Massachusetts law, M.G.L. c.111L, "Biotechnology", requires any institution that conducts human embryonic stem cell research in Massachusetts to obtain a Certificate of Registration from the Department of Public Health. Each corporation, association, partnership, nonprofit organization or other legal entity that plans to conduct or is currently conducting human embryonic stem cell research authorized by Chapter 111L must submit an application and fee to the Department. No institution may conduct such research after November 27, 2005 unless it has a valid Certificate of Registration.
Institutions must obtain a Certificate of Registration to conduct:
- Research involving the use of existing human embryonic stem cells; and
- Research involving the derivation of human embryonic stem cells.
Institutions must provide with the Application for Certificate of Registration, documentation demonstrating that the institution has an Institutional Review Board which will review the Institution's research to the extent required by M.G..L. c.111L, s.3(b). This can be demonstrated by providing:
- A copy of the Institution's Federalwide Assurance (OMB No. 09990-0278);
- A copy of the contract between the Institution and a Private or Public Institutional Review Board; or
- Other documentation demonstrating that the Institution has an Institutional Review Board.
An Institutional Review Board is defined, pursuant to M. G.L. c. 111L, s.2 as "a board that has a minimum of 5 members who meet regularly to review research applying the standards of 45 CFR Part 46 or 21 Parts 50 and 56, as may be amended from time to time".
An application form is listed below, which includes instructions on how to complete and return it. The Department will issue a Certificate within thirty days (30) of receipt of the application, provided that the application is complete and the applicant meets the requirements for a Certificate of Registration. The Certificate will be valid for three (3) years from date of issuance. The Department will notify all holders of Certificates at least sixty (60) days before expiration of the Certificate of the need to renew.
If you have any questions about applying for a Certificate of Registration, please feel free to contact Sheila Faiella, Financial Manager, at 617-753-8000.
This information is provided by the Division of Health Care Facility Licensure and Certification within the Department of Public Health.