Now that you have submitted and received approval for your research proposal, you must go before the IRB (institutional review board) at the site where you plan to select subjects and conduct your research. In this final project, describe the role of an IRB in a research process. What types of concerns might they have about your planned study? What documents are they likely to want to see. Prepare a POWERPOINT presentation (5-8 SLIDES) that you would give to this group to gain approval for your study and to gain access to the subjects connected to this site. The first slide should list and summarize their key areas of concern and their role in research.
Summary of IRB roles and responsibilities.
- Provide guidance regarding the interpretation of regulations, laws, and policies to researchers, staff, and administrators.
- Ensure compliance with the terms of facility as well as with state and federal policies and procedures, federal regulations, and state and local laws related to the review of human research.
- Participate in the development and subsequent implementation of human research protection policies and procedures.
-Perform quality assurance monitoring of research protocols and investigate matters of non-compliance. Implement corrective action(s) as needed in accordance with federal regulations, policies, and IRB policies and procedures.
- Provide human research protection training for investigators, key study personnel, IRB members, and IRB staff.
-Complete all training requirements and stay informed of current research-related and regulatory developments.
-Monitor federal regulatory websites and other research-related resources to stay current with regulatory changes in human research protection guidelines and policies. Communicate pertinent information to other IRB staff, IRB members, and investigators in a timely manner.
-Maintain IRB study-related documentation in accordance with system policies, IRB policies, and federal regulations.
Slides should include:
-Overview of planned research question and purpose
-Use of Human Subjects in the study-size and description of selection criteria
-Data collection tools and strategies
-Process for selection of subjects
-Plan for disclosure and forms to document willingness to participate in study to be given to subjects
-Plan for protection of information and protection of human subjects.
The solution applies research concepts and principles by developing a research strategy and proposal for a project.