January 22, 2001
Re: Faculty Sponsorship of Student Research Involving Human Subjects
The preponderance of human subjects research at our campus is conducted by master's degree students under faculty sponsorship. One problem, which has tended to slow down both review and response time, is the lack of detailed information about the actual research procedures within the protocol application. The incompleteness of applications frequently indicates a misunderstanding concerning human subject protection issues. In other cases, it may be that faculty have not adequately reviewed the protocol with the student.
There is no clearer sign of inadequate review than the existence of egregious typographical and grammatical errors. The problems of incompleteness and gross errors of presentation suggest the responsibilities of faculty sponsorship may have been misunderstood. It is this situation that we wish to address in this letter. In order to facilitate the internal review process, we request that greater care be taken by students in their preparation of the protocol and that faculty be more stringent in their review in order to eliminate these problems. This letter concludes with specific suggestions for the faculty sponsorship statement.
The primary responsibility of the Institutional Review Board is to understand the purposes and procedures of the research and to discern the nature and extent of the risks, if any, to human subjects. Accordingly, the goal of the Board is to determine whether the procedures being used reduce or eliminate these risks so that the benefits of the research outweigh the risks.
Nothing is more important than an applicant's honest assessment of the risks to the human subjects involved in these research projects, not only legal, social, or physical risks, but psychological risks and discomfort as well. This requires a meticulous, step-by-step review of (1) every research process that touches human subjects; and (2) the process of obtaining informed consent. The Board expects every sponsoring faculty and student to complete this process, to describe the research situation adequately and honestly, and to address the elements of risk and the procedures used to reduce or eliminate those risks.
In submitting applications for Human Subjects review, all elements of the application must be present (e.g., research instruments, informed consent, agency letters of approval, completed Faculty Sponsor Statement).
The IRB has revised the Faculty Sponsor's Statement to provide faculty with the opportunity to more adequately address the "stage-setting" issues of each student research project. Simply signing the Faculty Sponsorship Form will result in the protocol being returned to the student and faculty member for more information. Moreover, perfunctory statements that "there are "no risks, modest benefits, and normal procedures" are not helpful.
It is recommended that in completing this form the faculty sponsor begin with (1) a succinct statement of the risks, followed by (2) a brief description of the measures to be taken against these risks, and (3) a brief statement which places the research methodology within the broader context of similar research in the discipline. Please make sure that you (4) explain how the student's proposed study complies with (a) Federal regulations and (b) University policy with regard to protection of human subjects from potential harms or risk and (c) with respect to the principles of justice, beneficence, and respect for persons. These comments will be greatly appreciated and will hopefully lead to improvements in the entire review process.
For fundamental conceptual concerns the individual members of the IRB and the Office of University Research staff, particularly Dr. Brett and Ms. McIntosh, are ready to provide advice and assistance as the researcher and faculty sponsor encounter unique circumstances.
Elizabeth Deschenes, Professor of Criminal Justice Chair, IRB (Fall 2000)
Bonnie Kellogg, Professor of Nursing Chair, IRB (Spring 2001)