Institutional review boards (IRBs) or independent ethic committee (IEC), 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).

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 from http://_www.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_Annotated_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