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Institutional Research Board

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III:  Distribution of Responsibility

 

The responsibility for the protection of subjects in research is distributed among several parties: the responsible principal investigator (RPI), the Institutional Review Board (IRB), and those at cooperating institutions who participate in VU-approved research or provide access to subjects.

A. Responsible Principal Investigator

The primary responsibility for the day-to-day protection of the rights and welfare of human subjects lies with the responsible principal investigator (RPI). Specifically, the RPI is charged with assuring that:

  1. the information provided in the IRB application is complete and correct.
  2. as RPI, she(he) takes ultimate responsibility for the protection of the rights and welfare of human subjects, the conduct of the study, and the ethical performance of the project.
  3. she(he) will comply with all VU policies and procedures, the terms of its Federalwide Assurance, all applicable federal, state, and local laws, and policies of both the sponsoring agency and cooperating institutions, as applicable, regarding the protection of human subjects in research.
  4. the project will be performed by qualified personnel according to the VU IRB-approved protocol.
  5. the equipment, facilities, and procedures to be used in the research meet recognized standards for safety.
  6. no change will be made to the human subjects protocol or consent form(s) until approved by the VU IRB.
  7. legally effective informed consentor assent will be obtained from human subjects as required.
  8. adverse events and effects, unanticipated problems, complications, and injuries involving subjects will be promptly reported to the VU IRB Office and to the appropriate Departmental Executive Officer.
  9. she(he) is familiar with the latest edition of the VU Handbook for Investigators and will adhere to the policies and procedures explained therein.
  10. student and guest investigators on the project are knowledgeable about the regulations and policies governing this research.
  11. she(he) will meet with the project's other investigator(s) on a regular basis to monitor study progress.
  12. if she(he) will be unavailable, as when on sabbatical or other leave, including vacation, she(he) will arrange for an alternate faculty sponsor to assume responsibility during her(his) absence and will advise the VU IRB by letter of such arrangements.
  13. the proposed research has not been done, is not underway, and will not begin before IRB approval has been obtained.
  14. required research records are retained for a period of at least three years after the research is completed.


B. Departmental Executive Officer

The Executive Officer of the department is responsible for:

  1. ensuring that faculty, staff, and students are kept informed of VU policy and procedures and of their responsibilities for protecting the rights and welfare of human subjects involved in research;
  2. ensuring that, for any course offered by the department in which students are expected to serve as human subjects, notification to this effect is given in the course description in the official University bulletins and timetables; and
  3. reporting promptly to the IRB any unanticipated problems involving risks to subjects or others.

C. Institutional Review Board

The VU IRB Board is responsible for:

  1. providing initial and continuing review of human subjects research;
  2. ascertaining the acceptability of the proposed research in terms of applicable regulations, policies, and procedures;
  3. documenting that reviews are conducted according to applicable regulations, policies, and procedures;
  4. appropriate oversight and monitoring of the research; and
  5. providing advice and information to investigators engaged in research involving human subjects.

The VU IRB Board is additionally responsible for:

  1. developing policy, procedures, information, and instructions regarding human subjects research;
  2. adjudicating differences and reviewing problems arising in research involving human subjects;
  3. ensuring compliance with externally mandated policies and regulations; and
  4. reporting to the appropriate institutional officials and, for research governed by HHS regulations, to the Secretary of HHS, any serious or continuing adverse events, unanticipated problems or investigator noncompliance with the requirements and determinations of the IRB.


D. Institutional Oversights

Research that has been approved by the VU IRB may be subject to further appropriate review and approval or disapproval by officials of the Viterbo University. Under federal regulations, university officials may not approve the research if it has been disapproved or not yet approved by a VU IRB.

The VU IRB has the authority to suspend or terminate approval of any research conducted at or sponsored by the VU that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected harm to subjects. Any suspension or termination of approval will include a statement of the reasons for the IRB's action and shall be reported promptly to the RPI and to the appropriate institutional officials. For any HHS-supported work so terminated or suspended, HHS regulations require that the Secretary of HHS be notified as well.

E. Individual or Institution Providing Access to Subjects

If access to research subjects is obtained through cooperating institutions, the authorized official of the cooperating institution must be informed of the research and should satisfy herself or himself that the subjects' rights and welfare will be protected and that institutional commitments to the subjects will not be abridged. For federally funded research, the cooperating institution may be required to file with the federal government a formal, written assurance that human subjects research will be done in accordance with ethical and regulatory guidelines and to enter into a binding agreement with the VU regarding IRB oversight of the research.

If professional practitioners or service agencies provide access to subjects, the individual providing access should ensure that his or her professional and legal commitments to the clients are not abridged.