Office for Human Research Protections
[3] Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight.
In exchange for their participation, the men were promised free medical exams, hot meals and a burial fund.
[7] Before the founding of the OHRP, the United States went through several precursory entities whose goals were to handle ethics in human experimentation.
[8] One of the early and longstanding groups concerned with experimental subject safety was the American Psychological Association (APA), who first published their "Ethical standards of psychologists" in 1953.
[10][11] In 1978, the Food and Drug Administration added their first regulations protecting human research subjects, which were revised in 1981.
[15] In another case that occurred in 2013, the OHRP challenged the practice of the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT), a research project in which 1300 premature infants were used as subjects to test the optimum levels of oxygenation to be used for proper care of premature infants in hospitals.
[16] As a leader in the DHHS, the Office of the Director oversees all functions of the OHRP and works closely with DHHS officials including the Secretary of Health and Human Services and the Assistant Secretary for Health to ensure that human research policies, plans, and procedures meet ethical standards.
A committee within the Office of the Director, the SACHRP consists of mainly researchers and lawyers who aid the Secretary of Health and Human Services with their expert advice.
This committee works to enhance ethical policies and procedures that protect human research subjects around the world.
The Division of Compliance Oversight is in charge of evaluating substantive noncompliance reports based on the Health and Human Services (HHS) regulations.
Based on written investigation reports, the office determines whether regulatory actions will be needed to protect the human research subjects.
The Office for Human Research Protections adheres to the principles of the Belmont Report in order to carry out its responsibilities.
The Belmont Report is a set of guidelines created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
[17] Respect for persons incorporates emphasis on the subjects and their autonomy, meaning their ability to make decisions in the research.
This means they must be mature enough to and mentally capable of self-determination, must fully understand their role in the procedures, and must be completely voluntary to participate.
Justice delineates a need for fair distribution in the selection of subjects, meaning bias in participants is minimized.
The U.S. Department of Health and Human Services sets required conditions for any research is done on pregnant women or fetuses.
[20] For research on pregnant women and fetuses, condition topics include preclinical risk studies, minimizing risk, no money (or other benefits) given to terminate pregnancy, direct potential benefit to pregnant women and fetuses (otherwise special consent provisions are required), pregnant children (requires special consent provisions), and research participants inability to choose neither how a pregnancy is terminated nor if a neonate (an infant under 4 weeks old) is viable.
If a study cannot be approved by these conditions but offers great potential for the health of pregnant women, fetuses, or neonates, there is a special process by which The Secretary may or may not approve the study; this process involves consultation with a panel of experts, as well as ethical and consent codes.
"Prisoner" is defined by HHS regulations at 45 CFR part 46.303(c) as "any individual involuntarily confined or detained in a penal institution.
This rule may be circumvented if the child stands to gain a direct benefit to his/her health even if the procedure may have greater than minimal risk.
If the institution or organization decides to disband a currently operating and functioning IRB, a report must be sent to OHRP within 30 days.
