Charge to the Ad Hoc IRB Review Committee for 2007-08.
The UNR Office of Human Research Protection maintains Institutional Review Boards (known as
IRBs) to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects. It is the function of the IRBs to 1) determine and certify that all projects reviewed by the IRBs conform to the regulations and policies set forth by the HHS and FDA regarding the health, welfare, safety, rights, and privileges of human subjects; and 2) assist the investigator in complying with federal and State regulations.
The issue of gaining approval from the Office of Human Research Protection to conduct human subjects research solicits a range of reactions from faculty. Many faculty see the Office as a significant obstacle to conducting research while other faculty see the Office as a necessary part of the research process that works well. Criticisms include inappropriate changes in research design, slow response time, a burdensome administrative process for studies with little or no risk to human subjects, underuse of the exempt or expedited status, and protocols returned for trivial changes not related to regulations or participant safety. Examples include formatting or minor wording changes. Other questions that have emerged include establishment of separate review processes or boards for student research and use of electronic system for submission of forms.
It is clear that the university has a responsibility to follow federal regulations and to ensure that individuals who participate in research at UNR are fully informed of the risks and treated appropriately. However, the determination of what constitutes risk can be challenging and can be further complicated when study descriptions are unclear or incomplete. In addition, it is not certain that the Office of Human Research Protection has an adequate staff and budget.
As UNR continues to expand its research mission, it is critical that the university has an effective and efficient process for approval of human subjects research. The UNR Faculty Senate has established the Ad Hoc IRB Review Committee to address these issues and to report back to the
Senate by April 2008. The specific charges listed below.
1.
To what, if any, extent are the above issues enhancing or hindering the research enterprise at UNR?
2.
What are the statistics on the number of applications, average approval time, number of rejections, and other relevant measures?
3.
To what extent is the UNR Office of Human Research Protection effectively and accurately implementing the required federal regulations?
4.
Are there steps that could be taken to improve the efficiency of the approval process? This might include but is not limited to separate boards for students research and an electronic submission and review system.
5.
Is the office adequately supported and staffed?
6.
What should be done to improve the faculty and students ’ awareness and understanding of the IRB process?
7.
Should faculty service on the IRB be better recognized and supported by the university.