Â鶹´«Ã½

DHHS regulations in 45 CFR 46.104 (Common Rule) identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects. Federal HIPAA regulations, California state law and Â鶹´«Ã½  institutional policies further limit exempt research categories.

Exempt research involves human subjects, and although it is exempt from the federal policy, you must submit the study to the IRB.  The IRB will review the application and certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval.

For exempt research only, you can make minor changes to your study without notifying the IRB. Significant changes must be submitted to the IRB. Exempt studies have no expiration date and do not require continuing review. You cannot certify your own study as exempt!

​Exempt research must be minimal risk AND fit into one (or more) of the following categories.  If you feel more than one category applies, file under the lowest numbered category that applies. The majority of IRB Protocols submitted at Â鶹´«Ã½ fall under Exempt Category 2.

Category 1: Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices that are not likely to adversely impact students' opportunity to learn required educational content and does not adversely impact the assessment of educators who provide instruction. This includes:

• Most research on regular and special education instructional strategies, and
• Research on:
  • The effectiveness of instructional techniques, curricula, or classroom management methods
  • The comparison among instructional techniques, curricula, or classroom management methods.

Category 2: (Common Rule): Research that only includes: interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in a way that the identity of the human subjects cannot be established, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
3. The information obtained is recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination. The IRB will determine whether there are adequate plans to protect the privacy of subjects and to maintain the confidentiality of the data as required by 46.111(a)(7).

Category 3: (Common Rule): Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and collection of the information and at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in a way that the identity of the human subjects cannot be established, directly or through identifiers linked to the subjects;
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation; or
3. The information obtained is recorded by the investigator in a way that the identity of the human subjects can be established, directly or through identifiers linked to the subjects, and the IRB conducts a limited IRB review to make the determination of whether there are adequate plans to protect subject privacy and confidentiality as required by 46.111(a)(7).

Benign behavioral interventions means:

Brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing.  Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.

• If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement (consent) to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.

Category 4: (Common Rule) Secondary research for which consent is not required

1. The identifiable private information or identifiable biospecimens are publicly available.
2. Information, which may include information about biospecimens, is recorded by the investigator in a way that the identity of the human subjects cannot be established directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   1. The identifiable private information or identifiable biospecimens are publicly available.
   2. Information, which may include information about biospecimens, is recorded by the investigator in a way that the identity of the human subjects cannot be established directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
   3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, 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
   4. The research is conducted by, or on behalf of a Federal department or agency using government-generated or government-collected information obtained for non-research 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.