700.009:  Research Involving Controlled Substances

Research projects and studies covered by M.G.L. c. 94C, § 8 shall be carried out in accordance with the regulations of the Commissioner.

(A)   Persons Covered.  No person, unless he supplies the Commissioner and the Commissioner of Mental Health (a) with satisfactory evidence of compliance with any applicable Federal law, and (b) with a protocol describing the research project, or study involving:

(1)    Any narcotic drug in Schedule II or

(2)    The investigational use on human beings of any new drug defined in § 201(p) of the Federal Food, Drug and Cosmetics Act, as amended.

(B)   Information to be Submitted.  The person immediately responsible for a research project or study covered by M.G.L. c. 94C, § 8, before commencing any such research project or study shall submit to the commissioner and to the Commissioner of Mental Health:

(1)    Satisfactory evidence of compliance with any applicable Federal law, as described in 105 CMR 700.009(C), and

(2)    A proposed written “Statement of Informed Consent”, and

(3)    A statement of “Assurance of Compliance” with the requirements for the protection of human research subjects by an Institutional Review Committee, pursuant to 105 CMR 700.900(F) and 700.009(G), and

(4)    A protocol describing the research project or study to be undertaken if the Commissioner so requires, and

(5)    Such further information as the Commissioner, in his discretion many require.

(C)   Evidence of compliance with Applicable Federal Law.  Satisfactory evidence or compliance with applicable Federal Law shall consist of:

(1)    Any of the following which are required by the Federal Food and Drug Administration:

(a)    Notice of Claimed Investigational Exemption for a New Drug (Form FD 1571); and

(b)    Statement of Investigator (Clinical Pharmacology) (Form 1572); and

(c)    Statement of Investigator (FD 1573); and

(2)    A copy of the Bureau Registration of each person required to be registered by the Bureau.

(D)   Protection of Human Subjects.  No person shall undertake any research project or study covered by M.G.L. c. 94C, § 8 unless:

(1)      The rights and welfare of all human subjects are adequately protected, and

(2)      The risks to any human subject are outweighed by the potential benefits to him or by the potential benefits to mankind, and

(3)      Every human subject has given his written “Statement of Informed Consent”, by signing a written statement describing:

(a)    The nature, duration and purpose of the investigation, and

(b)      The method and means by which the investigation is to be conducted, and

(c)       All inconveniences, hazards, discomforts, and risks reasonably to be expected, and

(d)      The effects upon the subject’s health or person which may reasonably be expected to come from his participation, and

(e)       A description of the controlled substances and other substances to be used, and their anticipated effects, side effects and interactions, and

(f)        An identification of those procedures which are experimental, and

(g)       A description of the benefits to be expected, and

(h)       A disclosure of appropriate alternative procedures which would be advantageous to the subject, and

(i)        An offer to answer any inquiries concerning the procedures, and

(j)        An instruction that the subject is free to withdraw his consent and to discontinue participation in the project or activity at any time.

(E)     Statement of Informed Consent.  Every written “Statement of Informed Consent” shall:

(1)      Contain no exculpatory language, through with the subject is made to waive or appear to waive any of his legal rights or release an institution or its agents from liability or negligence,

(2)      Contain a statement from the subject to sign, that:

(a)       He has read the “Statement of Informed Consent”, and

(b)      He understands the “Statement of Informed Consent” and the attendant risks described, and

(c)       He understands he may terminate his consent at any time, and

(d)      He voluntarily consents to be a research subject in the described project.

(3)      Be obtained from the subject himself unless he is legally incompetent, in which case it may be obtained in writing from his legal representative, and

(4)      Not obtained in any event from a minor who refuses his consent.

(F)      Assurance by Institutional Review Committee.  No person shall undertake any research project unless an Institutional Review Committee:

(1)      By majority vote with the record of the number in favor and the number opposed recorded, and by the signature of an authorized representative signifies its approval of:

(a)       The protocol; and

(b)      The “Statement of Informed Consent”; and

(2)      Describes how it will monitor the person immediately responsible for the research project, including how and when such person will be required to:

(a)       Submit written reports or

(b)      Appear for interviews or

(c)       Be visited by the Institutional Review Committee or its representatives, and

(3)      Describes how it will notify the Commissioner regarding any:

(a)       Proposed changes or

(b)      Emergent problems, including significant hazards, contraindications and side effects.

(G)    Institutional Review Committee.

(1)      The Institutional Review Committee:

(a)       May be an existing body, or

(b)      May be specially constituted to review a research project.

(2)      The Institutional Review Committee:

(a)       Must exist in affiliation with the Department or the Department of Mental Health, or with a hospital licensed or maintained by the Department or the Department of Mental Health or the Commonwealth; and,

(b)      Must be composed of at least five members with sufficiently varying backgrounds to assure complete and adequate review of any research project; and,

(c)       Must include persons other than health professionals who have no business nor professional connection with such agency or hospital as not less than 1/3 of its members; and,

(d)      Must include documentation to identify the committee members by name, occupation or position, and by indications of experience and competence in areas pertinent to the areas of review.

(3)      No member of such committee shall be involved in either the initial or continuing review of an activity in which he has a professional responsibility, except to provide information requested by the committee.

(H)    Protocol.

(1)      The protocol shall describe:

(a)       The identification and qualifications of the person in charge of the research project, and

(b)      The objectives of the research project or study, and

(c)       The procedures to be used, including:

1.           the pertinent diagnostic classification or a description of the symptom or symptom characteristics, of the human research subject under investigation with a statement as to their general health status; and

2.           The age range of the research subjects and whether one sex or both sexes will be used; and

3.           Each specific controlled and any other substance which has not been approved by the Federal Food and Drug Administration for safety and effectiveness for use on humans to be used in the study;  the forms in which the substances are supplied;  and the methods by which the substances are to be administered or dispensed; and

4.           the dosage range of each substance to be dispensed or administered, by either describing the specific dosage units, or the rate of administration, or the daily dosage regimens and the maximum period for which it will be dispensed or administered; and

5.           The overall research design model to be employed; and

(d)      The institutions or places where the project will be conducted or from which the substances will be dispensed or administered, and

(e)       The projected period of time to complete the study, and

(f)        The procedures to be used to ensure the security of the controlled substances; and

(g)       Any other pertinent data or clarification which the Commissioner in his judgment may require or request.

(I)        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 his 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.

(J)     Request to Inspect Protocol.  If a request is made to inspect and/or release one of the protocols on file with the Department, the Department shall promptly notify the researcher and the pharmaceutical company(ies) sponsoring the clinical trial of the request, by telephone and followed up by written notification by certified mail.  Such notification shall not include the identity of the person requesting inspection 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 completing commercial interest.  In the case of a general request for inspection involving more than a specified researcher, protocol, drug or pharmaceutical company, and association representing pharmaceutical manufacturers and/or researchers may be notified in lieu of individual researchers and pharmaceutical manufacturers.  Notification shall be at least eight calendar days prior to inspection.