The most significant noncompliance risks in an institution’s research enterprise frequently involve the administrative, regulatory and ethical issues in human subjects research broadly as well as those that are more specific to clinical research (see Clinical Research page).  Research Compliance Consulting can assist you in evaluating and addressing any and all of them.

• Human subjects protection programs and accreditation
• Institutional Review Board (IRB) review processes
• IRB operations and documentation
• Human subjects research monitoring programs
• Tissue and data repositories
• Informed consent process and documentation
• Researcher education on human subjects research ethics and regulations
• Conflict of interest policies and review in human subjects research
• Confidentiality and privacy, HIPAA, laws restricting use of social security numbers and beyond
• Human subjects research agreement clauses and provisions, including human subject injury provisions, data access rights and more
• FDA regulations
• OHRP regulations