Overview

In compliance with DHSS Policy Memorandum 55, all research projects involving DHSS clients as subjects must be approved by the Human Subjects Review Board (HSRB), regardless of funding source.   This research, and the Board’s activities, are guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, and (b) other appropriate ethical standards recognized by Federal departments and agencies that have adopted the Federal Policy for the Protection of Human Subjects, known as the Common Rule.

In addition, the HSRB is the DHSS Privacy Board, and all research projects coming under the auspices of the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) are reviewed to assure their compliance with the requirements of 45 CFR 160 and 164. 

Research is defined, by federal regulation, as follows:

“Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities."

The information and materials referenced above, and others dealing with the protection of human subjects, can be accessed via the following web sites:

• http://www.hhs.gov/ohrp/

Specific information about HIPAA can be found on the website of the Office of Civil Rights:

• http://www.hhs.gov/ocr/hipaa/

Responsibilities of Researchers

• Training – Anyone seeking to carry out research under the jurisdiction of the HSRB must be trained on these issues and must give high priority to the protection of human subjects and their privacy.  One tutorial that the Board accepts can be found at the following web site: 
  
  phrp.nihtraining.com/users/login.php
  
  Once this is completed, a  "certificate of completion" can be printed out, which needs to be included with the packet provided to the Board.
  
  If the researcher has already completed some other formal training on this subject, the Board will consider substituting it, based on a review of documentation regarding the training that has been taken.   That documentation should be sent as soon as possible to the Board chairperson for review.
• Obtaining cooperation from affected Division(s) – The researcher must obtain the cooperation of the Division whose clients are to be the research subjects.  Project design and methodology need to be approved by the relevant Division Director before an application is submitted to the Board.
• Forms required – The ‘protocol’ describing the project needs to be completed and signed.  Specific instructions pertaining to the form and submission of other required materials can be found with the application form itself (a copy of which can be found on this Intranet site).   Researchers also have to complete and submit an Investigators Agreement (a copy of which can be found on this Intranet site).
• Appearance at Board Meeting -  The researcher or a representative is expected to be present at the meeting when the project is being considered.  Presence via teleconference can be arranged.
• Ongoing interaction with Board – Once a project is approved, the researcher is required to maintain an ongoing relationship with the Board, until the project is completed.   That relationship is spelled out in the “approval letter” that the researcher will receive.  The researcher is required to inform the Board chairperson as soon as possible in the event of unanticipated problems involving risks to subjects or others.  Electronic communication (e-mail and attachments) is the preferred medium, with telephone follow-up, as necessary.
• Protocol Revisions - The researcher is required to report any desired changes in approved research protocols prior to initiating them, except when necessary on a temporary basis to eliminate apparent immediate hazards to the subjects.   Any significant change will require full Board review and approval. Any such revision needs to be incorporated into the written protocol, once approved. This practice ensures that there is only one complete protocol with the revision dates noted on each revised page and the first page of the protocol itself.
• Continuing review and final report – Researchers are required to report to the Board on an annual basis (or more frequently, if warranted by the degree of risk posed by the project or because of a history of problems with the researcher) -- using the Board’s form.  A copy of the standard form can be found on this Intranet site   Occasionally,  modifications are made to the form for specific projects, as needed.  The form that each project is required to use will be supplied to the researcher along with the approval letter.  A final report is also required, using this same report format.  

Responsibilities of Division Whose Clients are Involved in the Research

• Making an initial determination regarding implementation of research – The initial decision to allow research involving a Division’s clients is made at the Division level.  The Director and staff make this decision based on such considerations as the value of the project to them and their clients, the time commitment required from staff and clients, and the resources being made available by the researcher.   The Division must consider any HIPAA-related obligations that would be imposed by the research, such as being able to account for disclosures, and be prepared to do any required recordkeeping.
• Review by Attorney General's Office - If the Division agrees to support the project, it must determine whether feedback from the Division’s Deputy Attorney General is required, regarding any possible legal implications of the project.  Depending on the sensitivity of those implications, the project proposal should not be forwarded to the Board Chairperson until such feedback is received and all issues resolved.

Responsibilities of HSRB

• Initial Screening – When a protocol is received by the Board chairperson, a preliminary review is made, in collaboration with another member of the Board, as to whether the proposed activity qualifies for exemption from the requirements of the Common Rule or HIPAA’s Privacy Rule.  If so, all relevant parties would be notified that no further HSRB involvement is needed.
• Expedited Review – The HSRB does not use expedited review for new projects, even though they might meet Federal criteria for it.  The full Board has elected to review all projects.  In the case of a minor modification to an already-approved project, expedited review might be authorized by the Board.
• Convening the Board – When project materials are received, the Board Chairpersonwill ensure that all needed documents have been received prior to scheduling the project for review at a Board meeting.    Project materials must arrive in sufficient time for them to be distributed to Board members at least two weeks in advance of the meeting date.
• Board meetings -  Meetings are scheduled once a month on a set day for both initial and continuing reviews.  Teleconference or videoconference links are established between Dover and New Castle County, unless it is determined that a face-to-face meeting of the full group is needed.  All materials are distributed to Board members at least two weeks prior to the meeting, either electronically, or by inter-office or US mail.   During the meeting, projects (s) will either be approved as submitted, require modifications, or be disapproved.  There is no appeal if a project is disapproved; however, researchers are free to revise projects and resubmit them.
  
  For projects which are approved, the determination is made during the meeting as to whether the required continuing review needs to take place more frequently than once a year and whether the project will need subsequent verification from sources other than the researcher that no material changes have occurred since the previous Board review.  Decisions on these matters are based on such criteria as whether the project poses a significantly high risk to participants or if there has been negative prior experience with the researcher.  Minutes are taken to document all Board decisions.
• Notification of Board decision – The Board chairperson is responsible for notifying the DHSS Cabinet Secretary, who has final sign-off authority for DHSS.  The Secretary is not authorized to approve a project that the Board has rejected but can reject a project for reasons unrelated to the protection of human subjects.  Such rejection is subject to reconsideration.   Once the Secretary makes his/her decision regarding approval, the Board chairperson will inform the researcher in writing. 
• Steps taken to ensure that investigators do not implement any protocol changes without prior Board review and approval – The notification letter specifies that no changes are to be made prior to Board review and approval, except when necessary to eliminate apparent immediate hazards to subjects.  This is also something addressed through the training that all researchers are required to take.
• Ongoing interaction with researchers – Researchers are required to notify the HSRB chairperson immediately if unanticipated problems involving risks to subjects or others occur, as described above under “Responsibilities of Researcher.” The Board has the authority to withdraw approval and terminate a project, if appropriate safeguards to protect client rights are not being adhered to.  As with the initial approval process, the researcher can develop and submit revised procedures to avoid project termination.  Also, as specified above, researchers must notify the Board chairperson of any plan to modify the project.
• Notification of violations – The Board chairperson is responsible for promptly informing the DHSS Cabinet Secretary and the federal Office of Human Research Protection (when a federally-funded project is involved) in writing of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of Board approval.

HIPAA-Specific Policies

“Minimum Necessary” rule -   Researcher requests for access to protected health information will be reviewed to ensure that approval is given to release only such information which is reasonably necessary to accomplish the purpose(s) for which the request is being made.

Access to protected health information under HIPAA’s “preparatory to research” provisions –  The HIPAA regulations give institutions the authority to allow external researchers to view client/patient/consumer files that contain protected health information if a request is made to do so and if the external researcher meets certain conditions – such as not removing the protected health information from the premises.  However, DHSS has a more restrictive policy toward disclosures of this kind and will not permit external researchers to have such access unless warranted by the nature of the research and unless all other possible ways of accessing the information have been exhausted. 

Board Membership/Policies

Board members are appointed for two-year terms, with no term limitations.  All Board members are required to go through the training modules found at the following site:  phrp.nihtraining.com/users/login.php

In accordance with federal regulations, no Board member may participate in the initial or continuing review of a project in which the member has a personal financial conflict of interest, except to provide information requested by the Board.  Such members will absent themselves from the meeting room after providing requested information, for the remainder of   the discussion and vote on the project.

The Board Chairperson can be contacted via Planning and Quality Control.