Protection of Human Subjects in Research
Researchers requesting access to confidential MDPH records are expected to demonstrate compliance with federal human subject regulations (45 CFR Part 46), including review by their sponsoring or affiliated IRB, as a prerequisite to receiving final approval to obtain access to confidential MDPH records for a research project.
Studies Involving Human Subject Contact
For studies involving contact with human subjects identified through MDPH confidential records, contact will be initiated by the Department. Approved researchers will provide selection criteria to the appropriate data registry or program and an initial contact letter inviting participation will be sent by the Department to the selected sample. Researchers will also provide a brief description or study brochure to be included with the initial contact letter. Following the initial contact process, information for individuals who do not decline participation will be provided to the approved researcher to conduct the study.
The following guidelines concern recruitment letters and consent forms for studies involving contact with research subjects. Applicants for authorization for public health research and IRB approval, including access to confidential Department data, should carefully review these guidelines and incorporate the sample language, or its equivalent, below:
The initial recruitment letter should contain the following:
- An explanation of how you got the subject's name and contact information.
Sample language: Your name was obtained from the Massachusetts Department of Public Health, which maintains records of births, deaths, and certain health conditions that are required by law to be reported to the Department. These records are confidential, but by law may be shared with qualified researchers conducting public health research if approved by the Department after a careful review and after the researchers sign strict confidentiality agreements.
- A statement that agreement to participate in the study also means that the subject agrees to allow the Department to share certain information.
Sample language: Your agreement to participate in this study also means that you agree to allow the Massachusetts Department of Public Health to share certain confidential records it maintains about you with the research team.
- A statement that the Department is not conducting or sponsoring the study.
Sample language: The Department is not conducting or sponsoring this study, but has approved the research team to have access to confidential Department records because it believes the study has an important public health purpose to help people in Massachusetts.
No specific consent form or template is required. However, consent forms must clearly describe the study and explain what participation involves. In addition, consent forms should clearly contain, at a minimum, the following:
- A statement that participation is voluntary;
- A statement that declining to participate will not affect a subject's health care benefits or eligibility for services;
- A statement that a subject may withdraw at any time;
- A statement that a subject may choose not to answer any question;
- A statement concerning the risks and benefits to participants if any;
- A statement regarding any compensation that is offered and any conditions for receiving that compensation;
- A statement concerning all of the planned uses of the subject's information and how it will be protected;
- A statement about how long the information will be kept and rights to request that information be destroyed;
- Options for agreeing to the use of personal information for some parts of a study and not others; and
- Specific agreement options for testing of tissue, blood, or urine, including how long samples will be kept, limits on their use, de-identification if an option, and destruction if a person withdraws.
Consent forms should be written at a literacy level appropriate to the subjects to be recruited.
Sample language: You are being asked to take part in a research study. Your participation is voluntary which means you can choose whether or not to participate. Before you make a decision you will need to know the purpose of the study, the possible risks and benefits of being in the study and what you will be asked to do if you decide to participate.
If you do not understand what you are reading, do not sign it. Please ask us to explain anything do you not understand, including any language contained in this form. If you decide to participate, you will be asked to sign this form and a copy will be given to you. Keep this form; in it you will find contact information and answers to questions about the study. You may ask to have this form read to you.