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    Mission Statement

    The Roger Williams University Human Subjects Review Board (HSRB) ensures the health, safety, privacy and dignity of all persons participating in research under the auspices of the University.

    Ethical Issues

    In accordance with federal regulations, Roger Williams University (RWU) has adopted a policy that controls procedures that may be used in research involving the participation of human respondents or subjects.

    Roger Williams University is guided by the ethical principles set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research, also known as The Belmont Report.  The Belmont Report, published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, provides the philosophical underpinnings for current federal laws that govern research involving human subjects.

    Federal Regulations

    Regulations protecting human subjects first became effective on May 30, 1974 in the United States with the intention of protecting the civil rights of all citizens. The Department of Health and Human Services (DHHS) policy as expressed in Title 45, Part 46 of the Code of Federal Regulations, also known as 45 CFR Part 46, is the heart of the federal policy on protecting human subjects in research. In 1991, many federal agencies adopted Subpart A, the general provisions of 45 CFR Part 46, as the federal Common Rule. Each "Common Rule agency" publishes an identical version of this Federal Policy for the Protection of Human Subjects in its own section of the Code of Federal Regulations. The DHHS Office for Human Research Protections (OHRP) exercises an important leadership role among Common Rule agencies.

    The Federal Policy applies to all research sponsored by the Common Rule agencies. Roger Williams University has pledged that the institution and all investigators will follow the US Department of Health and Human Services (DHHS) regulations for protecting human research subjects.  Additionally, the National Institutes of Health (NIH) requires that all key research personnel complete a human subjects training program before an NIH-sponsored project can begin.

    Further information concerning research funded by federal monies can be obtained at the following website: http://ohrp.osophs.dhhs.gov/irb/irbguidebook.htm

    General Policies and Procedures

    Each institution that engages in federally sponsored human subject research must provide the government with a written assurance that it will comply with the Common Rule. In accordance with concern for human dignity, individual freedom and integrity, and the civil rights of all citizens, Roger Williams University has adopted a policy that controls procedures that may be used in research involving the participation of human respondents or subjects. This policy ensures the health, safety, privacy and dignity of all persons participating in research under the auspices of the University.

    Definition of Human Research

    Human research is defined as any systematic investigative activity including research development, testing and evaluation, interviews, questionnaires, or treatments of any kind requiring the participation of human subjects or respondents with the intent of contributing to generalized knowledge. At RWU, activities that meet this definition include faculty and student research projects, classroom demonstration, service programs, and other university classroom research whether conducted on or off campus, as a classroom or research exercise, with or without the intent to publish. Specifically, it requires that the principal investigator determine and be prepared to demonstrate:

    • that all methods and procedures to be employed are safe and involve no undue risk to life, health, safety or well-being of subjects;
    • that the risks to the subject are clearly outweighed by the potential benefits to him or to her, or by the importance of the knowledge to be gained;
    • that the methods and procedures reflect respect for the feelings and dignity of respondents or subjects and avoid unwarranted invasion of privacy or disregard for anonymity in any way;
    • that participation is informed and completely voluntary, and that procedures for obtaining such consent are adequate and appropriate;
    • that data be retained for at least 3 years according to the federal code of regulations (45 CFR46.115).
    • that data be used only for the purposes for which such consent was obtained and then appropriately destroyed; and that methods of data collection, analysis, storage and reporting are consistent with these principles;
    • that proposed recruitment materials such as phone calls, fliers, brochures, advertisements, e-mail, have received the approval of the HSRB before posting.  (Adapted from St. Joseph University, Pennsylvania, RRB policies)

    Roger Williams University has delegated to the Human Subjects Review Board (HSRB) the responsibility of review and written approval of all research and related teaching activities involving the use of human subjects, conducted under the auspices of a school, department, or other unit within the University.

    Administrative responsibility for overseeing these functions has been delegated to the chair of the HSRB who is appointed by the Chief Academic Officer (CAO) of the University. The CAO also serves as the research oversight official as required by federal policy.

    Each institution may file an "Assurance of Compliance with DHHS Regulations for Protection of Human Research Subjects." Roger Williams University is preparing to apply for federal assurances. Nonetheless, the RWU policy stipulates that all research involving human subjects at RWU will be reviewed and approved by the HSRB, whether Federally sponsored or not.

    Any faculty member or student preparing proposals for research or class projects involving human subjects should arrange to have his/her proposal or class project protocol reviewed by the HSRB prior to initiation of the project. In addition, any changes in research protocols involving human subjects must be approved by HSRB as the need arises.

    Administrative Duties

    Roger Williams University has delegated to the Human Subjects Review Board (HSRB) the responsibility of review and written approval of all research and related teaching activities involving the use of human subjects, conducted under the auspices of a school, department, or other unit within the University.

    Administrative responsibility for overseeing these functions has been delegated to the chair of the HSRB who is appointed by the Chief Academic Officer (CAO) of the University. The CAO also serves as the research oversight official as required by federal policy. In essence, the CAO of the University shall serve as an ex officio member of the committee, but not as its chair. The CAO will sign off on all recommendations of the committee, as s/he has the legal authority to speak and act for the institution and thus bears responsibility for oversight of research conducted under the aegis of the University.