1982-1983





                                 SENATE DOCUMENT #38



                                    EC DOCUMENT #2



              POLICIES FOR THE PROTECTION OF HUMAN SUBJECTS IN RESEARCH

                   AT THE UNIVERSITY OF NORTH CAROLINA AT ASHEVILLE







           PURPOSE



           This document implements the University policy which directs

           that all human research projects conducted under the auspices of

           the University are subject to review, toward the end of insuring

           protection of the rights and welfare of the individuals who

           participate as subjects.  This document does not constrain the

           continuation or adoption of review procedures at the

           departmental level.



           POLICY



           For the purpose of reviewing research for the protection of

           human subjects, research at UNC-Asheville shall be divided into

           two categories:



           (A)  research explicitly contracted through federal or state

                funds, and



           (B)  research not involving such contracts.  This category

                includes research conducted by students for instructional

                purposes.



           The review of research in these categories requires two

           evaluation processes:



           (1)  Research in category A shall be evaluated by the

                Institutional Review Committee, using the Department of

                Health and Human Services (DHHS) guidelines to determine

                whether or not the proposed research provides the necessary

                protections to human subjects.



           (2)  Research in category B only requires review at the

                departmental level, except in certain instances (see

                below).  The following policies shall be established 

                regarding evaluation of research in category B:



                (a) The various academic departments are charged with

                    developing mechanisms for the evaluation of research

                    involving human subjects by students and/or faculty

                    in those departments.


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                (b) Each department shall submit to the Institutional

                    Review Committee a copy of its review process, 

                    including any guideline statements on human subjects

                    research adopted by the discipline's national 

                    association and a sample of the forms used for

                    departmental review.  To be approved by the

                    Institutional Review Committee, the departmental

                    review process must provide the same protections to

                    human subjects afforded by the DHHS policy.



                (c) Any academic department that does not wish to create

                    such a mechanism for review shall automatically have

                    its research reviewed by the Institutional Review

                    Committee.



                (d) A copy of each research proposal approved at the

                    departmental level shall be forwarded to the

                    Institutional Review Committee for information

                    purposes and will be kept on permanent file.



                (e) Any student or faculty researcher(s) who desire review

                    at the institutional level may submit his proposal

                    directly to that committee for review.  If approved

                    by that committee, a signed copy of the approved

                    proposal shall be forwarded to the departmental

                    committee and retained in its permanent files.



                (f) Any departmental review committee may request review

                    at the institutional level for a research proposal if

                    its members judge that such a review is appropriate. 

                    If approved by the Institutional Review Committee, a

                    signed copy of the approved proposal shall be forwarded

                    to the departmental committee and retained in its

                    files.





           APPEALS PROCESS



           The appeals process for research not approved by either the

           Institutional or Department Review Committees shall be divided

           into two categories:



           (A)  research not approved that is explicitly contracted through

                federal or state funds and, therefore, reviewed by the

                Institutional Review Committee, and,



           (B)  research not approved that does not involve such contracts

                and, therefore, is reviewed by the Department Review

                Committee.


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           The appeal of research not approved in these categories requires

           two appeal processes:



           (1)  Research in category A should be resubmitted with

                modifications suggested by the Institutional Review

                Committee. 



                Should repeated resubmissions to the Instititional Review

                Committee not be approved, the decision may be appealed to 

                the Faculty Grievance Committee.  The procedures for

                submission of a grievance, as outlined in the Faculty

                Handbook, must be followed.



           (2)  Research in category B should be resubmitted with

                modifications suggested by the department review.



                Should repeated resubmissions to the department review

                not be approved, the decision may be appealed to the

                Institutional Review Committee.



           INSTITUTIONAL REVIEW COMMITTEE MEMBERSHIP



           The members of the Institutional Review Committee will be

           nominated by the University Research Council and approved by the

           Chancellor.  The Review Committee shall be composed of the

           Director of Institutional Research and five faculty members,

           three of whom will be experienced in human subjects research.

           Only one member may come from any subject matter department.

           The Assistant to the Director of University Relations, Grants

           and Contracts will be non-voting members of the Institutional

           Review Committee.