What Does Exempt Mean?

• Exempt research is research with human subjects. "Exempt" means that ongoing review is not required unless the research is amended in such a way that it not longer meets the exemption criteria.

• Six categories of research activity, as defined in the federal regulations for protecting research subjects, are inherently risk free, such as the secondary analysis of de-identified data. If research falls into one of the 6 categories it may qualify for exemption.
  
  
• In addition to research activity, eligibility criteria include subject population, and the use of deception.
  
  
• In accordance with Duke policy, a determination of eligibility for exemption must always be made by the administrative staff of the IRB, rather than by the investigator. This determination must be made regardless of the source of funding and when the research is unfunded.
  
  
• Research determined to be exempt is subject to the provisions of the Belmont Report, a statement of ethical principles adopted by the University. Thus, although the regulatory requirements in regard to informed consent do not apply, the principle of respect for persons does require a consent process that includes full disclosure in manner understandable to subjects and voluntary participation.
  

Restrictions on Subject Population
An exemption cannot be secured for research using the following subject populations:

• Pregnant woman (When pregnant woman are the targeted subject population.)
  
• Students in the Psychology Subject Pool
  
• Students if the investigator is their instructor
  
• Duke employees if the investigator is their supervisor
  

Deception
According to Duke policy projects that include deception of subjects are not eligible for exemption. Deception necessarily involves waivers of elements of consent. These waivers must be approved by the IRB.

Research Activity
Research may only be screened for exemption if it falls into one of six categories of activity defined in the federal regulations for the protection of human subjects, summarized below.

Note: Experimental manipulations of subjects do not qualify for exemption. The sole exception to the rule is when the manipulation involves giving different versions of a questionnaire to different groups of subjects.

The bulk of research approved for exemption at Duke falls into two categories:

1. Research involving the use of educational tests, survey procedures, interview procedures, or observation of public behavior is exempt unless the information is obtained and recorded by the investigator in such a way that the subject can be identified, and any disclosure of the human subjects' response 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.
   
2. Research involving the study of existing data, documents, records, pathological specimens, or diagnostic specimens is exempt if these sources are publicly available, or if the information is recorded by the investigator in such a manner that the subjects cannot be identified directly, or through identifiers linked to the subjects.

Some research at Duke falls in the category of educational research defined as follows:

Research conducted in established or commonly accepted educational settings, involving normal educational practices such as (1) research on regular and special educational strategies, or (2) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

The remaining exempt activities include research when elected or appointed public officials are the proposed subjects, taste and food quality evaluations, and research and demonstration projects conducted by federal departments or agencies.

Securing an Exemption

A minimal level of screening must take place to determine if research is eligible for exemption.

• A Request for Screening for an Exemption may be submitted to Lorna Hicks, 337 North Building.
• If you wish to submit the text of the application via email, please feel free to do so.
• Requests may be submitted at any time. The screening process usually takes two or three days.

Investigator Certification Requirements

Investigators conducted research approved as exempt are subject to the same certification requirements as are researchers conducting research subject to expedited or full review. In additional, if the investigators are students, graduate or undergraduate, their advisors must be certified. Advisors bear responsibility for the conduct of student research.