Clinical research is a time consuming process because of the risks involved. Based on the ICH-E6 clinical research guidelines, “A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. The CRO should implement quality assurance and quality control” (ICH, 1996, section 5.2.1).

An Informed consent guide in section 4.8 of the ICH-E6 is not an authorization to misuse subjects personal and health information, but rather it is a document that allows potential subject participants to make an informed decision on whether to participate in a clinical trial (ICH-E6, 1996).  In section 4.11.1 of the ICH guidelines “Safety Reporting”, it was clearly stated “…The immediate and follow-up reports should identify subjects by a unique code numbers assigned to the trial subjects rather than by the subjects’ names, personal identification numbers, and/or addresses. The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority (ies) and the IRB/IE” (ICH-E6, 1996).

These guidelines were designed for the purpose of protecting subject’s well-being, privacy, personal and health information. For instance, the United State has gone further in strengthening the ICH-E6 guidelines by introducing the health insurance portability and accountability Act (HIPAA) of 1996. HIPAA has several positive effects in clinical research, but one of the vital aspect of HIPAA in clinical research is restoring patient confident in the system (HHS.2003). It is obvious that one of the good intention why HIPAA was set up is to achieve this goal (Cliff, & Muhlbaier, 2003). Perhaps, for patients/subjects and patients advocates, enacting of HIPAA is a necessary and long battle, which ended in a victorious note. The HIPAA regulation endorsed and relinquished ownership of personal health medical records to patients/subjects. However, the “ownership” clause can be interjected for the purpose of legal or investigational purposes (Cliff, & Muhlbaier, 2003). Nevertheless, proponents of the HIPAA Act believe that it is a great achievement in boosting credibility in the health care system. Privacy advocates believe that the individual exclusive autonomy right included in the HIPAA Act is necessary in thrusting a barrage of confidence, trust and security in the public health system. The introduction of HIPAA in the healthcare system, is indicative of public resolve for a better healthcare security, respect to personal privacy and in fostering justice (Cliff, & Muhlbaier, 2003).

On the other hand, opponents of a stronger personal medical record autonomy (HIPAA regulations) argue that the health insurance portability and accountability Act regulations deter medical advancement. They also indicated that the “de-identification” clause in the HIPAA regulation will inhibit necessary clinical research data linkage (Cliff, & Muhlbaier, 2003). HIPAA critics further indicated that the “de-identification” clause will not allow scientists to link any meaningful course and effect case scenario, demographics or geographical localization of a given research study or how a study will reflect or represent public health issues with available scientific data (Cliff, & Muhlbaier, 2003). Moreover, HIPAA opponents suggested that the Act, could easily initiate a “lethal lag” and may expose “covered entity” of an already fragmented and troubled medical system in more vulnerable legal implications (Cliff, & Muhlbaier, 2003).

Perhaps, “lethal lags”, can be prevented as long as the government is willing to streamline the system and make necessary changes that will protect personal medical records and at the same time, strongly encourage medical innovations and advancements.

References

Califf, R., & Muhlbaier, L. (2003). Health Insurance Portability and Accountability Act    (HIPAA):  Must There Be a Trade-Off Between Privacy and Quality of Health Care, or Can We Advance Both? Circulation, 108: 915-918, doi: 10.1161/​01.CIR.0000085720.65685.90.  Retrieve from http://circ.ahajournals.org/content/108/8/915.full.

CSLBehring. (2012). Your Rights in a Clinical Trial. Retrieve from http://www.cslbehring .com/clinical-trials/volunteer-rights.htm

CSLBehring. (2012). Your Responsibilities in a Clinical Trial. Retrieve from http://www.cslbehring.com/clinical-trials/volunteer-responsibilities.htm.

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

Health and Human Servces. (2003). Summary of the HIPAA Privacy Rule. Retrieve from http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/

Hook, C. C., DiMagno, E. P., & Tefferi, A. (2004). Primer on medical genomics part XIII: Ethical and regulatory issues. Mayo Clinic Proceedings, 79(5), 645–650. Retrieved from http://ezp.waldenulibrary.org/login?url=http://search.ebscohost.com/login.aspx?direct=true&db=rzh&AN=2004168485&site=ehost-live&scope=site.

International Conference on Harmonisation. (1996). ICH Harmonised tripartite guideline. Guideline for good clinical practice E6(R1). Retrieved from http://www.ich.org/fileadmi n/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1Guideline.pdf.

National Institute of Health. (2007). Why should researchers be aware of the HIPAA privacy rule? Retrieved from http://privacyruleandresearch.nih.gov/pr_03.asp

National Institute of Health. (2003). Institutional review boards and the hipaa privacy rule. Retrieved from http://privacyruleandresearch.nih.gov/irbandprivacyrule.asp

National Research Council. (2009). Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research. Retrieved from http://www.nap.edu/open           book.php?record _id=12458&page=200

Woodin, K. (2012). HIPAA and Patient Rights. Retrieved from http://sylvan.live.ecollege.com/ec/crs/default.learn?CourseID=6493792&Survey=1&47=10828390&ClientNodeID=984 640&course nav=1&bhcp=1.