National Research Act at 50: An Ethics Landmark in Need of an Update; The Hastings Center, July 12, 2024

Mark A. Rothstein and Leslie E. Wolf, The Hastings Center; National Research Act at 50: An Ethics Landmark in Need of an Update

"On July 12, 1974, President Richard M. Nixon signed into law the National Research Act, one of his last major official actions before resigning on August 8. He was preoccupied by Watergate at the time, and there has been speculation about whether he would have done this under less stressful circumstances. But enactment of the NRA was a foregone conclusion. After a series of legislative compromises, the Joint Senate-House Conference Report was approved by bipartisan, veto-proof margins in the Senate (72-14) and House (311-10).

The NRA was a direct response to the infamous Untreated Syphilis Study at Tuskegee whose existence and egregious practices disclosed by whistleblower Peter Buxtun were originally reported by Associated Press journalist Jean Heller in the Washington Star on July 25, 1972.  After congressional hearings exposing multiple research abuses, including the Tuskegee syphilis study, and legislative proposals in 1973, support coalesced around legislation with three main elements: (1) directing preparation of guidance documents on broad research ethics principles and various controversial issues by multidisciplinary experts appointed to a new federal commission, (2) adopting a model of institutional review boards, and (3) establishing federal research regulations applicable to researchers receiving federal funding.

This essay reflects on the NRA at 50. It traces the system of research ethics guidance, review, and regulation the NRA established; assesses how well that model has functioned; and describes some key challenges for the present and future. We discuss some important substantive and procedural gaps in the NRA regulatory structure that must be addressed to respond to the ethical issues raised by modern research." 

AI use must include ethical scrutiny; CT Mirror, June 24, 2024

 Josemari Feliciano, CT Mirror; AI use must include ethical scrutiny

"AI use may deal with data that are deeply intertwined with personal and societal dimensions. The potential for AI to impact societal structures, influence public policy, and reshape economies is immense. This power carries with it an obligation to prevent harm and ensure fairness, necessitating a formal and transparent review process akin to that overseen by IRBs.

The use of AI without meticulous scrutiny of the training data and study parameters can inadvertently perpetuate or exacerbate harm to minority groups. If the data used to train AI systems is biased or non-representative, the resulting algorithms can reinforce existing disparities."

Register for ‘Ethics, Institutional Review Boards and Scholarly Activities: Pitfalls and Parapets’; WV Mountaineer ENews, March 7, 2023

WV Mountaineer ENews; Register for ‘Ethics, Institutional Review Boards and Scholarly Activities: Pitfalls and Parapets’

"All faculty are invited to attend the WVU Health Sciences Center Faculty Development Program presentation “Ethics, Institutional Review Boards and Scholarly Activities: Pitfalls and Parapets” from noon to 1 p.m. on March 14.

The presenter is Steve Davis, associate professor in the Department of Health Policy, Management and Leadership.

To register by noon on March 13, contact HSCfacultydevelopment@hsc.wvu.edu. Make sure to include the date and title of this presentation in your email. 

Registration is required to receive the Zoom access code. Access information will be sent to participants the day prior to the session. Please do not share the Zoom code."

Did Facebook's experiment violate ethics?; CNN, 7/2/14

Robert Klitzman, CNN; Did Facebook's experiment violate ethics? :

"Editor's note: Robert Klitzman is a professor of psychiatry and director of the Masters of Bioethics Program at Columbia University. He is author of the forthcoming book, "The Ethics Police?: The Struggle to Make Human Research Safe." The opinions expressed in this commentary are solely those of the author...

In 1974, following revelations of ethical violations in the Tuskegee Syphilis study, Congress passed the National Research Act. At Tuskegee, researchers followed African-American men with syphilis for decades and did not tell the subjects when penicillin became available as an effective treatment. The researchers feared that the subjects, if informed, would take the drug and be cured, ending the experiment.

Public outcry led to federal regulations governing research on humans, requiring informed consent. These rules pertain, by law, to all studies conducted using federal funds, but have been extended by essentially all universities and pharmaceutical and biotech companies in this country to cover all research on humans, becoming the universally-accepted standard.

According to these regulations, all research must respect the rights of individual research subjects, and scientific investigators must therefore explain to participants the purposes of the study, describe the procedures (and which of these are experimental) and "any reasonably foreseeable risks or discomforts."

Facebook followed none of these mandates. The company has argued that the study was permissible because the website's data use policy states, "we may use the information we receive about you...for internal operations, including troubleshooting, data analysis, testing, research and service improvement," and that "we may make friend suggestions, pick stories for your News Feed or suggest people to tag in photos."

But while the company is not legally required to follow this law, two of the study's three authors are affiliated with universities -- Cornell and the University of California at San Francisco -- that publicly uphold this standard."

Questioning Privacy Protections in Research; New York Times, 10/23/11

Patricia Cohen, New York Times; Questioning Privacy Protections in Research:

"Hoping to protect privacy in an age when a fingernail clipping can reveal a person’s identity, federal officials are planning to overhaul the rules that regulate research involving human subjects. But critics outside the biomedical arena warn that the proposed revisions may unintentionally create a more serious problem: sealing off vast collections of publicly available information from inspection, including census data, market research, oral histories and labor statistics."