Overview:

45 CFR 46.111 (a)(2) states, "In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)." How the study is designed can minimize potential risks to participants. Studies that are deemed "minimal risk" have greater options when it comes to using an expedited review system and options for consent.

Risk rating also affects how elaborate a data safety monitoring plan will be required and measures put in place to protect privacy for the individuals and confidentiality of the data. The more that is done to reduce or minimize potential risks to research participants, the fewer regulatory requirements there are reducing burdens on the researchers and their teams. Attending this webinar will give you insight into research studies are assigned a risk rating, what that risk rating means, and what you can do to minimize risks to participants.

Why should you attend: All researchers want their studies be reviewed and approved quickly. Risks in the study can slow the process as the level of risk assigned a research protocol affects: mode of review, whether or not additional approvals outside of the IRB are needed, additional protections put in place, frequency of review, consent requirements, negotiation of indemnification language and several other factors. Understanding how risk levels are assigned and making preliminary determinations when designing the study can help you put protections in place that would reduce the level of risk that could provide greater flexibility in areas of your protocol such as mode of review, consent, or data safety monitoring.

Areas Covered in the Session:

• What is risk assessment?
• Why is risk assessment important?
• How can you make preliminary risk assessments?
• What does risk assessment affect?
• What are some methods of reducing risks in a research study?
• Examples
  

• Principal Investigators / Sub-investigators.
• Clinical Research Scientists (PKs, Biostatisticians,)
• Safety Nurses
• Clinical Research Associates (CRAs) and Coordinators (CRCs)
• Recruiting staff
• QA / QC auditors and staff
• Clinical Research Data managers
• Human Research Protection professionals