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Research on Human Beings
Transcript of Research on Human Beings
by Alexann Marielle M. Paulino
A report on the ethics of biomedical research, study and/or experimentation involving human subjects
Human is a living individual about whom a research investigator obtains data through intervention or interaction with the individual or from individually identifiable information.
Research is a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalized knowledge.
Research in human subjects means a research study, inquiry, interviews in social science, environments and environmental conditions, a clinical trial of pharmaceutical products and medical devices, a study of the nature of disease, the diagnosis of, the treatment of, the health promotion of, and the prevention of a disease which is related to humans or conducted in humans.
Also, such researches include research studies using the information from patient’s medical records or databases, laboratory specimens, body fluids, human tissues, and studies about the physiology, biochemistry, pathology, responses to treatment in physique, biochemistry, psychology of normal subjects and patients. These researches are collectively called biomedical research.
Human research is controversial because while it has undoubtedly beneficial outcomes, it has the potential to cause harm physically or mentally to participants.
Why should we conduct human researches?
Research in human subjects is necessary for promoting scientific progress and building a better understanding in order to improve human’s well-being.
To generate a new body of knowledge and new understandings;
3 Main Purposes of Human Researches
To enhance scientific advancement that benefits the research subjects. Through researches, the subjects may gain benefits from the development of new treatment, from new findings for their better living standard, from new discoveries, from writing, speech, and traditional culture, or from satisfaction in improving society;
Also, researches provide for benefits for a society at large or for certain groups of people or have influence on political behavior, which may lead to an improved health policy. The statistical information about the disease incidence may help to improve public health. The information about living conditions and behavior may lead to social development.
A Timeline of Abuse on the Human Subjects
Edward Jenner infected a young boy named James Phipps with cowpox and then treated him. He noticed that the milk maids who had cowpox are immune to smallpox.
Dr Arthur Wentworth performed the first lumbar puncture on a 2 year old girl with a doubtful case of tuberculosis meningitis in a children’s hospital in Boston. He performs another 29 spinal taps on children without their mothers’ consent to determine is the procedure was safe.
Richard Pearson Strong, the head of Philippine biological laboratory, inoculated 24 inmates of Manila’s Bilibid prison with cholera vaccine that had been contaminated with plague organisms. 13 died after they were intentionally not given any intervention.
Dr. Joseph Goldberger was asked by the US Surgeon General Rupert Blue to investigate pellagra, an endemic disease in southern US. He theorized that pellagra was associated with diet rather than the commonly held opinion that it was an infectious disease. After multiple restricted diet experiments on Mississippi prisoners over several years, he was able to demonstrate that individuals who consumed heavily corn-based diets are of greatly increased risk to contracting pellagra.
Watson aimed to test the idea of whether fear was an innate or conditioned response. An 11month old orphan named little Albert was recruited. Watson conditioned a fear response so strong the little Albert became terrified of anything white or fluffy and was never desensitized.
Tuskegee Syphilis study. Sharecroppers in Macon County, Alabama were denied treatment for syphilis and deceived by physicians of the US public health services. The study was designed to document the natural history of the disease, but the men were told that they were being treated for “bad blood.” It was only aimed at black people.
The monster study. Speech pathologists at the University of Iowa set out to prove their theory that stuttering was a learned behavior caused by a child’s anxiety about speaking. They told the orphans that they could not speak unless they could pronounce the words right. This made the children silent, anxious and withdrawn from talking.
Nazi scientists forcibly experimented on prisoners of the concentration camp using biological agents.
Dr. Black infected a 12 month old baby with herpes as part of medical experiment.
Human subject Rights
1. Voluntary, informed consent
2. Respect for persons: treated as autonomous agents
3. The right to end participation in research at any time
4. Right to safeguard integrity
Objectives of the Ethical Guidelines for Research in Human Subjects
1. To ensure that the dignity, rights, safety and well-being of subjects participating in research are protected, and the result of the researches are credible.
2. To serve as guidelines for researchers, ethics committees, organizations, institutions, and people who are related to research ethics;
3. To serve as a basis for an ethics committee to derive a standard operating procedure (SOP) for the review and approval of a biomedical research conducted within each institution
5. Benefits should outweigh cost
6. Protection from physical, mental and emotional harm
7. Access to information regarding research
8. Protection of privacy and well-being
Ethical laws, codes and guidelines
The Nuremberg code
In 1949 the Nuremberg Code was published to be a set of guidelines to guide researchers who work with human subjects. Among the points of the code are the following concepts: participants must continually give their voluntary consent, the study must have the goal of producing good for society, and considerations must be taken to protect participants from even the remote possibility of injury.
The Declaration of Helsinki
In 1964, the World Medical Association published a code of research ethics, the Declaration of Helsinki. It was based on the Nuremberg Code, focusing on medical research with therapeutic intent. Subsequently, medical professionals and researchers began requiring that research follows the principles outlined in the Declaration. This document was one of the milestones towards the implementation of the institutional review board (IRB) process.
The Belmont Report
The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Three primary areas of application are also stated. They are informed consent, assessment of risks and benefits, and selection of subjects. According to Vollmer and Howard, the Belmont Report allows for a positive solution, which at times may be difficult to find, to future subjects who are not capable to make independent decisions.
The Council for International Organizations of Medical Sciences
It is a set of ethical principles regarding human experimentation first created in 1993 by CIOMS and updated in 2002. These 21 guidelines (15 in the original report) address issues including Informed consent, standards for external review, recruitment of participants, and more. The Guidelines are general instructions and principles of ethical biomedical research.
In the Philippines
In 1984, the National Ethics Committee (NEC) was organized by the Philippine Council for Health Research and Development (PCHRD) under Special Order No. 84-053 of then Executive Director, Dr. Alberto G. Romualdez, Jr. The following year, the NEC put together the first set of guidelines for the conduct of biomedical research in the country. These guidelines subsequently underwent revisions in 1996 and 2000 to address various developments in health research including multicenter clinical trials, genetic research, and organ transplantation research.
The 2006 version of the National Health Research Ethical Guidelines aims to put global health research norms in the context of Philippine values and realities. It embodies the adherence of Philippine health researchers to ethical principles to protect human life and the dignity of the human person.
Just like the other guidelines, these are meant to promote, and not to stifle, good and ethical scientific research. After all, advancement of the frontiers of knowledge brings hope for the good life, even for survival. But rules, codified as they are, are only rules on paper.
In the final analysis, all individuals concerned with health research must resolve for themselves the omnipresent conflict between present peril or risk and future benefits of the study at hand.
The human subjects being taken advantage were of lower “status” than the scientists and were easier to dehumanize.
US scientists injected hospital patients with plutonium to study effects of radiation on the body. The patients were not informed on the contents of their injections.
Interpersonal dynamics in simulated prison. Zimbardo’s Stanford prison experiment on interpersonal dynamics between prisoners and guards in simulated prison has gotten out of control and was quickly terminated only after 6 days from a previously planned 2 week experiment.
Behavioral study of obedience. Milgram's study on obedience had participants administering increasingly strong electrical shocks to other participants.
Drug manufacturer pays doctors to administer Thalidomine to pregnant women. The women were not aware that the drug was experimental and not yet approved by the FDA.
Japanese biological welfare center, unit 731. Shiro Ishii under the Japanese imperial Army conducted biological warfare and medical testing on civilians in 11 cities of China. He tested the effects of frost bite on them and attempted to reverse the effects of hypothermia. People were sprayed with various deadly diseases are some of the examples then dissected while still awake to observe the behavior of the disease internally. 200,000 people were killed; any survivors of the infections were also killed.