Peter Thiel sponsors offshore testing of herpes vaccine, sidestepping U.S. safety rules

Marisa Taylor
Kaiser News
Originally posted August 28, 2017

Here is an excerpt:

“What they’re doing is patently unethical,” said Jonathan Zenilman, chief of Johns Hopkins Bayview Medical Center’s Infectious Diseases Division. “There’s a reason why researchers rely on these protections. People can die.”

The risks are real. Experimental trials with live viruses could lead to infection if not handled properly or produce side effects in those already infected. Genital herpes is caused by two viruses that can trigger outbreaks of painful sores. Many patients have no symptoms, though a small number suffer greatly. The virus is primarily spread through sexual contact, but also can be released through skin.

The push behind the vaccine is as much political as medical. President Trump has vowed to speed up the FDA’s approval of some medicines. FDA Commissioner Scott Gottlieb, who had deep financial ties to the pharmaceutical industry, slammed the FDA before his confirmation for over-prioritizing consumer protection to the detriment of medical innovations.

“This is a test case,” said Bartley Madden, a retired Credit Suisse banker and policy adviser to the conservative Heartland Institute, who is another investor in the vaccine. “The FDA is standing in the way, and Americans are going to hear about this and demand action.”

American researchers are increasingly going offshore to developing countries to conduct clinical trials, citing rising domestic costs. But in order to approve the drug for the U.S. market, the FDA requires that clinical trials involving human participants be reviewed and approved by an IRB or an international equivalent. The IRB can reject research based on safety concerns.

The article is here.

Are research ethics guidelines culturally competent?

Ben Gray, Jo Hilder, Lindsay Macdonald, Rachel Tester, Anthony Dowell, & Maria Stubbe
Research Ethics May 20, 2016

Abstract

Research ethics guidelines grew out of several infamous episodes where research subjects were exploited. There is significant international synchronization of guidelines. However, indigenous groups in New Zealand, Canada and Australia have criticized these guidelines as being inadequate for research involving indigenous people and have developed guidelines from their own cultural perspectives. Whilst traditional research ethics guidelines place a lot of emphasis on informed consent, these indigenous guidelines put much greater emphasis on interdependence and trust. This article argues that traditional guidelines are premised on relationships of equal power, and that often the researcher has more power that is not fully equalized by providing information. Where there is a relationship of unequal power, then focusing on interdependence and trust is more likely to achieve ethical safety. We illustrate this thesis by describing the detail of a research project looking at the use of interpreters, where we video-recorded live consultations and then interviewed the patient, interpreter and doctor. We conclude by suggesting that mainstream research ethics guidelines should pay more attention to the development of a trustworthy relationship between subject and researcher, and that, following the lead from clinical medicine, we should develop a culturally competent ethical framework for research on human subjects.

The article is here.

How journals like Nature, Cell and Science are damaging science

The incentives offered by top journals distort science, just as big bonuses distort banking

By Randy Schekman
The Guardian
Originally posted on December 9, 2013

I am a scientist. Mine is a professional world that achieves great things for humanity. But it is disfigured by inappropriate incentives. The prevailing structures of personal reputation and career advancement mean the biggest rewards often follow the flashiest work, not the best. Those of us who follow these incentives are being entirely rational – I have followed them myself – but we do not always best serve our profession's interests, let alone those of humanity and society.

We all know what distorting incentives have done to finance and banking. The incentives my colleagues face are not huge bonuses, but the professional rewards that accompany publication in prestigious journals – chiefly Nature, Cell and Science.

The entire story is here.

The Crisis in Social Psychology: Paul Bloom on Bloggingheads.tv

Paul Bloom interviews Joseph Simmons about the crisis in social psychology.  They discuss the experimental method, the ability to replicate studies, false positives, and studies with "sexy findings".



The entire web site is here.

Scholars call for new ethical guidelines to direct research on social networking

By Jennifer Sereno
University of Wisconsin-Madison News
Originally published January 2013

The unique data collection capabilities of social networking and online gaming websites require new ethical guidance from federal regulators concerning online research involving adolescent subjects, an ethics scholar from the Morgridge Institute for Research and a computer and learning sciences expert from Tufts University argue in the journal Science.

Increasingly, academics are designing and implementing research interventions on social network sites such as Facebook to learn how these interventions may affect user behavior, knowledge, attitudes and psychological health. Online games are being used as research interventions. However, the ability to mine user data (including information about Facebook "friends"), sensitive personal information and behavior raises concerns that deserve closer ethical scrutiny, say Pilar Ossorio and R. Benjamin Shapiro.

Ossorio is a bioethics scholar-in-residence at the Morgridge Institute, a private, nonprofit biomedical research institute on the University of Wisconsin-Madison campus. She also holds joint appointments as a professor of law and bioethics at the University of Wisconsin Law School and the School of Medicine and Public Health. Shapiro is an assistant professor in computer science and education at Tufts, where he is a member of the Center for Engineering Education and Outreach. He previously held appointments in educational research at Morgridge and the Wisconsin Institute for Discovery.

"Given the unprecedented ability of online research using social network sites to identify sensitive personal information concerning the research subject and the subject's online acquaintances, researchers need clarification concerning applicable ethical and regulatory standards," Ossorio says. "Regulators need greater insights into the possible benefits and harms of online social network research, and researchers need to better understand the relevant ethical and regulatory universe so they can design technical strategies for minimizing harm and complying with legal requirements."

For instance, Ossorio says, researchers may be able to design game features that detect player distress and respond by modifying the game environment, and marry those features to data collection technologies that maximally protect users' privacy while still offering useful data to researchers.

Consent for online research is tricky, particularly when it involves minors. Under Shapiro and Ossorio's analysis, current law does not require that researchers obtain parental permission to conduct studies of adolescents on social networking sites. Parental permission is required for younger children, while adolescents and adults provide their own consent. Of course, parents can prohibit their adolescents from any online activity, including research participation, regardless of legal limits on researchers. Parents have the same amount of control over their adolescents' online research participation as they do over any other online activity in which their teens engage.

"Researchers should use the online environment to deliver innovative, informative consent processes that help participants understand the dimensions of the research and the accompanying data collection," Shapiro says. "This is especially important given the general public's ignorance about the ability to collect massive amounts of personal data over the Internet."

If traditional approaches to consent are of limited value for protecting online subjects, Ossorio says, then researchers and regulators should emphasize other aspects of research ethics, such as using all reasonable approaches to minimize research risks. Also, researchers should seek innovative methods for generating transparency around the research enterprise.

Writing in the Policy Forum section of the Jan. 11 edition of Science, Shapiro and Ossorio conclude by emphasizing that the richness of online information should not become the sole domain of commercial marketing interests but should be used to advance understanding of human behavior and inspire positive social outcomes. Elucidating ethical and legal guidelines for design research on social media will create new opportunities for researchers to understand and improve society.

The news release is here.