TAG ARCHIVES FOR study enrollment

3
Nov2020

Amid both promising and worrying signs in the development of treatments and vaccines for COVID-19, and in the context of a considerable amount of scrutiny of medical research, some researchers, ethicists, and advocates are working to make sure science doesn’t lose sight of a critical issue: diversity in the clinical trial participant pool. The distribution of research benefits to participants—and the consideration of race in subject selection—is tightly woven into the Belmont Report and has been a mainstay in research ethics discussion ever since. But despite the decades-long consideration of race and ethnicity in clinical trials, many trials still don’t enroll populations that reflect the diversity of the general populace or the group affected by the condition being studied. Read more

13
Jun2018

Just a year or two ago most people didn’t even know what the term “wearable” meant. Today, they are one of the largest growing technology segments, and are predicted to continue growing exponentially. As this technology continues to improve, more uses are being invented and implemented, including in the realm of health care and clinical trial research. Read more

8
Jun2017

For this month’s question you are a member of a local IRB reviewing an influenza vaccine study. The investigator wants to ask enrolled study participants to help recruit additional study participants. The investigator wants to express her gratitude for this assistance. She has asked the IRB whether tangible expressions of gratitude, e.g., cash, would be acceptable. Read more

16
May2017

For this month's question, you are a principal investigator in a very promising Phase 3 pancreatic cancer study. The sponsor has just informed you that you can enroll only one more patient before enrollment closes. Enrolling in this study might save your patient’s life. Ten of your patients are eligible for the study. Who do you invite to participate in the study, and how do you decide? Read more

8
May2017

In April, PRIM&R hosted the webinar Compensation or Inducement? What IRBs Need to Know about Paying Subjects for Participation. Presented by Alex John London, PhD, and Betsy Ripley, MD, MS, RAC, this webinar provided foundational knowledge about the underlying ethical principles that govern compensating tresearch subjects. Through case studies, examples, and review of existing guidance and regulations, attendees learned strategies for evaluating payment to subjects for their participation in studies. Here, the presenters answer some of the questions time didn’t permit us to answer live. Read more