Consent Procedures

(1) The consent procedure set out in 115 CMR 10.07 is applicable to all research. The content of the written consent form and the manner in which such consent will be sought shall be part of the Committee's review of the research proposal. (2) The consent formmust be written in language understandable to the participant and the guardian, if applicable. The form may not include any waiver of a participant's rights or any exculpatory language absolving the investigator, the sponsor, the Department, the program or their agents from liability for research-related injury. The form must provide the following information to each prospective participant and their guardian, if applicable: (a) a statement that the study involves research, what is expected of the participant, with a full explanation of the purposes and objectives of the research; (b) the basis for selection of the participant and the expected duration of the individual's participation; (c) a description of the procedures to be followed and the identification of any procedures which are experimental; (d) a description of any reasonably foreseeable risks or discomforts to the participant, their expected severity and duration; (e) a description of any benefits to the participant or others which may reasonably be expected from the research; (f) a statement describing how confidentiality of records and privacy of participants will be maintained; (g) a descriptionofanyappropriate alternative procedures or courses of treatment that could be used in lieu of the experimental procedure, or if there is no alternative procedure; (h) an offer to answer any questions concerning the procedures and the participant's rights and a statement of whom to contact and how for further information; (i) a statement that participation is voluntary and the individual shall be informed, bothverbally and in writing, that he or she is free to withhold consent or to withdraw consent and to discontinue participation in the research at any time without penalty or loss of benefits, services or supports which the individual is otherwise receiving; (j) if the prospective participant is an individual receiving services provided or purchased by the Department or a family member of such an individual, a statement that the provision of such services to the individualdo not depend on participation by the individual or family member in the research; (k) where applicable, a description of any controlled substance as defined in the Massachusetts Department of Public Health regulations implementing M.G.L. c. 94, and any other substances to be used, and their anticipated effects, side effects and interactions. The description must be in language understandable to the prospective participant or guardian. (3) A copy of the consent form, as approved by the Committee, must be given to each participant and his or her guardian, if applicable. The Committee may require a witness to be present at the time consent is sought, unless 115 CMR 10.08(2): Additional Requirements, applies. (4) Notwithstanding the consent of the guardian, an individual's participation in a researchprojectmust cease if the individual objects, by verbal or nonverbal means, to participation. (5) The Committee may approve a modified consent form, but only if it finds and documents that all of the conditions listed in 115 CMR 10.07(5)(a) through (c) are met. (a) The proposed research involves no more than minimalrisk of social, psychological, or physical harm to the participant; (b) A full explanation of the purpose(s) or objective(s) of the research before its completion would compromise or invalidate the study; (c) The consent form provides the following information to each prospective participant and their guardian, if applicable: 1. a statement that the study involves research; 2. a general description of the nature of the research; 3. a statement that some aspects of the research purpose(s) or objectives are being withheld from the participant; 4. a statement that after the individual's participation in the research, the participant will be provided a written full explanation of the research purpose(s) and objective(s); 5. a statement that the individual agrees to participate in the research in the absence of a full explanation of the purpose(s) and objective(s) of the research study. (6) The consent procedures described in 115 CMR 10.07(1) through 10.07(5) do not apply to a researchproject involving access to private information, but only if the Committee finds anddocuments that: (a) the research consists of the study of historical records, and the researcher presents plans to protect the confidentiality of the information and to preclude the identification of particular individuals; or, (b) the researchconsists of a review of records for the sole purpose of extractinginformationfor a demographic or statistical study in which no person can be identified. (7) Where a research investigator wishes to utilize the consent procedure described in 115 CMR 10.07(5) or (6), he or she must submit to the Committee, as part of the research proposal submission, specific and detailed reasons for seeking such consent procedure. The Committee may impose such conditions as it deems appropriate to safeguard the rights and welfare of the participants. Such conditions may include the appointment of advocates and monitors and stringent procedures to protect the confidentiality of personal information.