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FORMERLY HEPP Report FORMERLY HEPP Report September 2005 Vol. 8, Issue 9 ABOUT IDCR ESEARCHINORRECTIONS IDCR, a forum for R C correctional problem solving, targets By David Paar*, MD, David Thomas**, MD, an incentive that today would be considered correctional physicians, nurses, Jacqueline Thomas**, DO, Danielle Thomas**, highly coercive - while other participants administrators, outreach workers, and MS-IV, and Courtney Colton**, IDCR received special privileges or compensation case managers. Published monthly DISCLOSURES:*Consultant: Gilead, Abbott, such as cigars or cigarettes. Many inmates who and distributed by email and fax, Boehringer Ingelheim, Speaker's Bureau: participated in studies during this period did not IDCR provides up-to-the moment Gilead, Bristol Myers Squibb, GlaxoSmithKline, give truly informed consent. Few understood information on HIV/AIDS, Abbott, Boehringer Ingelheim, **Nothing to dis- the risks and benefits, if any, of the research hepatitis, and other infectious close protocols, and some may not have even been diseases, as well as efficient ways asked to participate.1,2,3 to administer treatment in the Whether or not the inclusion of incarcerated correctional environment. Continuing individuals in clinical research studies is justifiedThe Second World War had a significant impact Medical Education credits are has generated heated debate over the later parton the inclusion of prisoners in research investi- provided by the Brown University of the past century. Some have advocated thatgations. On the one hand, with the onset of the Office of Continuing Medical no research study can ethically include prison-war, investigators appealed to inmates to make Education. IDCR is ers living in an inherently coercive environment,a patriotic contribution to the war effort by par- distributed to all members of the while others counter that incarceration does notticipating in medical research that would assist Society of Correctional Physicians strip an individual of his or her ability to make anthe military. The research included injections of (SCP) within the SCP publication, blood from cattle to investigate alternate CorrDocs (www.corrdocs.org). informed decision regarding participation as a research subject. sources of blood products, studies of atropine as an antidote, as well as experiments in which CO-CHIEF EDITORS Much of this debate is fueled by the competingsubjects were infected with sleeping sickness, Anne S. De Groot, MDconcerns of protecting inmates as a vulnerabledengue fever, gonorrhea, malaria, and agents of Director, TB/HIV Research Lab, population while respecting their individualgas gangrene.1,2,3 Brown Medical School autonomy. This conflict is waged against the David Thomas, MD, JDbackdrop of a historical legacy of unethicalHowever, at the conclusion of World War II, the Professor and Chairman, treatment of incarcerated, institutionalized anddiscovery of human experimentation conducted Department of Surgery, by the Nazis on those they had imprisoned led Division of Correctional Medicine other vulnerable groups during clinical research NSU-COM studies. to a wide scale re-evaluation of the ethics of research of human subjects and the study of the DEPUTY EDITORS HISTORY OF RESEARCH IN PRISONS IN incarcerated in particular. The Nuremberg War Joseph Bick, MD Chief Medical Officer, THE TWENTIETH CENTURY Crime Tribunal was convened to investigate and California Medical Facility, California Research involving prisoners has had a trou-punish war time crimes perpetrated by the Department of Corrections bled past. During the early part of the twentiethNazis, including hideous trials performed by the Renee Ridzon, MDcentury, there were well-documented instancesGermans in concentration camps. In 1947, the Senior Program Officer, of investigators in the United States, and else-tribunal produced the Nuremberg Code, a set of HIV, TB, Reproductive Health, where, using prison inmates to study the patho-10 basic tenets, which was drafted as the stan- Bill & Melinda Gates Foundation genesis, prevention, and treatment of a varietydard by which to judge physicians and scientists Bethany Weaver, DO, MPHof illnesses including cholera, beriberi, pellagra,during their trial at Nuremberg. It became an Acting Instructor, Univ. of Washington, and tuberculosis. Notorious experiments, suchethical standard for research for decades. Center for AIDS and STD Research as the transplantation or injection of human or animal testicular material into senile men, wereThe first of these tenets, that "the voluntary con- SUPPORTERS conducted, and, although rare, reflected thesent of the human subject is absolutely essen- IDCR is grateful for tial . [and] should be so situated as to be the support of the following belief at the time that inmates were a population Continued on page 2 companies through unrestricted that could be subjected to experimentation that educational grants: could not be performed on the general popula- tion. The unique vulnerabilities of inmates in HATSNSIDE Major Support:Abbott Laboratories W ’I these studies were often exploited. For exam- IDCR-o-gram pg 5 and Roche Pharmaceuticals. ple, many of the participants were death row State Laws 101 pg 6 inmates, some of whom died following injection Sustaining:Pfizer Inc., Gilead IDCR 101 pg 7 of cholera toxins or similarly dangerous proce- Sciences, Inc., GlaxoSmithKline, Merck In The News pg 8 & Co., and Schering-Plough. dures. "Volunteers" were recruited by promising them clemency if they survived the experiment - Self-Assessment Test pg 9 Brown Medical School Providence, RI 02912 401.453.2068 fax: 401.863.6087 www.IDCRonline.org If you have any problems with this fax transmission please call 800.748.4336 or e-mail us at [email protected] September 2005 Vol. 8, Issue 9 visit IDCR online at www.IDCRonline.org 2 RESEARCHINCORRECTIONS... and behavioral research involving humanbecame law in 1978, was revised in 2001 (continued from page 1) subjects and to develop guidelines, whichand provides some guidance regarding the able to exercise free power of choice with-should be followed to assure that suchinclusion of prisoners in research. 45 CFR out . the intervention of any element ofresearch is conducted in accordance with46 applies to all research involving human force, fraud, deceit, duress . or coercionthose principles. The Belmont Reportsubjects that is conducted, supported by, or . ." has been widely interpreted asresulted from an intensive four-day periodotherwise subject to regulation by any fed- excluding prisoners from research sinceof discussions held at the Smithsonianeral department or agency. It provides incarceration is a necessarily coercive con-Institution's Belmont Conference Centerdirection on how agencies and institutions dition. However, in the U.S., the prevalentsupplemented by monthly deliberations ofcan file letters of assurance that they will opinion in the medical community,The Commission held over a four-year peri-comply with these regulations, direction on endorsed by the American Medicalod. It was published in The Code of Federalthe composition and duties of institutional Association, was that the Nuremberg CodeRegulations (CFR), commonly called thereview boards (IRBs) that oversee federal- pertained to Nazi atrocities, but not to thefederal register or common rule, on Aprilly funded research, requirements for increasingly prevalent medical experiments18, 1979 as a statement of the Departmentinformed consent, and documentation of being conducted using inmates in state andof Health, Education, and Welfare's policyinformed consent. Subpart B of this law federal jurisdictions. In fact, the post-warof ethical principles and guidelines for thelists additional protections for pregnant flourishing of medical experimentation with-protection of human subjects of research.women, human fetuses, and neonates, and in the U.S. penal system was being drivenLater this department evolved into theSubpart C lists additional DHHS protec- by increased federal funding to investigateDepartment of Health and Human Servicestions pertaining to biomedical and behav- medical illness, the formation of academic-(DHHS) which remains responsible for theioral research involving prisoners as sub- pharmaceutical alliances, and the need toprotection of human subjects involved injects (6 45 CFR 46). test various products in human subjects tobiomedical research through the Office of The additional protections of Subpart C meet U.S. Food and Drug AdministrationHuman Research Protection (OHRP). The provide for prisoners that participate in bio- regulations.1,2,3,4 three basic principles that were detailed in this report were respect for persons, benef-medical research including: 1. Inclusion of Prisoners were enlisted in a broad range oficence, and justice. Respect for personsa prisoner or a prisoner representative on clinical studies and the inclusion of inmateshas two important components: individualsthe IRB reviewing the research; 2. in investigation became routine. Inshould be treated as autonomous agentsAssigning additional duties to the reviewing Holmesburg Prison, a county facility inand those with diminished autonomy areIRB to be sure that the research is permis- Philadelphia, in the late 1960’s inmatesentitled to protection. The report itselfsible, free of undue influence, safe, acces- were recruited to participate in studies thatdirectly addresses the issue of prisonersible and fair to all inmates, presented in explored everything from simple detergentsparticipation in research: understandable
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