The basic tenets of ethics in human experimentation are that subjects should be given freely and fully informed consent. They should be treated as autonomous agents and not as mere resources.
Informed consent should describe the research, its purpose and expected duration; any risks and benefits; possible discomforts; and alternative treatments that might be helpful to the subject. It should also include a statement that the subject can refuse participation.
Informed Consent
Informed consent is a fundamental ethical principle that enables patients to make informed decisions about treatment options. It is a legal requirement for most medical tests and procedures.
In addition, consent is important for medical research involving human subjects because it establishes patient autonomy and ensures that the research is done only with the subject’s permission. Informed consent requires that the subject receive information about the study – including expected benefits and risks – and understands that he or she has the right to withdraw from participation at any time.
The concept of informed consent was first developed in the 1940s and evolved into an internationally recognized standard for ethical research. The World Medical Association’s Declaration of Helsinki states that participants must be informed about the aims, methods, sources of funding, and other aspects of the research.
At medical schools and teaching hospitals, trainees often practice obtaining consent from patients before they perform procedures. This helps them to develop their skills and learn the language of the process. It also helps to reassure patients that they are making the right choice.
Ethics Committees
Ethics committees are a vital component of medical research, as they ensure that human subjects in clinical studies and trials are protected from harm. They review proposed projects to ensure they comply with local and international ethical guidelines.
In the United States and Canada, ethics committees are known as Institutional Review Boards (IRBs) or Research Ethics Committees (RECs). The purpose of these organizations is to protect the rights, safety and wellbeing of people who participate in scientific trials.
These organizations are constituted to fulfill the purposes set forth in the Helsinki Declaration, which calls for ethically responsible conduct of research. They also address issues related to bioethics training and the development of ethical guidelines for researchers.
RECs are comprised of a range of professionals, including physicians, scientists, advocates, researchers and members of the community formally designated to review and monitor the research. Their primary responsibility is to safeguard the interests of participants in the trial and to consider whether there is a risk that the study will hurt the community or the environment.
Confidentiality
Keeping research records confidential is an important part of ethical practice in human experimentation. Researchers can protect the confidentiality of their subjects’ personal information by encrypting computer-based files, storing consent forms in a locked file cabinet and removing identifying materials from study documents as soon as possible after the study is over.
Researchers may also need to secure their subject’s identifiers, including identifying numbers and symbols (e.g., patient IDs), medical record codes, and a variety of other identifiers. If such identifiers are used in research, researchers must obtain a Certificate of Confidentiality from the NIH before using them.
Since the late 19th century, numerous questionable and unethical experiments have been performed on humans. These include tests of chemical and biological weapons, interrogation/torture, injections of toxic or radioactive chemicals, surgical experiments, mind-altering drugs, and a number of other procedures.
Privacy
Historically, human subjects have often been used as research subjects without their consent. This has created a major concern about privacy.
In order to understand the significance of privacy, we must look at its historical roots and examine the philosophical debates surrounding it. These include whether or not privacy is a right, how it can be defined and whether it is culturally relative.
A key challenge to the value of privacy has been the development of a legal and political system that allows governments and agencies to collect information about individuals. This leads to an important clash between the right to privacy and the need to protect national security.
The Supreme Court has recognized the right to privacy as a constitutional right, which means that it can be defended in court. This right has largely been interpreted as a right to individual autonomy in making certain personal decisions about one’s family, life and lifestyle.
