1. A. The IRB shall review all applications submitted pursuant to this chapter.

2. B. The IRB shall recommend:

   1. (1) Approval, disapproval, or termination; or
   2. (2) Modifications in research or security to secure approval.
3. C. The IRB shall meet as necessary in order to provide timely responses to requests for information.

4. D. Requests for information within the scope of this chapter shall include a description of the:

   1. (1) Research use to be made of the information;
   2. (2) Intent, if any, to present or publish the findings;
   3. (3) Nature of the requested information;
   4. (4) Safeguards and procedures that the applicant will take to protect the identity of the data; and
   5. (5) A description of any potential risks or benefits.
5. E. Upon receipt of an application within the scope of this chapter, the Commission shall immediately forward the request and all supporting documentation to the IRB for a recommendation.

6. F. The IRB shall require an applicant to provide any:

   1. (1) Documentation necessary to satisfy itself that the security of the released data will be preserved; and
   2. (2) Information necessary to assist the IRB in making a decision on an application.
7. G. The IRB shall make a timely recommendation concerning release of the requested information.
8. H. An IRB recommendation shall be made on the basis of a majority of the full IRB membership.
9. I. If the IRB denies an application, the IRB shall inform the applicant promptly in writing of the reasons for denial.

10. J. Deliberations.

    1. (1) In conducting its deliberations, the IRB shall be mindful of conflicts of interest and the appearance of conflict.
    2. (2) IRB members with an actual or apparent conflict concerning a particular application shall recuse themselves from deliberating and voting upon that application.

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

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)