333-025-0120 - Anonymous, Coded, or Exempt Genetic Research

333-025-0120. Anonymous, Coded, or Exempt Genetic Research

(1) Any person proposing to conduct genetic research that is thought to be anonymous shall obtain from an IRB, prior to conducting such research, a determination that the research is anonymous. The person shall furnish the IRB with assurances that the criteria in (3) below are met.

(2) Any person proposing to conduct research that is thought to be exempt from review shall obtain an IRB determination that the research is exempt from review under 45 CFR 46.101 (b) or other applicable exemption from the Federal Common Rule.

(3) A human biological sample or clinical individually identifiable health information may be used in anonymous or coded genetic research only if prior to the time the research is conducted:

(a) The subject has granted informed consent for the specific anonymous or coded research project; or

(b) The subject has granted consent for genetic research generally; or

(c) The subject was notified in accordance with OAR 333-025-0165 that the individual's sample or information may be used for anonymous or coded research, and before the sample or information was obtained, the subject did not request that the sample or information be withheld from anonymous or coded research; or

(d) The subject was not notified, due to emergency circumstances, in accordance with OAR 333-025-0165, that the individual's sample or information may be used for anonymous research or coded research, and the individual died before receiving the notice; or

(e) The subject has granted blanket informed consent and the sample or information was obtained before June 25, 2001; or

(f) The subject was deceased when the sample or information was obtained; or

(g) An Institutional Review Board:

(A) Waives or alters the consent requirements pursuant to the Federal Common Rule; and

(B) Waives authorization pursuant to the Federal Privacy Rule.

(4) In addition to the requirements of section (3) of this rule, genetic research in which the DNA sample or genetic information is coded shall satisfy the following requirements:

(a) The research has been approved by an Institutional Review Board after disclosure by the investigator to the board of risks associated with the coding;

(b) The code is:

(A) Not derived from individual identifiers;

(B) Kept securely and separately from the DNA samples and genetic information; and

(C) Not accessible to the investigator unless specifically approved by the Institutional Review Board.

(c) Data is stored securely in password protected electronic files or by other means with access limited to necessary personnel;

(d) The data is limited to elements required for analysis and is a limited data set; and

(e) The investigator is a party to a data use agreement with any limited data set recipient. The data use agreement must:

(A) Establish the permitted uses and disclosures of such information by the limited data set recipient, limited to research uses. The data use agreement may not authorize the limited data set recipient to use or further disclose the information in a manner that would violate the requirements of the Federal Privacy Rule, if done by the investigator;

(B) Establish who is permitted to use or receive the limited data set; and

(C) Provide that the limited data set recipient will:

(i) Not use or further disclose the information other than as permitted by the data use agreement or as otherwise required by law;

(ii) Use appropriate safeguards to prevent use or disclosure of the information other than as provided for by the data use agreement;

(iii) Report to the investigator any use or disclosure of the information not provided for by its data use agreement of which it becomes aware;

(iv) Ensure that any agents, including a subcontractor, to whom it provides the limited data set agrees to the same restrictions and conditions that apply to the limited data set recipient with respect to such information; and

(v) Not identify the information or contact the individuals.

(OHD 14-2002, f. & cert. ef. 9-27-02; PH 16-2003(Temp), f. & cert. ef. 10-27-03 thru 4-16-04; PH 9-2004, f. & cert. ef 3-23-04; PH 21-2005, f. 12-30-05, cert. ef. 1-1-06)

Stat. Auth.: ORS 192.537 & 192.547

Stats. Implemented: ORS 192.535, 192.537 & 192.547

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