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Biomedical subjects

Jerry Menikoff

Publications and source records attributed to Jerry Menikoff.

11 recordsLinked to original sources

Full disclosure: telling patients when not being a research subject is a good choice.

Informed consent to participation in research generally requires giving a person information about the alternatives to being in the research study. It is quite common, however, for research subjects not to be given one particularly significant piece of information: the possibility of obtaining the "new" treatment being studied directly from a doctor without participating in the study. Since many people enroll in studies precisely to get such a new treatment, they frequently would prefer that option--which guarantees them that new treatment--to enrolling in a study where there is only a 50% chance of getting the new treatment. This issue becomes more complicated in the context of pediatric oncology research, since physician-researchers in this field have entered into a unique informal agreement not to offer such new treatments outside of research studies. That agreement, which in effect forces physicians to behave in a manner that subordinates the well-being of some of their current patients to that of future patients, is ethically and legally questionable.

Choice Behavior↗

The hidden alternative: getting investigational treatments off-study.

Research studies commonly randomise patients between standard care and some new form of treatment. In a substantial number of studies, the new treatment could have been obtained by the patient directly from their doctor, without participating in a study. Yet it is a common practice, endorsed and encouraged by the US government, not to advise potential research participants about their ability to get the new treatment outside of the study. This policy is even occurring in one of the largest studies ever funded by the US government, the 22000 patient, 5-year comparison of tamoxifen and raloxifene in the prevention of breast cancer. This practice has the effect of encouraging more individuals to participate in research studies, but the result is that their consent to participate is not fully voluntary. Many ongoing studies may therefore be of questionable ethical soundness.

Biomedical Research↗

Perinatal substance abuse and human subjects research: are privacy protections adequate?

Privacy incursions in the clinical care of substance abusing pregnant women have gained lay and professional attention recently as the result of a high-profile Supreme Court finding in Ferguson vs City of Charleston et al. In March, 2001 the Supreme Court determined that nonconsensual drug screening of pregnant women by clinicians in a public hospital violated the women's Fourth Amendment rights to be secure against unreasonable search and seizure. Coercive or punitive policy approaches to perinatal substance abuse are often based on mistaken assumptions about the nature of addiction and the outcomes of punitive interventions. Much attention has been given to efforts to criminalize pregnancy for drug using women, and civil laws are also coming under increasing scrutiny. Although no state has passed a law criminalizing pregnancy and drug use, an estimated 250 women in more than 30 states have been prosecuted around the country on theories of "fetal abuse." A growing number of states (eighteen to date) have amended their civil child welfare laws to address specifically the subject of a woman's drug use during pregnancy. No one has examined how these laws and social policies could affect research that includes pregnant and parenting women; women (and their families) who stand to lose a great deal should their drug use be brought to the attention of child welfare or criminal justice authorities. We examine the adequacy of current protective mechanisms, such as federal certificates of confidentiality, in protecting research subjects (and investigators) who may be subject to punitive civil or criminal sanctions. We determine that current protective mechanisms may be insufficient to protect research subjects and that investigators and IRB members are often ignorant of the risks imposed by punitive policy approaches to perinatal substance abuse or fall prey to the same mistaken assumptions that inform punitive policies. We conclude that investigators and IRB members have a moral responsibility to understand local, state and national policies and laws governing perinatal substance abuse. Investigators and IRB members should balance the harms of punitive interventions against the protections that may, or may not be afforded to prospective research subjects as well as the prospective benefits, individual and social, of the research. In situations where criminal or punitive policies are in effect, investigators and IRB members should consider whether adequate protections can be achieved. In the context of inadequate protections, potential risks to prospective research subjects and their families may outweigh the individual or social benefits that accrue from the research. Clinical researchers are professionally obligated to work toward amending laws and policies that are not in the best interests of prospective research subjects.

Confidentiality↗

Equipoise: beyond rehabilitation?

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.

Disclosure↗

The importance of being dead: non-heart-beating organ donation.

There is no definitive answer to the question of how long one must wait, after a person's heart stops beating, before concluding that the person meets the heart-lung criteria for death. This question has assumed new importance with attempts to remove transplantable organs from people declared dead using those criteria. An examination of the legal definition of death suggests that organs are indeed being procured from some of these people prior to their being legally dead. Moreover, the fact that the donors have consented to these procedures does not eliminate reason for concern regarding this state of affairs, since patient autonomy must at times be overridden in pursuance of important social goals.

Attitude to Death↗