3
Sep2019

Some of the most significant changes in the revised Common Rule involve the provisions around informed consent, including the new requirement that informed consent begin with a “concise and focused presentation of key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research” [46.116(a)(5)(i)]—the “key information requirement,” for short. I welcome the key information requirement and think it has the potential to greatly improve informed consent, but it is bringing with it several complexities. Read more

12
Aug2019

Attending the 2018 Advancing Ethical Research (AER) Conference was a fantastic opportunity to connect with colleagues, hear renowned speakers address regulatory hot topics, and share ideas and best practices. Science and technology are expanding exponentially; as a result, our research community is becoming increasingly diverse and multi-center research is booming. While historically the regulations have remained relatively unchanged, in recent years the regulatory community has worked together to provide feedback on suggested major updates and new guidance which are greatly shifting the regulatory world. This year's AER Conference takes place November 18-20, 2019 in Boston, MA Read more

5
Aug2019

Enthusiasm for data sharing and research transparency has grown across the social sciences. This newer scholarly imperative has begun to overlap with the long-standing mandate to minimize risks for human subjects in research. IRBs play a crucial role in this realm, as the IRB’s recommendations on a social science research protocol will often determine whether or not the data obtained through the study may be shared in the future. IRBs are tasked with assisting and educating social scientists to include the appropriate elements, language, and procedures in their protocol materials in order for researchers to approach data sharing in an ethical and responsible manner. Read more

30
Jul2019

In June, the FDA issued a draft guidance, "Enhancing the Diversity of Clinical Trial Populations—Eligibility Criteria, Enrollment Practices, and Trial Designs." The issuance of this guidance satisfies a mandate of the FDA Reauthorization Act of 2017 (FDARA), and builds on other recent efforts by the FDA to broaden eligibility criteria for clinical trials and avoid unnecessary exclusions. PRIM&R submitted comments on the guidance this week, and we wanted to share them with you and encourage you to consider submitting your own comments on this important topic—the FDA is accepting comments until August 6. Read more

23
Jul2019

For a variety of reasons, increasing numbers of institutions are developing research ethics consultation services to provide guidance to investigators, study teams, research subjects, and IRBs about ethical issues arising in particular research studies. The principal source of ethical review for human subjects research has traditionally been the IRB, and so the presence of an consultation service can raise questions about each entity’s role in the research review process. Read more

16
Jul2019

Why are people taken in by pseudoscience and the accompanying “scientific” jargon that gives a false impression claims are backed by laboratory research and facts? Why have scientists like me gone from being viewed as god-like, having put mankind on the moon, to nimrods who’re in the pocket of big pharma? And most of all, how is it that I had not heard of Timothy Caulfield before the 2018 Advancing Ethical Research Conference (AER18)? Read more