As a valued Relias Media subscriber, you can find the latest issue of your publication online. The articles below provide timely strategies and research for healthcare providers:
Some new technology companies that are developing novel human subjects research face challenges and design issues that have never been explored. Companies engaging in cutting-edge technological services and solutions can raise public concerns for what they do on the business side, but there is less public awareness of privately funded research.
New companies using cutting-edge technology can enter the research arena, but they might lack resources and a knowledge base that academic research organizations take for granted. IRBs can help companies fill some of those knowledge and experience gaps by forming a collaborative relationship and working with them from the beginning of the study design process.
Continuing review might have gone away for many studies, but a research protection program’s responsibilities have not. This is why many IRBs have devised an alternative annual review process that combines workflow efficiency with enhanced research protection. One model for this regular review is an annual status report. Minimum risk, expedited review, and some additional studies do not need to go through the annual continuing review by the IRB, but they can be monitored through this review.
The consent calendar is a century-old tool, but it can work well in saving time during IRB meetings. Typically, IRBs review each study up for continuing review, discussing and voting for each, separately. But that might not be the most efficient way to handle these on the board meeting agenda.
A large cancer research institution in New York City overhauled its protocol review process, devised a library of scientific terms commonly used in consent forms, and invested in more staff. Within a couple of years, the updated process resulted in a striking reduction in the median time for protocol and consent review by the IRB. Time-to-IRB approval decreased from 135 days in 2017 to 80 days in 2018.
Dedicated editors help a research program manage an informed consent library of terms that can be included in consent forms as a substitute for medical/scientific language.
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.
