The Clinical Perspective - Biomedical Informatics in Translational Research - page 13

cal concepts in research: respect for persons, beneficence, and justice. Also legislated
by the National Research Act was the establishment of institutional review boards
(IRBs) for reviewing research involving human subjects. The Department of Health
and Human Services (DHHS) Office for Human Research Protections (OHRP) is
the oversight body for IRBs in the United States. Federal regulations governing the
protection of human subjects, under the statutory authority of the OHRP, can be
found in Title 45, Part 46, Subparts A, B, C, and D, of the Code of Federal Regula-
tions (CFR) [5]. Subpart A defines basic human subject protections that 15 other
departments and agencies within the federal government also adopted. Because the
language of Subpart A is identically reproduced in each of their different chapters of
the CFR, it is referred to as the Common Rule [6].
Returning to the international scene, another document addressing human sub-
ject protections in biomedical research was published in the early 1990s. In an effort
to address unique concerns of human subject protections for research conducted in
developing countries, the World Health Organization collaborated with the Coun-
cil for International Organizations of Medical Sciences (CIOMS), to publish the
International Ethical Guidelines for Biomedical Research Involving Human Sub-
jects in 1993, and again in 2002 [7].
IRBs and institutional ethics committees (IECs) exist to protect the rights and
the welfare of human subjects participating in research. These oversight bodies
require assurances that staff involved in research are trained in the ethics of human
subject protection. Many IRBs require research staff to complete established
trainings, usually offered online. References to available trainings in human subject
protection can be found later in Section 2.8.2.

2.3 Regulatory Policies for Protecting a Research Subject's Privacy

Regulatory policies for safeguarding the privacy of personal information vary
among countries and have an impact on the use of data in research. Privacy policies
governing personal data originate from different perspectives, such as banking,
e-commerce, business, and health care, in different countries. Regardless, safe-
guarding the privacy of research subjects is an aspect of ethical practice that is now
highly legislated. Researchers in Canada are impacted by the Personal Information
Protection and Electronic Document Act [8]; researchers in the European Union, by
the European Union Directive on Data Protection [9]. Researchers in the United
States must comply with the Health Insurance Portability and Accountability Act
(HIPAA) [10].
HIPAA was enacted to address many disparate needs of health care consumers
and government agencies such as protecting employee health insurance when work-
ers changed or lost their jobs, reducing waste and fraud, and simplifying adminis-
trative processes. One of the many mandates of HIPAA produced the HIPAA
Privacy Rule, which requires agencies to protect an individual's health information
[11]. The Privacy Rule is administered through DHHS's Office for Civil Rights.
Although HIPAA was enacted in 1996, the HIPAA Privacy Rule was implemented
in April 2003.