Review Process

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.

Examples:

• Effectiveness of on-line training as supplement to regular instructional approach 
• Evaluation of two currently implemented instructional techniques, curricula, or classroom management methods 

Research only includes interactions involving educational tests, survey procedures, interview procedures, or observation of public behavior. Information must be obtained so that the participant cannot be identified, and the research does not put them at risk in their personal lives including legal issues, employment, or educational advancement.

Examples:

• An online survey that collects anonymous data about factors contributing to student success. 
• An interview about living on-campus that does not record any identifying information about the participant.

Research involving benign behavioral interventions that are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects. Information must be obtained so that the participant cannot be identified, and the research does not put them at risk in their personal lives including legal issues, employment, or educational advancement. 

Examples:

• Subjects can play a short video game while their physiological stress is measured.
• Subjects can complete an anonymous survey before and after brief exercising to study the effect of physical activity on wellness.

Secondary research use of identifiable private information or identifiable biospecimens for which consent is not required because it is publicly available information.

Examples:

• Patient data extracted from medical records without name or ID number every 6 months as follow up visits occur.
• An analysis of biospecimens from an IRB-approved biorepository.

Research supported by a federal agency studying, evaluating, or examining public benefit or service programs. This includes 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.

Examples:

• Outcomes assessment from government-sponsored mental health services.
• Study of barriers to obtaining new Medicare benefits.

Research involving taste and food quality evaluation of consumer acceptance studies.

Examples:

• A taste-test on different varieties of fruit that do not have additives to determine consumer preference.
• Study looking at approved levels of an agricultural chemical on taste of vegetables.

Storage or maintenance of identifiable private information or identifiable biospecimens for secondary research use. 
Examples:

• Creating a dataset containing identifiers from a previous study to conduct future research.
• Saving blood samples from collaborator’s study for a future research question

Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use.

Examples:

• Using dataset from prior study containing identifiers to answer subsequent research question.
• Using blood samples from collaborator’s study for an additional research question.

Clinical studies of drugs or which an investigational new drug application (21 CFR Part 312) is not required and medical devices for which an investigational device exemption application (21 CFR Part 812) is not required or (the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling. 

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected may not occur more frequently than 2 times per week.

Prospective collection of biological specimens for research purposes by noninvasive means including but not limited to; hair, nails, teeth, external secretions and skin cells

Collection of data through noninvasive procedures routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing.

Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes.

Collection of data from voice, video, digital, or image recordings made for research purposes. 

Research on individual or group characteristics or behavior employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.

Continuing review of research previously approved by the convened IRB but is not active in data collection and the research activities are limited to data analysis.

Continuing review of research that involves no greater than minimal risk and no additional risks have been identified.