24
Jul2018

On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of the revised Common Rule. [Update] On July 25, OHRP issued a Federal Register Notice and the community and public has until August 24, 2018 to Read more

13
Jul2018

On May 25, 2018, the European Union (EU) General Data Protection Regulation (GDPR) became effective in the 28 member states of the EU and the three additional countries (Iceland, Liechtenstein, and Norway) that, together with the EU member states, constitute the European Economic Area (EEA). (It replaces the Data Protection Directive 95/46/EC.) The GDPR affects US-based life science and academic research communities engaged in various arrangements, such as US-sponsored clinical trials occurring in the EEA, or studies that involve transferring personal data from the EEA to the US. To comply with the GDPR, all institutions need to be equipped with strategies for determining whether the GDPR will apply to them and, if it applies, how to process and transfer personal data to the US lawfully. Read more

9
Jul2018

You are a member of an IRB that is reviewing a study on the effectiveness of placebo “treatments.” It is well known that different sizes, shapes and colors of pills cause different levels of the placebo effect, which also varies by the therapeutic indication and the country/culture. The investigators want to test the placebo effect across a broad range of diseases and countries. The placebo pill will be presented as a “booster” to their current treatment--not a placebo.  Read more

29
Jun2018

Duke Morrow, MDiv, DMin, one of the speakers of the recent PRIM&R webinar Exploring and Enhancing Diversity for IACUCs and IRBs, presented registrants with a helpful metaphor for conducting a comprehensive IRB/IACUC review of a proposal—bread making. Bread making is a step-by-step process that takes time, care, love, and some elbow grease. This wonderful analogy helped us understand the influence of diverse viewpoints as the “ingredients” for a complete review of research proposals. So, let us review IRB/IACUCs through the lens of making bread. Read more

27
Jun2018

Providing payment for participation in research studies is an accepted practice, but until recently little guidance existed on the ethical aspects when deciding research payments. Gelinas et al recently presented a framework that researchers and IRBs can use when deciding ethical payments. Yet one major gap remains beyond the framework: data on the types and amounts of incentives provided historically in research studies. Read more

20
Jun2018

On May 10, PRIM&R hosted a webinar, Forward-Looking Strategies for IRBs in the Genomic Age: Preparing for Shifting Concepts of Identifiability, to provide expert input on the impact of breakthroughs in genomics research on traditional notions of identifiability.The panel consisted of Jiayan Chen, JD, a partner at McDermott Will & Emery, LLP, and Suzanne Rivera, PhD, MSW, vice president for research and technology management at Case Western Reserve University. After the webinar, Ms. Chen and Dr. Rivera responded to some of the attendee questions time didn’t permit us to address live. We’re pleased to share those responses with the readers of Ampersand. Read more