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Overview: In the previous week, you reviewed your research study and how the research questions could be measured with research. At this point, you are ready to draft sections that will ultimately lead to IRB application. Directions: Using the appropriate Word version of the IRB application from the IRB and Research Organization/Doctoral Research site, complete the following sections of the appropriate IRB application: Human subjects recruited Interaction with participants Identifiable private data Population and sampling Subject recruitment materials and procedures informed consent form and procedures.

Paper For Above instruction

This paper aims to guide the preparation of an Institutional Review Board (IRB) application based on a research study previously reviewed. It discusses the essential sections involved in the IRB submission process, including human subjects recruitment, interaction with participants, handling identifiable private data, defining the population and sampling methods, and developing recruitment materials and informed consent procedures.

Ethical approval from an IRB is crucial for research involving human subjects to ensure compliance with ethical standards and protect participant rights. The process begins with a clear understanding of the study's design and objectives, which informs the development of specific IRB sections. These sections must be completed meticulously to facilitate review and approval, ensuring the research adheres to ethical guidelines and regulatory requirements.

Human Subjects Recruited

Recruiting human subjects requires careful planning to ensure ethical standards are maintained. The target population must be clearly defined, including demographic characteristics such as age, gender, ethnicity, and other relevant factors. Recruitment strategies should be designed to reach potential participants effectively while minimizing coercion or undue influence. It is vital to provide potential subjects with comprehensive information about the study's purpose, procedures, risks, and benefits to enable informed decision-making.

Interaction with Participants

The interaction protocol with participants must be outlined to specify how researchers will communicate with subjects throughout the study. This includes how data collection will occur, whether in-person, via phone, or online. Researchers must also describe measures taken to ensure participant comfort, confidentiality, and voluntary participation. Training of research staff on ethical interaction and confidentiality procedures is essential for maintaining professionalism and compliance with IRB standards.

Identifiable Private Data

Handling identifiable private data involves strict confidentiality measures to protect participant anonymity. Researchers must specify the type of identifiable data collected, such as names, contact information, or medical records. Data storage protocols should include secured digital or physical storage, encryption, and access restrictions. Data sharing policies, data destruction timelines, and procedures for handling incidental findings should also be clearly articulated to conform with privacy regulations like HIPAA or GDPR.

Population and Sampling

The population refers to the total group from which research participants will be drawn. Sampling methods—probability or non-probability sampling—must be described, along with the rationale for choosing the specific method. Sample size calculations should be justified based on statistical power analyses to ensure the study's validity while avoiding unnecessary exposure of participants to research risks. Inclusion and exclusion criteria help delineate the sampling frame, ensuring the sample accurately represents the target population.

Subject Recruitment Materials and Procedures

Effective recruitment materials such as flyers, emails, or online advertisements should be developed with clear and concise information about the study. These materials must include details about the voluntary nature of participation, confidentiality guarantees, and contact information for questions. Procedures for recruiting subjects may involve initial contact methods, screening processes, and scheduling interviews or data collection sessions, all coordinated ethically and transparently.

Informed Consent Form and Procedures

The informed consent document must be comprehensive yet understandable, explaining the study's purpose, procedures, risks, benefits, confidentiality, and voluntary participation rights. Consent procedures may include verbal explanations, opportunities for questions, and documentation signatures. Researchers must ensure that consent is obtained freely, without coercion, and that participants understand they can withdraw at any time without penalty.

Conclusion

Preparing the IRB application involves detailed documentation of all aspects related to human subjects research. By carefully addressing recruitment, interaction protocols, data confidentiality, population sampling, recruitment materials, and informed consent, researchers can facilitate an ethical review process. Proper completion of these sections not only ensures compliance with regulatory standards but also reinforces the commitment to safeguarding participant rights and integrity of the research.

References

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• Office for Human Research Protections (OHRP). (2018). Guidance on Institutional Review Boards and Human Subjects Research. U.S. Department of Health & Human Services.
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• National Institutes of Health (NIH). (2020). Protection of Human Subjects. NIH Guidelines.
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• Sharp, L. A., & Han, D. Y. (2017). Privacy and confidentiality in health research. American Journal of Public Health, 107(3), 344–349.
• McWilliams, A. M., & M. (2016). Recruitment and retention of research participants. Clinical Trials, 13(3), 259-268.