by Suzanne M. Rivera, Ph.D. Much attention has been paid to the government shutdown that started last week. Many of us heard heart-tugging stories on public radio about the NIH closing down new subject enrollment at its “House of Hope,” the clinical trial hospital on the NIH main campus. These stories gave many people the…
by Suzanne M. Rivera, Ph.D. The Office of Human Research Protections (OHRP) has issued revised guidance about research subject compensation. And, although it has not attracted a great deal of fanfare, it deserves attention because the new guidance offers greater flexibility to investigators and to the Institutional Review Boards (IRBs) charged with reviewing proposed human…
by Suzanne M. Rivera, Ph.D. Earlier this month, the American Association of University Professors (AAUP) recommended that researchers should be trusted with the ability to decide whether individual studies involving human subjects should be exempt from regulation. The AAUP’s report, which was prepared by a subcommittee of the Association’s Committee on Academic Freedom and Tenure,…
by Suzanne M. Rivera, Ph.D. The principle of justice articulated in The Belmont Report requires equitable selection of human research subjects. Equitable in this context means that the risks and benefits of the study are distributed fairly. Fairness has two components: 1) avoiding exploitation of the vulnerable (e.g. preying upon a poor, uneducated population) and…
by Suzanne M. Rivera, Ph.D. For some time, animal rights activists in the US and abroad have been trying to pressure commercial airlines out of their long-standing practice of transporting research animals. Last week, a coalition of more than 150 leading research organizations and institutions sent a letter to the CEOs of the targeted airlines,…
by Suzanne M. Rivera, Ph.D. While attending the annual Advancing Ethical Research Conference of Public Responsibility in Medicine and Research (PRIM&R) last month in San Diego, I had the opportunity to hear a talk by Dr. John Ioannidis, in which he debunked commonly accepted scientific “truths.” Calling upon his own work, which is focused on…
By Suzanne M. Rivera How to Survive a Plague is a moving chronicle of the onset of the AIDS epidemic as seen through the lens of the activists who mobilized to identify and make available the effective treatments we have today. Beginning at the start of the epidemic, when little was known about the HIV…
by Suzanne M. Rivera, Ph.D. In regulatory and research ethics circles, it is fairly common to hear people say they prefer the term “research participant” to “research subject” because they feel it’s more respectful. They think the word “subject” is demeaning. I respectfully disagree. I think it’s honest. The federal agencies that oversee human research…
by Suzanne M. Rivera, Ph.D. For years, mainstream and extremist organizations have waged campaigns against the use of animals. While PETA successfully deploys propaganda featuring provocative models in sexually explicit positions to denounce the use of animals for food, clothing and experimentation, other groups, such as the Animal Liberation Brigade, engage in violent (some would…
by Suzanne M. Rivera, Ph.D. I was giving a workshop presentation at the annual meeting of the National Council of University Research Administrators and my co-presenter raised an interesting idea. Tommy Coggins of the University of South Carolina was talking about the importance of integrity for preserving the public’s trust in the research enterprise, and…
