Tutorial Chapter 18: What should investigators do during the application process and the course of their projects?

The regulations for research involving human subjects are established by the Federal government in conjunction with state and local requirements. The University is responsible for their implementation by developing internal policies and procedures.

Primary responsibility for incorporating and adhering to the regulations and policies, however, rests with the principal investigator and the research staff. In carrying out any research work with human subjects, the principal investigator is responsible for:

• Knowing, understanding, and adhering to the ethical principles and current Federal, state, local and institutional regulations, relating to research activities involving human subjects
• Considering and incorporating these principles and regulations and the welfare of potential subjects in all aspects of designing and carrying out the research
• Fully completing the Application for Activities Including Human Subjects, and providing all necessary documentation and associated information, including when appropriate, IRB approvals from cooperating institutions and the application for waiver of HIPAA authorization.
• Submitting the completed application to the UCAIHS at the appropriate point in the research development process (timing may be particularly important if external support is being sought for the project)
• Responding to any requests from the UCAIHS for revision or additional information and clarification as part of the approval process
• Receiving full approval from the institutional IRB before initiating any research activities with human subjects and completing only such work with human subjects as approved by the IRB
• Training and supervising research staff in all aspects of the ethics and individual responsibilities of research involving human subjects
• Informing potential subjects fully of the purpose and nature of the research work in which they are being asked to participate
• Assuring the voluntary nature of participation and that of the data obtained
• Informing subjects of the extent to which their privacy will be protected
• Submitting modifications to the project to the UCAIHS for review and approval before implementing them
• Completing and submitting an annual Continuing Review Progress Report before the end of the current approval period if the project is not deemed exempt
• Notifying the IRB immediately of any adverse outcomes or effects involving human subjects and the steps being taken to remedy such outcomes or effects.

Chapter Review

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