2014 Webinar: Practicing Good Science Through Ethical Study Design

Webinar Archives - Members  Webinar Archives - Non-Members

Overview

The process of identifying and addressing the ethical issues raised by human research studies is often thought to be separate from the process of study design, and within the purview solely of the institutional review board (IRB). However, ideal study design incorporates ethical considerations, and many of the study design decisions made by research teams carry direct ethical implications. This session examined the pivotal points of research design and the ethical questions that should be addressed at each step along the way. Specifically, this webinar:

  • Identified the ethical issues that arise around study designs, statistical analysis plans, and sample size considerations
  • Demonstrated how addressing ethical concerns at these various stages of study design can improve the science of the study
  • Examined questions for IRBs to ask investigators about the design of their research that have ethical implications

Audience
This intermediate-level webinar was of interest to investigators as well as IRB chairs, members, directors, and staff, or anyone involved in the research design process.

Faculty

Susan S. Fish, PharmD, MPH, is a professor of biostatistics and epidemiology at the Boston University School of Public Health. Dr. Fish received her Doctor of Pharmacy degree from the University of Minnesota and her Masters of Public Health from Boston University. She received a bachelor’s degree in pharmacy from Massachusetts College of Pharmacy and Allied Health Sciences and a bachelor’s degree in chemistry and education from the University of Massachusetts. Dr. Fish is the co-director of the masters in clinical research program at Boston University School of Medicine (BUSM). She previously held positions as director of human subjects protection and associate director of the Office of Clinical Research at Boston University Medical Center (BUMC), director of the BUMC IRB, and director of research participant safety at the General Clinical Research Center at BUSM. She has also served as director of regulatory affairs at CareStat, Inc. (a contract research organization), vice chair for research in the Department of Emergency Medicine at Boston City Hospital/Boston Medical Center, and associate professor of emergency medicine at BUSM. Prior to that, she was associate director of the Massachusetts Poison Control System and an associate professor at Massachusetts College of Pharmacy and Allied Health Sciences. On the national level, Dr. Fish is an active member of many organizations, including the Society for Academic Emergency Medicine and PRIM&R, where she serves on the Board of Directors. 

Certificates of Attendance

Certificates of attendance for the Practicing Good Science Through Ethical Study Design webinar were made available at the conclusion of the webinar. To access the certificate, you must first complete the online evaluation. Such certificates are useful for obtaining continuing education (CE) credits (not Continuing Medical Education credits) from professional associations. Note that guidelines concerning CE credits may differ, and you should consult the appropriate professional association representative for further guidance.

If you would like to receive a certificate of attendance for a previous PRIM&R educational program, please email info@primr.org [link to email address] or call 617.423.4112, ext.0.

CE Credit for Certified IRB Professional (CIP®) Recertification
Webinar participants holding the CIP credential who wish to apply credits from Practicing Good Science Through Ethical Study Design toward CIP recertification may submit the Certificate of Attendance they received upon completing the online evaluation as documentation of their participation. Participation in this 60-minute webinar counts as 1.0 CE credit hour.

For recertification by CE, CIPs must complete 30 documented hours of continuing education, of which at least 15 must carry CE credits issued by a recognized accrediting body. Credits from PRIM&R webinars do not count as credits issued by a recognized accrediting body.

Additional information about CIP recertification can be found here.