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institutional review board

 

Review Categories

Research subject to IRB review can be reviewed at two levels.

Level 1

Level 1 includes research development, or related activities that involve no more than minimal risk to participants, or that involves minimal changes to previously approved research during the period of one year or less from the approval date. Minimal risk is understood to mean "that the probability and magnitude of 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 physical or psychological examinations or tests" 45 CFR §46.102 (i).

Level 1 Categories

Level 1 categories do not apply to research involving prisoners, children*, fetuses, or pregnant women, but to other research with human subjects. For example:

1. Education Research
2. Surveys, Interviews, Educational Tests, Public Observations (that do not involve children*) and are of minimal risk.
3. Analysis of Previously-Collected, Anonymous Data
4. Public Benefit or Service Program
5. Consumer Acceptance, Taste, and Food Quality Studies

* The only research activities involving children that may fall under this level are those involving educational tests or observation of public behavior where the investigators do not participate in the activity being observed. Please see an IRB member for clarification.

Level 1 FAQ

What Research Does Not Qualify for Level 1 Review?

In general, Level 2 review is required when your research:
• is greater than "minimal risk" (Federal regulations define "minimal risk" as the probability and magnitude of 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 physical or psychological examinations or tests).
• involves children or adolescents as subjects (less than 18 years old).
• involves administration or use of drugs or devices.
• involves prisoners as subjects.

Level 2

The Level 1 review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing.

Level 2 includes research development, or related activities that involve more than minimal risk to participants, including work that uses deception of participants.

Level 2 Categories

1. All research development or related activities that include more than minimal risk (see Level 2 FAQ for specific examples)
2. All research development or related activities that involve children, adolescents, or prisoners.
3. Clinical studies of drugs and medical devices only when certain conditions are met
4. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
5. Prospective collection of biological specimens for research purposes by noninvasive means (e.g. hair or nail clippings, teeth, secretions, etc.)
6. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves (e.g. physical sensors, EEG, ECG, weight measurements, etc.).
7. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
8. Collection of data from voice, video, digital, or image recordings made for research purposes
9. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

Level 2 FAQ

Examples of research requiring Level 2 include:
• Surveying participants about

–Their sexual preferences
–Whether they have sexually transmitted diseases
–Whether they use or have used performance enhancing drugs

• Conducting interviews with immigrants or refugees
• Collecting height and weight measurements
• Asking participants to complete any physical testing
• Deceiving participants