Or. Admin. Code § 407-014-0060

Current through Register Vol. 63, No. 12, December 1, 2024

Section 407-014-0060 - Uses and Disclosures of Protected Information for Research Purposes

The Department may use and disclose an individual's information for research purposes as specified in this rule.

(1) All research disclosures are subject to applicable requirements of federal and state laws and rules including but not limited to 45 CFR part 46 and 21 CFR part 50.0 to 50.56, relating to the protection of human research subjects.

(2) The Department may use and disclose de-identified information or a limited data set for research purposes, pursuant to OAR 407-014-0070.

(3) The Department may use and disclose information regarding an individual for research purposes with the specific written authorization of the individual. The authorization must meet all requirements in OAR 407-014-0030, and may indicate an expiration date with terms such as "end of research study" or similar language. An authorization for use and disclosure for a research study may be combined with other types of written authorization for the same research study. If research includes treatment, the researcher may require an authorization for use and disclosure for the research as a provision of providing research related treatment.

(4) Notwithstanding section (3) of this rule, the Department may use and disclose an individual's information for research purposes without the individual's written authorization, regardless of the source of funding for the research, provided that:

(a) The Department obtains documentation that a waiver of an individual's authorization for release of information requirements has been approved by an IRB registered with the Office for Human Research Protection. Documentation required of an IRB when granting approval of a waiver of an individual's authorization for release of information must include all criteria specified in 45 CFR part 164.512(i)(2).

(b) A researcher may request access to individual information maintained by the Department in preparation for research or to facilitate the development of a research protocol in anticipation of research. The Department may determine whether to permit such use or disclosure, without individual authorization or use of an IRB, pursuant to 45 CFR part 164.512(i)(1)(ii).

(c) A researcher may request access to individual information maintained by the Department about deceased individuals. The Department may determine whether to permit such use or disclosure of information about decedents, without individual authorization or use of an IRB, pursuant to 45 CFR part 164.512(i)(1)(iii).

(5) The Department may collect, use, or disclose information, without individual authorization, to the extent that the collection, use, or disclosure is required by law. When the Department uses information to conduct studies as required by law, no additional individual authorization is required nor does this rule require an IRB or privacy board waiver of authorization based on the HIPAA privacy rules.

(6) The Department may use and disclose information without individual authorization for studies and data analysis conducted for the Department's own quality assurance purposes or to comply with reporting requirements applicable to federal or state funding requirements in accordance with the definition of "health care operations" in 45 CFR part 164.501.

Or. Admin. Code § 407-014-0060

OMAP 26-2003, f. 3-31-03 cert. ef. 4-1-03; Renumbered from 410-014-0060 by DHSD 5-2009, f. & cert. ef. 7-1-09; DHSD 2-2011(Temp), f. & cert. ef. 7-1-11 thru 12-27-11; DHSD 11-2011, f. & cert. ef. 12-16-11

Stat. Auth.: ORS 409.050

Stats. Implemented: ORS 409.010