By Jennifer S. Bard
Until more is known about how to mitigate the threat of AI-fueled persuasion in human subject research, a ban on its use is the only reasonable way to keep the promise that we, as a country, made to those harmed while participating in research.
By Matthew Chun
He Jiankui — a high-profile Chinese scientist convicted for conducting unethical gene-editing experiments — has been released from prison and is currently fundraising for his new gene therapy endeavor. As the scientific community grapples with how to respond, theories of criminal justice can provide important perspectives to better inform the conversation surrounding Dr. He’s return to research.
By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson
This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 and Part 2.
EA is considered treatment, not research. EA was not established as a means to collect research data, even though certain safety data must be collected and shared with the FDA and the sponsor. But, once sponsors decide to capture/share EA-derived data above and beyond that needed to report SAEs, what should IRBs do when reviewing such plans: view this as research, and thus hold it to (higher) research standards, or continue to view this as treatment? This distinction is important for patients’ rights and welfare.
By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson
This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance. Read Part 1 here.
Real world data (RWD) are data relating to patient health status and/or the delivery of health care such as medical bills/claims, electronic health records, and product/disease registries. RWD are derived from sources outside of randomized controlled trials (RCTs). Real world evidence (RWE) may be derived from the analysis of quality RWD.
By Alison Bateman-House, Hayley M. Belli, and Sage Gustafson
This series is adapted from a webinar hosted by PRIM&R on August 5, 2021: IRB Review of Expanded Access Protocols that Collect Real World Data: Considerations and Guidance.
Expanded Access (EA) is a regulatory mechanism that allows patients, through their physicians, to request the use of an unapproved medical product in a treatment setting.
By James Toomey
The story of Henrietta Lacks is surely among the most famous in the history of bioethics, and its facts are well-known. Ms. Lacks sought treatment for cervical cancer. After conducting a biopsy on her tumor, her doctors learned that her cancer cells reproduced uniquely effectively. Without her knowledge or consent, her doctors derived from the cells the HeLa cell line — the world’s first immortal human cell line, worth billions and a driver of the biotechnology revolution. Lacks died in poverty.
No doubt her doctors’ behavior was not consistent with today’s standards of informed consent. But another question has remained more persistently challenging — did the doctors steal something from Lacks? Did she own the cells of her tumor? Or, perhaps more precisely, because few argue that HeLa is really the same thing as Lacks’s tumor cells, did she own the genetic information contained in her tumor?
In a new paper, Property’s Boundaries (forthcoming in the Virginia Law Review, March 2023), I develop a theory of what can and cannot be owned to answer these kinds of questions — pervasive in bioethics, from debates about ownership of organs to embryos. My conclusion, in short, is that because the essence of the idea of ownership is a relationship of absolute control, anything that can be the subject of human control can, in principle, be owned. But that which we cannot control we cannot own. From this perspective, Henrietta Lacks owned the cells of her tumor, and the tumor itself. But the genetic information within them — facts about the universe subject to no human control — simply cannot be owned, by her or anyone else.
By Ameet Sarpatwari, Aviva Wang, Liam Bendicksen, and Aaron S. Kesselheim
Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division.
Below are the abstracts/summaries for papers identified from the month of July. The selections feature topics ranging from how Wikipedia pages communicate drug efficacy information, to addressing pharmaceutical industry payments to physicians, to the frequency with which the Food and Drug Administration removes hazardous dietary supplements from the market. A full posting of abstracts/summaries of these articles may be found on our website.
By Leah Pierson
Academia often treats all areas of research as important, and two projects that will publish equally well as equally worthy of exploring. This, I believe, is misguided.
Instead, we should strive to create an academic culture where researchers consider and discuss a project’s likely impact on the world when deciding what to work on.
By James Toomey
When the world went into lockdown in March 2020, many commentators noticed that social isolation could offer scammers an unprecedented opportunity to take advantage of people’s fear and loneliness. But they didn’t anticipate that fraud would generally affect a range of age groups. Indeed, much like the virus itself, the risks of frauds and scams related to the COVID pandemic were thought primarily to affect older adults.
This assumption seems to have been wrong. Recently, I conducted a study on the prevalence of scam-victimization during the pandemic across age groups. Specifically, I recruited two populations — one of adults between 25 and 35 and one of adults over than 65—and asked whether they had been contacted by people making specific fraudulent promises during the pandemic, and whether they’d engaged with the scammer by giving personal information, sending money, or clicking a link. In the study populations, the younger group engaged with scammers three times more frequently than the older group — a disparity that was statistically significant and persisted regardless of how I sliced the data.
By Leah Pierson
The Biden administration plans to greatly increase funding for the National Institutes of Health (NIH) in 2022, presenting the agency with new opportunities to better align research funding with public health needs.
The NIH has long been criticized for disproportionately devoting its research dollars to the study of conditions that affect a small and advantaged portion of the global population.