University of Missouri - Kansas City

 

News

Adult Health Sciences IRB is accepting electronic submissions.  (more information)

The Office for Human Research Protections has recently launched its new Spanish web page

The Spanish web page includes:

HRP believes this will help Spanish-speaking IRB members and investigators to better understand the requirements of 45 CRF 46, as well as to obtain IRB registration and FWA approval.



Research Protections Program

IRBs at UMKC

University of Missouri-Kansas City has the responsibility for reviewing all proposed projects and campus activities involving human subjects. Protocols must be submitted to, and approved by, the appropriate Institutional Review Board before a study is undertaken.

UMKC IRB's and affiliations: (click in the IRB name to go to the appropriate UMKC IRB)

  • Adult Health Sciences IRB - The Adult Health Sciences Institutional Review Board (AHIRB) ensures the appropriate care of human subjects involved in Biomedical research.
  • Social Sciences IRB - The Social Sciences Institutional Review Board (SSIRB) protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the University of Missouri-Kansas City. Studies submitted to the SSIRB are considered medically noninvasive.
  • Children's Mercy IRB and Pediatric Research

The fundamental responsibility of the IRB is to assure that all ethical issues have been fully addressed in the protection of human subjects who volunteer to participate in research studies.

To fulfill this responsibility, the IRB is guided by three overriding principles: protecting the autonomy of the subjects (i.e., subjects must be informed about the nature of the study, the details of their participation must be voluntary), ensuring beneficence (i.e., the benefits of the research must outweigh the risks) and promoting fair procedures in the selection of subjects (i.e., the risks and benefits of research should be evenly distributed among the possible subject populations). The IRB reviews all protocols for research using human subjects, weighing the ethical issues raised, assessing potential benefits against risks, and assuring that appropriate recruitment and consent procedures are used. Through this process, compliance with both the spirit and the letter of federal, state and university policies is achieved. All IRBs consider:

1. Risks to the subjects

2. Anticipated benefits to the subjects and/or others

3. Importance of the knowledge that may be gained

4. Informed consent process to be employed

What is an Institutional Review Board?

To comply with the US Department of Health and Human Service's regulations for human experimentation surveillance, the University of Missouri-Kansas City has the responsibility for reviewing all proposed projects and campus activities involving human subjects. Protocols must be submitted to, and approved by, the appropriate Institutional Review Board before a study is undertaken. Failure to comply with this policy or to follow the directives of the appropriate committees exposes both the university and the investigators to potential liability and sanctions. The primary purpose of the review is to assure the protection of the rights and welfare of the human subjects. IRBs were established as an outcome of Senate hearing (1972) and legislation passed in 1974 as a result of unethical treatment of human subjects. Prior to this other committees existed as a requirement of the United States Public Health Services policy established in 1965. IRBs are currently regulated by the Food and Drug Administration and the National Institutes of Health.

Origins of the Institutional Review Board (IRB)

An Institutional Review Board is a committee mandated by the National Research Act, to be established within each university or other institution that conducts biomedical or behavioral research involving human participants and receives federal funding for research involving human participants. The purpose of the IRB is to review all proposals for human research before the research is conducted to determine whether the research plan has adequately included the ethical dimensions of the project. The administration of IRBs is conducted by the Office for Protection from Research Risks (OPRR), within the National Institutes of Health. Institutions not in compliance with the law may lose federal funding. As a result of worldwide opinion after World War II, the Nuremberg Code came into effect, the first principle of this code states that humans must not be participants in research projects unless they are fully informed of the proposed procedures and voluntarily consent to the procedures. Due to reports of some biomedical research carried on in the United States in the late 1950s and early 1960s, the Surgeon General enforced regulations that govern all research sponsored by the Department of Health, Education, and Welfare (now DHHS). In 1974 Congress passed the National Research Act that together with the Multiple Project Assurance broadens the regulations by having them apply to all research involving human participants conducted at institutions receiving federal funding, not just projects that are federally funded.

What does an IRB mean to me?

The purpose of the IRB is to inform and protect human subjects through the information provided in the informed consent document. Therefore, the IRB is acting as an advocate for the research subject. This means that the IRB, during it's review of the informed consent, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks and alternative treatments that are available if participation in the study is refused.

 

(UMKC Information)