"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 participant research" do not require review for the protection of human participants. The following kinds of activities do not require such review:
Accepted and established service relationships between professionals and clients where the activity is designed solely to meet the needs of the client;
Research using only historical documents; and
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 to 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 potential participants.
Quality improvement and quality assurance activities conducted solely for the intent of maintaining or improving quality of services provided by an institution, likewise, are 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.
Research activities in which the only involvement of human participants will be in one or more of the following categories are considered exempt. Each of the categories is quoted from 45 CFR, Part 46.101.B, and is followed by an explanatory paragraph.
"Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular or special education instructional strategies, or (b) research on the effectiveness of or on the comparison among instructional techniques, curricula, or classroom management methods."
Explanation: 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 an 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.
"Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
a. Information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participants; and
b. Any disclosure of the participant's responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, or reputation."
Explanation: "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 participants can be identifies from the records, and there are risks to the participants due to the sensitive nature of their responses.
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 participants.
Claremont Graduate 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.
"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 (2)(b) of this section, if:
a. The human participants are elected or appointed officials or candidates for public office; or
b. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
"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 the participants cannot be identified, directly or through identifiers linked to the participants."
Explanation: Historical, literary, and journalistic research of the type described earlier as being excluded typically would also be described by point 4.
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.
"Research and demonstration projects which are conducted by or subject to the approval of the US Federal department or agency heads, 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; or (c) possible changes in or alternatives to those programs or procedure; or (d) possible changes in methods or levels of payment for benefits or services under those programs."
Explanation: The "US Federal 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.
"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."
The following five categories of research are not exempt, and always require review.
Research involving Prisoners;
Studies of pregnant women where the focus of the research is on pregnancy and/or the fetus;
Research on fetuses in utero;
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
Research activities involving "no more than minimal risk" and in which the only involvement of human participants will be in one or more of the following categories may be reviewed using an expedited procedure by the Institutional Review Board Chair. Each of the categories is quoted by the Federal regulations at 45 CFR, part 46, and followed by an explanatory paragraph.
"Collection of data from voice, video, digital or image recordings made for research purposes"
Explanation: Because recordings made of participants are de facto identifiable, research involving these techniques which would otherwise be exempt are eligible for minimal risk review using the expedited procedure. Such studies will be approved if the researcher outlines appropriate mechanisms to minimize the risks of invasion of privacy and breach of confidentiality.
"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, evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: some research in this category may be exempt from the HHS regulations, 45 CFR, Part 46.101 (b)(2) and (b)(3), for the protection of human participants. This listing refers only to research that is not exempt.)"
Explanation: Much behavioral research that does not qualify from 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 participants and that are not eligible for exemption. Please note that this category now includes minor participants.
"Medical research with minimal risk:
a. Clinical studies of drugs and medical devices only when either of the following conditions is met.
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.)
Research on medical devices for which:
i. an investigational device exemption application (21 CFR, Part 812) is no 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.
b. "Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
i. From healthy, nonpregnant adults who weigh at least 110 pounds. For these participants, 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
ii. From other adults and children, considering the age, weight, an 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 lessor 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."
Explanation: This category allows minimal risk review of activities involving invasive blood draws from healthy normal participants and from non-healthy, pregnant, and minor participants 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.
c. Prospective collection of biological specimens for research purposes by noninvasive means.
Example: Hair and nail clippings.
d. "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. This includes studies of cleared medical devices for new indications."
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."
Explanation: 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.
"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 in this category may be exempt from the HHS regulations, 45 CFR, Part 46.101 (b)(4), for the protection of human participants. This listing refers only to research that is not exempt.)"
Explanation: 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 participants of inadvertent disclosure.
"Continuing review of research previously approved by the convened IRB as follows:
i. the research is permanently closed to the enrollment of new participants;
ii. all participants have completed all research-related interventions; and
iii. the research remains active only for long-term follow-up of participants; or
b. where no participants have been enrolled and no additional risks have been identifies; or
c. where the remaining research activities are limited to data analysis."
Explanation: Researchers who wish to have their applications for continuing review of projects previously reviewed by the IRB will have to demonstrate that the above conditions have been met.
"Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories 2 through 5 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."
Explanation: This category applies to situations in which the full IRB conducts a continuing review of a study and determines that the following activity poses only minimal risks.