Human Research Protection

The office for Human Research Protections (OHRP) is an office in the United States under the department of Health and Human services. It is the top organ in the Federal government that has the mandate to oversee the internal system, which usually protects the well-being, the general welfare, and the rights of individuals who conduct research activities in the United States. One of the duties of this office is to ensure that these individuals conduct research according to the stipulated regulations and rules in the Code of Federal regulations, part 46, or any other equivalent in other institutions (Burt, 2010).

The office of Human Research Protection conducts leadership duties in research on human subjects through the provision of services, such as interpreting and guiding on the regulations of research, coming up with educational programs and facilities, and maintaining an oversight on the regulations. In actual sense, the main focus of the Human Research Protection office is educating researchers, regulating the research activities, coordinating the research activities to ensure compliance and to enact policies that govern the research activities. This office is coordinating various national health institutions in implementing the above roles and responsibilities (Cone, 2001).

The main duty of this office is the implementation of specific rules, ‘45CFR46’. These are rules that govern food and drug administration in the United States, which covers all researches, which pharmaceutical companies conduct, especially the clinical researches. The office of Human Research Protection also has the mandate to advice on matters to do with professional ethics in research and regulatory issues in behavioral and biomedical research. It also helps the secretary’s Advisory Committee on Human Research Protections (SACHRP), which is an advisory organ to the secretary of Health and Human Services on matters to do with protection of human subjects. Without the existence of this office, the outcomes of research activities will not be sufficient, because a researcher will not put into consideration all the required regulations, and without guidance, they will end up making many mistakes (Constance Forbes Citro, 2003).

Health and Human Services Regulations

The above protection regulations on human subjects first came into existence in 1974. Later on, in the year 1978, the national commission that protects human subjects in behavioral and biomedical research published the Belmont Report. It included the guidelines and ethical principles to protect human subjects in research activities. This report brings out three basic ethical principles that govern research on human subjects. These principles include respect for persons, justice, and beneficence.

The present version of these regulations composes of five sections.

The first section includes the primary protection requirements for all human subjects, in researches, which the HHS conducts or supports.

Three of the five sections provide protection for vulnerable groups of individuals in the society.

Section B, which came into existence in the year 1975 provides extra protection rights for pregnant women, young infants usually at the neo natal stage, who are part of the human research, and human fetuses.

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The third section of these regulations came into action in the year 1978 and has provided extra protection on research on behavioral and biomedical conditions of prisoners.

The fourth section of the regulations came into action in the year 1983, which role was to provide extra protection for children who are subjects of research.

The last section of the rules came into action in the year 2009, which calls for the registration of all Institutional Review Boards (IRBs) that usually review research studies, which the HHS conducts, or supports (Eckstein, 2003).

Looking at the above provisions, one can clearly see that the existence of this office is by far a very vital element and development in the field of human research. We see a situation, where there is assurance of the protection of the rights of all categories of the individual involved in human research.

Reasons for the Existence of the Office of Human Research Protection

to Ensure Protection of Human Beings with AIDS in Human Research

AIDS is a highly sensitive issue and, therefore, a research involving victims of AIDS should consider all the requirements of the Office of Human Research Protection. IRBS must, therefore, maintain high levels of care so that they observe all the available regulation provisions involving AIDs victims. They have a responsibility to ensure that the AIDS victims involved in the human research study have less vulnerability to risk, in line with the research design that the IRB is using. In some cases, the IRBs should use procedures that have worked on such subjects for purposes of diagnosis and treatment. The IRB must realize that the risks, which the subjects are exposing themselves to be realistic in relation to the benefits from the research and the outcomes from the research, they are conducting. The IRBs must, therefore, formulate a sufficient structure to ensure that they obtain consent from the subject and that they must give full information about the research they are conducting. The IRBs should also exercise great care to ensure that they get accurate and complete consent and documentation. This helps in assuring the protection of the rights and welfare of the AIDS victims (Elizabeth A. Bankert, 2006).

The office of Human Research Protection also has the mandate to ensure a high degree of confidentiality while conducting research on AIDS individuals. This is true, because any unaccepted disclosure of information about the individual can have serious consequences for the individuals participating in the research. Disclosure of such information may threaten family ties such as marriages, an individual’s job, one’s employability, and the ability to access credit and insurance. Considering the above risks, individuals conducting human research on individuals who are AIDS victims should preserve confidentiality with a lot of care. In addition, the potential individuals taking part in the research should receive advice on the extent of confidentiality, to allow them to make a critical examination as to whether they can take part in the research or not (Institute of Medicine (U.S.), Committee on Assessing the System for Protecting Human Research Subjects, 2001).

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The IRBs should also put into consideration the information about the individuals who are participating, which they should record in the medical records of these individuals. They should actually reduce the amount of data they record from AIDS related investigations in their medical records.

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