Most people know precious little about the risks and benefits of participating in a clinical trial--a medical research study involving some innovative treatment for a medical problem. Yet millions of people each year participate anyway. Patients at Risk explains the reality: that our current system intentionally hides much of the information people need to make the right choice about whether to participate. Witness the following scenarios: -Hundreds of patients with colon cancer undergo a new form of keyhole surgery at leading (...) cancer centersnever -Tens of thousands of women at high risk of developing breast cancer are asked to participate in a major research study. They are told about the option of having both breasts surgically removed but not told about the option of taking a standard osteoporosis pill that might cut the risk of getting breast cancer by one-half or more. Patients at Risk written by two nationally prominent experts, is the first book to reveal the secrets that many in the research establishment have fought long and hard to keep from patients. It shows why options not commonly knownincluding getting a new treatment outside of a research studycan often be the best choice. It explains how patients can make good decisions even if there is only limited information about a treatments effect. And it does this through the eye-opening stories of what is happening daily to thousands of people. Day after day, we are learning how little we know about what really works. Headlines regularly announce that a previously unquestioned treatmenthormone replacement therapy, drugs such as Vioxx or Celebrexmay now be much riskier than we thought. The latest book in a surge of recent books criticizing the medical establishment (but the first to look at clinical trials specifically), Patients at Risk helps to empower patients to survive in a world of medical uncertainty, and makes positive recommendations for systemic reform. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

Traditionally, organ retrieval from cadavers has taken place only in cases where the declaration of death has occurred using “brain death” criteria. Under these criteria, specific tests are performed to demonstrate directly a lack of brain activity. Recently, as a result of efforts to increase organ procurement, attention has been directed at the use of so-called “non-heart-beating” donors : individuals who are declared dead not as a result of direct measurements of brain function, but rather as a result of the (...) cessation of heart and respiratory functions. Attempts to obtain organs from such individuals have recently resulted in substantial negative publicity. Claims were made that the deaths of patients were being accelerated in order to get organs, and that sometimes organs were being removed from patients who were not yet dead. (shrink)

More than 50 years ago, in a front-page article in the New York Times, the truth about what happened to hundreds of black men in a government-conducted research study was revealed to the American p...

Volume 20, Issue 7, July 2020, Page 80-82.

People of a certain age will immediately recognize the image of a distraught woman, hand to her forehead, bemoaning how she just now realized that she forgot to have children. Nielsen Busch and Mja...

The U.S. review system for human subjects research has been widely criticized in recent years for requirements that delay research without improving human subjects protections. Any major reformulation of regulations may take some time to implement. In the meantime, current regulations often allow for streamlined ethics review without jeopardizing—and possibly improving—protections for research participants. We discuss underutilized options, including research that need not be classified as “human subjects research,” categories of studies that can be exempt from ethical review, and studies (...) that need only undergo expedited review by one IRB member. In addition, we consider ways to simplify review of multi-center research using one institution’s IRB. We speculate on multiple reasons for the underuse of these mechanisms, and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process. (shrink)

Few would disagree with the notion that it would be a wonderful thing if we could more quickly learn how to treat, or better yet cure, diseases afflicting millions of people. Alex John London argue...

Much of what Ruth Faden and colleagues say squarely meshes with the ideas of the U.S. Department of Health and Human Services about reforming the system for protecting research subjects. Having said that, I want to turn to a very different part of the research universe, the elephant in the room, as it were: the world of interventional randomized clinical trials. Under the current regulatory system, these research subjects receive substantial protections. Most importantly, they are generally enrolled only after they (...) give their informed consent. The rationale for this approach is that research subjects are denied the core ethical protection provided to patients: there is no requirement that everything done to them be in their best interests. Faden and colleagues appear to be proposing to eliminate this informed consent requirement for a significant range of such trials. (shrink)

Volume 20, Issue 5, June 2020, Page 1-3.

Some transplant centers are making use of a four‐person organ exchange to encourage live donor kidney transplantation. Although no money changes hands, it is a quasi‐contractual arrangement and a step toward for‐profit transactions, and it threatens to undermine the organ donor system.

: Challenging the interpretation of Charles Fried's use of "equipoise" presented by Paul Miller and Charles Weijer in a recent issue of the Kennedy Institute of Ethics Journal , this commentary argues that Fried was in no way promoting the concept of equipoise. In fact, his key point was that patients have a right to know and to make their own decisions about participation in clinical trials, regardless of equipoise, however it is defined.

When seriously ill patients for whom existing treatments are inadequate are invited to participate in clinical trials that offer a new treatment, should those persons be considered “vulnerable”? And if so, what additional protections should they be accorded? This article attempts to provide some answers.

Suppose that someone has a serious illness. The illness will likely lead to significant disabilities, and may even cause death. Existing treatments are unsatisfactory. The patient learns about a clinical trial, in which some allegedly promising new treatment for that illness is being tested.Such seriously ill patients for whom existing treatments are unsatisfactory have sometimes been categorized as medically vulnerable in the literature. Should these patients indeed be considered vulnerable subjects and be provided with special protections? And if the answer (...) is yes, then what are those special protections? This article explores the possible answers to these questions.The federal regulations for the protection of research subjects have several provisions addressing the concept of vulnerability. The three subparts Subparts B, C, and D deal with specific categories of vulnerable subjects, but do relatively little to address broader issues relating to vulnerability that might apply to a category such as the medically vulnerable. The Common Rule is the only section containing general discussions of vulnerability. (shrink)

The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of the consent forms in (...) that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

Informed consent is the bedrock principle on which most of modern research ethics rest. That principle, like most others, has some exceptions, such as for emergency situations and for some studies involving very low risk. But what about situations that do not fall into either of these categories? Are there such research studies that are so important to society that we nonetheless are willing to involuntarily enroll subjects, without their informed consent?

The factual premise: A clinical trial takes place, with results suggesting that a new treatment is better than standard care for a particular medical problem. One large group of physicians—call the...