Conducting clinical research studies, and selecting appropriate subjects within the inclusion criteria is the key to a successful ethical scientific study (Dombey, Markel, & Derenzo, 2012). In any clinical trial, human subjects’ selection is directly related to the external validity, safety and efficacy assessment of the medicinal product in question. Thus, if the subjects selection were not within the inclusion/exclusion criteria or even when the subjects selection follows the inclusion/exclusion criteria, if the inclusion/exclusion criteria does not cover the necessary research variables or account for possible confounding factors, then the application of the investigational medicinal product to the rest of the population is an unacceptable problematic sequel, one which may cause serious life threatening consequences or become an unethical medical practice. Therefore, thorough evaluation of positive factors that affect subjects’ recruitment must be reasonable, and becoming reasonable, researchers must take into account the type of research question being addressed.

Recruitment tools such as incentives, advertisement, professional influential privilege, informed consent/assent, insurance coverage assurance, medical privacy protection such as enforcement of the HIPAA rules (in the case of US based-study) to mention but a few are very important positive recruiting tools to address in order to avoid conflict of interest or undue influence in a clinical research (Grant, & Sugarman, 2004).  ). On the other hand, some of the hindrances affecting clinical research studies include but are not limited to the language barrier (in the case of international studies), cultural/ religious belief (such as religious belief on certain medical procedures, blood transfusion, contraceptives etc), literacy, the impact of past historical misconduct in clinical research such as the Nazi experiment or the Tuskegee abuse, and most importantly, the fear of losing medical insurance and lack of medical privacy (Frank, 2004). These are factors that may deter prospective subjects from participating in a clinical trial.

The appropriateness of incentive offered to human subjects depends on the type of incentives or the amount of money involved. In addition, it is also dependent on how or by what means the subjects were recruited. For instance, targeted-recruitment of vulnerable population in exchange of monitory incentives for their participation may deem such incentive or compensation an undue influence and thus may constitute a form of psychological persuasive coercion (Factnet, 2012). Incentives initiated in good faith should not be excessive and should have a direct beneficial outcome to participants (Dombey, Markel, & Derenzo, 2012). Thus, creating compensation excessiveness, such that the offered incentive has the power to influence human subjects in changing their aversive opinion on a principle research question being tested is an unacceptable form of “compensation” (Shamoo, 2006). Nevertheless, equitable compensation should cover the subjects’ time-loss for participating in a clinical study and must be evaluated on the basis of pure willful participation and not of persuasive coercion (Factnet, 2012).

Without enough sample size population, establishing valid statistical data in any clinical study is improbable; hence, the study is a waste and become an inconclusive study, which is insufficient in making valid scientific conclusion. Therefore, some recruiting tools such as advertisement are used to increase awareness and sample size volume of any clinical study (Frank, 2004). However, when advertising a clinical research study, institutional review board (IRB) must review the advertisement contents and its appropriateness as it relates to the study, ensuring that the advertisement is not coercive in nature or induces any form of undue influence (Frank, 2004). In addition, a clinical research advertisement must not mention the amount of intended incentives being offered, or target medical professionals or investors for solicitations (Frank, 2004).

Ultimately, the primary objectives of the IRB as required by regulatory agencies, is for a thorough review of all contents of clinical research recruitment tools including protocols and research designs, before the enrollment begins. In the US, some exception to this rule is a research involving the National cancer institute (PDQ) or a government-sponsored AIDs clinical trial information service (ACTIS) (FDA, OSCC. 1998). Clearly, the IRB review is meant to protect and reduce preventable risks and harms in clinical research, and to foster the well-being, welfare, and privacy of human subjects (FDA, OSC.C. 1998). More importantly, human subjects have the right to remove themselves at any time from a research study even if compensations were offered in the study. This autonomy right creates appropriate checks and balances in making a participatory decision based on subjects’ individual well-being.

References

Dombey, S., Markel, D., & Derenzo, E. (2012). Selecting and recruiting subjects [Waldenu video file]. Retrieve           fromhttps://class.waldenu.edu/webapps/portal/frameset.jsp?tabtab group id= _2_1&url=%2Fwebapps%2Fblackboard%2Fexecute%2Flauncher%3Ftype%3D Course% 26id%3D552454_1%26url%3D.

Factnet. (2012). How does mind control work? A technical overview of mind control tactics. Retrieve from http://factnet.org/node/897/.

Food and Drug Administration/Office of Science Coordination and Communication. (1998). Guidance for Institutional Review Boards and Clinical Investigators. Retrieved from http ://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/GuidancesInf ormationSheetsandNotices/ucm113709.htm.

Frank, G. (2004). Current challenges in clinical trial patient recruitment and enrollment. SoCRA SOURCE, 30–38. Retrieved from http://www.socra.org/pdf/200402Current_Challenges_ Re cruitment_Enrollment.pdf.

Grant, R., & Sugarman, J. (2004).  Ethics in human research. Do incentives matter? JMP, 29(6), 717-738. Retrieve from http://www.waisman.wisc.edu/events/ethics/sprin06-sem2-incentives-compensation.pdf.

Shamoo, A., & Resnik, D. (2006). Strategies to minimize risks and exploitation in phase one trials on healthy subjects. American Journal of Bioethics, 6(3), W1–W13. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=a9h&AN=21011099&site=ehost-live&scope=site.