Table of Contents
History of Medical and Research Ethics
Back in the 19th century, there was no specific ethic devised for use of human subjects in research. There was total lack of consumer regulations, food and drug administration (FDA) and institutional review board (IRB). The history of ethics in medical sciences and research on human subjects started after 1906. IRB devised several codes of ethics and manual in order to protect research methods. From 1906 onwards ethics have been designed, conducted and reviewed for safe clinical practices. The modern code of ethics started after the end of World War II in order to deal with war crimes trials in Nuremberg.
The first initiative in this regard was Nuremberg code. It was devised to deal with war crimes trials in Nuremberg after the end of World War II. The Nuremberg code comprised of ten basic points related to ethics in human research.
These points included:
- The consent of human subject in absolute legal capacity is required.
- The aim of the research should be to create positive impact in society
- It should be based on any previously approved experiment in order to extend the ongoing research process
- The research procedure should not cause any physical or mental injuries or harms for people
- It should never be conducted where the risk of death of any participant or member of society is evident
- The risk associated with the research process should be correlated with benefits associated with it for social wellbeing.
- Proper arrangements and facilities should be arranged before conducting research process in order to limit the risk of harm to subjects
- The researchers and staff members involved in research should be properly trained and scientifically qualified
- In case human subjects feel at risk of death or injury during an experiment, they can quit at any moment
- If risks in a research process become so evident that it may cause harm to human subjects, the researchers should immediately stop the process
Declaration of Geneva
Immediately post-World War II the world’s medical association adopted physician oath known as Hippocratic Oath in its first at Geneva in 1948. The conference embraced modern ethics by setting humanitarian goals. The adoption of Hippocratic Oath was a move against medical crimes of Nazi Germany soldiers to harm Jewish community.
The oath was set as a mandatory commitment by medical students and members related to the medical field to ensure safe humanitarian practices.
The 11 tenets of this oath included:
- I commit to consecrate my life for humanity
- I will be respectful towards my teachers and mentors
- I will practice medicine profession with dignity and integrity
- My patient’s health will be my priority
- I will take care of my patient’s secrets even after his death
- I will honor all traditions and customers of medical profession
- I will treat my peers with compassion
- I will not let any impediment like disease, gender, race, sexual orientation etc. to intervene between my duties as doctor or researcher
- I will show utmost respect for human life
- I will not use my medical knowledge to violate human rights even under threats
- I will make these promises upon my honor
The Belmont Report
This report was issued after a famous Tuskegee Syphilis Study conducted from 1932-1972. This report was created to codify the protection of human subjects. It was issued on 30th September 1978 during a conference of Howard community college in Belmont Conference Center. It was named after the location where it was conducted.
The core principles of this report included:
- Respect for persons
- Informed consent
- Assessment of risks and benefits associated with research process
- Selection of subject
The report was devised for positive solution of problems associated with research process for independent decisions. The report received criticism for its one size fits all recommendations. The simple solution provided by this report for ethical issues in research process don’t cater problems associated with ethnic, gender and cultural differences. It does not provide any guidance to prioritize the core principles of the report.
The Declaration of Helsinki
World medical association adopted a new set of ethical rules and regulations regarding human experimentation 1964. It was upgraded in 2013 termed as cornerstone document related to human research ethics. This declaration ties together Nuremberg code and declaration of Geneva. It is not a binding document and is not enforced under international law. The major points of this declaration included respect decisions of capable people, autonomy, and respect for vulnerable people. Beneficence emphasized good deeds by researchers, non-Maleficence to avoid bad acts, Justice to treat each ethical issues differently and best interest to act in best interest of patients.
There was severe criticism on Declaration of Helsinki as it had no legal regime. It is not enforceable by law and provides no guidance how to rank pillars of ethics. It is an autonomous framework considered as Western Ideal. It states informed consent as the best expression of autonomy.
Pillars of Ethical Research
The ethics of research and human experimentation is based on several pillars including:
- Autonomy: It states that all patients should be treated equally without any differentiation. They should be provided necessary treatment they need to cure their diseases and problems.
- Beneficence: The doctors and researchers should aim at doing best in the interest of people whether they are patients or society on the whole. The risk associated with the research process should be correlated with benefits associated with it for social wellbeing.
- Non-Maleficence: any kind of bad acts and deeds should be avoided in any case in order to ensure -safe treatment to patients. In case human subjects feel at risk of death or injury during an experiment, they can quit at any moment. If risks in a research process become so evident that it may cause harm to human subjects, the researchers should immediately stop the process.
- Justice: The doctors and researchers should do justice for the conduct of a research. Any impediment like a disease, gender, race, sexual orientation etc. to intervene between duties as doctor or researcher should be avoided.
- Acting in the best interest of patients: A physician and doctor should act in best interest of a patient. The consent of human subject in absolute legal capacity is required.
- Fidelity: A researcher should be morally an ethical person and should bound to fidelity.
- Trustfulness: A physician should be truthful to its patients in order to help them to overcome their problems and issues
- Confidentiality: A researcher should take care of my patient’s secrets even after his death.
The common factor in all principles or pillars of ethics of research is ‘Informed consent’ of a patient. It includes communicating all risks associated with research process along with benefits. It should avoid any coercion or intimidation to obtain consent. The permission of medical research is mandatory for safe practices. There are several challenges associated with taking informed consent of patients including consent received halfheartedly, lack of proper understanding of a medical subject and researcher lack of legal documents of informed consent leading to legal issues.
Elements of Valid Consent
The core elements of a valid consent include:
- Disclosure or risks associated with a research process to subject
- The subject should be educated and capable to deal with lingual, emotional and intellectual problems.
- Coercion should never be practiced to obtain consent.
Health Insurance Portability and Accountability Act (HIPAA)
This act was enacted in 1996 by the United States Congress for health insurance of workers and their families. It enacted the management of electronic health records of workers. The consent measures were also improved through the written authorization process. The authorization process under this act is waived for records of patients who have already died.
Research Ethics Board
The research ethics board is formed in order to protect the rights and welfare of workers. The board ensures that the risks associated with a research process are minimized, only acceptable risks are tolerated and informed consent is accurate. It also keeps an eye on research in an ethical manner. The board does not enforce ethical laws but forward it to institutions.
Types of Epidemiological Research
In this type, the research data is collected from new human subjects specifically for research purposes.
In this type, researchers work on data already gathered from previous researchers on same topics without the involvement of human subjects.