The Office for Human Research Protections (OHRP) is a small office within the United States Department of Health and Human Services (DHHS), specifically the Office of the Assistant Secretary for Health in the Office of the Secretary of DHHS, that deals with ethical oversights in clinical research conducted by the department, mostly through the National Institutes of Health (NIH).
The office's primary duty is the implementation of , a set of regulations for Institutional Review Boards (IRBs) that mirrors the U.S. Food and Drug Administration (FDA) regulation that covers clinical research conducted by pharmaceutical companies as well as other regulations under the guidance of the Federal Policy for the Protection of Human Subjects, which is also known as the "Common Rule".
Institutions that conduct DHHS-sponsored research must have a "Federal-Wide Assurance" (FWA), an agreement with OHRP regarding ethical oversight. OHRP also provides education for IRBs, gives guidance on research ethics, and advises the HHS Secretary on issues of medical ethics.
History
Human experimentation prior to the OHRP Unethical human experimentation in the United States has been practiced in the United States for a long time prior to creation of the OHRP. A major characteristic of experimentation done during this time was the disregard for suffering inflicted on patients. In the 1840s, J. Marion Sims performed hundreds of surgical operations on enslaved African women without using anesthesia. Robert Bartholow applied electric currents into the exposed brain matter of patients. One egregious example was in 1874 when a lady came in for treatment of a cancerous ulcer on her skull that made a 2-inch hole. Bartholow inserted electrodes into her brain and caused her great distress. The lady went into a coma and died 4 days later. Another theme of human experimentation in the 19th and early 20th century was the unjust treatment of ethnic minority patients. At the turn of the 20th century, US Army doctors infected 34 Filipino prisoners with bubonic plague and beriberi. Between 1932 and 1972, the Tuskegee syphilis experiment observed the natural progression of syphilis in 600 African American males (399 of which had syphilis and 201 control subjects who did not have syphilis). In exchange for their participation, the men were promised free medical exams, hot meals and a burial fund. The men were never told that they had syphilis nor were they provided treatment when penicillin became available as an effective cure in 1947. By the end of the study in 1972, only 74 of the test subjects were alive. Of the original 399 men with syphilis, 28 had died of the disease, 100 had died of syphilis-related complications. Additionally, 40 wives had been infected and 19 children had been born with congenital syphilis. A common misconception of the Tuskegee Syphilis Experiment is that subjects were injected with syphilis.
Notable precursory research ethics entities Before the founding of the OHRP, the United States went through several precursory entities whose goals were to handle ethics in human experimentation. Many were transitory committees that lasted no more than a year or two, such as the Advisory Committee on Human Radiation Experiments and the Ethics Advisory Board. 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. The APA has since published many versions of their Ethics Code and currently operate under the code passed in 2002 The National Research Act then established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which was the first national commission whose entire focus was the protection of experimental subjects. In 1978, the Food and Drug Administration added their first regulations protecting human research subjects, which were revised in 1981. The National Bioethics Advisory Commission was signed into existence by President Bill Clinton in October 1995 and was terminated in October 2001.
Founding On June 13, 2000, the United States Secretary of Health and Human Services, Donna Shalala, created the OHRP as a component of the Office of Public Health and Science, with the main function of overseeing research done on human test subjects and ensuring its compliance with regulations set forth by the United States Department of Health and Human Services. The OHRP replaced the Office for Protection from Research Risks, and Greg Koski was named as the first director. The director of the OHRP was to report to the United States Assistant Secretary for Health under the Department of Health and Human Services (then David Satcher).
Case involvement Since its founding, the OHRP has interfered in several cases involving human subject research experiments in which violations were made to the health and rights of the participants, as well as the regulations put in place for human research. In 2001, the OHRP temporarily suspended the research license of Johns Hopkins University and its associated research facilities following the death of a participant in a hexamethonium inhalation experiment. The experiment was found to be violating regulations in that the researchers failed to inform the participants of the possible dangers of hexamethonium as well as obtain proper information on the effect of hexamethonium prior to experimentation. 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. This experiment was determined to be in violation of federal regulations in that the parents of these infants were not informed of the possible effects of the experiment on their child, which included blindness or death, and were therefore unable to give informed consent.
Organizational structure
Office of the Director 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. The committees that fall under the Office of the Director include International Activities and the Secretary's Advisory Committee on Human Research Protections (SACHRP).
Secretary's Advisory Committee on Human Research Protections (SACHRP) 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. The Assistant Secretary for Health acts as a middleman presenting the committee's advice to the secretary for consideration. In addition, the SACHRP also holds three annual meetings which are open for public audience and questions.
International activities This committee works to enhance ethical policies and procedures that protect human research subjects around the world. These global efforts ensure that the people who participate in any research funded and or conducted by the DHHS are given protection equal to those participating in the United States.
Division of Compliance Oversight 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. Both for-cause compliance and not-for cause surveillance evaluations are conducted.
Division of Education and Development (DED) The DED is responsible for much of OHRP's publicity. Its tasks include hosting events, advising researchers involved in affiliated experiments, and propagating educational materials about human research subject protections. Education materials are also presented online via the official OHRP website.
Division of Policy and Assurances The Division of Policy and Assurances prepares the policies, guidelines, and requirements for human subject protection and provides the information to the research community. It is also in charge of the administration of the Federal-wide Assurances of Compliance and registration of institutional review boards.
Responsibilities
Belmont Report 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. Intended to serve as ethical parameters for those conducting research involving human subjects, the Belmont Report has three main aspects: boundaries between practice and research, basic ethical principles, and application of these principles.
There is major difference between regulations for practice of approved procedures and research. As such, the Belmont Report defines each term in order to help determine what constitutes what. Practice is defined as an established methodology designed to improve an individual's condition with confidence for success. Research is defined as a procedure designed to test a hypothesis and draw conclusions in an experimental style. The OHRP only reviews activity categorized as research.
The three basic ethical principles outlined in the Belmont Report are respect for persons, beneficence, and justice. Respect for persons incorporates emphasis on the subjects and their autonomy, meaning their ability to make decisions in the research. To have autonomy, subjects must give informed consent. 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. Beneficence requires that the research have intentions to produce benefits, or potential for benefits, for the individual or others with similar conditions that outweigh any risk that may be involved. Justice delineates a need for fair distribution in the selection of subjects, meaning bias in participants is minimized. Participants cannot be all from a vulnerable or easily accessible population without violating the justice principle.
45 C.F.R. 46
Basic HHS policy for protection of human research subjects Subpart A, more commonly known as the "Common Rule", of 45 C.F.R. 46 is the fundamental guidelines for ethics of all human research. Any establishment that wants to do research involving humans must submit a document that states they will comply with this policy and all pertinent policies to the federal department or agency with authority. The institutional review board (IRB) must initially review and approve the research and in the case the study is approved, the IRB will then continue to monitor the research. If at any point the research does not follow the guidelines approved by the IRB, then the IRB has the authority to suspend or terminate the research. The department or agency in charge also has the power to suspend the research. During the course of the study, the IRB must document all meetings and activities.