Report on Policicies and Procedures for Research Involving Human Subjects

Background

The Research committee was charged to:

Examine the question of the application of federal rules for protection of human subjects, formulated primarily for biomedical research, to research in the social sciences and humanities and suggest guidelines for protecting human subjects that are compatible with established research methods in the social sciences and humanities.

The Committee met twice and had many e-mail communications, to consider the Rutgers policy and practices on human subject research, especially as they relate to research in the social sciences and humanities. At its first meeting, on February 1,2002, it met with Michael Breton, Associate Vice President for Research & Sponsored Programs, and Karen Janes, Associate Director for Research Integrity and Compliance, in the Office of Research & Sponsored Programs (ORSP). We learned very much about the onerous nature of the federal requirements for oversight of research involving human subjects in the social sciences, especially because these requirements were, in many cases, written primarily for research in the biomedical sciences. We were impressed by the need for the University to have appropriate controls on human subject research in the social sciences in order to keep us in compliance with federal regulations. None of us would like for Rutgers to be targeted for failure to comply with federal regulations in this area as has happened at other universities.

On the other hand, Institutional Review Boards need to be cognizant of ethics from the perspective of social research as well as from that of the participant subjects.  Ethics of research demands that a study meet appropriate standards of design and methods to answer the question it addresses.  A study that fails to meet these requirements is imposing on the time and energy of its participants and failing to meet its various obligations to the larger society, a key one of which is to introduce ideas backed by sound data into the market of ideas involved in the analysis of important social issues.  There are many players in this market other than the university and some are actively engaged in research to enhance their ability to manipulate social and individual processes for their own gain. Few non-university players in the social sciences are constrained by Institutional Review boards.  It would be unfortunate if there were rules on social research that prevented the generation of the ideas and data to compete in this market.  University-based social-science investigators are critical contributors to the open forum that is vital for a free society.  Their activities should meet the rigorous rules of good science and the ethics of safe treatment of participants with due attention to the fact that the ultimate safety of participants is also dependent upon having access to the free distribution of valid information.  Rules generated by fears of short-term injury in biomedical projects that may not apply in social science projects should not be allowed to eliminate a voice that is important for longer-term individual and social gains. The University should regularly advise and urge the federal government regarding the adoption and issuance appropriate guidelines and rules relating to research involving human subjects, especially research in the social sciences.

The Faculty Council has heard a number of complaints from faculty members in the social sciences and humanities about the burdensome and inappropriate nature of the approval process for protocols involving human subjects at Rutgers in so far as they touch upon research in the social sciences and the humanities. Because of the complexity and ambiguity of the approval process faculty sometimes experience significant delays before funds are released that will enable them to perform their research.  Anecdotal evidence suggests that, in the past, faculty conducting survey and market research, seemingly innocuous projects, have found their work impeded. Clearly there is, at the very least, a need for better communication between the faculty, the ORSP, and the Institutional Review Board (IRB), the faculty committee which oversees the approval of protocols involving human subjects.

Faculty need to know that IRB approval is required for all studies involving human subjects, whether or not the studies are federally financed. This formal approval is required by the federal regulations even though the faculty member may have generated similar and even more restrictive guidelines on their own, without IRB review. We are especially concerned that faculty in the social sciences, faced with guidelines that seem designed for bio-medical research and with little relevance to the humanities and social sciences, may consider carrying out some projects involving surveys and interviews without any form of review, either out of ignorance of the rules or in an effort to avoid a poorly adapted approval process. Some revision of both the procedures and the means of conveying them to the faculty would seem to be appropriate.

The Committee heard anecdotal evidence that other comparable research universities employ simpler protocol approval procedures than Rutgers for social science projects.  Many universities (mostly ones with medical schools) empanel two separate IRB's, one for the biomedical sciences and another for the social sciences and humanities.

We found Michael Breton, himself a former researcher involving human subjects, to be very understanding and sympathetic to the plight and needs of researchers in the social sciences or humanities involved in human subject research.  He assures us that ORSP has developed procedures designed to expedite the approval process and he has offered to do everything feasible to improve communication with the faculty. ORSP has recently created a new, two-page application form for “"exempt"” projects that can be approved by the administration rather than requiring full review by the Institutional Review Board.  This new process is intended to enable faculty performing research that involves minimal risk to human subjects to forgo the full IRB protocol approval process.  We are encouraged that the ORSP, under Michael Breton, wishes to work to make the process as simple as possible under federal law.

Nevertheless this is a complicated issue for which it is important to have much better communication between potential researchers and the ORSP. The issue, for example, of determining what kinds of research are to be designated as “minimal risk” is one that requires sensitivity on the part of the ORSP and training on the part of faculty.  Determining how best to safeguard human subjects calls for flexibility and imagination since each research project is by its very nature entirely unique.  Much research involving human subjects involves collaboration with researchers in other institutions, with different rules, and even in other countries where it may be conducted in multiple languages. The ORSP needs to become far more cognizant of the needs and constraints of faculty conducting social science research in culturally and demographically complex regions and when multiple institutions are involved.

Recommendations

• Each Rutgers Department, Center, or other appropriate academic unit carrying out research involving human subjects should identify a knowledgeable and responsible senior faculty member to serve as liaison with the Office of Research and Sponsored Programs for issues related to human-subjects research. This person would be expected to be familiar with the rules and procedures related to the approval of protocols involving human subjects, especially as they relate to typical research projects in that discipline; he/she should also be able to articulate for ORSP common practices and understandings about research from the perspective of the relevant discipline. Each liaison will also serve as a mentor for junior faculty  graduate students to assist the ORSP in guaranteeing that Rutgers is in compliance with federal guidelines.  In this way faculty will have a better understanding of the protocol approval process and a greater willingness to adhere to it.  From time to time ORSP staff should meet with the faculty liaisons to gather feedback on the procedure and to     update the faculty on developments relevant to human-subjects protocols at the federal and state levels.  Putting a human face on the process will go a long way to improving communication and protecting Rutgers’' compliance status.

• The ORSP should create a website with answers to frequently asked questions regarding Rutgers rules and procedures for research involving human subjects. At present the materials available have little relevance for those faculty doing research in the social sciences.  The lack of transparency about the review process may be an impediment to faculty compliance.  Sample protocols illustrating different categories of review and the procedures and timetables that are likely to apply to similar research would be helpful.  Examples of protocols that might qualify for "exempt”" status and therefore for relatively rapid administrative approval should be posted along with the rationale that applies. Examples of protocols that would be suited for expedited review, as well as those that would call for a full IRB panel review, would also be helpful.

• The ORSP should immediately create a task force charged with making recommendations for streamlining as much as possible the procedures for reviewing human subjects protocols.  Faculty who have recently submitted protocols for review should be polled for their feedback on the process.  The task force should conduct a more systematic review than has been possible for us of the review practices of other major research universities comparable to Rutgers.

• The ORSP should, as a clarification of the current situation, refer to protocols that may be “exempt” from full IRB review,“ projects  presently called "exempt", as "expedited projects", "minimal risk projects", "projects needing administrative approval only", or some other suitable label.”  This relabelling might help faculty understand better that although some research protocols do not need to be approved by the IRB, they nevertheless must be reviewed by an ORSP administrator.

• The faculty understand that the ORSP and the IRB are its allies in  guaranteeing that research at Rutgers be conducted effectively in an ethically sound fashion.  Therefore we encourage a supportive and collaborative spirit in devising the best possible research protocols as well as the best possible approval processes.  Faculty should work closely and cooperatively with ORSP staff.  However they should be encouraged to contact or appeal to a higher level at the ORSP, including the Associate Vice President Michael Breton, should the process appear to require adjustment, clarification, or improvement.

• The staff of the ORSP dealing with protocols involving human subject research very much need to be increased. While the present staff are very helpful, they seem to be very overworked. Rutgers ability to remain in compliance with federal regulations, to avoid possible future problems, and to better assist faculty and students would be greatly enhanced by another staff member in this area.

• The University should use its influence in Washington, DC to advise and urge the government to adapt its rules, procedures, and guidelines to better take into account the special needs of university research programs in the social sciences.