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Ethical requirements for clinical trials

Ethical requirements for clinical trials

The International Committee of Medical Journal Editors (ICMJE) defines a clinical trial as any research project wherein human subjects are prospectively assigned to an intervention group or a control group to study the cause-and-effect relationship between a medical intervention and a health outcome.  A report published in the Journal of the American Medical Association lists seven major ethical requirements that should be fulfilled while conducting a clinical trial.

(1) Value—Ensure that the study enhances health or generates knowledge that can form a basis for further research.

(2) Scientific validity—The research must be methodologically sound for the results to be scientifically reliable, valid, and reproducible.  

(3) Favorable risk-benefit ratio— It is very important that the potential benefits to individuals and knowledge gained for society outweigh the risks associated with the study.  In case the risks exceed the potential medical benefit, the clinical study would not be justifiable.

(4) Independent review—Unaffiliated individuals must review the study and approve, amend, or terminate it.

(5) Fair subject selection—Selection of subjects should be governed by the objectives of the study and not by any bias. For example, exclusion of women from the study population without a logical reason would be considered unethical.

(6) Informed consent—Individuals should be informed about the research in its entirety— its purpose, methods, risks, and benefits—before providing their voluntary consent in writing.  

(7) Respect for enrolled subjects—The confidentiality of the subjects should be well protected. For example, all personal and identifiable information, like the subject’s name and date or place of treatment should be removed.  If photographs are to be used in the study report, they should be modified to ensure that the subjects cannot be identified. In addition, the subjects should be allowed to change their mind and withdraw their participation at any point in the study, without being penalized. 

Researchers tend to miss out on items 7–10 in the above list because these issues are not directly related to the overall impact and value of the study. Very often, peer reviewers or ethical review committee members raise an alarm when a clinical trial fails to mention the inclusion and exclusion criteria for subject selection, or in case signed informed consent forms are not submitted. The above-mentioned guidelines would prove very helpful in such situations.

As an aside, apart from adhering to all the above-mentioned ethical guidelines, the ICMJE mandates that all clinical trials be registered.

Some of the suggested registries are available at the following links:

www.anzctr.org.au

www.clinicaltrials.gov

www.ISRCTN.org

www.umin.ac.jp/ctr/index/htm

www.trialregister.nl

https://eudract.ema.europa.eu/

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This content belongs to the Conducting Research Stage

Conducting research is the first and most exciting step in a researcher's journey. If you are currently in this stage of your publishing journey, subscribe & learn about best practices to sail through this stage and set yourself up for successful publication.