Section 2075.10  Confidentiality of research subjects

Authority:  The provisions of this Part issued under Sec. 508(b) of the Illinois Controlled Substances Act [720 ILCS 570/508(b)].

a)         Any person authorized to conduct research in controlled substances under the Illinois Controlled Substances Act [720 ILCS 570], who intends to maintain the confidentiality of those persons who are the subjects of such research, shall upon authorization, or within a reasonable time thereafter, submit to the Secretary of the Department of Human Services, a separate request for each research project involving controlled substances, which shall contain the following:

1)         The researcher's authorization number for that project;

2)         The location of the research project;

3)         A general description of the research or a copy of the research protocol;

4)         A specific request to withhold the names and/or any other identifying characteristics of the research subjects; and

5)         The reasons supporting the request.

b)         Within 30 days from the date of receipt of the request, the Secretary shall issue a letter, either granting confidentiality, requesting additional information, or denying confidentiality, in which case the reasons for the denial shall be included.  A grant of confidentiality shall be limited solely to the specific research project indicated in the request.

c)         Within 30 days after the date of completion of the research project, the researcher shall so notify the Secretary.

d)         Persons who are given this authorization may protect the privacy of individuals who are the subjects of such research by withholding from all persons not connected with the conduct of the research the names and other identifying characteristics of such individuals.  Persons so authorized shall not be compelled in any civil, criminal, administrative, legislative or other proceeding to identify the individuals who are the subjects of research for which the authorization was granted, except to the extent necessary to permit the Department to determine whether the research is being conducted in accordance with the authorization.