Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 SYNTHESIS PAPER EVOLUTION OF RESEARCH ETHICS GUIDELINES Lastimosa, Kharylle BSN 3E Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 Nuremberg Code The International Military Tribunal were the ones who handled the primary trial at Nuremberg succeeding World War II, and the tribunal consisted of judges from the four allied nations of the United States, Britain, France and the Soviet Union. This tribunal was tasked and entrusted to judge Germany’s senior war criminal. This was considered to be the first of its kind in the world of international trials, however the United States had held 12 subsequent trials succeeding the first international tribunal. One of the first trials of this kind was called the Doctors’ Trial consisted of 23 defendants, 20 of them being doctors who were being put on trial for murder and torture. Apparently, they had abused concentration camp prisoners by abusing them with medical experiments. It’s important to note that during these years, concentration camp prisoners were not treated humanely anymore, and were all subject to death in the long run. Because of this, the Nuremberg Code was established and this maintained that human subjects needed to agree to whatever medical Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 experiment/operation was done on them. The code posits the idea that patients should be involved in the decision making process if conscious, and have the right and freedom of choice to agree or disagree. Hence, outside forces/elements such as fraud, deceit, force, bribery and coercion are highly prohibited. The code also posits the idea that individuals have the right to be educated about their choices and the outcomes of the procedure. Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 Declaration of Helsinki The Declaration of Helsinki was curated by the World Medical Association and was established as a means to declare certain ethical principles in guiding doctors and participants with regards to medical research and experimentation. Essentially, the DoH are ethical guidelines for human experimentation, and was created in 1964. Similar to the Nuremberg Code, this declaration was established to help avoid mistreating and abusing patients. The DoH focused mainly on establishing rules for physicians and doctors by reminding them of their moral and ethical duties when it came to making sure that the human rights of the subjects were safeguarded throughout research processes. It also gave doctors suggestions as to how to properly do clinical research. Since medical research usually requires a set of scientific and moral principles, they should also follow scientific literature and other suitable laboratory experiments. Subsequently, the DoH declares that medical research participants need to be given informed consent form so that they are properly informed on the study’s goals and methods. Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 The Tuskegee Syphilis Study The Tuskegee Syphilis Study is a notorious clinical experiment conducted in Macon County, Alabama, USA between 1932 and 1972 on a large group of black males, around 600, of which 400 were afflicted with syphilis and the remaining 200 were not. The study sought to determine if blacks and whites react similarly to syphilis and to determine how long a human being may live with untreated syphilis. The Tuskegee Syphilis Study was considered unethical for various reasons. This study had presented so many ethical concerns throughout its process, and these included the lack of informed consent, racism, paternalism, maleficence, injustice, among others. Subsequently, the study has violated the basic bioethical principles that posit the idea of respect for autonomy. The participants of the study were not informed of the study’s goals, procedures and the discomfort it may bring to the participants. Racism was also involved because only African American men were involved in the study, and these participants were withheld of their choice to receive treatment. Some study participants experienced adverse effects ranging from paralysis of limbs Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 due to an extremely dangerous spinal tap procedure used by the researchers to obtain fluids from the patients' spinal cords to extreme neuronal damages, some died from advanced syphilitic lesions, wives were infected, and many of the participants' offspring were born with congenital syphilis. Republic of the Philippines UNIVERSITY OF NORTHERN PHILIPPINES Tamag, Vigan City 2700, Ilocos Sur College of Nursing Website: www.unp.edu.ph Mail: cn@unp.edu.ph Tel: (077)604-2500 CP: 09177148749, 09175785986 RA 10532 (Philippine National Health Research System Act of 2013) The Philippine National Health Research System (PNHRS) is a system that ensures that Filipinos get great health care by ensuring that health research is related to our health system's requirements. This also formalized a memorandum of understanding that was held between DOST, DOH, CHED, and UP Manila in order to improve the health status of Filipinos, improve the quality of care they receive medically, and ensure that health related research in the country is linked to the needs of the country. It also aims to ensure that investments made into medical research will be able to get the greatest benefit/results.