Exempt Review
Expedited Review
Full Board Review

At this institution, if your research plan involves intervening with humans, or if you are collecting and/or receiving and/or analyzing human tissue or human data, then you must receive either confirmation of exemption, or approval, prior to the commencement of the activity.

If your study involves ‘no foreseeable risk’, and involvement of human subjects is described in one of the exemption categories listed under Section 2, then review section A below. ‘Exempt’ in this case means ‘exempt from IRB review’, but not exempt from Institutional review, which is why such applications are reviewed and handled by the staff of ORC, on behalf of SBU.

For all other activities (those involving minimal risk and qualify for expedited review, in accordance with the categories provided at Section 2, as well as all studies that don’t qualify for exempt or expedited review, and must be reviewed by the full committee), review sections B. and C. respectively for details.

A. Exempt Review Category

Research activities qualify for exemption status (i.e., exemption from committee member review), as long as the activity fits into one of the categories below and the activity involves no foreseeable risk. The exempt procedure is authorized by 45 CFR 46.101

Note that the exemptions below do not apply to research involving prisoners.

Exempt Research Categories

1. Research 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.


2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, UNLESS ALL OF THE FOLLOWING CONDITIONS EXIST:
• information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, AND
• any disclosure of the human subjects' response outside the research could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.

The exemption for research involving survey or interview procedures or observation of public behavior does not apply to research with minors (17 years old or younger) except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

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 #2 above, if:


• the human subjects are elected or appointed public officials or candidates for public office; OR
• 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 the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. Proposed research involves using specimens that already exist, i.e. already collected and are 'on the shelf', stored or frozen at time of protocol submission to CORIHS.

* IMPORTANT NOTE PERTAINING TO EXEMPTION #4:

a) CORIHS has specific policies regarding biological specimens. See Sections 18 and 19 for details.

b) CORIHS waives the requirement for submission of exemption application materials for activities involving only the re-analysis ('secondary analysis) of data that had previously been collected from human subjects as part of a prior study, provided that:

1. the data will be analyzed in an anonymous manner (none of the 18 identifiers listed on the HIPAA De-Identification form will be collected); AND
2. the prior study was conducted under IRB approval (where applicable, e.g., research on census data would be covered by this waiver, but IRB approval in this instance would not be relevant.)

This waiver includes re-analysis of publicly available datasets, provided the 2 conditions (i. and ii.) cited above apply.


c) If the proposed data, documents, or records contain health information, review Section 25 for specific federal regulations ('HIPAA') concerning privacy rules affecting use of such information.

5. Research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine (a) Public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) 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, (a) if wholesome foods without additives are consumed or (b) if a food is consumed 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.

Exempt Review Procedure: Application for exemption may be made electronically via IRBNet (http://www.stonybrook.edu/research/orc/humans/irbnet.shtml). If the investigator determines that his/her proposed research activity involves no risk, and falls into one of the exemption categories, s/he can complete the Application for Exemption Review, available in the IRBNet User’s Study Designer (Forms and Documents Library). The primary reviewer for that application will be one or more administrators within the Office of Research Compliance (ORC). Once the review has been completed, the Administrator will electronically notify the investigator regarding the status of the application. Notification will indicate that the application was fully approved or that it required modifications/clarifications in order to secure approval. Approval is valid for three years as long as the project continues as stated in the original proposal. No changes of any kind may be implemented until first reviewed and approved by CO. Approval is subject to recall at any time if conditions and requirements of the ORC are not met.

CORIHS receives and approves a report at the monthly meeting of all applications that have been reviewed and approved using the exempt review procedure.

B. Expedited Review Category

NOTE: Research activities that present no more than minimal risk to human subjects, AND involve only procedures listed in one or more of the following categories, may be reviewed by CORIHS through the expedited review procedure described below.

• The categories in this list apply regardless of the age of subjects, except as noted.
  
• The expedited review procedure is not permitted when 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.


• Categories one (1) through seven (7) below pertain to both initial and continuing IRB review.


• CORIHS can review minor changes to research approved by the full committee via the expedited review procedure. CORIHS defines a minor change as one that has no substantive effect upon or reduces the protocol risk already approved by the full committee.

Expedited Research Categories

1. Clinical studies of drugs and medical devices only when the following conditions are met:
• Research on drugs for which an investigational new drug application 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.);   AND


• Research on medical devices for which an investigational device exemption is not required, OR the medical device is cleared/approved for marketing and is being used in accordance with its cleared/approved labeling.
2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
• from healthy, nonpregnant 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


• from other adults and children (persons under 18 years old) 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.
3. Prospective collection of biological specimens for research purposes by noninvasive means. (Note that SBU has specific local policies regarding biological specimens. See Sections 18 and 19 for additional guidance)

Examples:
• 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 gum base or wax or by applying a dilute citric solution to the tongue;


• placenta removed 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.
4. 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:

• 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;


• 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.
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: See Section 2.A for similar research that may fall into the exempt category. This listing refers only to research that is not exempt.)

*SBU has specific policies regarding data registries and biological specimens. See Sections 18 and 19, respectively for details. Also, if the proposed data, documents, or records contain health information, review Section 25 for specific federal regulations ('HIPAA') concerning privacy rules affecting use of such information.

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



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: See Section 2.A for similar research that may fall into the exempt category. This listing refers only to research that is not exempt.)



8. Continuing review of research previously approved by the full committee as follows:

(a) Where:

• the research is permanently closed to the enrollment of new subjects;


• all subjects have completed all research-related interventions; and


• the research remains active only for long-term follow-up of subjects; OR

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

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

9. 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 CORIHS 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 Review Procedure: Application for expedited review may be made electronically via IRBNet (http://www.stonybrook.edu/research/orc/humans/irbnet.shtml). If the investigator determines that his/her proposed research activity involves minimal risk, and falls into one of the expedited review categories, s/he can complete the Application for Expedited and Full Committee Review, available in the IRBNet User’s Study Designer (Forms and Documents Library). Once submission is sent to ORC, and an initial determination concurs with expedited review status, the study is shared with one or more experienced reviewers, chosen from among the members of CORIHS. In reviewing the research, the reviewers may exercise all of the authorities of CORIHS except that the reviewer(s) may not disapprove the research (disapproval may only be decided at a meeting of the full committee).

Once the review has been completed, the investigator will be electronically notified regarding the status of the application. This notification will indicate that the application was fully approved, required modifications/clarifications in order to secure approval, or deferred for full committee review.

Approval is granted for 1 year. The principal investigator is required to submit continuing review materials in sufficient time to avoid any lapse between approval periods.

CORIHS receives and notes a report at the monthly meeting of all applications that have been reviewed and approved using the expedited review procedure.

C. Full Review Category

Return to Human Subjects Research at SBU

Last Updated: 2008-01-07