After having completed a study that involved the collection of tissue from the subjects, an investigator wishes to perform additional analysis of the archived tissue samples. This nature of this analysis was not explicitly stated in the original consent form.

Should the investigator be required to obtain explicit consent for the new research?

During the conduct of a large clinical trial of an investigational drug, preliminary analysis of results show that there were three times as many participants in the experimental group who experienced severe nausea and vomiting compared to the control group. Two of the cases were severe enough to require that the participants be hospitalized. This is despite the fact that the preliminary analysis shows that there may be a moderate benefit with the drug.

What should be done?
 

Mrs. Franklin, an 81-year-old Alzheimer's patient hospitalized under your care has been asked to participate in a clinical trial testing a new drug designed to help improve memory. You were present when the clinical investigator obtained a signed informed consent from Mrs. Franklin a few days ago. However, when you visit Mrs. Franklin today and ask her if she is ready to begin the study tomorrow, she looks at you blankly and seems to have no idea what you are talking about.

What should you do?

Childhood Obesity and Parental Responsibility
(From BH509: When Life Makes You Sick: Ethics and the Social Determinants of Health, Erika Blacksher, instructor)

Health Care Disparities and Priority for Treatment
(From BH509: When Life Makes You Sick: Ethics and the Social Determinants of Health, Erika Blacksher, instructor)

Forced Treatment for Multidrug-Resistant Tuberculosis

MW is a 33-year-old man with multidrug-resistant tuberculosis (MDR-TB). He is homeless, and has a pattern of missing many of his scheduled clinic visits. Upon starting a multi-drug regimen for his condition, MW initially comes to his scheduled clinic visits, but after a few weeks begins missing them. The provider contacts the social work case manager, who arranges supervised drug administration (also known as “directly observed therapy”). Nevertheless, MW often cannot be found and this approach is deemed to be failing.

Sexually Transmitted Diseases and Contact Tracing

MG is a 27-year-old graduate student, recently married, who comes into the student health clinic for a routine pelvic exam and Pap smear. During the course of the exam, the gynecology resident performing the exam obtains the Pap smear, but also obtains cervical cultures for gonorrhea and chlamydia. The examination concludes uneventfully.

B.R. is a term female infant from an unexpected pregnancy. She has Down syndrome (Trisomy 21) and also has a complex cardiac lesion that will require at least two major surgical procedures during early infancy for her to have a chance to survive beyond childhood. B.R.'s parents, ages 44 and 45, have three other children, all in college. They have considerable ambivalence as to what to do: continue to pursue potentially beneficial though burdensome and costly treatments, or forego such treatments in favor of a more conservative approach.

What are the issues involved?