Making Research a Requirement of Treatment: Why We should Sometimes Let Doctors Pressure Patients to Participate in Research‪.‬

In recent years, a number of events have raised concerns about the adequacy of safeguards to protect people who volunteer for medical research. Individuals without a serious illness, like Jesse Gelsinger and Ellen Roche, have died unexpectedly while participating in clinical trials. (1) The federal Office for Human Research Protections temporarily halted studies at several major academic centers for their failure to observe research guidelines. (2) Overseas trials of HIV-therapy during pregnancy have been criticized for including a placebo control arm. (3) For some studies, we must worry whether research subjects are placed at too great a risk by physicians seeking to advance medical knowledge. At the same time, we must also question whether research safeguards are sometimes overly protective of people who might enter clinical trials. Progress in treating trauma patients, for example, was hampered for many years by the requirements of informed consent--seriously injured patients often lack the decision-making capacity necessary to agree to enrollment in a research trial, and family members may not be available to consent to the trial on their behalf. These difficulties in enrolling patients slowed the development of promising therapies--including more effective methods for cardiac resuscitation and substitutes for blood to transfuse patients who have suffered major blood loss. (4) To address this problem, federal guidelines for informed consent were modified in 1996 to permit valuable research in the emergency setting. (5)