Human Research Protection Program: Guidance

Research that May Qualify for Exempt Status

The federal Common Rule identifies six categories of research that may be eligible for exemption from IRB review. (45 CFR 46.101(b)(1-5)) UW-Madison IRBs apply these six exemption categories only to protocols determined to be no more than minimal risk. UW-Madison IRBs also apply the FDA regulations exempting from IRB review clinical investigations involving taste and food quality evaluations and consumer acceptance studies and emergency use of test articles. (21 CFR 56.104(c) and (d)) The Common Rule exemptions do not apply to FDA-regulated research.

 

Research that qualifies as exempt under one of the federal categories must nonetheless satisfy the UW-Madison’s ethical standards for the protection of human research participants.

 

If an investigator believes his or her research falls into one of these exemption categories, he or she must still submit a protocol to an IRB. Only an IRB can determine whether the research is exempt from review. The IRB has the right not to exempt a protocol and to require full review by the convened IRB or expedited review by an IRB member or IRB subcommittee, particularly if the research involves a sensitive population or sensitive topic.

 

If a protocol is determined to be exempt from review, it is not subject to continuing review or other rules governing human research, such as the rules on informed consent.  See, Informed Consent guidance on the Human Research Protection Program website. (http://info.gradsch.wisc.edu/research/hrpp/index.html).

 

However, the HIPAA Privacy Rule (45 CFR Parts 160 and 164) applies to all exempt research that uses protected health information (PHI).  Privacy Rule requirements do not apply to exempt research using information that has been de-identified.  For more information, see UW-Madison's HIPAA Privacy Rule Research Guide (http://www.wisc.edu/hipaa/ResearchGuide/exempt.html).

 

Categories of Research that may be exempt from IRB Review as defined in the federal Common Rule (45 CFR 46.101 (b)):

 

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

 

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:

 

1. information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
2. any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

 

NOTE: The exemption for survey and interview research does not apply to research in which the subjects are children, except for research involving observation of public behavior if the investigator does not participate in the activities being observed.

 

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under 45 CFR 46.101 (b)(2), if:

 

1. the human subjects are elected or appointed public officials or candidates for public office; or
2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

 

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

 

NOTE: Research involving certain datasets may not need IRB approval. For more information, see UW–Madison Existing Datasets Policy for determining when publicly-available social science datasets may be used without prior IRB approval, posted on the Human Research Protection Program website. (http://info.gradsch.wisc.edu/research/hrpp/index.html).

 

5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:

 

1. Public benefit or service programs;
2. procedures for obtaining benefits or services under those programs;
3. possible changes in or alternatives to those programs or procedures; or
4. possible changes in methods or levels of payment for benefits or services under those programs.

 

NOTE: The OHRP has issued additional guidance on applying this exemption. See, http://www.hhs.gov/ohrp/humansubjects/guidance/exmpt-pb.htm.

 

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. (See, 45 CFR 46.101 (b)(6) and 21CFR 56.104 (d))

 

NOTE: None of the exemptions listed above apply to research involving prisoners (45 CFR 46, Subpart C).

 

NOTE: All of the exemptions listed above are applicable to pregnant women, human fetuses and neonates involved in research (45 CFR 46, Subpart B).