Research Involving Controlled Substances

105 CMR 700.009 applies to the safety and security of research drugs for research projects or studies which have federal approval to proceed. (A) Persons Covered. No person shall carry out any research projects or studies involving any research drug unless the researcher or the research project applies to the Commissioner for registration. In the case of research involving an investigational new drug, as defined in 21 CFR 312.3, the researcher shall be the principal investigator, as required therein. Applicants shall supply the Commissioner with: (1) satisfactory evidence of compliance with any applicable Federal law; and (2) such information regarding the research project as the Commissioner requires, including a list of all research drugs and other controlled substances involved in the research project. (B) Information to Be Submitted. The application by a person for a registration to work with research drugs, as authorized by M.G.L. c. 94C, § 8, shall be submitted on a form provided or approved by the Commissioner. The Commissioner may, in their judgment, require additional information. Multiple research projects or studies of the same category may be included in a single application, provided all required information is included for each study or project. (C) Evidence of Compliance with Applicable Federal Law. Satisfactory evidence of compliance with applicable federal law shall consist of: (1) Any of the following which are required by the Federal Food and Drug Administration: (a) New Drug Application (Form FD 1571); and (b) Statement of Investigator (Clinical Pharmacology) (Form FD 1572). (2) The DEA registration of each person required to be registered by the DEA. (D) Requirement of Confidentiality. Records maintained by researchers, including every "Statement of Informed Consent", shall be closed to the public, and shall not be used in the criminal prosecution of any research subject in connection with their participation as a research subject, nor shall they be admissible in evidence against any such research subject in connection with such participation in any criminal, civil, legislative or administrative proceeding. (E) Request for Accesss to Protocol. If the Department receives a request for access to one or more protocols on file with the Department, the Department shall promptly notify the researcher or research program and the pharmaceutical company(nies) sponsoring the clinical trial of the request, by telephone and followed up bywritten notification by certified mail. Such notification shall not include the identity of the person requesting access unless otherwise required by law, but may, in the discretion of the Department, include any known connection of the requesting party to organizations or entities with a competing commercial interest. In the case of a general request for access involving more than a specified researcher, protocol, drug or pharmaceutical company, and association representing pharmaceutical manufacturers and/or researchers maybe notified in lieu of individuals and pharmaceutical manufacturers. Notification shall be gives prior to providing the requested access.