An IRB submission is required for all research projects using human subjects in accordance with the Federal Policy for the Protection of Human Rights 45 CFR 46, the Food and Drug Administration (FDA) regulations 21 CFR 50, 56 , and with the Federalwide Assurance granted by the H.H.S. Office of Human Research Protections (OHRP).
Every doctor, nurse, hospital administrator, drug or device company involved in human research knows this.
As a researcher on human subjects, I am required to re certify that I understand certain inalienable principles that govern experimentation on human subjects. I re-learn about the 10 principles of the Nuremberg Code and the Belmont Report that grew from our own US Public Health Service's Tuskegee syphilis experiment performed between 1932 and 1972 that studied the natural progression of untreated syphilis on 399 African-American sharecroppers. (The 40-year study was controversial primarily because researchers failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure for syphilis.)
From this grew the six fundamental ethical principles used by the Department of Health and Human services for using any human subjects for research:
(1) Respect for persons: protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent;These principles are the basis for the Health and Human Services human subject protection regulations.
(2) Beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; and
(3) Justice: ensuring reasonable, non-exploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits to potential research participants.)
(4) Fidelity: fairness and equality.
(5) Non-maleficence: Do no harm.
(6) Veracity: Be truthful, no deception.
Health Care Reform's Upcoming Research
With the passage of the Patient Protection and Affordable Care Act (PPACA) Congress developed the construct for our new health care system going forward, but many, many portions of the law require further study. For instance, experiments (called "pilots" in the legislation) include a national payment pilot on payment bundling (Sec 3202), evaluation of community-based prevention and wellness programs for Medicare beneficiaries (Sec 4202), Pilot testing pay-for-performance programs for certain Medicare providers (Sec 10326), testing the law's affordability provisions, medical home pilot project, and medical liability and medical liability demonstration projects to be undertaken by the states, to name a few. This research will be conducted by a nacient branch of the Department of Health and Human Services called the Center for Medicare and Medicaid Innovation (CMI). It goes without saying that many of the pilots proposed could have grave consequences (either positively or negatively) for our patients. From a recent paper in the New England Journal of Medicine describing the function of the CMI (emphasis mine):
First, the CMI would run pilot programs rather than demonstration projects. The proposal would give the secretary of health and human services authority to expand pilots that she determines would reduce spending or improve the quality of care. This provision is critical, because the need for congressional approval has delayed or derailed past initiatives.Now given this broad authority granted in this legislation, the poorly defined "objectives" (is cost, quality or quantity of care the "objective?) and no disclosed requirements for the members of CMI, we should ask ourselves a very important question:
. . .
Second, although the CMI proposal lists 18 payment or delivery models for consideration, the center would have broad authority to select the programs best suited to its objectives. In contrast, the CMS’s Office of Research, Development, and Information has far less flexibility, because a large proportion of its resources are devoted to congressionally mandated projects.
A third critical difference is that the CMI would not have to require projects to be budget-neutral during their initial testing period. Many health care innovations require initial investments in staff, training, and infrastructure to achieve long-term efficiencies. But federal budget-neutrality requirements frequently discourage potential applicants, leave valuable concepts on the cutting-room floor at the Office of Management and Budget, and cut short promising programs that appear to be increasing Medicare costs.
Who will sit on the Investigational Review Board overseeing the government's principle investigator, the Secretary of the Department of Health and Human Services, to assure our patients' most fundamental ethical principles are maintained?