Accreditation Information

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Boston University School of Medicine and Northwest Association for Biomedical Research.  Boston University School of Medicine is accredited by the ACCME to provide continuing medical education for physicians.

Boston University School of Medicine designates this live activity for a maximum of 6.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

This educational activity has been provided by Continuing Nursing Education Provider Unit, Boston University School of Medicine and co-provided by and Northwest Association for Biomedical Research

Continuing Nursing Education Provider Unit, Boston University School of Medicine is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

Contact Hours: 6.75 of which 0 is eligible for pharmacology credit

Nurses will receive contact hours for those sessions attended, after completion of the evaluation.

Conference Sessions that meet the criteria in the Certified IRB Professional (CIP) recertification guidelines are eligible for accredited CIP continuing education credits. Up to 7.25 hours of eligible credit can be earned for this program.

 

Needs Statement

The current landscape impacting researchers and IRBs is being disrupted on all levels due to new regulations (Common Rule), new laws (21st Century Cures and potential repeal of ACA), new technologies (eConsent); and new thinking (clinical research can serve as clinical care). This summer, thought leaders from around the country, and regulators from the FDA and OHRP, will meet for a day of education and networking that will challenge thinking regarding the ethical and regulatory issues generated by disruption in the research and IRB field. Attendees can expect a comprehensive program that addresses the challenges faced by researchers and IRBs who are experiencing this disruption first hand.

 

Objectives

At the end of this conference participants will be able to:

  • Highlight the patient perspective regarding the use of mHealth technology.
  • Review emerging models, trends, and regulatory requirements regarding the use of technology in research.
  • Summarize agency perspectives regarding the use of technology in research.
  • Review issues raised by the Notice of Proposed Rulemaking (NPRM).
  • Discuss the ethical issues and challenges faced by IRBs when evaluating technology used in research.
  • Highlight Big Data, Precision Medicine, and Research Oversight.
  • Identify issues related to federal agencies’ regulation of social, behavioral, education research.
  • Discuss patient and expert perspectives on confidentiality beyond data security.
  • Review perspectives regarding the sharing of individual and aggregate results.
  • Review institutional issues regarding acting as a central IRB and outsourcing to a Central IRB.

 

Target Audience

  1. IRB chairs, members, administrators, and staff
  2. Medical doctors, registered nurses, and other staff involved in clinical research
  3. Regulatory affairs and compliance oversight personnel, scientists, and ethicists
  4. Sponsors and contract research organization staff involved in developing, managing, or administering informed consent

 

Faculty Disclosure