TAG ARCHIVES FOR human subjects protections

26
Sep2017

Study teams and regulatory teams have different perspectives when it comes to executing research protocols, due simply to the different day-to-day responsibilities of a study team member versus a regulatory team member. While the ultimate goal of any research protocol is to generate new knowledge while protecting the rights and welfare of research subjects, sometimes study and regulatory teams differ on how to best achieve this goal. I have been fortunate enough to have worked as both a study and regulatory team member and have gained insight into how these teams differ and how they can best work together to ensure that research protocols run smoothly and achieve the highest standards of ethical research conduct. Read more

7
Jul2017

Many of us have read the Common Rule revisions around informed consent and scratched our heads. What exactly does it mean that “informed consent must begin with concise and focused…key information that is most likely to assist in understanding reasons one might or might not participate”? My hope is that key information will become the vehicle that drives greater subject understanding and gives reviewers some relief. I look forward to seeing how the guidance around and the implementation of this section develops. Read more

20
Dec2016

Research partners”—that’s what scientists and doctors call people who serve as study subjects. Government officials and ethicists use the same term, depicting subjects as equal to the professionals who conduct and oversee health research. But there’s a problem with the egalitarian language. It simply isn’t accurate. Read more

6
Sep2016

In Case You Missed It (ICYMI): From time-to-time, PRIM&R will feature particularly well-received posts from the recent past. These posts remain timely as topics of discussion in the fields of research ethics, human subjects protections, or animal care and use. Highlighting them now enables readers who may have missed them a chance to read and comment. In this ICYMI, Michael Zimmer delves into one of the most important - and ethically fraught - new fields of research: Big Data. Read more

2
Sep2016

This week’s Research Ethics Roundup highlights the research implications of the Drug Enforcement Administration (DEA) decision to keep marijuana a Schedule 1 drug, public concern about hackers and stored genetic information, one bioethics professor’s take on the National Institutes of Health’s proposed policy for funding chimera research, and the European Medicines Agency’s response to a French clinical trial that left one man dead. Read more

Page 1 of 512345