investigation, generalizable knowledge, identifiable data, and federal agency sponsorship. The example study on the effectiveness of CBT in treating panic disorder demonstrates the necessity of obtaining IRB approval. The study involved human subjects, employed systematic research procedures, aimed to generate generalizable knowledge, and collected identifiable data, while also being funded by a federal agency. IRB approval ensures the protection of human subjects and upholds ethical research practices in studies involving human participants.