Regulatory Aspects of Human Subject Research and the Role of the Institutional Review Board

Needs Statement

Physicians, residents, fellows, physician assistants, nurses, and other healthcare professionals in the fields of Pediatrics, Obstetrics, Pediatric Surgery, Perinatology, and Family Medicine need to receive regular updates on the latest advances in the diagnosis and treatment of neonatal disorders and on research activities within the Section of Neonatology. The series aims to increase the knowledge of learners with regard to neonatal treatment modalities, refine neonatal research methodologies, enhance the quality of neonatal care, and improve patient outcomes.

Educational Objectives

At the conclusion of the session, the participants should be able to:

• Define human subject research.
• Explain the role of the institutional review board (IRB) in protecting patients who participate in clinical studies.
• Identify strategies to improve IRB protocols.
• Demonstrate how to navigate the IRB process.

Target Audience

Accreditation/Credit Designation

Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Baylor College of Medicine designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This activity has been designated by Baylor College of Medicine for 1 credit of education in medical ethics and/or professional responsibility.

Disclosure Policy

Baylor College of Medicine (BCM) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians. BCM is committed to sponsoring CE activities that are scientifically based, accurate, current, and objectively presented.

In accordance with the ACCME Standards for Commercial Support, BCM has implemented a mechanism requiring everyone in a position to control the content of an educational activity (i.e., directors, planning committee members, faculty) to disclose any relevant financial relationships with commercial interests (drug/device companies) and manage/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships at the time of the activity or within 24 months prior.

In addition, BCM has requested activity faculty/presenters to disclose to participants any unlabeled use or investigational use of pharmaceutical/device products; to use scientific or generic names (not trade names) in referring to products; and, if necessary to use a trade name, to use the names of similar products or those within a class. Faculty/presenters have also been requested to adhere to the ACCME's validation of clinical content statements.

BCM does not view the existence of financial relationships with commercial interests as implying bias or decreasing the value of a presentation. It is up to participants to determine whether the relationships influence the activity faculty with regard to exposition or conclusions. If at any time during this activity you feel that there has been commercial/promotional bias, notify the Activity Director or Activity Coordinator. Please answer the questions about balance and objectivity in the activity evaluation candidly.

All of the relevant financial relationships listed for these individuals have been mitigated.