An institutional review board (IRB), also known as an independent ethics committee, ethical review board, or research ethics board, plays a crucial role in overseeing clinical research and ensuring that capstone projects involving human subjects are conducted in an ethical manner. As the name suggests, the IRB is intended to provide institutional review and approval of research studies to ensure they are properly designed and do not expose participants to unreasonable risks.

Any clinical research management capstone project that involves interacting with or collecting private information from human subjects is required to secure approval from the student’s university or college IRB before beginning data collection or recruitment activities. This applies whether the proposed research involves direct interaction with participants through surveys, interviews, focus groups, or medical procedures, or if it only involves the collection and analysis of existing private data.

The primary responsibility of the IRB in the context of a capstone project is to review the student’s proposed research methodology and ensure adequate provisions are in place to protect participants. This includes evaluating items like the research design, recruitment plans, informed consent processes, data security measures, potential risks and benefits, and procedures to address unanticipated problems. The IRB wants to verify the proposed research offers value while imposing minimal risks to participants.

Some key aspects the IRB will examine related to a clinical research management capstone proposal include: carefully assessing the research objectives and methodology to determine any potential physical, psychological, social, legal, or economic threats to participants; ensuring recruitment plans do not involve coercion or undue influence and that participation is voluntary; reviewing the informed consent document to confirm it clearly outlines the study purpose, procedures, risks/discomforts, benefits, confidentiality practices, and participants’ rights; evaluating data collection tools like surveys, questionnaires or interview guides for sensitive, intrusive, or misleading questions; determining appropriate measures are in place to protect privacy and securely store any identifiable data collected.

Depending on the level of risk involved, the IRB may require modifications to the research design, consent process or plans prior to approval. Once approved, many IRBs also conduct continuing reviews of projects that pose greater than minimal risk to ensure proper procedures continue to be followed. Students are expected to promptly report to the IRB any unexpected problems, adverse events, or protocol deviations that occur during their study.

Upon completion of a capstone project, the IRB will usually require the student to submit a final report or closure form summarizing their research findings, how many participants were enrolled, any issues encountered, and confirming all data has been anonymized or destroyed as outlined in the approved application and consent document. This allows the IRB to close out the review record for that particular study.

Securing IRB approval is a necessary step for any clinical research management capstone that involves human subjects and is intended to provide an essential oversight function. Through its review processes, the IRB aims to help students design ethical research methodologies that produce valuable results or insights while minimizing potential harms to participants. Completing the IRB approval process offers students experience navigating research standards and regulations, plus helps ensure their capstone work complies with ethical principles for conducting research involving human subjects.

The institutional review board or IRB serves a critical gatekeeping role for clinical research management capstone projects that involve interacting with or collecting private information from human participants. Through its study review and approval functions, the IRB aims to protect research subjects from physical, psychological and other risks while also supporting the student in designing rigorous and ethical research to fulfill their capstone requirements. Securing IRB approval is a mandatory part of the clinical research process that students must successfully navigate.