POLICIES and PROCEDURES MANUAL Page 1 of 2

HEALTHEAST POLICY #: 111.B-23 POLICIES AND PROCEDURES MANUAL Page 1 of 2

POLICY TITLE: RESEARCH PROJECT APPROVAL PROCESS

PURPOSE:

It is in the best interests of HealthEast that its employees and admitting physicians engage in research that involves the use of HealthEast’s facilities, resources, staff and other assets. It also is in the best interests of HealthEast that it receive and accept gifts and grants which are earmarked for research. However, in order to comply with applicable statutes, rules and regulations, to insure that the mission of HealthEast is properly fulfilled, and to ensure that research is conducted according to HealthEast criteria and guidelines, employees may not participate in research activities, and may not solicit, accept, or make gifts, or grants which are earmarked for research or allow HealthEast’s facilities, staff, resources or assets to be used for research activities, except in accordance with: (I) the policies and procedures set forth herein; (ii) the policies and procedures of the Institutional Review Board, if applicable; and (iii) applicable statutes, rules and regulations. The HealthEast research approval policy ensures that necessary documentation is collected regarding proposed research projects, including principal investigator(s), the soundness of the research design and protocol, the need for Institutional Review Board (IRB) approval, budget, time line, impact on HealthEast facilities/resources/staff/assets, to ensure that proposed research meets the requirements of established HealthEast criteria, guidelines, policies and procedures.

PROCEDURE:

All research proposed involving HealthEast facilities, resources, staff, or assets is subject to this review and approval process. Investigators will complete the "HealthEast Research Proposal Review Form,” and a “HealthEast Financial Disclosure Form.” These forms contain the information necessary for initiation of a research project. The completed "HealthEast Research Proposal Review Form" and the “HealthEast Financial Disclosure Form” will be sent to the System Director for Research for initial review. POLICY #: 111.B-23 Page 2 of 2 The System Director for Research will ensure: 1. that the information gathered on the forms is accurate and complete; 2. that the research protocol and patient informed consent documentation is reviewed and approved by the HealthEast Institutional Review Board (IRB) if needed; 3. that the research protocol is reviewed and recommendations for approval/disapproval are made by the appropriate executive and management staff of any HealthEast department(s) involved in the implementation of the research, and by any other HealthEast staff as appropriate. Once the project has completed the above review process the System Director for Research and the Vice President of Medical Affairs will provide written notice of final approval to the principal investigator for the research project. Final approval will be given with consideration of: 1. The recommendations of the reviewers; 2. The advice and counsel of the HealthEast Research Advisory Committee when there is uncertainty regarding whether the project meets the approved criteria and guidelines for research established by that committee; 3. The HealthEast Medical Research Institute’s research project approval process policy specifically for research conducted in HealthEast Clinics; and 4. The advice of legal counsel when there is uncertainty as to whether the proposed research qualifies as tax-exempt research, or whether proposed research agreements and contracts are properly written and executed. Once final approval has been given, the project will be initiated under the direction of the HealthEast System Director for Research.

Effective Date: April 1, 1997

Authorized By: [signed by Timothy H. Hanson]

Source/Submitted By: System Director for Research

Date of Review/Revision:

Unit and Department Distribution List: All HealthEast Facilities and Staff