Institutional Research Boards for Adult Health Sciences and Social Sciences

IRB Contact Information

AHS-IRB Administrator: Debbie Miller SS-IRB Administrator: Germaine Hughes Research Compliance Manager: Sheila Anderman UMKC's IRBs are the Institutional Review Boards for research at UMKC, Truman Medical Center (TMC) and Children's Mercy Hospital (CMH).

UMKC 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.

Adult Health Sciences IRB The Adult Health Sciences Institutional Review Board (AHS-IRB) ensures the appropriate care of human subjects involved in Biomedical research. Social Sciences IRB The Social Sciences Institutional Review Board (SS-IRB) protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the UMKC. Studies submitted to the SS-IRB are considered medically noninvasive. Children's Mercy Hospital has a Pediatric IRB

Fees for IRB Proposal Review

There are no fees for the review of the following research conducted by UMKC, TMC, and CMH staff: Unfunded research Federally funded research Foundation funded research Fees for industry-sponsored research conducted by UMKC, TMC, and CMH staff. The initial fee, for the life of the project, is based on the initial budget: Budget: up to $ 10,000 $     600 Budget: $ 10,001 to $ 15,000 $ 1,200 Budget: $ 15,001 to $ 50,000   $ 1,800 Budget: $ 50,001 and over $ 2,400 Fees for IRB review of Unfunded, Federal or Nonprofit research proposals conducted by others. UMKC occasionally agrees to review research for investigators affiliated with organizations other than UMKC, TMC, or CMH. Type of review:   Initial   Continuing   Amendment Full Board $ 500 $ 250 $ 250 Expedited $ 250 $   75 $   75 Exempt (admin) $ 200 $   50 $   50

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: Risks to the subjects Anticipated benefits to the subjects and/or others Importance of the knowledge that may be gained Informed consent process to be employed

What is an Institutional Review Board?

To comply with the US Department of Health and Human Service's (DHHS) regulations for human experimentation surveillance, UMKC 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 Office of Human Research Protections (OHRP), a part of DHHS.

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 Human Research Protections (OHRP). 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, now known as Federal Wide Assurance (FWA), 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.