Research Compliance

Institutional Review Board Options for Proposal Approval

*The type of review your project needs rests solely with the IRB. Below are some general guidelines that the IRB follows in making the review decision.

Full Board Review

If your research project meets any of the following criteria, you will need to apply for full board review:

• The research involves funding from a federal agency.
   

• The research involves greater than minimal risk. (Definiton from the UA IRB Policy and Procedures Manual: "Minimal Risk means the probability and magnitude of physical or psychological harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine medical, dental, physical, or psychological examinations or tests.")
   

• The research involves vulnerable populations, such as cognitively impaired individuals, or incarcerated individuals.
   
• The research involves the collection of very sensitive, highly personal, or incriminating information.

• Collection of blood samples (depending on amount drawn, age, weight and health of subjects).
   
• Collection of biological specimens for research purposes by noninvasive means (examples include hair and nail clippings, deciduous teeth, saliva and sweat, etc.).
   
• Collection of data through noninvasive procedures routinely employed in clinical practice (examples include physical sensors, electrocardiography, untrasound, muscular strength testing, body composition assessment, etc.—procedures involving x-rays and microwaves are not included).

   
• Research involving materials that have been collected solely for nonresearch purposes.
   
• Collection of data from voice, video, digital, or image recordings made for research purposes.
   
• Research on individual or group characteristics or behavior (including perception, cognition, language, social behavior, etc.) or research employing survey, interview, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Exempt Status

Exempt means that the project has been submitted for IRB approval, and has been judged to meet federal guidelines for research that does not require IRB oversight. Investigators whose proposals are judged to be exempt will receive a letter certifying their project as exempt. There will be no further need to report to the IRB changes to the procedure or to make annual reports on the progress of the study. However, the researcher is obliged to seek IRB approval if any changes to the procedure are made that affect the participants' rights, safety, or well-being. Researchers are urged to seek the advice of an IRB member if they are unsure whether their proposed changes will require a change in the project's status as exempt

The procedure for submitting proposals is the same regardless of whether or not the investigator believes that the project qualifies as exempt.
 

Research may be exempted from IRB approval if it meets at least one of the following criteria:

• (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:
       (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
       (ii) 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 involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
      (i) the human subjects are elected or appointed public officials or candidates for public office; or
      (ii) 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.
   
• (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:
       (i) Public benefit or service programs;
       (ii) procedures for obtaining benefits or services under those programs;
      (iii) possible changes in or alternatives to those programs or procedures; or
      (iv) possible changes in methods or levels of payment for benefits or services under those programs.
   
• (6) Taste and food quality evaluation and consumer acceptance studies,
      (i) if wholesome foods without additives are consumed or
      (ii) if a food isconsumed 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.