Consent in Clinical Research - On Research Podcast

On Research - with CITI Program

Linda Reuter has been involved with IRB Administration in various capacities for over 30 years, currently serving as the Sr. Director for BRANY IRB. Responsibilities include supervising the IRB staff, maintaining compliance with the IRB SOPs and applicable regulations, supervising pre and post-IRB meeting activities, expedited reviews, continuing reviews, protocol monitoring, continuing education, development of strategic goals for the organization, maintaining AAHRPP accreditation standards, policy maintenance and development, and training/mentoring of IRB staff. Linda formed IRB Consulting, LLC in 2012, providing IRB administrative services, training and education, audit services, and general consulting to numerous IRB programs nationwide.

According to the Food and Drug Administration, the purpose of clinical trials is to study medical products in people. In doing so, consent is critical in clinical trials for these people to understand they are the research subjects and not imply a patient. Consent within research ensures individuals have an informed choice on whether they want to participate in a research study. Informed consent within research is meant to protect human subjects from harm that could occur from participating in research and should always be voluntary.

Resources:

• https://www.niaid.nih.gov/research/dmid-protocols-informed-consent
• https://www.nsf.gov/bfa/dias/policy/docs/45cfr690.pdf
• https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5980471/
• https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials