1. (1) All proposed research involving patients shall meet the requirements of s. 51.61 (1) (j), Stats., 45 CFR 46, and this section.

2. (2) No patient may be subjected to any experimental diagnostic or treatment technique or to any other experimental intervention unless the patient gives informed consent, the patient’s informed consent is confirmed by the consent monitor and the research and human rights committee has determined that adequate provisions are made to:

   1. (a) Protect the privacy of the patient;
   2. (b) Protect the confidentiality of treatment records in accordance with s. 51.30, Stats., and ch. DHS 92;
   3. (c) Ensure that no patient may be approached to participate in the research unless the patient’s participation is approved by the person who is responsible for the treatment plan of the patient; and
   4. (d) Ensure that the conditions of this section and other requirements under this chapter are met.

History

History: Cr. Register, January, 1987, No. 373, eff. 2-1-87; correction in (2) (b) made under s. 13.93 (2m) (b) 7., Stats., Register, April, 2000, No. 532; correction in (2) (b) made under s. 13.92 (4) (b) 7., Stats., Register November 2008 No. 635.