Category 1 - Education research

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.

This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

Notes about involving children:

• Children can be included in this category of research.

Examples:

• Evaluating a new curriculum or delivery methodology
• An evaluation of a continuing education workshop

Category 2 - Surveys, interviews, educational tests and public observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
   • Data identifiability: Research data is anonymous (identifiers are never collected), and participants cannot be re-identified.
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement or reputation.
   • Data identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID) or anonymous (identifiers are never collected).
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) (adequate provisions for data confidentiality and subject privacy).
   • Data identifiability: Research data is identifiable or de-identified (data is linked to identifiers using a study ID).

Notes about involving children:

• Only criteria (1) and (2) can include children; criterion (3) cannot involve children.
• Children can be included when research will involve the use of educational tests (cognitive, diagnostic, aptitude or achievement) or when the investigator will observe public behavior but does not participate in that behavior or activity.
• Children cannot be included when research will involve the use of survey procedures, interview procedures or observation of public behavior when investigators will be involved in the activity.

Examples:

• Conducting a quality of life survey
• Conducting a focus group about an experience or program
• Interviewing physicians about patient management practices
• Administering a numerical aptitude test and a working memory cognitive test to children
• Observing elementary children playground interactions, as long as the investigator has no involvement or does not manipulate the environment in any way

Category 3 - Benign behavioral interventions

Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:

1. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects.
   • Data identifiability: Research data is anonymous (identifiers are never collected), and participants cannot be re-identified.
2. Any disclosure of the human subjects' responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, educational advancement, or reputation or
   • Data identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous (identifiers are never collected).
3. The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination required by §46.111(a)(7) (adequate provisions for data confidentiality and subject privacy).
   • Data identifiability: Research data is identifiable or de-identified (data is linked to identifiers using a study ID).

Benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that they will be unaware of or misled regarding the nature or purposes of the research.

Notes about involving children:

• Children cannot be included in this category of research.

Examples:

• Having subjects play an online game and then answer questions about it
• Video recording subjects solving puzzles under various noise conditions
• Having subjects decide how to allocate a nominal amount of received cash between themselves and someone else

Category 4 - Secondary data or specimen research that does not require consent

Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

1. The identifiable private information or identifiable biospecimens are publicly available.
   • VCU’s interpretation of publicly available: “Publicly available” refers to situations where a member of the general public could request information or biospecimens. Examples include data and specimens that are commercially available, available upon request or for a fee, or available under other conditions (such as having to register for an account or sign a privacy agreement)
   • Data identifiability: Research data may be identifiable, de-identified (data is linked to identifiers using a study ID), or anonymous
2. Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects.
   • Data identifiability: Research data is anonymous, and participants cannot be re-identified. Neither identifiers nor a key linking study ID with identifiers may be retained at any point during the conduct of the research.
3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is regulated by HIPAA [45 CFR 160, 164(A) and (E)] for the purposes of health care operations, research, or public health activities and purposes.
   • Limitation: This category applies when information is obtained from an entity regulated by HIPAA and that information will continue to be maintained within either the same HIPAA-covered entity or another HIPAA-covered entity. If information is moved or shared to an outside entity NOT regulated by HIPAA the research will need expedited review.
   • Data identifiability: Research data can be identifiable or de-identified (data is linked to identifiers using a study ID).
4. The research is conducted by, or on behalf of, a federal department or agency using government-generated or government-collected information obtained for non-research activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with federal standards for safeguarding privacy
   • Data identifiability: Research data may be identifiable, de-identified (data are linked to identifiers using a study ID) or anonymous.

Notes about involving children:

• Children can be included in this category of research.

Examples:

• Analyzing publicly accessible Facebook posts (criteria i)
• An investigator obtains a list of MRN from the Informatics Core of patients records that meet the eligibility criteria. The investigator uses the MRN only to look up the relevant charts but does not write the MRN down anywhere in or connected to the research data. No other identifiers are written down in the research data. There is no way to go back to that particular patient’s chart later to collect additional information (criteria ii)
• An investigator receives an anonymous dataset from a registry (criteria ii)
• Analyzing anonymous waste tissue samples (criteria ii)
• Analyzing medical records of patients when the data are not shared outside the VCU HIPAA Covered Entity and when consent is not required (criteria iii)
• Conducting analyses of national student exam scores at the request of (or under contract to) the Department of Education (criteria iv)

Category 5 - Public benefit or service program research

Research and demonstration projects that are designed to study, evaluate, improve or otherwise examine public benefit or service programs, including:

• Procedures for obtaining benefits or services under those programs
• Possible changes in or alternatives to those programs or procedures
• Possible changes in methods or levels of payment for benefits or services under those programs

In addition, projects that are:

• Conducted by a federal department or agency
• Supported by a federal department or agency
• That are otherwise subject to the approval of (federal) department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated to conduct the project).

Such projects include, but are not limited to, internal studies by federal employees and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.

See OHRP guidance on types of programs that qualify for this exemption.

Notes about involving children:

• Children can be included in this category of research.

Examples:

• Initiating and evaluating a program supported by a federal grant that administers financial or medical benefits under the Social Security Act.
• A state department received a federal award to administer a demonstration project with the state Medicaid services. The VCU investigator will evaluate the program as a consultant for the state department.

Category 6 - Taste and food quality evaluation and consumer acceptance studies

Taste and food quality evaluation and consumer acceptance studies, (1) if wholesome foods without additives are consumed or (2) if a food is consumed that contains a food ingredient at or below the level 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.

Notes about involving children:

• Children can be included in this category of research.

At this time, VCU is NOT implementing exemption categories 7 and 8.

Exempt research studies are reviewed to ensure that all research activities of the study fit into one or more of the exempt research categories (see above) and are no greater than minimal risk. Research that is determined to be exempt is not regulated by the DHHS or FDA regulations for conducting human subject research. However, all exempt studies should be conducted in accordance with the Belmont Principles for ethical research, and in accordance with institutional standards and requirements.

• Upload all supporting study documents such as:
  • Information sheets to inform participants about the research activity
  • Recruitment materials
  • Survey instruments and interview questions
  • Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators and/or medically/psychologically responsible investigators)
• Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.

Because exempt research is not regulated by federal requirements, informed consent is not required. VCU does, however, require some sort of information sheet be shared with prospective research participants. The information sheet may be brief and may or may not include all of the consent elements. At minimum, it should address:

• The activity involves research
• Participation is voluntary
• Brief description of what participants will be doing
• Whom to contact with questions (generally the principal investigator)
• Note any compensation to participants

Category 1

Clinical studies of drugs and medical devices only when condition (a) OR (b) is met.

(a) Research on drugs for which an investigational new drug application (21 CFR 312) is not required. (Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

(b) Research on medical devices for which (1) an investigational device exemption application (21 CFR 812) is not required; or (2) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2

Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows:

(a) From healthy, non-pregnant adults who weigh at least 100 pounds. For these participants, the amounts drawn may not exceed 550 ml in an eight-week period and collection may not occur more frequently than two times per week; OR

(b) From other adults and children, considering the age, weight, and health of the participants, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these participants, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an eight-week period, and collection may not occur more frequently than two times per week.

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means. Examples include:

• Hair and nail clippings in a non-disfiguring manner
• Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
• Permanent teeth if routine patient care indicates a need for extraction
• Excreta and external secretions (including sweat)
• Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue
• Placenta removal at delivery
• Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
• Supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques
• Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
• Sputum collected after saline mist nebulization

Note: On Oct. 4, 2010, OHRP clarified that it agrees with the FDA’s position that the following procedures are considered noninvasive:

• Vaginal swabs that do not go beyond the cervical os
• Rectal swabs that do not go beyond the rectum
• Nasal swabs that do not go beyond the nares

Category 4

Collection of data through non-invasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications. Examples include:

• Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy
• Weighing or testing sensory acuity
• Magnetic resonance imaging
• Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow and echocardiography
• Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual

Category 5

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

NOTE:

• Some research using only retrospective data may qualify for exempt category 4.
• This category is applicable to research involving the use of data obtained from medical charts when the investigator wishes to collect both retrospective and prospective data.
• This category includes materials that are collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.
• The phrase "...or will be collected solely for non-research purposes" pertains to the origin of the materials. For example, blood samples that were collected for a clinical test.

Category 6

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

Category 7

Research on individual or group characteristics or behavior (including but not limited to research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation or quality assurance methodologies.

Note: Some research utilizing these procedures may qualify for exempt category 2.

Category 8

Continuing review of research previously approved by the convened IRB as follows:

(1) Where (1) the research is permanently closed to the enrollment of new subjects; (2) all subjects have completed all research-related interventions and (3) the research remains active only for long-term follow-up of subjects; OR

(2) Where no subjects have been enrolled and no additional risks have been identified; OR

(3) Where the remaining research activities are limited to data analysis.

Note: Closure of enrollment only has to apply to the local site, not to all sites.

Category 9

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Expedited research means a study may be reviewed by a single IRB member, rather than by the convened IRB, if all research activities of the study fit into one or more of the expedited research categories (see above) and are no greater than minimal risk. Expedited review does not necessarily mean the review will occur more quickly than other types of review.

• Upload all supporting study documents such as:
  • Informed consent form(s)
  • Recruitment materials
  • Survey instruments and interview questions
  • Grant proposal, if applicable
  • Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators and/or medically/psychologically responsible investigators)
• Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.

Full board review is conducted by the convened IRB. Studies that require full board review are those that are greater than minimal risk and/or do not qualify for an exempt or expedited research category.

Full board studies undergo an administrative pre-review process prior to IRB review. Following completion of pre-review, studies are forwarded to a convened panel for IRB review.

• Upload all supporting study documents such as:
  • Informed consent form(s)
  • Recruitment materials
  • Survey instruments and interview questions
  • Multi-center study protocol
  • Grant proposal, if applicable
  • FDA regulatory documents, if applicable
  • Principal Investigator CV/Biosketch (and, if applicable, CVs/Biosketches for lead student investigators and/or medically/psychologically responsible investigators)
• Be sure all submitted documents include version numbers and/or dates in the footer. When documents are changed, a new version number and/or date should be applied. This helps the IRB track approved versions most efficiently.