14- 472 C.M.R. ch. 1, § A-XI

Current through 2024-51, December 18, 2024

Section 472-1-A-XI - PROTECTION DURING EXPERIMENTATION AND RESEARCH

A. Recipients have the right to refuse to participate in experimentation and research without loss of services.

B. All participation in experimentation and research shall be voluntary with full written informed consent, except as provided in these rules.

C. A recipient's refusal to participate in a research project or an experimental activity shall not be cause for denying the provision of indicated services to that recipient.

D. Definitions

(1) Experimentation and research

a. Experimentation and research means the use of any medical, behavioral, or environmental intervention involving practices not commonly accepted by the discipline involved, or the systematic accumulation and codification of data designed to develop or contribute to general knowledge.

b. Experimental drug use means:

i. the use of any Food and Drug Administration non-approved drug.

(2) Informed consent means the agreement obtained from a subject, or from his or her authorized representative, to participate in an activity. Informed consent requires that subjects understand the purpose, benefits and risks of research in which they are asked to participate and are given the opportunity to consent to, reject, or withdraw from participation without penalty.

(3) Minimal risk means that the risk of harm anticipated in the proposed research or experimentation is not greater, considering probability and magnitude, than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tasks.

(4) Board means the Research and Experimentation Review Board.

E. Research and Experimentation Review Board Membership

(1)

A. Research and Experimentation Review Board, selected by the administrative head of the particular facility or agency, shall have at least five members with varying backgrounds, in order to promote complete and adequate review of research and experimental activities proposed for consideration.

(2) The Board shall be sufficiently qualified, through the experience and expertise of its members and the diversity of the members' backgrounds, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects.

(3) In addition to possessing the professional competence necessary to review such activities, the Board shall be able to ascertain the acceptability of proposed research or experimentation in terms of institutional commitments, regulations, applicable law, and standards of professional conduct and practice.

(4) The Board shall consist of interdisciplinary members of both sexes including at least one member whose primary concerns are in non-scientific areas, such as law, ethics or theology, and at least one member who is not otherwise affiliated with the institution or agency proposing the research or experimentation.

(5) No Board member may participate in the Board's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the Board.

(6) At the Board's discretion, individuals with competence in special areas may be invited to assist in the review of complex issues which require expertise beyond or in addition to that available on the Board. These individuals may not vote.

F. General Procedures

(1) All experimentation and research shall commence only after review and approval by the Research and Experimentation Review Board.

(2) The Research and Experimentation Review Board shall have the authority to approve, require modifications in, or disapprove, any proposed research or experimentation activities.

(3) The Rights Protection or Advocacy Agency of the Maine mental health system shall be informed of any proposed experimentation or research involving more than minimal risk.

(4) The Board shall maintain adequate documentation of its activities.

(5) The Board shall provide written notification of its approval or disapproval of the proposed research or experimentation activity or of any modifications required to secure research and experimentation review board approval of any activity in question.

(6) If the Board decides to disapprove a research or experimentation activity, it shall include, in its written notification, a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(7) Investigators and others directly involved in the research or experimentation shall, both in obtaining the consent and in conducting research, adhere to the ethical and research standards of their respective professions concerning the conduct of research or experimentation and to the regulations for research involving human subjects required by the U.S. Department of Health and Human Services in effect at the time of the adoption of these rules.

(8) Researchers must report substantial changes or unanticipated problems immediately to the Chairperson of the Board.

(9) The Board shall conduct continuing review of research covered by these regulations at intervals appropriate to the degree of risk, but not less than once a year, and shah have authority, to observe or have a third party observe the consent process and research.

(10) The Board shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with the Board's requirements, these rules, or that has been associated with unexpected harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the Board's action and shall be reported promptly to the investigator, appropriate institutional officials, and the secretary of the Department of Health and Human Services as required by federal regulations.

(11) Upon completion of the research and/or experimentation procedures the principal investigator shall attempt to remove any confusion, stress, physical discomfort, or other harmful consequences that may have been inadvertently produced as a result of the research or experimentation procedures.

G. Criteria for Board Approval of Research and Experimentation. In order to approve research covered by these regulations the Board shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized by using procedures which are consistent with sound research or experimentation design and which do not unnecessarily expose subjects to risk and, wherever appropriate, by using procedures already, being performed on the subject for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relationship to anticipated benefits to subjects. In evaluating risks and benefits, the Board shall consider only those risks and benefits that may result from the research and experimentation, as distinguished from the risks and benefits of therapy these subjects would receive in not participating in the research, or possible long-range benefits of applying knowledge gained in the research.

(3) Selection of subjects is equitable, taking into account the purposes of the research and the setting in which the research will be conducted.

(4) Informed consent will be sought and appropriately documented in accordance with these rules.

(5) The research or experimentation plan makes adequate provisions for monitoring the data collected or the activities allowed to ensure the safety of the subjects.

(6) There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(7) Where some or all of the subjects are likely to be vulnerable to coercion or undue influence, appropriate additional safeguards have been included in the project to protect the rights and welfare of these subjects.

H. Special Procedures; Exceptions to Informed Consent

(1) Research Involving the Need for Non-disclosure

a. If the research or experimentation methodology requires that the purpose, nature, expected outcome and/or implications of the research not be disclosed to the participants before it begins, the researcher shall clearly and vigorously justify to the Research and Experimentation Review Board the need for non-disclosure.

b. The Board may approve research or experimentation procedures which do not include, or which alter, some or all of the elements of informed consent set forth in these rules, or waive the requirements to obtain informed consent provided the Board finds and documents that:

i. the research involves no more than minimal risks to the subjects;

ii. the waiver or alteration will not adversely affect the rights and welfare of the subjects;

iii. the research or experimentation could not practicably be carried out without the waiver or alteration; and,

iv. whenever appropriate, the subjects will be provided with full disclosure or additional pertinent information after the research or experimentation project is completed.

(2) Research Involving Archival Review, Statistical Compilation or Record Review.

a. Research which is limited to archival review, statistical compilation or record review may be carried out pursuant to Title 34, M.R.S.A. §1207(2). Such research may be carried out without informed consent provided that:

i. said research is reviewed and approved by a Research and Experimentation Review Board;

ii. all data involved in said research shall not be identifiable as to individual recipients of services;

iii. the research plan shall be submitted to, and approved by, the head of the mental health facility or his or her designee.

(3) Research Involving Minors, Persons Unable to Give Informed Consent, and Involuntary Recipients.

a. No experimentation or research involving more than minimal risks shall be conducted with persons unable to give informed consent, minors, or involuntary patients unless:

i. the experimentation or research poses a clearly expected benefit to the individual recipient involved; and,

ii. the experimentation or research has been reviewed and approved by the Research and Experimentation Review Board.

b. Notwithstanding the provisions of sections A.XI.H.1. and A.XI.H.2, in the case of recipients under the age of 18 and in the case of recipients adjudicated incapacitated, consent must in all instances be obtained from the recipient's legally responsible parents, guardians or custodians, and such consent must be reviewed by the Rights Protection and Advocacy Services of the state mental health system.

c. In the case of minor recipients over the age of 12, informed consent must also be obtained from the prospective recipient participant, except as described in sections AXI.H.1. and A.XI.H.2. This provision does not change the provision in section A.XI.H.3.b. requiring the consent of the legally responsible parents, guardians or custodians.

(4) Any use of drugs approved by the Food and Drug Administration, when applied in an unlabeled manner, shall receive prior approval from the Clinical Director or equivalent.

I. Applicability

(1) Questions regarding the applicability of this section to specific recipients or activities shall be referred in writing to the Chairperson of the Research & Experimentation Board who shall determine applicability.

(2) Where disagreement continues to exist, questions may be presented through the Grievance Procedure, Section VI.

(3) In issues regarding professional standards, referral of the question may be made to the appropriate national professional standards committee whose decision shall be final and binding.

14- 472 C.M.R. ch. 1, § A-XI