Scientific integrity requires all research personnel to work with a high level of ethical code and conduct free of fraudulent behavior and conflict of interest.  Therefore, any suspicion of fraud or potential physical evidence of fraudulent and maleficent activities in a clinical trial site, is an ethical responsibility and moral obligation of research participants to ensure the well-being of subjects (Hamrell, & Dombey, 2012). For instance, if a study is under the jurisdiction of the US regulatory agency, irrespective of what organization the scientists are representing, the institutional review board (IRB), the office of research integrity (ORI) and the public health service (PHS) must be informed of any cases of maleficence involving human subjects in a clinical trial (ORI, 2012).  Organizations that are not under these agency’s jurisdiction should follow the region’s regulatory standards and the international conference on harmonization (ICH) guidelines.

The ultimate benefit for reporting misconduct is to save lives and protect human subjects from harm. Hence, in the US, the ORI offers technical assistance to any organization dealing with research misconduct via its rapid response technical assistance (RRTA) program (ORI, 2012).

Reporting fraudulent or maleficent incident helps an organization to achieve reasonable resolution to the problems, and establish a sense of trust and public awareness to a matter so sensitive that if kept a secret will even make things worse. Thus, reporting a misconduct in a timely manner is the key for maintaining confidence in the scientific community (Nabel, 2006).

Some experts indicated that fraudulent and maleficent activities are mainly attributed to lack of monitoring activities by the regulatory agencies across the world.  For instance, in the US, all clinical trial conducted in the US, or outside the US that are under the FDA jurisdiction, are under the purview of the agency.  Interestingly, based on the 2007 report, the United States department of health and human Services, Inspector General Daniel, R. Levinson, reported that the FDA inspect less than 1% of clinical trials in the USA. In addition, he stated that the FDA downgraded their findings 68% of the time (Shuchman, 2008). The report also stated that the FDA had about 200 inspectors to inspect approximately 350,000 sites (Shuchman, 2008).

Although, this number may have increased slightly over the years, it is also important to note that the number of clinical trials is also increasing every year.  Therefore, it is possible that some low standard clinical trial sites are taking advantage of this lack of strenuous inspection and lack of manpower by the FDA, hence enabling their greed for money and fraudulent activities. Also, it is possible that if the FDA and other international regulatory agencies would tighten their role and have more inspectors on the ground, it could deter fraudulent and maleficent activities significantly.

References

Hamrell, M., & Dombey, S. (2012). Scientific Integrity. 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.

Henney, J. E. (2000). Human subject protection and financial conflicts of interest [Speech]. U.S. Food and Drug Administration. Presented at the National Institutes of Health, Bethesda, MD. Retrieved from http://www.fda.gov/NewsEvents/Speeches/ucm054199.htm.

Lo, B., Wolf, L. E., & Berkeley, A. (2000). Conflict-of-interest policies for investigators in clinical trials. The New England Journal of Medicine, 343(22), 1616–1620. Retrieved  from http://ezp.waldenulibrary.org/login?url=http://proquest.umi.com.ezp.           waldenulibrary.org/pqdweb?did=64762462&sid=1&Fmt=4&clientId=70192&RQT=309&VName=PQD.

Nabel, E. G. (2006). Editorials: Conflict of interest—or conflict of priorities? The New England   Journal of Medicine, 355(22), 2365–2367. Retrieved from  http://ezp.waldenulibrary.org/login? url=http://proquest.umi.com.ezp.waldenulibrary.org/pqdweb?did= 1173810731&sid=2&Fmt =4&clientId=70192&RQT=309&VName=PQD.

ORI. (2012). Handling Misconduct. Retrieve from http://ori.hhs.gov/handling-misconduct.

Shuchman, M.(2008).Clinical trials regulation — How Canada compares. CMAJ, 179(7), 635-638.doi:10.1503/cmaj.081271 Retrieve from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2535743/.