MSUCHM Office of Research

Research Subjects

HUMAN

Federal and University regulations require that all research projects involving human subjects and materials of human origin be reviewed and approved by an institutional review board (IRB) before initiation. Michigan State University has two such boards: the University Committee on Research Involving Human Subjects (UCRIHS) and the Community Research Institutional Review Board (CRIRB). Both are under the auspices of the Office of Research Ethics and Standards (ORES) within the Office of the Vice President for Research and Graduate Studies (OVPRGS).

Under the regulations, research is defined as a formal investigation designed to develop or contribute to general knowledge. A human subject of research is an individual from whom an investigator obtains data by interaction or intervention or about whom the researcher obtains confidential information. All investigators (faculty and/or graduate students) who will conduct research that involves human subjects or materials of human origin (blood or tissue samples taken from live humans) must submit an application to an MSU IRB. Approval of the research protocol must be received before the investigator begins data collection. Examples of research involving human subjects include interviews, telephone or mail surveys, behavioral or educational testing, observation of individual or group behavior, and collection of blood (or other biologic) samples.

Researchers should apply to UCRIHS for IRB approval unless the protocol is biomedical in nature AND involves more than one research site in which case the researcher should apply to the CRIRB. The CRIRB reviews projects involving research conducted at two or more sites that would otherwise have to be approved by each participating institution’s IRB. Numerous institutions have committed to accepting CRIRB approval in lieu of their own review process. Investigators need to check with each institution on any additional approvals that may be required.

Some agencies (such as NIH) require that all key personnel on a grant application complete a human subjects’ tutorial prior to accepting any monetary awards. A tutorial can be completed online, either through the UCRIHS or NIH web sites and a certification of completion will be issued. An annual renewal of certification is required. UCRIHS requires that MSU investigators complete the UCRIHS tutorial the first time but will accept renewals from other sources such as NIH thereafter. Additional information and applications are available at http://www.humanresearch.msu.edu/.

University Committee on Research Involving Human Subjects (UCRIHS)
Community Research Institutional Review Board (CRIRB)
Peter Vasilenko, PhD, Chair
Director of Clinical and Community Research
Associate Professor of Ob/Gyn
202 Olds Hall
Phone: 517-432-4791
Fax: 517-353-2976 or 432-4503
Email: vasilenk@msu.edu
Email: UCRIHS@msu.edu

Health Insurance Portability and Accountability Act of 1996 (HIPAA)

The Department of Health and Human Services (HHS) issued the Standards for Privacy of Individually Identifiable Health Information (the Privacy Rule) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to provide the first comprehensive Federal protection for the privacy of personal health information. While certain provisions of the Rule specifically concern research and may affect research activities, the Privacy Rule recognizes that the research community has legitimate needs to use, access, and disclose Protected Health Information (PHI) to carry out a wide range of health research protocols and projects. The Privacy Rule protects the privacy of such information while providing ways in which researchers can access and use PHI when necessary to conduct research.

The following web sites are available for more information about HIPAA and how it might affect research:

http://privacyruleandresearch.nih.gov/
http://www.hhs.gov/ocr/hipaa/finalreg.html

ANIMAL

All University Committee on Animal Use and Care (AUCAUC)

The use of vertebrate animals in research, teaching, and outreach activities is subject to state and federal laws and guidelines. Faculty members planning to use vertebrate animals for any University-related activity must submit an animal use form (AUF) to the All University Committee on Animal Use and Care (AUCAUC) for review. The AUCAUC approval is required prior to the start of the project. The AUCAUC is a quasi-enforcement arm of the federal government; its decisions cannot be overruled administratively. The AUCAUC is under the auspices of the Office of Research Ethics and Standards (ORES) within the Office of the Vice President for Research and Graduate Studies (OVPRGS). The Vice President has designated the Assistant Vice President for Research and Graduate Studies to be the "Institutional Official" as defined in federal regulations. The AUCAUC works closely with the Institutional Official, and has responsibility and authority under federal law for specific actions.

There are several AUCAUC policies related to exclusion. If a principal investigator or project director believes that a particular animal project does not need to be reviewed, the secretary of the AUCAUC should be contacted. Some granting agencies require review and approval of the AUF before a grant application will be processed. An agency-approved grant will not be accepted by the Board of Trustees, nor will an account number be assigned, unless the AUF has been approved by the AUCAUC. In cases where MSU administers a grant but animal studies are conducted in another institution, the Public Health Service requires that a memorandum of understanding be exchanged between institutions that includes documentation of review and approval by the animal care committee responsible for the site at which the animals are used.

University Laboratory Animal Resources (ULAR), which also reports to the OVPRGS, provides a comprehensive program of animal care for all laboratory animal colonies, as well as training for researchers. See below for more information on ULAR. Additional information on AUCAUC can be obtained by visiting http://www.aucauc.msu.edu or contacting the AUCAUC office at 432-4151 or aucauc@msu.edu.

University Laboratory Animal Resources (ULAR)

ULAR is a campus-wide organization accredited by the American Association for Laboratory Animal Science (AALAS) that provides support for research involving animals. ULAR is under the auspices of the Office of the Vice President for Research and Graduate Studies (OVPRGS). Support for animal research includes acquiring laboratory animals, providing animal care (specimens or colonies) such as feeding, bedding, equipment, cage washing, trucking, etc. 365 days a year, training investigators, and providing diagnostic services, surgical facilities, and a resource library. ULAR is responsible for a wide variety of animals from fish and frogs to goats and guinea pigs. All animals are acquired legally and cared for in a humane way. All animal care and use at MSU conforms to the standards in “The Guide for Care and Use of Laboratory Animals”, DHEW publication number NIH 78-23 (Revised 1996), and to the “Guiding Principles for the Care and Use of Animals” of the American Physiological Society. Training programs are designed to ensure that every person involved with the care of animals is aware of the established standards and regulations. Supervisors in ULAR are certified as Animal Technologists by the AALAS and include veterinarians with animal science specialization.

ULAR facilities include animal rooms that meet NIH standards, options for group-housing and for floor housing of animals, surgical suites, and special equipment including:

micro-isolator caging
ventilated racks and laminar flow racks
laminar flow hoods for box change, etc.
trucks for on campus trucking
animal related equipment

ULAR offers consultation services including:

Consultation on facilities, experimental procedures, and utilization of species.
Consultation and/or veterinary inspection regarding disease prevention, diagnosis, and treatment of laboratory species.
Consultation on acquisition and distribution of animals and animal supplies.

Additionally, ULAR Technical Services include:

Surgery rooms and anesthetic services.
Technical services, injections, blood sampling, observations, etc.
Conduct of specific projects under Good Laboratory Practice regulations
Collaborate with researchers in the design and implementation of unusual projects.
Assist with breeding colonies

The MSU All University Committee on Animal Use and Care (AUCAUC) inspects every animal care site on campus at least twice a year. State and federal agencies that conduct additional inspections include the U.S. Department of Agriculture (USDA), Michigan Department of Agriculture (MDA), Michigan Department of Public Health (MDPH), and the U.S. Department of Health and Human Services (HHS).

Michigan State University College of Human Medicine