Research Ethics for Health Science Involving Human Experiments by Abhijith Yenikekaluva


During the early 1950s, the United States Atomic Energy Commission, over a period of 15 years, conducted radiation experiments on around 200 healthy subjects, who included pregnant women and school children. The participants of the study did not know anything about the experiments and their consequences, and had not been given to sign any informed consent for participation in the experiment.

 

Similarly, in the 1990s a pharmaceutical company in North America conducted a clinical trial, “Study 329”, to study the effects of an anti-depressant drug for teenagers. The drug was actually ineffective and most subjects developed suicidal tendencies after using the drug. However, a research article signed by the researchers was published in 2001, reducing the negative findings and falsifying the results. In 2003, Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) analyzed the results of “Study 329” and concluded that there was no evidence of drug’s efficacy, but there was a clear increase in suicidal behaviour in the teenagers using it. On further investigation, it was found that the article was actually ghostwritten by the pharmaceutical company, which made $11.6 billion income selling the drug between 1997 and 2006.

 

In both cases, there was a serious breach of ethics, which led to legal actions against the defaulters and eventually led to the termination of these projects.

 

During the course of time, Ethics Committees have been set up to oversee ethical issues like human rights, animal rights and environmental issues in academic research. An Ethics Committee or Institutional Review Board is responsible for ensuring that medical experimentation and human research are carried out in an ethical manner. It examines the complete study review application and deliberates on all possible ethical issues before making a decision on the feasibility of a research project. Any misconduct like misuse of grant funds or of personal information, discrimination, conflict of interest, fabrication of data, plagiarism can  compromise the validity of the research and reputation of the involved institutions. When research misconduct is suspected, or alleged, an Office of Research Integrity investigates the case and takes appropriate actions including termination of employment, suspension of research grant or debarment from receiving funds in the future, depending on the severity of the misconduct.

 

While every country may have local regulations on biomedical research like the Common Rule in the United States of America, the Good Clinical Practice (GCP) is an international guideline, which standardizes the designs, conducting, and reporting of clinical trials involving human subjects. Similarly, the “Declaration of Helsinki (DoH)” is considered the cornerstone document on human research ethics. It consists of a set of globally accepted ethical principles for human experimentation developed by the World Medical Association (WMA) in June 1964 in Helsinki, Finland. The document ensures the respect for all rights of the subjects, including health, privacy and confidentiality of personal information.

 

abhiClinicians and researchers performing human experiments should abide by all ethical, legal and regulatory norms in accordance with national and international laws. The researchers should explain the purpose of the project, its methodology and the type of information to be collected.  Subjects taking part in a medical research should be well informed about its direct and indirect risks. Informed Consent is a voluntary agreement to participate in a research. A consent form is signed informing the subject about his or her rights, the purpose of the study, the procedures to be undergone, and the potential risks and benefits of participation. Participants are generally recruited according to specific requirements and must participate in research willingly. The principal investigator and project staff members are responsible for ensuring the safety of participants in the project.

 

In my view, the successful research projects of the future will be those that integrate ethics and personal values. Research should create and develop new innovations in technology to lead the academic, industrial world and to enhance our knowledge of how to best address the world’s problems.

 

Image Courtesy: http://www.slane.co.nz/images/medicalethics.jpg

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