TAG ARCHIVES FOR webinar

8
Apr2019

As genomics and personalized medicine advance, there is increased awareness that “race” is an inappropriate proxy for groups that may share a genetic background. However, proposals that assume that self-reported race correlates with biological/genetic difference are still being submitted and approved at institutions across the country—even as genetic evidence reveals that the difference between races is smaller than differences among individuals of any particular race. Such studies risk perpetuating racist stereotypes, inappropriately influencing clinical medicine, and reinforcing inaccurate ideas about biology and race. It’s important that research oversight professionals understand how to approach the continued wave of race-based research. On February 21, PRIM&R hosted a webinar to provide guidance for IRBs in this area. After the webinar, presenters responded to some of the attendee questions that time didn’t permit us to address live; we’re pleased to share those responses with the readers of Ampersand. Read more

22
Jan2019

Postapproval monitoring (PAM) ensures that research is being carried out in the manner that was originally approved by the IACUC and many institutions employ PAM as a self-auditing mechanism to check on compliance. A well-run PAM program can also lead to improved animal welfare, science, and collaboration among departments in the animal care and use program. Having a robust framework for conducting PAM promotes education, transparency, and communication between researchers and the institution. Read more

17
Dec2018

The question of whether and how to return individual research results to subjects has been an ongoing area of uncertainty for investigators and research institutions. The recent report from the National Academies of Science, Engineering, and Medicine (NASEM), Return of Individual-Specific Research Results to Participants: Guidance for a New Research Paradigm, offered recommendations for “a process-oriented approach to returning individual research results that considers the value to the research subject, the risks and feasibility of return, and the quality of the research laboratory.” On October 3, 2018, PRIM&R hosted a webinar to summarize the recommendations of the report, and provide guidance specifically on its potential implications for IRBs. Read more

30
Aug2018

Expanded access, which is treatment access to experimental drugs (also referred to as "compassionate use" or "pre-approval access"), has generated increasing interest and debate over the last several years. On March 7, PRIM&R hosted a webinar, Pre-Approval Access to Drugs in Development: Navigating the Changing Regulatory, Ethical, and Legal Landscape, to educate HRPP professionals on FDA guidance, recent legislation, and ethical questions related to expanded access. The webinar featured Richard Klein, the former director of the FDA's Patient Liaison Program in the Office of Health and Constituent Affairs, and Beth E. Roxland, JD, MBioethics, an Attorney, Bioethicist, and Senior Advisor on Law, Health Policy and Ethics at Roxland Consultants, Ltd. After the webinar, Mr. Klein 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

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