Ethical Conduct for Research Involving Humans


Research has seen the field of medicine undergo tremendous growth in terms of disease identification and treatment. These recent developments have necessitated the inclusion of human subjects in the studies.5 However; most of these massive breakthroughs were achieved at the expense of vulnerable individuals in the society. Ethical issues concerning these studies have been brought to the limelight by historians and other scholars.

Many biomedical research projects were carried out on human subjects with the researchers making little or no effort at all to inform the subjects. Human beings are autonomous, their consent is critical before the onset of any medical intervention or research activity. There have been many lawsuits filed against medical practitioners by their patients for carrying out procedures on them without their approval. These cases formed a legal foundation for the articles governing the protection of human research subjects. In this discussion, some statements that guide the process of voluntary inclusion will be looked at. These statements revolve around voluntary consent defined from different perspectives emphasizing its criticality in research.

Consent shall be given voluntarily, and it can be withdrawn at any time

The idea of voluntary consent was born after the case of the Nazi doctors’ experimentations with prisoners at the concentration camps without their assent was revealed.7 This was documented in the Nurnberg code which was the first formal documentation of regulations of studies involving human beings. The first article defines voluntary consent as essential.8 Some inmates were deliberately killed to provide skulls and skeletons for use in the study.

Looking at the case of the Tuskegee syphilis study, the subjects in this case black men living in dire poverty. The greater number of these men had never been treated in their entire lives. They were enticed into the study by being told that they were going for free medical checks up and treatment for ‘bad blood’. 9 They were not informed that they would be involved in any study so that they can make a choice. They were denied treatment even after penicillin became widely available instead, they were given pain killers to create an illusion that they were being treated. As Jonas put it valuable as scientific research may be, it should not compromise human life or dignity; 3 and the Nurnberg code indicates that any form of study should not be done if the risk of death is involved.8

Everyone has a right to make a choice and Article 3.1 talks about voluntary consent and the first step to achieve this is the realization of the autonomous nature of humans and respecting their rights. The vulnerability of any individual or group of persons should not be used as an entry point into violation of their rights. A third party can stand-in for a person who is not in a capacity to make a decision may be due to age or mental challenges. 11 Human dignity is not about social placement or racial disparities, it is about the rule of nature and therefore each one’s decision should be respected.

Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project

In the hepatitis study on the mentally ill children at the Willow brook state school, consent was obtained from the parents of the children used in the study but the full information concerning the risks involved was not disclosed.10 This study took place in a time when hepatitis had taken a major toll on people. In their request for approval, the researchers did not include such things as what would happen if the cure under test does not work or why they opted to introduce the disease to kids and then try to treat it instead of trying to treat the already infected ones. This raises a lot of concern about what the researchers are hiding.

The idea of informed consent comes into play. As seen earlier, people should be left to make their decisions which should be respected; however, if they are not given relevant information, the voluntariness of such permission is questionable.2 The subject or the third party should be made to understand each step in the procedure; the activities, the risks and the benefits involved for them to make informed decisions.

The consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research

In the experiment with LSD where a doctor believed he could erase memories and rebuild them, 6 the subjects were not asked for their sanction to participate as LSD was administered without their knowledge, depriving their autonomous ability. Even if the researcher had acquired initial okay (in this case, he had not), ongoing consent could not be obtained. The subjects were not able to provide it. Some had lost their senses completely during the project while others were in comas for months. The human research subjects are not objects of research. They are people who have their rights and should therefore be treated as such. Consequently, it is important to feed the subject with all the updates on the progress of the research. They are part of it and so, whatever happens, affects them too; hence, they should know what is happening so that they can decide to continue or to quit.

Researchers must disclose to the participant any material incidental findings discovered during research

The recent revelation of the cases of Camilla Grondahl’s family shows the need to disclose any incidental findings. In this family, a gene mutation disorder that is passed on from the mother has seen the family bury five baby boys who succumbed to the effects of this disorder.1 The latest baby boy was conceived in a period when a team of experts were sequencing the family’s genes, and they knew that the boys born to this family were at a 50% risk of contracting the Ogden Syndrome. They did not tell the expectant mother before or during her pregnancy for fear of the outcome as this was an incidental finding not part of their research. If only they had, the young woman would have chosen even conceiving. It would be in the best interest of anyone to know their health statuses. This way they can make decisions concerning their lives in the way that suits them best.

Research shall begin only after the participants, or their authorized third parties, have provided their consent

This statement involves the initial consent acquisition. If a researcher is carrying out a study without approval, it means that the subject in question does not have any information relating to the research or they have been forced to take part. It is necessary to wait for the subject’s authority before starting any procedure related to the research. It is about them so it should be done with their permission. However, there may be special cases when the beginning of research before consent can be justified. For instance, if life is at stake, then any form of treatment even if it is still under study, can be administered to save a life.4


Respect for a person’s rights should always come first. This will ensure that their dignity and welfare are not compromised in any way before, during or after research. They may be research subjects, but they are human, people with their own identities and rights.


  1. Brian M. Ogden family at center of ethics debate in genetics research – Should researchers change their rules to make sure volunteers learn about health implications? The Salt Lake Tribune. 2012. Web.
  2. Faden R., Beauchamp T. A History and Theory of Informed Consent. New York: Oxford University P Press. 1986.
  3. Jonas H. Philosophical Reflections on Experimenting with Human Subjects. Daedalus.1969 98:219–247.
  4. Jones H. Bad Blood: The Tuskegee Syphilis Experiment. New York: The Free Press. 1981.
  5. Katz, J. Experimentation with Human Beings. New York: Russell Sage Foundation. 1972.
  6. Lecture 2. Canadian Government Funded LSD experiments.
  7. German scientists conduct research on concentration camp prisoners.
  8. The Nuremberg Code for research on human subjects is adopted.
  9. The Tuskegee Syphilis Study.
  10. Willow brook Hepatitis Experiments.
  11. National Bioethics Advisory Commission. Research Involving Persons with Mental Disorders That May Affect Decision-making Capacity. 2 vols. Rockville, MD: U.S. Government Printing Office. 1998.
  12. Ramsey P. The patient as person: Explorations in medical ethics. New Haven and London: Yale University Press. 1970.
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