Categories of Review

Under federal regulations, there are three possible IRB review categories:

    1. Exempt
    2. Expedited
    3. Full Board

The IRB Program Coordinator, IRB Chair, or the convened IRB, acting in accordance with federal regulations, not the investigator, determines if an application meets the criteria for each approval category.

The IRB does not review research enrolling prisoners, therefore the three research categories do not apply to prisoners.

Exempt Review 

The IRB uses the following criteria for reviewing and granting research under the exempt category (as stated in 45 CFR 46.101(b) and 21 CFR 56.104):

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.  This category may not be applied to FDA regulated clinical investigations.

     
  2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.  If the research includes children as participants, this category is limited to educational tests and observations of public behavior when the investigator(s) do not participate in the activities being observed.  This category may not be applied to FDA regulated clinical investigations.

     
  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 item 2 of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.  This category may not be applied to FDA regulated clinical investigations.

     
  4. Research involving 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.  The reviewed materials must already exist at the time the research is proposed and must not be prospectively collected.  This category may not be applied to FDA regulated clinical investigations.

     
  5. Research and demonstration projects which are conducted by or subject to the approval of Department of Agency heads, and which are designed to study, evaluate, or otherwise examine:  (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.  The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or a service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).  The research or demonstration project must be conducted pursuant to specific federal statutory authority.  There must be no statutory requirement that the project be reviewed by an IRB.  The project must not involve significant physical invasions or intrusions upon the privacy of participants.   This category may not be applied to FDA regulated clinical investigations.  Before granting this exemption, the IRB Program Coordinator or IRB Chair must communicate with OHRP to confirm that OHRP agrees that this exemption category may be applied to the proposed research.

     
  6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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.
       

Research that meets the criteria for exemption may be referred for further review or disqualified from exempt status if the IRB Chair determines at the time of initial review that the research does not uphold SFHMC ethical standards and/or there are concerns or issues with the protocol not related to the regulatory requirements.  Such protocols will be reviewed by expedited or full board review, as determined by the IRB Chair.  If there is a question about the potential for harm of participants in research exempt from federal regulations, that research will not be granted exempt status, and will be reviewed, approved and monitored by the IRB in a manner appropriate to ensure the safety of the participants.

Expedited Review 

The IRB uses the following criteria for reviewing and approving research by the expedited review category (as stated in 45 CFR 46.110 and 21 CFR 56.110):   

Applicability 

(A)  Research activities that

  1. Present no more than minimal risk to human subjects
  2. Involve only procedures listed in one or more of the following categories.  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.       

(B)  The categories in this list apply regardless of the age of subjects, except as noted.

(C)  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.

(D)  The expedited review procedure may not be used for classified research involving human subjects.

(E)  IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review-expedited or convened-utilized by the IRB.

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

Research Categories
 

 

 

  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.  (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 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.

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

    (a)  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

    (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.

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

    (a)  hair and nail clippings in a nondisfiguring manner;

    (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;

    (c)  permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat);

    (d)  gum base or wax or by applying a dilute citric solution to the tongue;

    (e)  placenta removed at delivery;

    (f)  the time of rupture of the membrane prior to or during labor;

    (g)  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;

    (h)  mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;

    (i)  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:

    (a)  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;

    (b)  weighing or testing sensory acuity;

    (c)  magnetic resonance imaging;

    (d)  electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;uncannulated saliva collected in an unstimulated fashion or stimulated by chewing 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 nonresearch purposes (such as medical treatment or diagnosis).  (NOTE:  Some research in this category may be exempt from the DHHS regulations for the protection of human subjects [45 CFR 46.101(b)(4)].  This listing refers only to research that is not exempt.)
     

  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:  Some research in this category may be exempt from the DHHS regulations for the protection of human subjects [45 CFR 46.101(b)(2) and (b)(3)].  This listing refers only to research that is not exempt.)
     

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

    (a)  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

    (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 2 through 8 above 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
     

  10. Minor changes in previously approved research.
     

  11. Other categories added to this list by DHHS and published in the Federal Register 

    The Chairman of the IRB reviews protocols qualifying for expedited approval.  If the Chairman is unavailable to review a protocol qualifying for expedited and exempt approval, a qualified member of the IRB with expertise in the area of the study will be designated by the Chairman of the IRB as a primary reviewer.  Studies involving vulnerable populations, such as children, that are eligible for expedited or exempt approval will be reviewed by the Chairman of the IRB.  If there is a question whether one of these protocols poses a greater than minimal risk, the study will be reviewed by a consultant with expertise in that area.  If there is a question whether additional state or local laws are applicable to the protocol, the IRB Chairman or qualified member of the IRB may ask Legal Services for assistance in interpreting and applying appropriate laws. 

    Full Board Review 

    All research protocols that do not meet the criteria for exempt or expedited review approval will be reviewed by the full board at a convened IRB meeting.  All decisions are rendered by a quorum (majority of the assembled).

    The IRB Chair reviews or assigns a primary reviewer to assess each protocol to ensure appropriate and complete review of submissions.  A summary of findings is presented by the IRB Chair or primary reviewer to the full board at fully convened meetings.  Investigators and study coordinators are invited and encouraged to attend meetings at which their research protocol will be presented in order to provide responses to questions that may arise during the protocol’s review and discussion.