JADA’s requirement for an independent advisory panel approval for all studies involving human subjects obliges all researchers to address ethical concerns.
The lack of understanding of the role of an institutional review board (IRB) has precluded many excellent submissions to The Journal of the American Dental Association from being accepted—or even from being sent out for peer review.
One of the more common misunderstandings is the need for an IRB approval for studies performed in private offices. The problem is not that research may have been conducted in an unethical manner, but rather, a possible lack of knowledge of essential ethical elements that need to be considered in studies involving human subjects, including informed consent.
Unethical research had been conducted long before the atrocities involving human experiments during the Nazi era were discovered. However, the postwar Nuremberg trials brought to the forefront the urgent need for universal ethical principles for protecting human research subjects.1 Standards for the protection of human subjects were created in 1947 and are known as the "Nuremburg Code." In the 60 years that have followed, the biomedical scientific community has promulgated several versions of these ethical standards.
The World Medical Association Declaration of Helsinki, Ethical Principles for Medical Research Involving Human Subjects, was adopted in 1964 and has since been amended five times. The most recent clarifications, in 2002 and 2004, addressed two major issues: poststudy treatment of subjects in trials who otherwise would not have access to such interventions and the role of placebo controls in trials where existing treatment options exist.2
The Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO), created international ethical guidelines for biomedical research involving human subjects. In the latest revision of these guidelines, in 2002, it was affirmed that "the [research] protocol should be scientifically and ethically appraised by one or more suitably constituted review bodies, independent of the investigators."3
The creation of the Belmont Report in the United States in 1979 was a response to the attention drawn to numerous instances of unethical research behavior in this country.4 One of the most infamous studies involved African-American men enrolled in a 40-year government-sponsored investigation of untreated syphilis at the Tuskegee Institute, where participants were not given an opportunity to use available effective therapy.5 Another notorious experiment was conducted at the Willowbrook State School, where parents were persuaded to enroll their mentally challenged children in studies on the natural history of hepatitis.6
Today, the basic regulatory policy for protection of human research subjects is incorporated into the U.S. Department of Health and Human Service’s (HHS) Code of Federal Regulations Title 45 part 46 (45 CFR 
46), also known as the "Common Rule."7 Statutory authority for the HHS Human Subject Protection Regulations (45 CFR 46) derives from 5 USC 301; 42 USC 300v-1(b); and 42 USC 289.
According to 45 CFR 46.102(d), research on human subjects is "[a] systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." "Generalizable knowledge" can be interpreted as data published in a national journal or on the Internet, presented at a national meeting or, at a minimum, used beyond the confines of the investigator’s institution.
In general, there are three levels of IRB review: exempt, expedited and full. An "exempt" review is appropriate for a study that poses "minimal to no risk" to human subjects. "Minimal risk," as defined within 45 CFR 46.102(i), means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." This level of review commonly is used for studies that involve assessment of patient data or records.
An "expedited" review can be performed by an IRB subcommittee and usually is done for studies defined as "minimal risk." This level of review commonly includes observational studies and studies involving routine office procedures.
Any study posing "greater than minimal risk" requires a full board review. This type of research usually involves investigational drugs or procedures, or includes vulnerable populations.
It is clear that any institution that is receiving federal funding, or that is subjected to regulation by any federal department or agency, is held to the standards of 45 CFR 46. But should this standard also be applied to private dental offices? This is a key question, one that has room for some interpretation. Although there are no specific standards governing research in private dental offices, established standards, such as the Common Rule, the Helsinki Declaration or CIOMS/WHO, can be applied.
Oral health care professionals can collect and interpret patient data for internal use, but as soon as they seek to publish these findings, specific ethical standards stipulated by the specific biomedical journal apply, possibly including approval by an independent review board. Private practitioners wishing to publish can contact an IRB at a local academic institution for help, or they can contact an independent IRB or ethics board.8
There exists an inherent problem with biomedical research conducted by health care professionals. On the one hand, the provider wants to give the best and most effective therapy, while, on the other hand, the investigator wants to collect data according to an established research protocol. This recognized conflict is one tenet of ethical behavior that is addressed by an impartial IRB.
The requirement for an independent advisory panel approval for all studies involving human subjects published in JADA serves two purposes. First, it is the right thing to do. Second, it obliges researchers outside of academic settings to address ethical concerns that otherwise may not be evident.
