20
Dec2018

Participate in a research study on human subjects protections and information privacy in retrospective database studies

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20 Dec
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Three researchers at the Texas A&M University School of Public Health—Hye-Chung Kum, PhD; Alva O. Ferdinand, DrPH, JD; and Cason Schmit, JD—invite ethical, legal, and social implications (ELSI) experts to participate in a three-round Delphi study. The purpose of the study is to design an IRB application template for patient-centered comparative effectiveness research that requires record linkage. The researchers are currently seeking feedback on their prototype software,  called Minimum Necessary Disclosure for Interactive Record Linkage (MINDFIRL), which is designed to mimimize identity disclosure via controlled information disclosure. Read more

18
Dec2018

Less (Tissue) is More (Complicated): Rethinking Research Involving Archival Specimens

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18 Dec
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As research activities go, the use of archival tissue has ranked pretty low on my list of ethical concerns. After all, the tissue has been or will be collected during a clinical procedure that patients would undergo regardless of their participation in research; there is no additional physical risk to subjects, and the primary ethical dilemma (or so the thinking goes) is the potential for a breach of confidentiality. By the end of the full-day preconference program Biobanking in an Era of Precision Medicine Research: Approaches to the Ethical, Regulatory, and Practical Challenges, the presenters had changed my thinking on this topic. I now have a much better appreciation of the complex relationship between researchers, patient-participants, pathologists, and IRBs, particularly when specimens will be used to investigate precision medicine applications. Read more

17
Dec2018

Webinar Follow-Up: Return of Individual Research Results

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17 Dec
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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

12
Dec2018

Single IRB Review: Does it really decrease administrative burden?

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12 Dec
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PRIM&R recently hosted a full-day preconference session at the 2018 Advancing Ethical Research Conference (AER18) discussing the challenges and strategies for successfully implementing single IRB review. Conferences like PRIM&R’s are an important venue for institutions to get together to discuss these challenges and find solutions. Read more

7
Dec2018

Clinical Research Ethics Question of the Month: December 2018

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7 Dec
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Scientists have created entities using artificial intelligence technology. These “betas” appear to have human-like intelligence and emotions so they could, for example, serve as companions for people who are lonely. The scientists want to conduct psychological experiments on them to improve their performance and reliability. While betas are not protected by human subjects protection regulations, the scientists have asked your institutional review board to review the ethics of the experiments anyway. Read more