Institutional review boards (IRBs), consist of, at least a 5 member team responsible in reviewing the clinical trial rationale and all the essential plan related to a trial.  The main objectives of an IRB, is to review all protocols, investigate the investigator and evaluate the risk-benefit assessment of human subject participant’s enrollment in a clinical trial. Their objective is to ensure that human subjects are protected, and in no way, in an unnecessary higher risk, in an experiment, before and after a clinical study (Wood, & Markel, 2012).  Also, IRB is responsible in reviewing the scientific rationale and the applicable methodology for the clinical trial safety, by ensuring that the trial conduct is designed in an ethical manner (Wendler, Emanuel, & Lie, 2004). Most importantly, if the informed consent is not free of ambiguity or easily understood or translated correctly or interpreted appropriately to the subjects, the lack thereof, indicates a serious incompetence and flaws in the informed consent and the trial design (O’Brian, 2009).

The validity in running a successful clinical trial depends on how strong the quality of the trial design.  Quality design should incorporate strong assessable experimental rationale with the ability to evaluate the applicability of the rationale in question. The applicability quality of a clinical trial involves assurance of reliable data, reproducibility of the experimental design and implementation of the highest safety standards in a clinical trial.  More importantly, obtaining informed consent from human subjects and ensuring that subject participants understood their rights and what is expected of them is equally critical.  It is unethical and illegal to use coercion during the enrollment process.  Human subjects participating in a clinical trial must not be subjected to duress or undue influence.  Thus, clinical trial managers or investigators are obligated to use reasonable discretion and highest ethical standards in designing and conducting clinical trials involving vulnerable or human subjects, in a manner that will generate a useful and scientific knowledge, and at the same time, give beneficence to human subjects participating in the clinical trial while minimizing any potential health risks associated with the trial (Grady, 2008). 

If human subjects are under duress or coercion, their rights are already violated. In addition, such individual’s state of mind or reasoning may not follow the study instructions properly, to produce reliable data. On the other hand, if such data is reliable, the process from which the data is generated is in violation of the human right clause in the Nuremberg code and the Belmont report regulations (Drewry, 2004).

Reproducibility of data is the most important aspect of scientific discovery. Thus, experiments done with human subjects under duress may not produce reliable data that will be reproducible when repeated with subjects under less or no duress. Such unreliable and unethical practices produce unwanted factors, such as stress-induced hormones, physical and psychological trauma or other hormonal effects that may affect the condition of the subject participating in the trial.  Hence, to accept maleficence in a clinical trial practices puts the public health at risk and sets a precedence which may require the applicability of the similar environmental factors or conditions to be able to reproduce the data in question. A good example of such precedence is the Stanley Milgram’s electric shock experiment in 1960’s at Yale University.  In the quest for reproducibility of the Nazi experiment of 1940’s, he subjected more innocent human subjects in duress with electric shocks (Drewry, 2004).

Nevertheless, the ability to conduct a clinical trial among vulnerable populations with greater success without violating subjects’ right or informed consent will demonstrate the investigator’s sense of cultural competency and ethical standards (O’Brian, 2009).  Furthermore, it is indicative of the investigator’s ability to mitigate between the divergent cultural differences, ethical and moral obligations, which if not taken into consideration may easily ruin the reliability of a clinical study (O’Brian, 2009).

There is no doubt that, private and for-profit IRBs can function without ethical conflicts. However, conflict of interest may dent the good-will of a clinical trial when IRBs have financial or vested interests in a trial.  In such cases, unduly influenced IRBs may influence the approval of a clinical trial when it is neither safe nor scientifically rationale to do so.  For this reasons, members of IRBs either for a profit or non-profit is not allowed to vote on or discuss the decisions regarding the approval of any clinical trial.

Reference

Drewry, S. (2004). The ethics of human subject’s protection in research. Journal of  Baccalaureate Social Work, 10(1), 105–117. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=sih&AN=14954454&site=ehost-live&scope=site

Gawrylewski, A. (2007). The Trouble with Animal Models. The Scientist, 21(7), 45–48, 50–51. Retrieved from http://proquest.umi.com.ezp.waldenulibrary.org/pqdweb?did=1298794191&sid=1&Fmt=3&clientId=70192&RQT=309&VName=PQD.

Grady, C. (2008). Ethical Principles in Clinical Research. NIH. Retrieve fromwww.nihtraining.com/cc/ippcr/current/…/Grady%2012-4-07.pdf.

O’Brien, R. (2010). Cultural_Competence_Annotated_Bibliography. Retrieve from             http://www.mfdp.med.harvard.edu/catalyst/publications/Cultural_Competence_Annotate            d_Bibliography.

Wendler, D., Emanuel, E., & Lie, R. (2004). The standard of care debate: Can research in             developing countries be both ethical and responsive to those countries’ health needs?    American Journal of Public Health, 94(6), 923–928. Retrieved from         http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=rzh&AN=2005018182&site=ehost-live&scope=site.

Wood, K. & Markel, D. (2012). Role of Institutions and Oversight Bodies. Walden DVD.             Retrieve from http://sylvan.live.ecollege.com/ec/crs/default.learn?CourseID=6493792             &Survey=1&47=10828390&ClientNodeID=984640&coursenav=1&bhcp=1