DHHS collects a variety of non-public data about the services and programs we oversee and the populations we serve. This data often contains confidential consumer information that is subject to HIPAA or other confidentiality laws, rules and regulations. DHHS understands that this data can provide valuable insights for those conducting institutional or academic research. To balance its legal requirements with its interest in supporting beneficial research efforts, DHHS has established a process for reviewing research requests to ensure that the privacy of consumer information is protected, and this data is utilized to benefit the public.
Maine DHHS adopts the Federal Office of Human Research Protections (the Common Rule) definition of “research”, which is, “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
If you are requesting non-public data sets for research purposes, as defined above, you must submit a data request through the DHHS Research Data Request Process outlined below. A Business Associate Agreement, Memorandum of Agreement or Understanding, letter of support, telephone call, or general email exchange are not sufficient foundation for DHHS to disclose confidential consumer information for research purposes.
If there are any questions regarding this process or research issues generally, please contact the Human Protections Administrator, Stacey Mondschein Katz, at Stacey.mondschein@maine.gov or 207-287-3707.
How to Submit a DHHS Research Data Request
Please make your request by completing and submitting the DHHS Research Data Request Form to the appropriate DHHS Office.
Note: If the request is for Maine Integrated Youth Health Survey (MIYHS) data, you must first contact the University of Southern Maine IRB.
DHHS Research Data Request Review Process
- When a research data request form is submitted, leadership in the requested DHHS Office will review and determine whether it wishes to participate in or provide consumer information for this research. Participation is not mandatory.
- If the DHHS Office or facility does not wish to participate, you, the requestor, will be informed.
- If the Office or facility does wish to participate and provide data, you will be asked to submit:
- Your research protocol (information about the study and protection of the proposed data);
- Any determination from your own IRB; and
- Any other documentation you would like us to consider.
- The request, protocol, and IRB approval/determination, where applicable, will be entered into DHHS' Research SharePoint system by office staff with appropriate permissions. The information will also be shared with the University of Southern Maine (USM) IRB, which is DHHS’ IRB of record.
- The USM IRB will respond with a determination, such as approval/disapproval of the submitted protocol, or with acceptance/rejection of the prior IRB's determination.
- If there is uncertainty about whether a request for the DHHS’s consumer information meets DHHS' definition of “research” (as defined above), the USM IRB also will make that determination upon request of the Department.
- If the USM IRB determines that a request for consumer information is part of a human subject research process, then the requester/researcher/investigator must seek IRB approval, either via USM or another venue.
- If the matter includes HIPAA-covered protected health information, either research subject authorization(s) or a HIPAA waiver of authorization must be obtained from a HIPAA Privacy Board. The USM IRB acts as DHHS' HIPAA Privacy Board, and information can be found on the University of Maine System HIPAA Policies & Forms page.
- If the IRB approves the research, accepts an outside IRB's determination, or determines that DHHS is not engaged in research, the requested information may be shared with the investigator/researcher after a Data Sharing and Protection Agreement is signed by the researcher and DHHS leadership.