TAG ARCHIVES FOR global research

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

26
Mar2018

Research conducted in international settings poses particular challenges for the reviewing IRB, as it must possess adequate knowledge of laws and regulations in the country where the research is taking place, and be sensitive to the area’s cultural norms, in order to appropriately evaluate the study. Social, behavioral, and educational research (SBER) in particular may involve the study of stigmatized health conditions or behaviors, and may require the recruitment of marginalized populations and minors. Conducting research on these topics is important, but it is equally essential that IRBs and researchers mitigate the risk of social consequences that might result from subjects’ participation in the study, such as rejection in their communities or conflict within their families. The regulations regarding human subjects protections vary greatly between countries as well, which can lead to additional difficulties for IRBs. Read more

8
Mar2018

As the ethicist for the Caribbean Public Health Agency (CARPHA) and founding president of the Bioethics Society of the English-Speaking Caribbean (BSEC), Dr. Derrick Aarons is on a mission to educate. His conscientious work has helped build a culture of bioethics in the Caribbean, and he is committed to sharing his region’s bioethical perspectives with the rest of the world. Read more

18
Jan2017

Just before entering the Arena to participate in Panel VI: Re-Framing Informed Consent: Respecting Participants When Barriers to Regulatory Consent Exist moderated by Christine Grady, RN, PhD, and panelists Michelle H. Biros, MD; Neal Dickert Jr., MD, PhD; and Robert Silbergleit, MD, I recalled the three questions that I formulated upon registering for the AER16 conference. Read more