ADULT;
AGE;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
CHILD;
ETHICS;
FEMALE;
FREEDOM;
HUMAN;
HUMAN EXPERIMENT;
INTERNATIONAL COOPERATION;
MEDICAL ETHICS;
MINORITY GROUP;
MISCELLANEOUS NAMED GROUPS;
NOTE;
PATIENT PARTICIPATION;
PATIENT SELECTION;
PERSONAL AUTONOMY;
RESEARCH;
RESEARCH ETHICS;
RESEARCH SUBJECT;
SEX DIFFERENCE;
SOCIAL CHANGE;
SOCIAL PSYCHOLOGY;
STANDARD;
UNITED STATES;
VULNERABLE POPULATION;
WOMEN'S HEALTH;
BIOMEDICAL AND BEHAVIORAL RESEARCH;
ADULT;
AGE FACTORS;
CHILD;
ETHICS;
ETHICS, MEDICAL;
ETHICS, RESEARCH;
FEMALE;
FREEDOM;
HUMANS;
INTERNATIONALITY;
MINORITY GROUPS;
NONTHERAPEUTIC HUMAN EXPERIMENTATION;
PATIENT PARTICIPATION;
PATIENT SELECTION;
PERSONAL AUTONOMY;
PERSONS;
PREJUDICE;
RESEARCH;
RESEARCH SUBJECTS;
SEX FACTORS;
SOCIAL CHANGE;
SOCIAL VALUES;
THERAPEUTIC HUMAN EXPERIMENTATION;
UNITED STATES;
VULNERABLE POPULATIONS;
WOMEN'S HEALTH;
The use of thalidomide in female subjects resulted in severe birth defects in some of their infants, for example. Also, animal models tend to be based on males, as females have rapid menstrual cycles that can alter research findings. A.F. Schatzberg, "Research Advances in Psychiatry," (Paper presented at the American Psychiatric Association 1999 Annual Meeting, 17 May 1999, in Washington, D.C.). Whether even these reasons are good ones is - especially with the benefit of hindsight - subject to debate.
For example, I can recall no instance in meetings of different IRBs, over literally decades, in which principal investigators have protested as vigorously as they have when informed that an IRB would not approve their protocol because it did not include women. As a second example, I recently attended a conference at which the presenters were describing new requirements to include children. The attendees' chagrin was so strong, even the presenters hastened to assure them there were many ways that researchers could "get around them."
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Childhood Maltreatment and Adverse Outcomes: A Prospective Developmental Approach
Paper presented 18 May in Washington, B.C.
Emphasis added. The following example illustrates how far we are from this now: Children subjected to sexual abuse are among those worst-off. There are more new cases of children subjected to sexual abuse each year than all new cancer cases combined, and the costs to society of child abuse and cancer are surprisingly commensurate. Nonetheless, the research dollars we will spend this year on child abuse are $29.9 million; on cancer, $3.1 billion. The annual cost from child abuse is estimated to be $56 billion dollars. F.W. Putnam, "Childhood Maltreatment and Adverse Outcomes: A Prospective Developmental Approach," (Paper presented at the American Psychiatric Association Meeting, 18 May 1999, in Washington, B.C.).
The Ethics of Placebo-Controlled Trials for Perinatal Transmission of HIV in Developing Countries
Summer
See, e.g., P.A. Clark, ""The Ethics of Placebo-Controlled Trials for Perinatal Transmission of HIV in Developing Countries," The Journal of Clinical Ethics 9, no. 2 (Summer 1998): 156-66, and R.J. Levine, "The 'Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries," The Journal of Clinical Ethics 9, no. 2 (Summer 1998): 167-72.
The 'Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries
Summer
See, e.g., P.A. Clark, ""The Ethics of Placebo-Controlled Trials for Perinatal Transmission of HIV in Developing Countries," The Journal of Clinical Ethics 9, no. 2 (Summer 1998): 156-66, and R.J. Levine, "The 'Best Proven Therapeutic Method' Standard in Clinical Trials in Technologically Developing Countries," The Journal of Clinical Ethics 9, no. 2 (Summer 1998): 167-72.
Mortality, if untreated, exceeds 80 percent. With other measures, including dantrolene, this figure may be less than 7 percent. G.C. Allen, "Malignant Hyperthermia and Associated Disorders," Current Opinion in Rheumatology 5 (1993): 719-24.
