1. A. An individual researcher or institution shall apply for and receive approval from the Department before starting research in collaboration with an OADPO program.

2. B. The Department shall:

   1. (1) Review each request; and

   2. (2) Approve or disapprove the proposed research based on whether the proposed research:

      1. (a) Advances scientific knowledge or practice related to opioid-associated disease prevention and outreach;
      2. (b) Has approaches, aims, and methods that will allow the researcher to perform descriptive analyses or test hypotheses;
      3. (c) Has one or more investigators who have training and experience with the approaches and methods;
      4. (d) Will impede or interfere with the operations of the OADPO program;
      5. (e) Is approved by the Department’s Institutional Review Board to ensure that the research will be conducted according to established ethical guidelines for research in the field of opioid-associated disease prevention and outreach; and

      6. (f) Will keep any data used for the research confidential as required by:

         1. (i) Health-General Article, §24-906(B), Annotated Code of Maryland;
         2. (ii) 42 U.S.C. §290dd-2; and
         3. (iii) 42 CFR Part 2.

Authority: Health-General Article, §§24-901—24-909, Annotated Code of Maryland

Effective date: April 24, 2017 (44:8 Md. R. 404)