Skip to Main Content
<< Back | Return to Main COMAR Search Page

14 records match your request.

FileAbstract
10.25.11.00.htm 10.25.11.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE Subtitle 25 MARYLAND HEALTH CARE COMMISSION Chapter 11 Institutional Review Board Authority: Health-General Article, §19-109(a)1) and (7) and (b)5) 19-103(c)3) and 19-133(d) Annotated Code of Maryland
10.25.11.01.htm 10.25.11.01. 01 Scope.. A. This chapter provides one method by which the Commission may consider requests for encounter level data from the Maryland medical care data base and any other Commission data base that contains data elements that qualify as "individually identifiable health information" as defined in the Health Insurance Portability and Accountability Act of 1996, P.L. 104-191 (1996) The Commission may also use another recognized Institutional Review Board to consider requests for enc
10.25.11.02.htm 10.25.11.02. 02 Definitions.. A. In this chapter, the following terms have the meanings indicated.. B. Terms Defined.. 1) "Application" means a request for information made pursuant to this chapter.. 2) "Commission" means the Maryland Health Care Access and Cost Commission.. 3) "Data base" means the Maryland medical care data base established at Health-General Article, §19-1507, Annotated Code of Maryland.4) "IRB" means the Institutional Review Board.. 5) "Personal records" has
10.25.11.03.htm 10.25.11.03. 03 IRB Membership.. A. The Commission shall appoint the IRB.. B. The IRB shall consist of at least nine members of which:. 1) Each member shall have expertise in health services research and information security; and. 2) At least one member's primary expertise is ethics.. C. The IRB shall be sufficiently qualified through the experience and diversity of its members, including consideration of race, gender, and cultural backgrounds, and sensitivity to such issues as com
10.25.11.04.htm 10.25.11.04. 04 IRB Review of Applications.. A. The IRB shall review all applications submitted pursuant to this chapter.. B. The IRB shall recommend:. 1) Approval, disapproval, or termination; or. 2) Modifications in research or security to secure approval.. C. The IRB shall meet as necessary in order to provide timely responses to requests for information.. D. Requests for information within the scope of this chapter shall include a description of the:.
10.25.11.05.htm 10.25.11.05. 05 Criteria for Approval.. The IRB shall recommend approval of an application only if:. A. It is satisfied that:. 1) The use proposed to be made of the requested information is in the public interest,. 2) The risks of release of the requested information are reasonable in relation to the anticipated benefits, and3) Safeguards adequate to prevent inappropriate disclosures will be implemented by the applicant; and
10.25.11.06.htm 10.25.11.06. 06 Commission Review of IRB Recommendations.. A. The Commission shall review:. 1) All IRB recommendations for approval of applications; and. 2) IRB denials of applications only for good cause shown by the applicant, which shall consist of evidence demonstrating that the IRB failed to follow the process set forth in this chapter.B. In order to secure Commission review of an IRB denial, an applicant shall file an appeal of the denial with the Commission, together with any suppo
10.25.11.07.htm 10.25.11.07. 07 Expedited Review Procedures.. A. The IRB may use an expedited review procedure to review applications relating to minor changes to already approved information requests.B. Under an expedited review procedure, the review shall be carried out by:. 1) The chairperson of the IRB; or. 2) An IRB member designated by the chairperson.. C. In reviewing the application under an expedited process, the reviewer shall exercise all of the authority of the IRB, except that the reviewer may
10.25.11.08.htm 10.25.11.08. 08 Suspension or Termination of IRB Approval.. A. The Commission shall require an applicant to file periodic progress reports concerning any aspect of the use of data released under this chapter.B. The Commission may:. 1) Investigate use made of data released under this chapter; and. 2) Require an applicant to provide information necessary to assist the Commission in its investigation.C. The Commission may delegate the function listed in §B of this regulation to the IRB..
10.25.11.09.htm 10.25.11.09. 09 Cooperative Research Activities.. Data release to a party with which the Commission has contracted pursuant to the State procurement process may not be referred to the IRB. However, other cooperative research activities involving data within the scope of this chapter shall be referred to the IRB for its opinion and recommendation.
10.25.11.10.htm 10.25.11.10. 10 IRB Records.. A. The IRB shall maintain the following records:. 1) Minutes of all IRB meetings describing:. a) Time and date of the meetings;. b) Members present;. c) Actions taken;. d) Votes on the actions including the number:. i) Voting for,. ii) Voting against, and. iii) Abstaining;. e) The basis for requiring changes in or disapproving research; and. f) A discussion of controverted issues and their resolution;. 2) Minutes which shall include:. a) Copies of all applicat
10.25.11.11.htm 10.25.11.11. 11 Completion of Research Activities.. Upon completion of research conducted with data released under this chapter, the applicant, at the IRB's discretion, shall:A. Destroy or return to the Commission all data and copies of data obtained from the Commission; and. B. Provide to the Commission and the IRB a copy of any report, article, paper, or other document prepared by the applicant with use of the released data.
10.25.11.12.htm 10.25.11.12. 12 Contract Provisions and Penalties.. As a prerequisite for release of any information under this chapter, the applicant shall enter into an agreement with the Commission which:A. Defines the scope of the use to be made of the released information;. B. Provides for safeguards for protecting the identity of data;. C. States that a breach of any condition of the agreement is a breach of contract;. D. Provides for the return or destruction of data upon a determination of b
10.25.11.9999.htm 10.25.11.9999. Administrative History Effective date: March 8, 1999 (26:5 Md. R. 391). Regulation .01 amended effective October 14, 2002 (29:20 Md. R. 1589). Regulation .01A amended effective August 22, 2011 (38:17 Md. R. 1013).
<< Back | Return to Main COMAR Search Page