Office of Research and Sponsored Programs

 

Exempt Research Policy

If you think your proposal may be exempt, for example, your study does not involve vulnerable populations, or it uses secondary public data sources, or it is conducted in customary educational settings and it meets additional criteria for exemption (see below for exemption criteria), you will still need to complete the IRB form and send your completed application to the IRB administrator (cortina@adelphi.edu). You can submit your proposal for consideration for exemption at any time and you do not have to submit 15 hard copies, one electronic and one signed hard copy are all that is needed at this point.

The chair and if necessary an IRB subcommittee will review your application and decide if it meets federal guidelines for exemption. If your proposal is deemed exempt, then an approval letter will be sent to you; if your proposal does not meet the requirements for exemption, then you will need to submit for a full IRB committee review as per our guidelines.

All studies conducted by Adelphi faculty, adjunct faculty, administrators or students must be brought to the attention of the IRB chair for determination of review category and possible exemption from review (45 CFR 46.101(b)).

For a research project to be exempt from IRB review all items in Part A of this section must apply AND at least one item in Part B of this section must apply.

Part A (All items must apply.)

  1. The research does not involve as subjects: prisoners, fetuses, pregnant women, the seriously ill or mentally or cognitively compromised adults.
  2. The research does not involve subjects under the age of 18 (Exception: Research with subjects under the age of 18 may still be considered exempt if the subjects are participating in projects that fall under categories 1, 3, 4 and/or 5 in Part B). Studies under Part B-2 that include minors should be submitted for expedited review.
  3. Study participants are not exposed to greater than minimal risks (i.e. those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests performed by a qualified professional).

Part B (At least one item must apply.)

  1. Research is conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
  2. Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior unless: (a) information obtained is recorded at any point in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) 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.
  3. Research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior if: (a) the human subjects are elected or appointed public officials or candidates for public office; and (b) 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 involves 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 provided to the investigator in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
  5. Research and demonstration projects are conducted by or subject to the approval of department heads, and are designed to study, evaluate or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.
  6. Taste and food quality is evaluated and consumer acceptance studied: (a) if wholesome foods without additives are consumed; or (b) 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 contaminants at or below the level found to be safe, by the 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.

If an application is deemed to satisfy the criteria to be considered as exempt, the Chair will advise the PI:

“Your application (# ) was reviewed by the IRB and determined to be exempt. Should you wish to make any modifications to your research you are required to submit an amendment to the IRB to have your classification as exempt reconfirmed. Please note that you remain obligated to observe the Belmont principles with respect to the protection of human subjects.”1

 

 

For further information, please contact:

Office of Research and Sponsored Programs
p – 516.877.3161

 
 
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