The Ethical Case for Decentralized Clinical Trials.

The recent pandemic spurred interest in innovative design for clinical trials. In particular, constraints on the public's ability to gather led to an increase in remote or decentralized clinical trials (DCTs). DCTs present an opportunity to extend the benefits of research to underserved populations, decrease burdens, increase access to trials, and fill knowledge gaps surrounding rare conditions, though they are not without their own unique challenges and risks.

Biospecimen research and the law.

In the well-known case of Henrietta Lacks, cells from her tumor were taken without consent and used more than 70 years ago to create the first immortal human cell line ("HeLa" cells). That event led to many scientific breakthroughs and to the debate about the ethics of consent and requirements for compensation. May 2024 saw two decisions by US federal courts-one related to Lacks-that could narrow the scope of research allowed on tissues obtained without consent and on nonidentified tissues, with implications for biomedicine.

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

Protecting Research Subjects During a Pandemic.

This commentary discusses twelve stories in which people who are involved in institutional review board (IRB) administration or serve as IRB members tell the stories of how the COVID-19 pandemic affected their work and lives. Among the aspects of these stories it highlights are the need to focus on the well-being of the institution's employees, and how issues involving protecting vulnerable subjects might relate to current policy debates about underserved communities. The final portion of this commentary focuses in particular on how one might measure success for a program in protecting its research subjects during a pandemic.

The use of human biospecimens for research.

This discussion presents many of the ethical, legal, and financial issues that underlie the contemporary regulatory framework for research with human biospecimens. Some considerations, such as claims of donor control over their biospecimens, could potentially constrain researchers' freedom of action. We first consider concepts underlying consent to donate biospecimens for research.

The Belmont Report at 40: Reckoning With Time.

It was the summer of 1972 when a stunned nation first learned of the infamous Tuskegee Syphilis Study, during which hundreds of poor, disease-stricken black men from Macon County Alabama, had been deliberately left untreated for 40 years. Coming on the heels of multiple, earlier examples of unethical human experimentation, the Tuskegee Syphilis Study made it plain that the moral foundation of human subject research was in desperate need of repair. Blind reliance on the Nuremberg Code and the Declaration of Helsinki was no longer going to suffice.

Use of PRO Measures to Inform Tolerability in Oncology Trials: Implications for Clinical Review, IND Safety Reporting, and Clinical Site Inspections.

Cancer therapeutics frequently lead to symptomatic adverse events (AE) that can affect treatment tolerability. The NCI has developed the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic AEs by direct patient self-report. Although longitudinal assessment of patient-reported symptomatic AEs holds promise to better inform treatment tolerability, using patient-reported outcome (PRO) measures to assess symptomatic AEs has raised several regulatory and good clinical practice issues among those who conduct cancer clinical trials.

Research involving human subjects: ethical and regulatory issues.

A history of past abuses on research with human subjects has led to various sets of rules that are designed to insure ethical practices to protect research subjects appropriately. To understand these rules, it is important to appreciate the significant differences between being a patient, where protecting the best interests of that patient is the primary goal, and being a research subject, where that is generally not the case. In the research setting, there can be a conflict between attempting to answer the research question, and doing what is best for the subject.

Streamlining ethical review.

The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants.