University of Washington
Human Subjects Manual

II. Categories of Research

Definition of Research - Research Requiring Review - No-Risk Research (Exemptions)
Minimal Risk ("Expeditable") Research - Research requiring full committee review
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1. Definition of Research

   "Research" means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition may be funded or unfunded, or may be conducted as a component of another program not usually considered research. For example, demonstration and service programs may include evaluation components, which constitute research activities under this definition.

   Precedent and practice have established the principle that certain kinds of activities that might be called "human subjects research" do not require review for the protection of human subjects. The following kinds of activities do not require such review:

   1. accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
   2. research using only historical documents; and
   3. research using only archaeological materials or other historical or pre-historical artifacts.

   Pilot studies, pre-tests, and other "preliminary" investigations are considered research, and must be reviewed unless they fall into one of the excluded categories listed above.

   Classroom activities may include instructing students in research methodologies and techniques. If the sole purpose of the activity is to teach students research techniques or methodology and not to develop or contribute to generalizable knowledge, it is not considered to be research. However, if students will practice research methodologies on human beings, they should be instructed in the ethical conduct of such activities and should be advised to obtain informed consent from their practice subjects.

   Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution, likewise, not considered research activities. However, if the data collected are generalizable and are to be shared outside of the institution through discussion, presentation, or publication, the activity qualifies as research. Sometimes, data from a quality improvement or quality assurance activity become of interest to the external community after they have been analyzed. In these cases, the research use of the data collected for another purpose must be reviewed.

   The same distinction may apply to routine surveillance activities. For example, what began as a disease outbreak investigation by a public health agency may evolve into a research project. The researchers are obligated to subject the research activity to the appropriate level of human subjects review as soon as the intent of the data collection or analysis changes. Often, the research activity for review consists of secondary analysis of the outbreak data collected originally for the purpose of protecting the public health.

2. Research requiring review

   There are two broad categories of studies requiring review: those that are required by Federal regulation to be reviewed at the University level, and those that are exempt from Federal regulation, and are reviewed by the University at the departmental or college level. The purpose of the departmental or college level review is to determine that the research studies in question are indeed exempt from Federal regulation, and to ensure that they conform with any additional requirements that the University or the State of Washington may impose.

   For all research not excluded from any level of review, the relevant department chairperson, director, or dean is responsible for the review of all proposed activities to determine that the investigators are qualified to conduct the research and that the research has scientific merit. The faculty sponsor should approve student research before approval is requested from the department chairperson, director, or dean.

3. No Risk Research (Exemptions)

   Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from university-level review and must be reviewed by the investigator's dean, director, or chairperson. Each of the categories is quoted from Title 45, Code of Federal Regulations, Part 46.101.B, and is followed by an explanatory paragraph.

   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 on the comparison among instructional techniques, curricula, or classroom management methods."
      
      The purpose of this category is to exempt research on educational practices, in an educational institution. This category does not extend to research conducted in a school setting but not related to the instruction in that institution. For example, an evaluation of two methods of fourth grade classroom instruction in a local school district would qualify as exempt research. A sociometric survey of children's preferences for playmates in the same school, involving the same children, would not qualify as exempt research. As the example indicates, research on minor students can be exempt if it is educational research in the sense intended here.
      
   2. "Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
      
      1. information obtained is recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects; and
      2. any disclosure of the 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."
      
      "Educational tests" refers to standardized tests used for educational purposes, such as a scholastic achievement test. It does not refer to personality tests or clinical evaluations. Survey or interview studies qualify as exempt unless the subjects can be identified from the records, and there are risks to the subjects due to the sensitive nature of their responses.
      
      The Federal guideline refers only to risks associated with sensitive aspects of behavior. The University of Washington has determined that there are other types of information that might be considered sensitive and damaging if revealed, even though the information is not associated with behavior. For instance, knowledge that a person was at risk for a genetically determined disease might be a factor in denying that person employment. Therefore, the University of Washington will not treat as exempt a survey or interview study where subjects can be identified and any information is collected that could be detrimental to the subject, regardless of whether or not that information is based on the subject's own behavior.
      
      Studies of publicly observable behavior are exempt from Federal regulations unless there are potential risks of the type described and the data are recorded in a way that could be used to identify subjects.
      
      The University interprets "public behavior" to mean behavior that is apparent to an unconcealed observer, without the use of any special or surreptitious equipment, such as binoculars, special microphones, or recording devices.
      
      
   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 paragraph (b)(2) of this section, if:
      
      1. The human subjects are elected or appointed public officials or candidates for public office; or
      2. federal statue(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 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."
      
      Historical, literary, and journalistic research of the type described earlier as being excluded typically would also be described by point 4. If a research project qualifies as excluded, the investigator may proceed without departmental review.
      
      Situations arise in which records may be excerpted from a data source that does contain identified, sensitive information, but are provided to the investigator without identifiers. For instance, physicians might be asked to provide case summaries without identifiers. Such studies may be exempt, providing that the person excerpting the records already has authorized access to them for research purposes, and the investigator has no access to the original records.
      
      "Existing" means that the data are "on the shelf" at the time the researcher develops a proposal for their use. Use of data not already on the shelf is not eligible for exemption.
      
      State and federal laws preclude the use of certain kinds of existing data (including health care information, records of drug and alcohol treatment, and records of psychiatric care) from use by researchers without human subjects review, regardless of whether they are "existing" or recorded by the investigator in such a way that subjects cannot be identified.
      
      
   5. "Research and demonstration projects which are conducted by or subject to the approval of the department or 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 "department or agency heads" referred to are federal, not state, local, or university. This category of exempt research refers to activities sponsored by federal agencies to evaluate their own benefit or service programs.
      
      
   6. 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 of and for a use 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."
      
      

   The following five categories of research are not exempt, and always require University review:
   

   1. research involving prisoners;
   2. studies of pregnant women where the focus of the research is on pregnancy and/or the fetus;
   3. research on fetuses in utero;
   4. research on minor children unless the research qualifies as educational research in the sense of items 1. and 2., above, or where the research does not involve direct interaction with the child, and
   5. research using non-public records.
      
   
   
4. Minimal Risk ("Expeditable") Research
   
   Research activities involving "no more than minimal risk" and in which the only involvement of human subjects will be in one or more of the following categories may be reviewed using an expedited procedure by a Subcommittee of a Human Subjects Review Committee: Each of the categories is quoted from the federal regulations at 45 CFR 46, and followed by an explanatory paragraph.
   
   
   1. "Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      
      1. 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 minimal risk review.)
      2. Research on medical devices for which
         
         1. an investigational device exemption application (21 CFR Part 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."

      
      This category is limited to drugs and devices that pose minimal risk to human subjects. Most of the activities eligible for review in this category will involve over-the-counter drugs and devices, pharmaco-economic studies of drugs and devices used in accordance with approved labeling, and "Phase 4" post-marketing studies of approved drugs and devices.
      
      
   2. "Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
      
      1. 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
      2. 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."
         
      
      This category allows minimal risk review of activities involving invasive blood draws from healthy normal subjects and from non-healthy, pregnant, and minor subjects, within certain limits. Unless the researcher can demonstrate that infants and other minors would undergo a blood draw as a part of a "routine" physical examination, blood draws from healthy minors will not be reviewed as minimal risk using the expedited procedure.
      
      
   3. 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."
      
      The examples listed are neither exclusive nor exhaustive. This category may be applied to research involving prospective collection of biological specimens for research purposes using non-invasive methods in addition to those listed as examples.
      
      
   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 minimal risk 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;
      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."
      
      The examples listed are neither exclusive nor exhaustive. This category may be applied to research involving prospective collection of data for research purposes using non-invasive methods in addition to those listed as examples.
      
      
   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 HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)"
      
      This category allows the prospective use of data collected for non-research purposes. Data include information from medical records, insurance claim data, educational testing data, and other non-public information in identifiable form. Data set linkages could be considered in this category. The researcher must demonstrate that sufficient measures will be used to protect the confidentiality of the data to minimize the risk to subjects of inadvertent disclosure.
      
      
   6. "Collection of data from voice, video, digital, or image recordings made for research purposes."
      
      Because recordings made of subjects are de facto identifiable, research involving these techniques which would otherwise be exempt are eligible for minimal risk review using the expedited procedures. Such studies will be approved if the researcher outlines appropriate mechanisms to minimize the risks of invasion of privacy and breach of confidentiality.
      
   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 HHS 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.)"
      
      Much behavioral research that does not qualify for exemption may be reviewed as minimal risk using the expedited procedure. This category is designed to accommodate research activities that pose no more than minimal risk to subjects and that are not eligible for exemption. Please note that this category now includes minor subjects.
      
   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."
      
      Researchers who wish to have their applications for continuing review of projects previously reviewed by the full Human Subjects Review Committee will have to demonstrate that the above conditions have been met.
      
   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 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."
      
      This category applies to situations in which the full Human Subjects Review Committee conducts a continuing review of a study and determines that the continuing activity poses only minimal risks.
   
   
5. Research requiring full committee review
   
   All research conducted by faculty, staff, or students that is not eligible for exempt review or minimal risk review must be reviewed by a full Human Subjects Review Committee.

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Section III: Review Procedures