Exempt Categories

Exempt Review

Exempt means that all the research activities fall under one or more of the exemption categories defined by the federal regulations. The significance of qualifying as exempt is that the research activity is not subject to continuing IRB oversight. Exemption does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in codes of professional conduct. Depending on the circumstances, investigators performing exempt studies may need to obtain informed consent, protect confidentiality, minimize risk, and address problems and complaints.

Exempt determinations are made by the Research Integrity office through application to the IRB. Please note that once exemptions are granted by the IRB, investigators are required to submit amendments to the IRB before making changes to the research activity. Significant changes can affect the eligibility of the research to continue to qualify as exempt.

When research includes any of the following, it does not qualify for exemption:

1. It is FDA-regulated (see Human Subjects Research Determination Worksheet)
2. The research involves prisoners and is conducted or funded by DHHS or Dept. of Defense (DoD)
3. The research involves prisoners and is inappropriate for the prison population being studied or involves interactions with prisoners (except for research aimed at involving a broader subject population and only incidentally including prisoners.)

The following types of research may qualify as exempt:

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 or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. 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 such a manner that the identity of the human subjects cannot be readily ascertained, 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 of 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 such a manner that the identity of the human subjects can be readily ascertained, directly or through identifiers linked to the subjects, and the IRB conducted a limited review to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
      
      Note: the only research activities involving children as subjects that may qualify for exemption under categories 2 (i) or (ii) is research involving educational tests or the observation of public behavior when the investigator(s) do not participate. Exempt category 2 (iii) may not be applied to research with children.
3. 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 information collection and at least one of the following criteria is met:
   1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot be readily ascertained, 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 of 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 such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and the IRB conducted a limited review to determine that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
      
      For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on 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 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.
4. Secondary research uses of identifiable private information or identifiable biospecimens, when consent is not required, if at least one of the following criteria is met:
   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 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 the 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 and 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 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.
5. Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs.
   
   Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants.  Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
   
   Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal website or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods are consumed; or (ii) if 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.

Note: Lehigh University is not offering the federal exemption categories 7 and 8 that require Broad Consent. The term “Broad Consent” as defined by the regulations applies to consent for storage and secondary research of identifiable private information or biospecimens. This concept must be implemented on an institutional level and requires tracking of individuals who decline to provide consent.

Because of the implications of tracking individuals who do not provide consent and excluding their data from all future research, Lehigh University is not pursuing broad consent at this time.  Investigators can continue to use biospecimens that are coded or to seek waiver of consent for use of biospecimens with identifiers retained consistent with current practices.

The following requirements apply to exempt research:

1. The research involves no more than Minimal Risk to participants.
2. The selection of subjects is equitable.
3. If there is interaction or intervention with subjects, either:
   1. A consent process is unnecessary. This must be justified in the IRB application. (Prospective consent is required for exempt category 3) or
   2. There is a consent process, that as appropriate:
      1. Provides sufficient opportunity to consider whether to participate and minimizes the possibility of coercion or undue influence.
      2. Does not include any exculpatory language.
      3. Discloses sufficient information to make a decision in an understandable language, such as:
         1. The study involves research
         2. The procedures to be performed
         3. That participation is voluntary
         4. The expected duration of subjects’ participation
         5. The extent, if any, to which confidentiality will be maintained
         6. The name and contact information of the investigator
4. (For Exempt Categories 2 & 3): If there is recording of identifiable information, there must be adequate protections to maintain the confidentiality of the data and the privacy interests of subjects.