Exemption Category 4: Secondary research for which consent is not required
Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use if regulated under 45 CFR parts 160- and 164, subparts A and E [HIPAA], for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S. C. 552a, and if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S. C. 3501 et seq.
* By “secondary research,” this exemption is referring to re-using identifiable information and identifiable biospecimens that are collected for some other ‘primary” or “initial” activity. The information or biospecimens that are covered by this exemption would generally be found by the investigator in some type of records (in the case of information) or some type of tissue repository (such as a hospital’s department for storing clinical pathology specimens).
* In relation to Exemption 4(i), examples of identifiable information or identifiable biospecimens which are publicly available, include:
o Use of archives in a public library,
o Government or other institutional records where public access is provided on request,
o From a commercial entity if the information is provided to members of the public on request of if the only requirement for obtaining the information is paying a user fee, registering or signing in as a visitor to an archive,
o A commercial entity made identifiable biospecimens publicly available to anyone on request or for a fee.
* NDSU is NOT a HIPAA Covered Entity (CE); therefore, exemption 4(iii) may not be used unless the research will take place at a covered entity and that entity determines through their IRB procedures that the exemption applies or NDSU Formally enters into a Business Associate Agreement with the CE.
* It is important to recognize that this exemption does not cover any primary collections of either information or biospecimens. For example, if an investigator wants to collect information directly from research subjects by asking them to complete a questionnaire, that would not be covered by this exemption. If an investigator wants to collect biospecimens by having subjects swab their cheek, that would similarly not be covered by this exemption.
Refer to SOPs 11.2, Human Biological Specimens and 11.3, Secondary Analysis of Existing Data for more information.