YADAO, Calvin Keith M.

BSN 3-F

ACTIVITY

Search and read the following historical events that helped shape guidelines for human

subject protection. Make a synthesis paper regarding the evolution of research ethics

guidelines.

Nuremberg Code

Since its release 60 years ago, the Nuremberg Code has served as a framework for ethical

clinical research. This groundbreaking paper, written in response to the atrocities of Nazi

physicians and investigators' human experimentation, focused critical attention on the

fundamental rights of study participants and the obligations of investigators. It was written at a

pivotal time in history, following Germany's formal surrender at the end of World War II.

The Allied Commanders were well aware of the German Forces' atrocities against civilians

and prisoners of war, and prosecuted the top German officials. The Nuremberg Trials were a

series of military courts held by the victorious Allied forces in which key members of the

vanquished Nazi Germany's political, military, and economic leadership were convicted. The

trials took place at the Palace of Justice in Nuremberg, Bavaria, Germany, from 1945 to 1946.

The Nuremberg Code, which was written after the conclusion of the Doctor's trial in

Nuremberg in 1947, has been recognized as a watershed moment in medical and research ethics.

This code was based on the Guidelines for Human Experimentation of 1931, according to a

closer analysis. The similarity between these documents is startling. It's regrettable that the

Nuremberg Code's creators passed it off as their own work. There is evidence that the defendants

in the prosecution wanted that their acts be assessed according to the German Guidelines of
YADAO, Calvin Keith M. BSN 3-F

1931. The prosecutors, on the other hand, refused the request and tried the accused for crimes

against humanity, with the Nuremberg Code being implemented into the judgment. Six of the

Nuremberg Code's ten principles are derived from the 1931 Guidelines, while two of the four

additional principles are open to interpretation. There is little doubt that the Code was written

after reviewing the Guidelines, but no mention of the Guidelines was provided for unknown

reasons. Using the Guidelines as a base document without providing credit is plagiarism, and

according to our current knowledge of ethics, this is unethical. Because, unlike the Declaration

of Helsinki, the Nuremberg Code is not reviewed and revised on a regular basis, it has gone out

of favor. The fact that various ethics rules are updated on a regular basis demonstrates the

dynamic nature of human ethics.

The Nuremberg Code has no legal basis, and it would be incorrect to credit it with serving as

the model for all subsequent codes. It looks to be a poor improvisation over the 1931 Guidelines

on human experimentation, despite the fact that it was drafted by legal luminaries of the time. It

has gotten far more attention than it deserves, owing to its historical significance and the fact that

it was written by Americans. The last word on ethics has yet to be written; even the most recent

edition of the Declaration of Helsinki requires revision and will undergo countless adjustments

throughout time. Ethics is a subject that is constantly changing, and the rewriting of ethical

standards shows that human morals and values are improving.

The voluntary consent of the human subject is absolutely essential. This means that the person

involved must have legal capacity to consent; must be in a position to exercise free will without

the use of force, fraud, deception, duress, over-reaching, or any other form of secondary

constraint or coercion; and must have sufficient knowledge and comprehension of the elements

of the subject matter at hand to make an informed decision. This last factor demands that the
YADAO, Calvin Keith M. BSN 3-F

experimental subject be informed about the type, duration, and purpose of the experiment, as

well as the technique and means by which it will be conducted, before making an affirmative

decision; the method and means by which it will be carried out; the inconveniences and hazards

that may be reasonably anticipated; and the potential effects on his health or person as a result of

his participation in the experiment. The task and obligation for determining the quality of the

consent rests upon each individual who initiates, directs, or engages in the experiment. It is a

personal obligation and duty that cannot be transferred to others without repercussions. The

experiment should be designed to produce useful conclusions for society, be unobtainable

through other methods or means of research, and be random and unneeded in nature. The

experiment should be devised and based on animal experimentation and knowledge of the

natural history of the disease or other condition under investigation in such a way that the

expected results justify the experiment's execution. The experiment should be carried out in such

a way that no needless physical or mental suffering or injury occurs. Except in those trials when

the experimental physicians also serve as subjects, no experiment should be done if there is an a

priori basis to assume that death or disabling harm will occur.6. The degree of risk to be taken

should never exceed that determined by the humanitarian importance of the problem to be solved

by the experiment. To protect the experimental subject from even the remote possibility of

damage, impairment, or death, proper preparations and suitable facilities should be made. Only

scientifically qualified individuals should conduct the experiment. Those who perform or

participate in the experiment should be obliged to use the highest level of expertise and care at

all times.9. During the course of the experiment, the human subject should be at liberty to bring

the experiment to an end if he has reached the physical or mental state where continuation of the

experiment seems to him to be impossible. During the course of the experiment, the scientist in
YADAO, Calvin Keith M. BSN 3-F

charge must be prepared to stop the experiment at any point if he has reasonable grounds to

believe, in the exercise of the good faith, superior skill, and careful judgment that continuing the

experiment will result in injury, disability, or death to the experimental subject.

Reference:

Perspect Clin Res. 2011 Apr-Jun; https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3121268/

YADAO, Calvin Keith M. BSN 3-F

Declaration of Helsinki

The Declaration of Helsinki, which outlines the ethical guidelines for clinical research

involving human beings, was first endorsed by the World Medical Association's 18th Assembly

in Helsinki, Finland, in June 1964. The Declaration was based on the ten principles first stated in

the Nuremberg Code in 1947, which followed the horrifying experiments Nazi scientists

conducted on Jewish concentration camp prisoners during World War II, as well as elements

from the 1948 Geneva Declaration, which outlined physicians' ethical obligations. Before the

Nuremberg Code of 1947, there was no generally accepted code of conduct that governed the

ethics of research involving human subjects. There was no universally agreed code of conduct

governing the ethics of human subject’s research prior to the Nuremberg Code of 1947.

The Declaration of Helsinki points out a number of principles that offer a solid foundation for

ethical norms in clinical research. The following are some notable guiding principles:

Protection of the health of patients. Medical researchers are obliged to act in a way that

promotes and protects the health and well-being of all research participants. The Declaration of

Helsinki emphasizes the significance of doing research in such a way that the risks of potential

harm are minimized and the anticipated benefits are realized. This approach is consistent with

the Hippocratic Oath, which declares, "First, do no harm," as well as the Geneva Declaration,

which states, "My patient's health will be my first focus. “The pursuit of knowledge can never

supersede the rights of patients.

The pursuit of knowledge can never supersede the rights of patients. Medical research usually

tries to learn more about the causes and progression of a disease. It also aspires to improve

diagnoses and therapy. "The objective of medical research can never take precedence over the
YADAO, Calvin Keith M. BSN 3-F

rights and interests of individual study participants," the Declaration of Helsinki declares.

Researchers are expected to preserve the lives, dignity, health, integrity, privacy, right to self-

determination, and confidentiality of all study subjects, according to the Declaration.

Additional factors to consider. There are certain extra considerations that must be taken in

order to achieve the Declaration's principles. To begin, any medical research involving human

beings must be carried out by people who have received the necessary scientific and ethical

education and training. The research should be overseen by qualified health care experts or

physicians. Additionally, the physician-scientists should verify that the environment is not

harmed in any way during the research. If the patient is harmed, they should receive proper care

and, if necessary, compensation. The physician's scientist is also expected to take into account

their own local regulatory norms and requirements for human subject’s study. The protections

specified in the Declaration of Helsinki should not be jeopardized or reduced as a result of these

measures. Physicians should embrace local regulatory rules where they provide additional

protection.

Reference:

John Lehmann on Fri, Apr 16,2021; https://www.imarcresearch.com/blog/bid/361861/the-

declaration-of-helsinki-1964
YADAO, Calvin Keith M. BSN 3-F

The Tuskegee Syphilis Study

The USPHS, in collaboration with the Tuskegee Institute, initiated research in 1932 to

document the natural history of syphilis. The "Tuskegee Study of Untreated Syphilis in the

Negro Male" (now referred to as the "USPHS Syphilis Study at Tuskegee") was initially known

as the "Tuskegee Study of Untreated Syphilis in the Negro Male." The study began with 600

Black males, 399 of whom had syphilis and 201 of whom did not. The informed consent of the

participants was not obtained. The guys were told they were being treated for "bad blood," a

local euphemism for a variety of illnesses such as syphilis, anemia, and weariness. The guys

received free medical tests, meals, and burial insurance in exchange for participating in the

study.

Penicillin was the treatment of choice for syphilis by 1943, and it was becoming widely

available, but the trial participants were not administered it. The Tuskegee Study violated basic

bioethical principles of autonomy (participants were not fully informed in order to make

autonomous decisions), nonmaleficence (participants were harmed because treatment was

withheld after it became the treatment of choice), and justice (participants were harmed because

treatment was withheld after it became the treatment of choice) (only African Americans were

recruited). The concussion experiment, like the one at Tuskegee, goes against basic bioethical

norms. There should be big adjustments in the game of football to reduce, if not eliminate, this

principal cause of head trauma in young men until the pathological processes of concussions are

understood and prevention approaches are tested.

The study was covered in an Associated Press story external symbol in 1972. As a result, the

Assistant Secretary for Health and Scientific Affairs convened an Ad Hoc Advisory Panel to

conduct an assessment of the study. The advisory group determined that the trial was "ethically
YADAO, Calvin Keith M. BSN 3-F

unjustifiable," meaning that the "results [were] disproportionately meager relative to recognized

risks to human beings involved," and recommended that the project be stopped in October 1972.

The Assistant Secretary for Health and Scientific Affairs released the study's conclusion a month

later. The panel also recommended that the Secretary of the Department of Health, Education,

and Welfare (HEW) (now known as the Department of Health and Human Services) instruct the

USPHS to provide all necessary medical care for the study's survivors in March 1973. The

Tuskegee Health Benefit Program (THBP) was created to provide these services. The wives,

widows, and children of participants were added to the program in 1975. The program was

expanded in 1995 to offer both health and medical benefits. The last person who took part in the

study passed away in January 2004. In January 2009, the final widow who received THBP

compensation passed away. Children of participants (10 at this time) continue to receive medical

and health benefits.

A class-action lawsuit was brought on behalf of the study participants and their families later

in 1973, and an out-of-court settlement of $10 million was reached in 1974.

Reference:

National Center for HIV, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control

and Prevention, April 22, 2021; https://www.cdc.gov/tuskegee/timeline.htm

YADAO, Calvin Keith M. BSN 3-F

RA 10532 (Philippine National Health Research System Act of 2013)

In 2005, the terms of reference of the different agencies participating in the PNHRS were

consolidated into the PNHRS bill that was finally enacted into law in 2013 after 9 years of

lobbying. The hard work involved in campaigning at the Philippine Congress to pass the bill into

law should be properly credited to PCHRD led by Dr. Jaime C. Montoya, its Executive Director.

The Philippine National Health Research System Act of 2013 (RA 10532) institutionalized

the memorandum of understanding among the DOST, DOH, CHED and UP Manila to work

towards “improving the health status,, productivity and quality of life of Filipinos by ensuring

that health research is linked to the health system needs; ensuring that investments in health

research yield the most benefit; promoting good governance among health research organizations

through efficient, effective, transparent and ethical health research management system;

engaging in national and international partnerships and networks for health research

development and ensuring sustainability of resources for health research

What I searched about RA 10532 (Philippine National Health Research System Act of 2013)

1. Health shall refer to a state of optimal physical, mental and social well-being and the ability to

function at the individual level.

2. Health Research Stakeholders shall refer to the national and the local public and private

agencies/organizations, policymakers, the academe, medical and health societies, people’s

organizations and others who are concerned with and affected by health and development.

3. National Unified Health Research Agenda shall refer to a set of research priorities determined

by the country’s stakeholders which addresses the health needs of the population vis-a-vis  the
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health sector’s goal for universal health care. This agenda is a platform to advocate for local,

national and international support.

4. Philippine Council for Health Research and Development (PCHRD)  shall refer to one of the

sectoral planning councils of the Department of Science and Technology (DOST) which

provides central direction, leadership and coordination in health science and technology (S&T).

5. Philippine Health Research Ethics Board (PHREB) shall refer to the national policymaking

body on health research ethics, created under DOST Special Order No. 091, which is mandated

to ensure that all phases of health research shall adhere to the universal ethical principles that

value the protection and promotion of the dignity of health research participants.

6. Philippine National Health Research System (PNHRS) shall refer to a framework anchored on

the principles of Essential National Health Research on inclusiveness, participation, quality,

equity, efficiency and effectiveness, which connect to, and converge with, the wider health,

economic, political, educational and S&T systems of the country.

7. Regional Health Research Systems  shall refer to the regional health research consortia or

communities in all the regions of the country which mirror the PNHRS framework at the

regional level.

8. Research shall refer to the development of knowledge with the aim of understanding health

challenges and mounting an improved response to them. This covers the full spectrum of

research in five generic areas of activity: measuring the problem, understanding its cause(s),

elaborating solutions, translating the solutions or evidence into policy, practice and products; and

evaluating the effectiveness of solutions.

YADAO, Calvin Keith M. BSN 3-F