Submitting a Complete Application
Submitting a project to the IRB for review requires an investigator to complete the application according to detailed instructions and enclose supporting material as necessary. Although no form can adequately address the wide diversity of research at an institution as large as the University of Minnesota, each application question needs to be addressed specifically and completely as ‘see protocol’ will not be acceptable.
Completing the IRB Application
- Ensure your application is the most up-to-date by downloading it from the web site before preparing each submission
- Respond to every question asked in the application, including a response for why a question might not apply to your proposed work
- Ensure you submit any appropriate appendices in addition to the application form
- Submissions should contain descriptions of
- Lay abstract describes the purpose of the study
- Study population
- Criteria for including and excluding participants
- Number of and process of identifying subjects
- Any other plans involving selecting subjects
- Description of tasks subjects will perform
- Full description of risks and benefits
- Strategy outline for minimizing risks
- Documentation of provisions to care for subjects in case of accident or injury
- Documentation of procedures for maintaining confidentiality
- Description of the process by which informed consent will be obtained from the appropriate individuals
Supplementary Documents
- Documentation of any required approvals or applications for approval from other committees and from cooperating agencies,
- Supporting materials and documents, including protocol, interview schedules, solicitation letters, advertisements, descriptions of any medications, and any survey instruments that are rarely used or are designed by the investigator (common standardized instruments can be merely cited), and
- Appropriate original signatures, including an academic adviser's signature for student research and department head signatures for all research.
Investigator Considerations
A research project is headed by a principal investigator (PI) who is the primary individual in charge of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project. The PI reports to a unit head or other designated official. Federal regulations for human subjects research at one time allowed the PI to shoulder most of the responsibility for a project. The regulations have recently emphasized that the whole research team shares responsibility, even though the PI directs the project and bears ultimate responsibility for its conduct.
The IRB must ensure that investigators have the training and experience required by each project. Researchers are given considerable latitude in designating the PI, and the IRB is most likely to have concerns about projects in which the principal investigator appears to lack training and experience in human subjects research or has a conflict of interest potentially influence the ability to ensure the subjects' well-being.
Some research projects include proposals delegating much of the recruitment or intervention to research associates. Those instances should have an explanation of the associates’ training accompanying the application.
Additional Information on Pre-Submission
Sponsored Projects: Roles and Responsibilities Oversight Model
Many of these responsibilities are delegated to various units and individuals within the institution. The University has adopted an institutional oversight model for sponsored projects. The Oversight Model establishes lines of authority within the University related to financial transactions on sponsored accounts.
Guide to Research Compliance
This guide provides regulatory resources to help researchers spot
typical compliance issues and communicate where to go for more information and help. This guide includes compliance checklists, following the lifecycle of a typical research project. Areas of potential compliance risk and the resources to contact for more information are provided for the following stages of research.
- Research Overview
- Research Classification
- Preparation
- Award
- Conducting Research
- Award Closeout.
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