In April, the EPA published a proposed rule titled, Strengthening Transparency in Regulatory Science. The rule would prohibit the EPA from basing regulatory action on scientific studies for which the underlying raw data and models are not publicly available “in a manner sufficient for validation and analysis.” The due date for comments on this rule is August 16. As a nonpartisan organization dedicated to advancing the highest ethical standards in the conduct of research that advances human health and well-being, PRIM&R decided it was important to comment on this proposed rule, detailing two main concerns. First, we believe that the proposed rule arbitrarily restricts access to and use of rigorous, peer-reviewed science in environmental policymaking, to the detriment of the public’s health and trust in the regulatory process. Second, we argue that the proposed rule fails to respect the contributions of human research participants. We urge EPA to withdraw this misguided rule immediately. Read more
This edition of Research Ethics Roundup covers African-American participation in DNA testing, difficulties recruiting participants for Alzheimer's trials, even when results are promising, the deaths of eleven babies born to mothers in a Dutch drug trial involving generic Viagra, and a call for research misconduct investigations across Britain by the United Kingdom’s House of Commons science and technology committee. Read more
PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance "Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials," which was published in the Federal Register on June 4, 2018.
We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to [...] Read more
On July 20, the Office for Human Research Protections (OHRP) published three new draft guidance documents related to the three “burden-reducing provisions” institutions can take advantage of during the “delay period” before the general compliance date of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
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
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