10-144 C.M.R. ch. 253, § 6 - ADVISORY BODY

A. Precedent for and establishment of the advisory body

1 In accordance with 22 MRSA Section1692-B an advisory body, independent from the department, shall be established and charged with responsibility for approving the protocol of the investigation, overseeing the conduct of the investigation to assure consistency with the protocol and the department's rules, and assessing both the scientific validity of the investigation and its effects upon patients, if any.

2 The advisory body to Maine chronic disease surveillance programs shall consist of the Maine Cancer Prevention and Control Advisory Committee to include a consumer representative, a practicing physician and a member of the Maine Medical Records Association. The Commissioner shall appoint additional members, if needed to meet these requirements, and they shall each serve a two year term.

3 The Cancer Prevention and Control Advisory Committee was appointed in accordance with 22 MRSA Section1405.

4 The Department may consider attempting to obtain recognition of the advisory body as a Federally approved Institutional Review Board (IRB) for the purposes of Human Subjects Protection. The Commissioner may appoint any additional members whose expertise is deemed necessary to accomplish this purpose.

B. Duties and responsibilities of the advisory body

1 Recommendations regarding these rules and any rule changes.

2 Review and approval of chronic disease and data quality investigation study protocols, either general or specific, for appropriateness, ensurance of patient confidentiality, adherence to ethical conduct concerning patient contact, and assurance that the study provides a substantial benefit to the public health of the citizens of the State of Maine.

3 Oversight of the conduct of all advisory body approved investigations to ensure the actions of the investigators and the investigation staff are consistent with the study protocol and the Department's rules and regulations.

4 Recommendation regarding data request expense reimbursement.

5 The advisory body may, when it deems necessary or appropriate, solicit peer review and comment from scientists, epidemiologists, physicians or other experts in the field of health for opinion on the scientific merit of an investigation.

6 The advisory body may advise, based on available data, on the appropriate course of action of an investigation or potential investigation, and define strategies for identification and/or resolution of a chronic disease health problem.

7 The advisory body shall not give approval to any study protocol which would violate federal or state law, and shall follow guidelines set forth in the Code of Federal Regulations 45 CFR 46, Protection of Human Subjects, in the review and approval of research/investigation protocols.

8 The advisory body shall ensure that the information requested from health care providers is reasonably related to the authorized investigation or the evaluation of completeness or quality of data submitted to the department's disease surveillance programs.

9 The advisory body shall determine if the use of a general protocol is appropriate when privileged medical information is requested.

Notes

10-144 C.M.R. ch. 253, § 6