Guest Speaker: Eddy Brown, Dean at TESC discussed updates to Human Subjects Review application http://www.evergreen.edu/deans/humansubjectsreviewapp.htm
Guest Speaker: Dennis McBride, DSHS Institutional Review Board member
Guest Lecture
Ethics and Policy for Research on Human Subjects
Evergreen State College
11-17-2005
Dennis McBride, PhD
The Washington Institute for Mental Illness Research and Training
University of Washington
• Brief Description of Policy Milestones
• Current Day Ethically Challenged Examples
• Sources for IRB Information
• The Tuskegee Syphilis Study, Public Health Service, 1932 - 1972
• Milgram Obedience Studies (1963,65).
• The Stanford Prisoner Experiment, Phillip Zimbardo (1971)
• Tea Room Trade Impersonal Sex in Public Places – Laud Humphries (1970)
Source: (http://www.wmich.edu/ethics/ESC/index.html)
In the early 1930s, the U.S. Public Health Service (PHS) began a program aimed at controlling venereal disease in the rural South. The Julius Rosenwald Fund - a philanthropic organization that was interested in promoting the welfare of Afro-Americans ("Negroes") - provided the funds for a two-year demonstration study in Macon County, Alabama where 82% of the residents were Afro-Americans, most of whom lived in poverty and had never seen a doctor. A principal aim of this study was to determine the incidence of the disease in the local population, while training both white and Afro-American physicians and nurses in its treatment. When the results revealed that 36% of the Macon County Afro-Americans had syphilis, which was far higher than the national rate, the Rosenwald Fund, concerned about the racial implications of this finding, refused requests to support a follow-up project
In 1932 the PHS decided to proceed with a follow-up study in Macon County. Unlike the project supported by the Rosenwald Fund, the specific goal of the new study was to examine the progression of untreated syphilis in Afro-Americans . Permission was obtained for the use of the excellent medical facilities at the teaching hospital of the Tuskegee Institute and human subjects were recruited by spreading the word among Black people in the county that volunteers would be given free tests for "bad blood," a term used locally to refer to a wide variety of ailments. Thus began what evolved into "The Tuskegee Study of Untreated Syphilis in the Negro Male," a project that would continue for forty years. The subject group was composed of 616 Afro-American men , 412 of whom had been diagnosed as having syphilis, and 204 controls.
The participants were never explained the true nature of the study . Not only were the syphilitics among them not treated for the disease -- a key aspect of the study design that was retained even after 1943 when penicillin became available as a safe, highly effective cure -- but those few who recognized their condition and attempted to seek help from PHS syphilis treatment clinics were prevented from doing so.
Eunice Rivers , an Afro-American PHS nurse assigned to monitor the study, soon became a highly trusted authority figure within the subject community. She was largely responsible for assuring the cooperation of the participants throughout the duration of the study. She was aware of the goals and requirements of the study, including the failure to fully inform the participants of their condition and to deny treatment for syphilis. It was her firm conviction that the men in the study were better off because they received superior medical care for ailments other than syphilis than the vast majority of Afro-Americans in Macon County.
The nature of the Study was certainly not withheld from the nation's medical community. Many venereal disease experts were specifically contacted for advice and opinions. Most of them expressed support for the project. In 1965, 33 years after the Study's initiation, Dr. Irwin Schatz became the first medical professional to formally object to the Study on moral grounds. The PHS simply ignored his complaint. The following year, Peter Buxtin , a venereal disease investigator for the PHS began a prolonged questioning of the morality of the Study. A panel of prominent physicians was convened by the PHS in 1969 to review the Tuskegee study. The panel included neither Afro-Americans nor medical ethicists. Ignoring the fact that it clearly violated the human experimentation guidelines adopted by the PHS in 1966, the panel's recommendation that the Study continue without significant modification was accepted.
By 1972, Buxtin had resigned from the PHS and entered law school. Still bothered by the failure of the agency to take his objections seriously, he contacted the Associated Press, which assigned reporter Jean Heller to the story. On July 25, 1972 the results of her journalist investigation of the Tuskegee Study of Untreated Syphilis in the Negro Male were published. The response to Heller's revelations was broad-based public outrage, which finally brought the Study to an immediate end.
Milgram Studies (1963,65). “Behavioral Study of Obedience,” Journal of Abnormal and Social Psychology, 67:371-378.
40 Adult men
Told that through drawing lots one was assigned ‘teach” and one “pupil.”
He was assigned teacher; other was assigned pupil.
Told that pupil was strapped to a chair in the other room (could not see but could hear) and was attached to electrodes. Electrodes administered from 15 to 315 volts. Student could see how much was being administered. (Also ominous danger signs were attached – Danger – Sever Shock “XXX”.
Questions were asked of pupil when a mistake was made a light went on at Teacher terminal and teacher was told to administer a shock was administered. Gradual increase – kicking screaming. 5 of 40 quit administering shock; 26 of 40 continued as they were told through the highest shock. Some pleaded with experimenter to let them stop but continued as experimenter insisted. Pupils became extremely upset and nervous since they thought they were hurting/killing pupil.
What happens when you put good people in an evil place? Does humanity win over evil, or does evil triumph? These are some of the questions we posed in this dramatic simulation of prison life conducted in the summer of 1971 at Stanford University.
How we went about testing these questions and what we found may astound you. Our planned two-week investigation into the psychology of prison life had to be ended prematurely after only six days because of what the situation was doing to the college students who participated. In only a few days, our guards became sadistic and our prisoners became depressed and showed signs of extreme stress.
Tea Room Trade Impersonal Sex in Public Places – Laud Humphries (1970)
Posed as a “Watchqueen” (the lookout in bathroom while others had sex)
Took car licenses in parking lots, got info from police, disguised and went to homes to conduct survey to get personal info for research. Issues of deception, invasion of privacy.
Declaration of Helsinki: ethical principals for research involving human subject (1964)
Adopted from Nuremberg Code by the World Medical Association.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974 )
Created by Congress as a result of the Tuskegee Syphilis Study concluded in 1972.
Created by the National Commission and serves as the foundation for IRB's.
Office for Human Research Protections (OHRP)
Federal Regulation:
45 CFR part 46 Subparts A,B,C,D
Washington State Regulation :
RCW 70.02 , Medical Records – Health Care Information Access and Disclosure
RCW 42.48 , Release of Records for Research.
This document was drafted by an international panel of experts on medical research, human rights, and ethics. It focused on the requirement for voluntary consent of the human subject and the weighing of the anticipated potential humanitarian benefits of a proposed experiment against the risks to the participant. The Code served as the initial model for those few public and private research and professional organizations that voluntary chose to adopt guidelines or rules for research involving human subjects.
Declaration of Helsinki: ethical principals for research involving human subject (1964)
Internationally, there is little argument that the pre-eminent document addressing research ethics is the Declaration of Helsinki , adopted by the World Medical Association (WMA) in 1964. This document evolved from the Nuremberg Code, which was put in place to protect human research subjects in response to atrocities committed by Nazi physicians in the name of medical science. The Declaration of Helsinki has been amended 5 times, most recently in 2000.
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974)
Created by Congress as a result of the Tuskegee Syphilis Study (1972).
Based on the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978), the Department of Health and Human Services (HHS) revised and expanded its regulations for the protection of human subjects 45 CFR part 46 in the late 1970's and early 1980's. In 1978, the Commission's report “Ethical Principles and Guidelines for the Protection of Human Subjects of Research” was published. It was named the Belmont Report , for the Belmont Conference Center, where the National Commission met when first drafting the report.
The Belmont Report explains the unifying ethical principles that form the basis for the National Commission's topic-specific reports and the regulations that incorporate its recommendations. The Belmont Report identifies three fundamental ethical principles for all human subject research – respect for persons, beneficence, and justice. Those principles remain the basis for the HHS human subject protection regulations.
In 1991, 14 other Federal departments and agencies joined HHS in adopting a uniform set of rules for the protection of human subjects, identical to subpart A of 45 CFR part 46 of the HHS regulations. This uniform set of regulations is the Federal Policy for the Protection of Human Subjects, informally known as the “Common Rule.”
Today, the Belmont Report continues as an essential reference for institutional review boards (IRBs) that review HHS-conducted or -supported human subjects research proposals involving human subjects, in order to ensure that the research meets the ethical foundations of the regulations.
In 1979 they published "Ethical Principles and Guidelines for the Protection of Human Subjects of Research," which is commonly referred to as "The Belmont Report." This document presents a well-developed ethical framework for the exploration of the issues associated with the use of human beings as the subjects of research. More comprehensive than the Nuremberg Code, it defined the boundary between accepted therapeutic practice and experimental research, and proposed the following three basic principles to guide in the evaluation of the ethics of research involving human subjects:
Anonymity
Confidentiality
Informed Consent
Active Consent
Passive Consent
Assent
• VIOXX
• Former University of Vermont researcher Eric Poehlman
• Havasupai Tribe “Diabetes” Study (Strong Heart Study)
• Fabre Research Clinic Clozapine Study
• UW Genetics Study
Source: ( http://www.illuminata-inc.com/News.html )
Merck Documents Show Aggressive Marketing of Vioxx After Studies Indicated Risk
Thursday, May 05, 2005 -- On November 9, 2004, the Committee on Government Reform requested that Merck provide the Committee with a wide range of documents related to the anti-inflammatory drug Vioxx. The request expressly sought "all presentations, training sessions, or materials given to Merck employees and agents who marketed Vioxx" and "all records of communication provided to healthcare providers and pharmacists concerning the safety and efficacy of the drug." In response to this request, Merck provided the Committee with over 20,000 pages of internal company documents, including course curricula, bulletins to the field, training manuals, company talking points, memoranda among senior executives, and promotional materials for use with physicians. The Committee also received documents from FDA related to Vioxx.
These documents provide an extraordinary window into how Merck trained its sales representatives and used them to communicate to physicians about Vioxx and its health risks. In fact, the documents may offer the most extensive account ever provided to Congress of a drug company's efforts to use its sales force to market to physicians and overcome health concerns.
Rep. Waxman has released an analysis these documents that suggests that Merck sent more than 3,000 highly trained representatives into doctor's offices and hospitals armed with misleading information about Vioxx's risks.
By Carey Goldberg and Scott Allen, Globe Staff | March 18, 2005
In the worst case of scientific fakery to come to light in two decades, a top obesity researcher who long worked at the University of Vermont admitted yesterday that he fabricated data in 17 applications for federal grants to make his work seem more promising, helping him win nearly $3 million in government funding.
Former University of Vermont researcher Eric Poehlman faces possible prison time, $196,000 in fines and restitution, and a lifetime ban on federal funding in what investigators say is the worst US scientific fraud in 20 years. Under a plea agreement, Poehlman will correct or retract 10 published research papers, while admitting to the following:
? From 1992 to 2000, Poehlman received $2.9 million in federal research funding based on fabricated research data intended to make his work sound more promising. During the period, he filed 17 fraudulent grant proposals to study the impact of menopause on women's health, the benefits of hormone replacement therapy, and other topics.
? Poehlman fabricated test results for all but three of the 35 women in his long-term study of the health effects of menopause, an influential paper indicating that women rapidly lose muscle mass, and gain fat after menopause . The Annals of Internal Medicine retracted Poehlman's findings in 2003 after the University of Vermont found evidence of fraud.
? Poehlman claimed that hormone replacement therapy helps slow weight gain after menopause based on fabricated data, helping him to win a $542,000 grant from the National Institutes of Health to continue the studies.
? In 2000, Poehlman exaggerated the health damage from menopause in the Vermont Longitudinal Study of Aging . A lab technician found that, when women's blood pressure or cholesterol improved over time, Poehlman would sometimes reverse the dates of the tests to make it seem that their health was declining.
? During the University of Vermont investigation of Poehlman's research fraud in 2000-2001, the US attorney in Burlington found that he ''destroyed electronic evidence . . . presented false testimony, presented false documents, and influenced other witnesses to provide false documents."
By Marija Potkonjak, East Valley Tribune |
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Office for Human Research Protections (OHRP):
http://www.hhs.gov/ohrp/humansubjects/guidance
Code Of Federal Regulations (Cfr), Title 45, Public Welfare, Department Of Health And Human Services, Part 46, Protection Of Human Subjects
45 CFR part 46 Subparts A,B,C,D:
http://www1.dshs.wa.gov/rda/hrrs/default.shtm
CITI Course in the protection of human research subjects
https://www.citiprogram.org/default.asp
The following federal regulations apply to all research proposals submitted to the Washington State Institutional Review Board
45 CFR Part 46 , Protection of Human Subjects
45 CFR Part 160 , HIPAA General Administrative Requirements
45 CFR Part 164 , HIPAA Security and Privacy
The following state laws apply to many research proposals submitted to the Washington State Institutional Review Board:
RCW 70.02 , Medical Records – Health Care Information Access and Disclosure
RCW 42.48 , Release of Records for Research
