1. Introduction

   When clients served by the Delaware Department of Health and Social Services are asked to function as subjects of research or when access is being sought to protected health information, the rights and privacy of those individuals must be protected. A formal process can provide the mechanism to ensure that such is the case. Further, certain Federal grants can only be awarded to the Department if a process has been followed to assure that client rights are being adequately protected. In addition, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) places specific responsibilities upon the Department to protect our clients' privacy.

2. Purpose

   The purpose of this policy is to establish a Human Subjects Review Board/Privacy Board (HSRB) that will ensure that the rights of Departmental clients are protected when any research is conducted using such clients as subjects and that protected health information is handled appropriately when access to it is requested for research purposes.

3. Scope

   This policy applies to all Divisions within the Department and their facilities, bureaus, offices and other administrative entities in addition to all Department contractors.

4. Composition of HSRB and Term of Service

   A Board, composed of at least thirteen members and appointed by the Secretary of the Department, will serve for two-year terms. The following Divisions will have one representative on the Board, as designated by the Division Director: Services for Aging and Adults with Physical Disabilities; Substance Abuse and Mental Health; Developmental Disabilities Services; Social Services; Visually Impaired; and Medicaid and Medical Assistance. The following Divisions will have two representatives, as designated by the Division Director: Management Services (one being designated to serve as Chairperson of the Board); and Public Health.

   In addition, at least three members of the Board will be persons not on the staff of the Department. These members will be drawn from such areas as law, philosophy, ethics, health care, social services, prisoner advocacy and education. For the initial term, half of the members will serve for one year to create a staggered membership. By the second year, all members will have two-year terms.

5. Applicable Projects

   All research involving Department clients as subjects and all protected health information is covered by this policy.

6. Applicable Federal Regulations

   The HSRB was designed to be compatible with the provisions of Federal regulations dealing with the protection of human subjects (45 CFR 46) and the regulations governing the use and disclosure of protected health information for research purposes (45 CFR 164). Any revisions to those regulations will be followed by changes in this policy to bring the Department's Board into compliance. This Board will function as the Privacy Board, as mandated under HIPAA.

7. Divisions' Responsibilities

   Researchers, through their Division Directors, are responsible for submitting projects in compliance with this policy before such projects are begun. They are also responsible for providing all information that the HSRB requires to conduct its review and periodic re-reviews and for cooperating with the Division charged with monitoring responsibilities.

8. Responsibilities of the Division of Management Services

   The Division of Management Services (DMS) will provide administrative support to the HSRB and ensure that appropriate procedures are in place to implement this policy memorandum. DMS staff will determine whether proposed projects meet Federally defined exemption criteria, as specified in 45 CFR 46 and 45 CFR 164. For those projects requiring HSRB review, DMS will arrange for the Board to conduct its review. DMS will handle all details such as notifying researchers of the HSRB decision and notifying the Federal government, if applicable. The Secretary of the Department will also be notified of each decision. Once a project has begun, DMS has the responsibility for ongoing monitoring.

9. Authority of the HSRB

   The HSRB has the full authority to approve or deny a project. If the procedures proposed do not adequately protect client rights, the decision of the HSRB to deny approval is final. Before such denial is issued, researchers will have the opportunity to develop revised procedures and present them to the Board. After a project has been approved, the HSRB will conduct periodic re-reviews; if appropriate safeguards to protect client rights are not being adhered to, the Board has the authority to withdraw approval and terminate the project. As with the initial approval process, the researcher will have the opportunity to negotiate with the Board and develop revised procedures to avoid project termination.

10. Periodic Evaluation

    After its first full year of operation and on a periodic basis thereafter, this policy will be subjected to evaluation so that any needed modifications can be made.

11. Implementation

    This policy shall become effective as of the date of signature.

Vincent P. Meconi 9/13/05
Vincent P. Meconi, Secretary  Date

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