Clinical Research Curriculum

The Clinical Research Curriculum series is an education program designed to provide beginning clinical researchers with information necessary to successfully engage in human research projects conducted within University Hospitals. Following are the broad topics that will be covered and what you can expect to learn after completing each topic session. Upon completion attendees will have an understanding of IRB processes and institutional and Federal policies relating to the responsible conduct of research.

View and complete the Clinical Research Curriculum Competency Checklist (PDF).

Introduction to Human Subjects Research

During this session, participants will gain an understanding of:

• The history of experimentation with humans which contributed to the development of current research regulation and guidance.
• Obtain an understanding of the Federal research regulatory organizations and their role in regulating human research participation.
• The importance of AAHRPP certification.
• The roles and responsibilities of the IRB.
• The role of the UH Center for Clinical Research and Technology in facilitating research at UH.

IRB Review Process

During this session, participants will gain an understanding of:

• How and when to apply for IRB review.
• UHCMC policies and procedures pertaining to human subject research.
• IRB submission and review process.
• Use of protected health information (PHI) in human subject research (HIPAA Privacy Rule).
• Red flags and potential problem areas in research submissions.

Informed Consent

• Informed consent as a process, not simply a document.
• The requirements of informed consent document including applicable Federal Regulations and UHCMC IRB Policies.
• The purpose and importance of obtaining informed consent from research participants.
• The importance and process for documenting the informed consent process
• The process of enrolling research participants who cannot provide consent for themselves (e.g. minors, decisionally impaired).

Grants and Contracts

During this session, participants will gain an understanding of:

• The services performed by the Pre-Award and Post-Award Offices in the Center for Clinical Research and Technology.
• Why all research grants and contacts are reviewed by the Office of Grants and Contracts.
• How to set up a grant account
• How to develop a research study budget.
• Research patient billing.

Event Reporting

During this session, participants will gain an understanding of:

• The definition of an Adverse Event (AE) and a Serious Adverse Event (SAE).
• The definition of a protocol deviation and unanticipated problem.
• Reporting requirements for AEs, SAEs, protocol deviations and unanticipated problems.
• The difference between an internal and external event.

Study Activities and Compliance

During this session, participants will gain an understanding of:

• The different roles and responsibilities of members on the research team.
• The tools and documents available for managing a clinical research study,.
• What happens during a 'monitor visit' and how to prepare.
• Drug and/or device accountability
• The critical documents required for the regulatory binder and maintenance to ensure compliance
• Scientific misconduct.
• The consequences of non-compliance with Human Subjects' Regulations
• The role of the UH Compliance and Ethics Committee.
• The role of the UHCMC Office of Research Compliance and availability of investigator support.