The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards (IRBs) should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment (ART) to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides antiretroviral treatment and care. Assuming the Institutional Review Board (IRB) raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address.

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on the presumption that the research enterprise owes subjects a duty of protection.

Access to human biospecimens is widely regarded as essential to the progress of medical research, and in particular, to the success of “personalized medicine.” Understanding the influence of genetic variation on human health and disease requires that researchers conduct genetic and other studies on thousands of human specimens. Over the past decade, human “biobanks” — vast collections of human biospecimens — have proliferated both in the United States and internationally. These biobanks are subject to a heterogeneous mix of standards that govern the collection and use of biospecimens.

The U.S. Department of Health and Human Services (HHS) has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking (ANPRM), entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers.

The proposed changes to the Common Rule, described in the recent Advanced Notice of Proposed Rulemaking (ANPRM), come more than 20 years after the U.S. Department of Health and Human Services adopted the Rule in 1991. Since that time, human subjects research has changed in significant ways. Not only has the volume of clinical research grown dramatically, this research is now regularly conducted at multiple collaborative sites that are often outside of the United States. Research takes place not only in academic medical centers, but also at outpatient clinics, community hospitals, and other nontraditional venues. In addition, technological advances, such as sophisticated computer software programs, the Internet, social media, new research methods, and mobile applications have exponentially increased the volume of data available and the possibilities for accessing, analyzing, and sharing that data.

Social media, meaning digital technologies and platforms such as blogs, wikis, forums, content aggregators, sharing sites, and social networks like Facebook and Twitter, have profoundly changed the way that information can be shared online. Now, almost anyone with a broadband internet connection or a smart phone can share ideas, data, and opinions with just about anyone else on the planet. This change has serious implications for the way in which human subjects research can be conducted and, concomitantly, for the ways in which such research may be regulated. This article explores some of these issues.

Almost all jurisdictions where physician-assisted death (PAD) is legal require that the requesting individual be competent to make medical decisions at time of assistance. The requirement of contemporary competence is intended to ensure that PAD is limited to people who really want to die and have the cognitive ability to make a final choice of such enormous import. Along with terminal illness, defined as prognosis of death within six months, contemporary competence is regarded as an important safeguard against mistake and abuse, arguably the strongest objections to legalizing PAD.

The insistence on contemporary competence is problematic. It means that someone who has dementia is ruled out as a candidate for PAD, even if she is terminally ill and suffering terrible and unrelievable pain. It also rules out individuals with strong and unwavering desires not to end their life in dementia.

The call for family and medical leave reform in the United States was largely the result of sweeping demographic shifts that occurred in the workforce after the 1950s, coupled with an ever-increasing life expectancy and changing social norms concerning the role of women as caretakers. By the early 1990s, the number of women in the workforce had nearly tripled from 1950. During that same period, life expectancy increased by six years for males and seven for females. Meanwhile, the first wave of the Depression-era generation began to reach the age of retirement. In short, the parents of American workers were living longer and retiring in greater numbers while more women, who were more likely to be informal caregivers, decided to join the workforce. As a result, many families with ill or elder parents began to turn to institutional long-term care.

According to the Social Security Administration, 98% of minor children are eligible to receive survivors benefits if a working parent dies. However, the eligibility of children born, and even conceived, after a working parent dies is less clear. In recent years, the Social Security Administration has received more than 100 applications for survivors benefits filed on behalf of children conceived after a parent's death, and one such case, Astrue v. Capato, was heard by the U.S. Supreme Court in 2012. In that case, whether the child is eligible to inherit under state intestacy law was accepted as a reasonable — and is a common — approach for determining eligibility for Social Security survivors benefits. The purpose of this study is to examine attitudes concerning access to Social Security survivors benefits (hereafter referred to as survivors benefits) in the context of various reproductive pathways and varying state intestacy laws.

On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.

It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions (FAQs), there have been no significant amendments to the Privacy Rule since 2003.

Major disasters and public health emergencies constantly test the nation's resolve to rally and recover from tragedy. Public health crises stemming from prolonged threats like the 2009/2010 H1N1 influenza pandemic require sustained preparedness and response over many months. Even shorter-duration events, like tornados, earthquakes, or hurricanes, leave lasting impacts for which full recovery may take years. Telling examples include the displacement of thousands of persons across the Gulf Coast states following Hurricane Katrina in 2005 and difficulties obtaining basic housing and services that persisted in the Northeast months after Hurricane Sandy in 2012. Whether the result of natural disasters, infectious disease outbreaks, bioterrorism, or other causes, these events can change the societal landscape in affected regions.

Despite the challenges of recovery across populations stemming from national or regional emergencies, Americans have consistently supported those directly affected.