10-144 C.M.R. ch. 253, § 8 - PROTOCOLS

A. The advisory body may approve a general protocol for use by the Department in situations involving routine verification of chronic disease or data quality investigations. The advisory body shall determine if the use of such a protocol is appropriate when privileged medical information is requested. Any investigation in which it is anticipated that individual patients/cases will be contacted, shall, prior to the investigation have an established advisory body approved study-specific protocol. The study protocol shall include or consider:

1 Statement of the health problem to be investigated

2 Relevant historical background with pertinent review of the literature

3 Purpose and objectives of the study

4 Methodology:

(a) Study design

(b) Variables to be collected

(c) Populations to be contacted; method of contact

(d) Data collection

(e) Data analysis

(f) Assurances of human subjects protection including:

i Confidentiality guidelines

ii Patient/case contact guidelines

iii Patient/case and physician consent guidelines

5 Reporting requirements

6 Statutory authority

7 Qualifications and affiliations of the investigators

B. The protocol for any investigation shall be designed to preserve the confidentiality of all medical information that can be associated with identified patients, to specify the manner in which contact is made with patients, and to maintain public confidence in the protection of confidential information. Through each specific study protocol, identifying information shall be kept as inaccessible as feasibly possible and protected by intermediate coding or scrambling, whenever possible.

Notes

10-144 C.M.R. ch. 253, § 8