Levels of Review

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The Level of Review and Minimal Risk

Full Committee Review

Expedited Review

Exempt Certification

Minimal Risk Tip Sheet

 

The Level of Review and Minimal Risk

If your study needs IRB review, the next step is to identify the level of review required – full committee reviewexpedited review or exempt certification.

The level of review reflects the level of risk to the subject. The risk level is compared to “minimal risk” as defined by the federal regulations:

Minimal risk is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45.CFR.46.102(i)).

Greater than minimal risk studies require full committee review, while minimal risk studies may be eligible for expedited review or exempt certification. Call the IRB Analyst of the Day at 415-476-1814 if you are unsure about which level of review is needed.

Full Committee Review

These studies are reviewed by the IRB committee at a convened meeting. Full committee review is required for: 

Examples of studies requiring full committee review

  • Randomized treatment studies
  • Studies using investigational drugs and/or devices
  • Behavioral studies involving risky interventions, observations of illegal behavior or very sensitive data/questions

Expedited Review

Expedited review (45 CFR 46.110 and 21 CFR 56.110) studies typically are reviewed by a small number of IRB reviewers. Expedited review is appropriate for studies that:

Additional restrictions and conditions

  • If subjects will be randomized to a treatment group as part of the study, then the study does not qualify for expedited review.
  • The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
  • The categories in this list apply regardless of the age of subjects, except as noted.
  • The expedited 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, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
  • The expedited review procedure may not be used for classified research involving human subjects.
  • The standard requirements for informed consent apply.
  • Categories one through seven pertain to both initial and continuing IRB review. See the Modification page to learn what kind of changes/amendments can be reviewed under expedited review procedures.

Expedited Review Categories

In addition to the information below, see the Minimal Risk Tip Sheet for examples of research activities that may be considered minimal risk.

Category 1: Approved drug or device being used for its approved indication

(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: 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 (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Comments: The drug or device must be approved and used exactly according to its labeling. All study procedures other than use of the drug or device must themselves be of minimal risk for the study to qualify for expedited review. Few studies fit this category.

Example: A study examines how well standard doses of ibuprofen relieve headache pain in adults.

Category 2: Blood sampling (limited amounts)

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 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or

(b) from other 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. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a).

Category 3: Noninvasive specimen collection

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

Examples:

  1. Hair and nail clippings in a nondisfiguring manner
  2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction
  3. Permanent teeth if routine patient care indicates a need for extraction
  4. Excreta and external secretions (including sweat)
  5. 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
  6. Placenta removed at delivery
  7. Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor
  8. 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
  9. Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings
  10. Sputum collected after saline mist nebulization

Category 4: Noninvasive, routine clinical procedures, such as MRI or EKG (no sedation, general anesthesia, x-rays or microwaves)

Collection of data through noninvasive 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:

  1. 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 subject or an invasion of the subject's privacy
  2. Weighing or testing sensory acuity
  3. Magnetic resonance imaging (FDA-approved scanners of 3 Tesla or under)
  4. Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow and echocardiography
  5. Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

Category 5: Use of data or specimens collected for non-research or research purposes (e.g. chart reviews)

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).

Comments:

(a) This category refers to materials collected for "non-research purposes," but can be used to cover research materials if the investigator's role is simply to analyze them. That is, if an investigator is receiving materials from colleagues who have separate approval to collect them, and the materials are handled with protections for confidentially, the investigator may apply for expedited review for the analysis.

(b) Under limited circumstances, research involving private information or specimens may be exempt or may not qualify as human subjects research. If the project is not human subjects research, IRB review is not required.

Examples: 

  1. Retrospective chart review
  2. Analysis of specimens that contain identifiable information (e.g. name or medical record number)

Category 6: Collection of data from voice, video, digital, or image recordings

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

Example: Using video recordings to examine communication styles between educators and students

Reminder: The expedited 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, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Category 7: Low-risk behavioral research

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 in this category may qualify for exempt certification, most commonly under exempt category 2.

Example: Interviewing teenagers about the influence of social media on body image.

Reminder: The expedited 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, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Category 8: Continuing review of inactive research or studies that are essentially complete

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

  1. Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) 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.

Category 9: Continuing review of other minimal risk research studies

Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (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.

Exempt Certification

DHHS regulations in 45 CFR 46.101 identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects. Federal HIPAA regulations, California state law and UCSF institutional policies further limit exempt research categories.

Exempt research involves human subjects, but IRB approval is not required. However, you must submit the study to the IRB. The IRB will review the application and certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval.

The IRB will NOT certify as exempt the following types of research at UCSF:

FDA regulated

Involves the collection of Protected Health Information (PHI)

Involves inpatients or prisoners as subjects

Demonstration projects and taste tests

Other notes about exempt studies:

Unique exempt consent templates and guidance are available

If your research involves interaction with subjects, there usually should be a process to ask subjects to participate and confirm their agreement. The IRB has created special consent templates and guidance for exempt studies. The consent documents are much simpler than those required for non-exempt research.

Not all changes to exempt studies need IRB review

For exempt research only, you can make minor changes to your study without notifying the IRB. Significant changes must be submitted to the IRB. See the Modification page for examples.

Exempt studies do not expire

Exempt studies have no expiration date and do not require continuing review. Submit a Study Closeout Report when the study is finished.

You cannot certify your own study as exempt

At this time, funding agencies do not allow investigators to make an exempt determination on their own, nor does the University. You must submit the study to the IRB, which will make this determination.

Exempt research must be minimal risk AND fit into one (or more) of the following categories:

Category 1: Research in established or commonly accepted educational settings, involving normal educational practices

The research is conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

  • Research on regular and special education instructional strategies, or
  • Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. 

Example: A researcher randomizes students to either a traditional hardcover textbook or an eReader textbook, and compares the effectiveness of the two textbooks.

Category 2: Educational tests, surveys, interviews or observations of public behavior, unless you collect identifiers and info that could place subjects at risk (subjects cannot be children, inpatients or prisoners)

The research involves the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observations of public behavior, except where any of the following conditions exist:

a. Information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; AND

b. Any disclosure of this information outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing —which may include loss of insurability or employability — or reputation. 

Note: UCSF requires expedited or full committee review – and does NOT exempt – research in category 2 under the following circumstances:

  • The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol, AND will not be conducted in an anonymous fashion. OR
  • The study involves any of the following subject populations: a) children (people under 18 who do not have the legal right to consent for themselves), or b) prisoners or c) inpatients.

Examples:

  1. A researcher asks outpatients who have diabetes to participate in a focus group about their exercise habits. The researcher does not collect any identifiable information about the participants during the focus group.
  2. A researcher asks nurses from several institutions to complete three online surveys about a new statewide mandate. The surveys include the nurses' email addresses so the surveys can be linked. However, the researcher will not share the email addresses with anyone outside the study team and will destroy the link after completing data collection. Note: Because the responses are linked, the study would not qualify for exemption if the survey responses may put the nurses' employment at risk.
  3. An investigator attends a community health fair and provides attendees with a pamphlet on reducing sodium intake and a cookbook that includes heart-healthy recipes. The investigator asks for permission to contact attendees one month after the health fair for an interview. During the interview, the investigator determines if subjects altered their diets after receiving the educational pamphlet and cookbook. (Exempt Categories 1 and 2) 

Category 3: Interviews/surveys with elected public officials

The research involves the use of educational tests, survey or interview procedures, or observations of public behavior when the human subjects are elected or appointed public officials or candidates for public office.

Example: A researcher observes SF Board of Education deliberations on school food services and interviews board members about childhood obesity.

Category 4: Use of existing data, documents, records or specimens, if a) sources are publicly available or b) you record info in a way that subjects cannot be identified

The 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 recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

*Existing means collected (i.e., on the shelf) prior to the research for a purpose other than the proposed research. It includes data or specimens collected in research and non-research activities.

**Publicly available means available to the general public.

Note: You cannot collect any identifiers, including dates. If you are not sure if your record review or specimen analysis is exempt, review the Not Human Subjects Research guidance page and flow chart.

Examples:

  1. Extra vials of identifiable specimens exist (are “on the shelf”) at the time the research is proposed. This may include specimens from Pathology or Laboratory Medicine. If the researcher obtains these specimens and removes the identifiers prior to the research, an exempt certification is required because the PI had access to identifiable information.
  2. A researcher conducts a retrospective chart review -- that is, the researcher only reviews data that was already in the medical record when the IRB certified the study as exempt. The researcher does not record any identifiers when abstracting the data or otherwise link data to individual subjects.
  3. A researcher studies publicly available data sets that include identifiers, i.e., NCI SEER, (Surveillance Epidemiology and End Results), NHANES, DMV records.
  4. As part of quality improvement, San Francisco General Hospital implemented an educational program on hepatitis B management for primary care providers from 2009-2011. The investigator evaluates this program by interviewing primary care providers. The investigator also reviews the medical records of patients with hepatitis B who were seen at SFGH from 2009-2011. The investigator does not collect any Protected Health Information from the medical records or link data to specific patients. (Exempt Categories 1, 2 and 4)